RESUMEN
BACKGROUND: Early life stress and adversity conveys risk for emotional, behavioral, and developmental disorders. To address this risk in the preschool population, Mother-Child Emotional Preparation (MCEP) was tested as an in-school dyadic intervention for facilitating mother-child emotional connection through mother-child calming cycles. In a computer-generated block randomized controlled trial enrolling preschool-aged children and their mothers, in partnership with an early childhood learning center, we at Columbia University Irving Medical Center tested effects of MCEP across multiple domains. Within this RCT we designed a qualitative sub-study to understand how MCEP aligns with calming cycle theory and its impact on mothers and the mother-child relationship. METHODS: A qualitative researcher observed 14 group MCEP sessions consisting of nurture specialists facilitating reciprocal calming interactions through shared emotional expression between mothers and their preschool-aged children. We conducted two waves of participant interviews in English or Spanish, per participant preference. Participants (n = 8) were majority Hispanic at or below the federal poverty level. Group session observations were coded and analyzed for frequency, co-occurrence, variance by session, and alignment with calming cycle theory, incorporating demographic variables and attendance. Interview transcripts were translated from Spanish to English if needed, then coded and analyzed using thematic analysis. RESULTS: Qualitative analysis revealed mothers' experiences of MCEP. Data demonstrated that calming position and emotional expression were mutually supportive, and that barriers to connection were calming cycle entry-points, not barriers. At the group level, supported by nurture specialists, fellow participants helped each other progress through calming cycles. Moreover, MCEP adapted to meet individual dyad needs, and mothers described its far-reaching impact. CONCLUSIONS: Qualitative methods show that MCEP helps mother-child dyads emotionally connect through the calming cycle and fills a gap in early childhood education services. This study generated insights for quantitative studies and suggested implications for MCEP dissemination. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03908268 , Registered April 9, 2019-Retrospectively registered.
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Emociones , Relaciones Madre-Hijo , Preescolar , Humanos , Femenino , Madres , Investigación Cualitativa , Instituciones AcadémicasRESUMEN
As research efforts in the field of pediatrics are oriented toward a better understanding of the synergistic relationship between different facets of early relational health (ERH) and child development and wellbeing, it is essential to focus on the quality of research instruments available for measuring different components of ERH. This study investigates the measurement characteristics of a widely used parent/caregiver-reported measure of bonding, the Postpartum Bonding Questionnaire (PBQ), in a US-based sample (n=610) of English-speaking biological mothers who completed the PBQ at 4 months postpartum. To evaluate the factor structure of the PBQ, confirmatory and exploratory statistical techniques were employed. The current study failed to replicate the PBQ's original 4-factor structure. Exploratory factor analysis results supported the creation of a 14-item abbreviated measure, the PBQ-14. The PBQ-14 showed evidence of good psychometric properties, including high internal consistency (ω=.87) and correlation with depression (r=.44, p<.001) assessed using the Patient Health Questionnaire (PHQ-9), as would be expected. The new unidimensional PBQ-14 is suitable for use in the US as a measure of general postnatal parent/caregiver-to-infant bonding.
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Importance: Associations between prenatal SARS-CoV-2 exposure and neurodevelopmental outcomes have substantial public health relevance. A previous study found no association between prenatal SARS-CoV-2 infection and parent-reported infant neurodevelopmental outcomes, but standardized observational assessments are needed to confirm this finding. Objective: To assess whether mild or asymptomatic maternal SARS-CoV-2 infection vs no infection during pregnancy is associated with infant neurodevelopmental differences at ages 5 to 11 months. Design, Setting, and Participants: This cohort study included infants of mothers from a single-site prospective cross-sectional study (COVID-19 Mother Baby Outcomes [COMBO] Initiative) of mother-infant dyads and a multisite prospective cohort study (Epidemiology of Severe Acute Respiratory Syndrome Coronavirus 2 in Pregnancy and Infancy [ESPI]) of pregnant individuals. A subset of ESPI participants was subsequently enrolled in the ESPI COMBO substudy. Participants in the ongoing COMBO study were enrolled beginning on May 26, 2020; participants in the ESPI study were enrolled from May 7 to November 3, 2021; and participants in the ESPI COMBO substudy were enrolled from August 2020 to March 2021. For the current analysis, infant neurodevelopment was assessed between March 2021 and June 2022. A total of 407 infants born to 403 mothers were enrolled (204 from Columbia University Irving Medical Center in New York, New York; 167 from the University of Utah in Salt Lake City; and 36 from the University of Alabama in Birmingham). Mothers of unexposed infants were approached for participation based on similar infant gestational age at birth, date of birth, sex, and mode of delivery to exposed infants. Exposures: Maternal symptomatic or asymptomatic SARS-CoV-2 infection. Main Outcomes and Measures: Infant neurodevelopment was assessed using the Developmental Assessment of Young Children, second edition (DAYC-2), adapted for telehealth assessment. The primary outcome was age-adjusted standard scores on 5 DAYC-2 subdomains: cognitive, gross motor, fine motor, expressive language, and receptive language. Results: Among 403 mothers, the mean (SD) maternal age at delivery was 32.1 (5.4) years; most mothers were of White race (240 [59.6%]) and non-Hispanic ethnicity (253 [62.8%]). Among 407 infants, 367 (90.2%) were born full term and 212 (52.1%) were male. Overall, 258 infants (63.4%) had no documented prenatal exposure to SARS-CoV-2 infection, 112 (27.5%) had confirmed prenatal exposure, and 37 (9.1%) had exposure before pregnancy or at an indeterminate time. In adjusted models, maternal SARS-CoV-2 infection during pregnancy was not associated with differences in cognitive (ß = 0.31; 95% CI, -2.97 to 3.58), gross motor (ß = 0.82; 95% CI, -1.34 to 2.99), fine motor (ß = 0.36; 95% CI, -0.74 to 1.47), expressive language (ß = -1.00; 95% CI, -4.02 to 2.02), or receptive language (ß = 0.45; 95% CI, -2.15 to 3.04) DAYC-2 subdomain scores. Trimester of exposure and maternal symptom status were not associated with DAYC-2 subdomain scores. Conclusions and Relevance: In this study, results of a novel telehealth-adapted observational neurodevelopmental assessment extended a previous finding of no association between prenatal exposure to maternal SARS-CoV-2 infection and infant neurodevelopment. Given the widespread and continued high prevalence of COVID-19, these data offer information that may be helpful for pregnant individuals who experience asymptomatic or mild SARS-CoV-2 infections.
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COVID-19 , Complicaciones Infecciosas del Embarazo , Efectos Tardíos de la Exposición Prenatal , Recién Nacido , Niño , Femenino , Embarazo , Humanos , Lactante , Masculino , Preescolar , Adulto , Estudios de Cohortes , Estudios Prospectivos , COVID-19/epidemiología , Efectos Tardíos de la Exposición Prenatal/epidemiología , Estudios Transversales , Complicaciones Infecciosas del Embarazo/epidemiología , SARS-CoV-2RESUMEN
OBJECTIVE: This trial (RCT-2) sought to replicate the EEG findings of a randomized controlled trial of Family Nurture Intervention in the NICU (FNI-NICU) (RCT-1) comparing infants receiving standard care (SC) with infants receiving SC plus FNI . METHODS: RCT-2 (NCT02710474) was conducted at two NICUs. Subjects were randomly assigned to receive SC or FNI during their NICU stay. The primary outcome was EEG power in the frontal polar region at 39-41 weeks gestational age (GA). Sixty preterm infants (26-34 weeks GA; 33 SC, 27 FNI) were assessed. FNI-NICU consisted of repeated calming sessions (â¼4 times/week) facilitated by Nurture Specialists during which mothers engaged in emotional expression during clothed or skin-to-skin holding, vocal soothing, and eye contact. EEGs were collected from 128 leads. EEG power was computed using Fast Fourier Transforms. RESULTS: RCT-2 replicated RCT-1 results; FNI-NICU led to significantly increased frontal polar power at frequencies > 12 Hz. Effects were spatially more widespread than in RCT-1, with substantial effect sizes (â¼0.50) in frontal and parietal regions. CONCLUSIONS: RCT-2 results provide further evidence that FNI-NICU increases term age brain activity. SIGNIFICANCE: FNI-NICU is designed to facilitate autonomic emotional connection and coregulation between mothers and infants in the NICU resulting in profound effects on early brain development.
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Recien Nacido Prematuro , Relaciones Madre-Hijo , Electroencefalografía , Femenino , Humanos , Lactante , Recién Nacido , Recien Nacido Prematuro/fisiología , Unidades de Cuidado Intensivo Neonatal , Relaciones Madre-Hijo/psicología , ProsencéfaloRESUMEN
Importance: Associations between in utero exposure to maternal SARS-CoV-2 infection and neurodevelopment are speculated, but currently unknown. Objective: To examine the associations between maternal SARS-CoV-2 infection during pregnancy, being born during the COVID-19 pandemic regardless of maternal SARS-CoV-2 status, and neurodevelopment at age 6 months. Design, Setting, and Participants: A cohort of infants exposed to maternal SARS-CoV-2 infection during pregnancy and unexposed controls was enrolled in the COVID-19 Mother Baby Outcomes Initiative at Columbia University Irving Medical Center in New York City. All women who delivered at Columbia University Irving Medical Center with a SARS-CoV-2 infection during pregnancy were approached. Women with unexposed infants were approached based on similar gestational age at birth, date of birth, sex, and mode of delivery. Neurodevelopment was assessed using the Ages & Stages Questionnaire, 3rd Edition (ASQ-3) at age 6 months. A historical cohort of infants born before the pandemic who had completed the 6-month ASQ-3 were included in secondary analyses. Exposures: Maternal SARS-CoV-2 infection during pregnancy and birth during the COVID-19 pandemic. Main Outcomes and Measures: Outcomes were scores on the 5 ASQ-3 subdomains, with the hypothesis that maternal SARS-CoV-2 infection during pregnancy would be associated with decrements in social and motor development at age 6 months. Results: Of 1706 women approached, 596 enrolled; 385 women were invited to a 6-month assessment, of whom 272 (70.6%) completed the ASQ-3. Data were available for 255 infants enrolled in the COVID-19 Mother Baby Outcomes Initiative (114 in utero exposed, 141 unexposed to SARS-CoV-2; median maternal age at delivery, 32.0 [IQR, 19.0-45.0] years). Data were also available from a historical cohort of 62 infants born before the pandemic. In utero exposure to maternal SARS-CoV-2 infection was not associated with significant differences on any ASQ-3 subdomain, regardless of infection timing or severity. However, compared with the historical cohort, infants born during the pandemic had significantly lower scores on gross motor (mean difference, -5.63; 95% CI, -8.75 to -2.51; F1,267 = 12.63; P<.005), fine motor (mean difference, -6.61; 95% CI, -10.00 to -3.21; F1,267 = 14.71; P < .005), and personal-social (mean difference, -3.71; 95% CI, -6.61 to -0.82; F1,267 = 6.37; P<.05) subdomains in fully adjusted models. Conclusions and Relevance: In this study, birth during the pandemic, but not in utero exposure to maternal SARS-CoV-2 infection, was associated with differences in neurodevelopment at age 6 months. These early findings support the need for long-term monitoring of children born during the COVID-19 pandemic.
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COVID-19 , Complicaciones Infecciosas del Embarazo , COVID-19/epidemiología , Niño , Femenino , Humanos , Lactante , Recién Nacido , Ciudad de Nueva York/epidemiología , Pandemias , Embarazo , Complicaciones Infecciosas del Embarazo/epidemiología , SARS-CoV-2RESUMEN
Early exposure to antibiotics has been shown to increase risk for poor neurobehavioral development, particularly with regard to attention deficit disorders. Clinically, electroencephalography (EEG) is increasingly used as a biomarker of these deficits. Less is known about the effects of antibiotics on neurobehavioral and neurophysiological outcomes in preterm infants, a population at particularly high risk for attention deficits and perinatal antibiotic exposure. This study examines the effects of perinatal antibiotic exposure on neonatal EEG and attention deficits as measured by the Child Behavior Checklist in 4- to 5-year-old children who were enrolled in an NICU-based randomized controlled trial comparing Family Nurture Intervention (FNI) to standard care. Antibiotic-exposed infants had increased attention problems and there was a main effect of antibiotic exposure such that exposed infants had higher EEG power. This effect was fourfold greater in infants who received standard NICU care compared to those who received the intervention, suggesting a buffering effect of the intervention. We hypothesize that the relationship between antibiotic exposure and altered neurodevelopment may be due to effects of antibiotics on the microbiome, and that FNI may buffer these adverse consequences.
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Antibacterianos/uso terapéutico , Encéfalo/fisiopatología , Conducta Infantil/fisiología , Efectos Tardíos de la Exposición Prenatal/fisiopatología , Preescolar , Electroencefalografía , Femenino , Humanos , Recien Nacido Prematuro/fisiología , Unidades de Cuidado Intensivo Neonatal , Masculino , EmbarazoRESUMEN
AIM: The Welch Emotional Connection Screen (WECS), assesses mother-infant Emotional Connection in clinical settings. It includes: Attraction, Vocal Communication, Facial Communication, Sensitivity/Reciprocity and clinical decision of Emotional Connection (yes/no). We tested concurrent and construct validity of the WECS and associations with behavioural and physiological measures in preterm infants. METHODS: Videos from 76 mothers-infants (gestational age 36 weeks) during an in-NICU caregiving paradigm were coded for maternal caregiving behaviour. Videos of mothers-infants were also obtained at 4 months during 10 minutes of face-to-face play (coded with WECS and for maternal positivity and infant social engagement) and the still-face paradigm (coded for infant behavioural approach towards mother; infant electrocardiogram acquired in vivo). RESULTS: WECS maternal scores were positively associated with maternal sensitivity and quality of vocal contact at 36 weeks (caregiving) and maternal positivity at 4 months (face-to-face). WECS infant scores positively correlated with infant social engagement and maternal positivity during face-to-face interactions at 4 months. Infants from emotionally not connected dyads (vs. emotionally connected dyads) displayed autonomic dysregulation and less approach-seeking behaviour towards mother during interactive/play sessions of the still-face paradigm. CONCLUSION: This preliminary evidence supports the WECS as a valid screen for rating mother-preterm infant emotional connection associated with healthier infant biobehavioural stress responding.
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Emociones , Conducta del Lactante/psicología , Recien Nacido Prematuro/fisiología , Recien Nacido Prematuro/psicología , Conducta Materna/psicología , Relaciones Madre-Hijo/psicología , Femenino , Humanos , Lactante , Masculino , Pruebas PsicológicasRESUMEN
Although preterm infants are at risk for social deficits, interventions to improve mother-infant interaction in the neonatal intensive care unit (NICU) are not part of standard care (SC). Study participants were a subset from a randomized controlled trial of a new intervention for premature infants, the Family Nurture Intervention (FNI), designed to help mothers and infants establish an emotional connection. At infants' 4 months corrected age, mother-infant face-to-face interaction was filmed and coded on a 1-s time base for mother touch, infant vocal affect, mother gaze, and infant gaze. Time-series models assessed self- and interactive contingency. Comparing FNI to SC dyads, FNI mothers showed more touch and calmer touch patterns, and FNI infants showed more angry-protest but less cry. In maternal touch self-contingency, FNI mothers were more likely to sustain positive touch and to repair moments of negative touch by transitioning to positive touch. In maternal touch interactive contingency, when infants looked at mothers, FNI mothers were likely to respond with more positive touch. In infant vocal affect self-contingency, FNI infants were more likely to sustain positive vocal affect and to transition from negative to positive vocal affect. In maternal gaze interactive contingency, following infants' looking at mother, FNI mothers of male infants were more likely to look at their sons. In maternal gaze self-contingency, following mothers' looking away, FNI mothers of male infants were more likely to look at their sons. Documentation of positive effects of the FNI for 4-month mother-infant face-to-face communication is useful clinically and has important implications for an improved developmental trajectory of these infants. (PsycINFO Database Record (c) 2018 APA, all rights reserved).
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Crianza del Niño/psicología , Educación no Profesional/métodos , Conducta del Lactante/psicología , Recien Nacido Prematuro/psicología , Unidades de Cuidado Intensivo Neonatal , Conducta Materna/psicología , Relaciones Madre-Hijo/psicología , Servicio Social/métodos , Adulto , Femenino , Humanos , Lactante , Masculino , Resultado del TratamientoRESUMEN
Preterm delivery can precipitate maternal psychological morbidities. Family Nurture Intervention (FNI) was designed to minimize these by facilitating the emotional connection between mother and infant, beginning early in the infant's neonatal intensive care unit (NICU) stay. We examined depression and anxiety symptoms of mothers of preterm infants at 4 months infant corrected age (CA). One hundred fifteen mothers who delivered between 26 and 34 weeks gestational age were randomized to receive standard care (SC) or standard care plus FNI. Mothers' self-reported depressive symptoms (Center for Epidemiologic Studies Depression Scale: CES-D) and state anxiety (Spielberger State-Trait Anxiety Inventory: STAI) symptoms were assessed at enrollment, near to term age, and 4 months (CA). At 4 months CA, mean CES-D and STAI scores were significantly lower in FNI mothers compared to SC mothers. Effectiveness of FNI can only be evaluated as an integrated intervention strategy as it was not possible to control all aspects of FNI activities. Although there was considerable loss to follow-up, analyses suggest that resulting biases could have masked rather than inflated the measured effect size for depressive symptoms. FNI may be a feasible and practicable way to diminish the impact of premature delivery on maternal depressive and anxiety symptoms.
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Ansiedad/diagnóstico , Depresión/diagnóstico , Recien Nacido Prematuro/fisiología , Unidades de Cuidado Intensivo Neonatal , Madres/psicología , Adulto , Ansiedad/psicología , Niño , Desarrollo Infantil/fisiología , Depresión/psicología , Trastorno Depresivo , Emociones , Femenino , Edad Gestacional , Humanos , Lactante , Recién Nacido , Recién Nacido de muy Bajo Peso , Relaciones Madre-Hijo , Embarazo , Nacimiento Prematuro , Resultado del TratamientoRESUMEN
BACKGROUND: Service Provision Assessment (SPA) surveys have been conducted to gauge primary health care and family planning clinical readiness throughout East and South Asia as well as sub-Saharan Africa. Intended to provide useful descriptive information on health system functioning to supplement the Demographic and Health Survey data, each SPA produces a plethora of discrete indicators that are so numerous as to be impossible to analyze in conjunction with population and health survey data or to rate the relative readiness of individual health facilities. Moreover, sequential SPA surveys have yet to be analyzed in ways that provide systematic evidence that service readiness is improving or deteriorating over time. METHODS: This paper presents an illustrative analysis of the 2006 Tanzania SPA with the goal of demonstrating a practical solution to SPA data utilization challenges using a subset of variables selected to represent the six building blocks of health system strength identified by the World Health Organization (WHO) with a focus on system readiness to provide service. Principal Components Analytical (PCA) models extract indices representing common variance of readiness indicators. Possible uses of results include the application of PCA loadings to checklist data, either for the comparison of current circumstances in a locality with a national standard, for the ranking of the relative strength of operation of clinics, or for the estimation of trends in clinic service quality improvement or deterioration over time. RESULTS: Among hospitals and health centers in Tanzania, indices representing two components explain 32% of the common variance of 141 SPA indicators. For dispensaries, a single principal component explains 26% of the common variance of 86 SPA indicators. For hospitals/HCs, the principal component is characterized by preventive measures and indicators of basic primary health care capabilities. For dispensaries, the principal component is characterized by very basic newborn care as well as preparedness for delivery. CONCLUSIONS: PCA of complex facility survey data generates composite scale coefficients that can be used to reduce indicators to indices for application in comparative analyses of clinical readiness, or for multi-level analysis of the impact of clinical capability on health outcomes or on survival.
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Atención a la Salud , Accesibilidad a los Servicios de Salud , Atención Primaria de Salud , Análisis de Componente Principal , Adulto , Instituciones de Atención Ambulatoria , Parto Obstétrico/estadística & datos numéricos , Servicios de Planificación Familiar , Femenino , Encuestas de Atención de la Salud , Humanos , Recién Nacido , Embarazo , Mejoramiento de la Calidad , Análisis de Regresión , TanzaníaRESUMEN
OBJECTIVE: This study assessed the impact of Family Nurture Intervention (FNI) on the quality of maternal caregiving behavior (MCB) while in the neonatal intensive care unit (NICU). FNI is a randomized controlled trial conducted in a high-acuity NICU to facilitate an emotional connection between mothers and their premature infants. FNI begins shortly after birth, continues until discharge, and involves mother/infant calming sessions that include scent cloth exchange, vocal soothing and emotion expression, eye contact, skin-to-skin and clothed holding, and family-based support sessions. METHODS: Maternal caregiving behavior was coded during a single holding and feeding session (â¼30 min) in the NICU before discharge at approximately 36 weeks gestational age (GA). Sixty-five mothers and their premature infants (34 male, 31 female; 26-34 wk GA) were included in these analyses (FNI, n = 35; standard care [SC], n = 30). RESULTS: Relative to mothers in the SC condition, those in the FNI group showed significantly higher quality MCB, which remained significant when controlling for birth order, twin status, maternal depression, and maternal anxiety. CONCLUSION: This is the first study to demonstrate that in-unit MCB can be enhanced by a hospital-based intervention. FNI provides a new rationale for integrating nurture-based interventions into standard NICU care.
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Unidades de Cuidado Intensivo Neonatal , Conducta Materna , Relaciones Madre-Hijo , Madres/educación , Nacimiento Prematuro/psicología , Adulto , Femenino , Humanos , Lactante , Recién Nacido , Masculino , Conducta Materna/psicología , Relaciones Madre-Hijo/psicología , Madres/psicologíaRESUMEN
BACKGROUND: Preterm infants are at high risk for adverse neurodevelopmental and behavioral outcomes. Family Nurture Intervention (FNI) in the Neonatal Intensive Care Unit (NICU) is designed to counteract adverse effects of separation of mothers and their preterm infants. Here, we evaluate effects of FNI on neurobehavioral outcomes. METHODS: Data were collected at 18 months corrected age from preterm infants. Infants were assigned at birth to FNI or standard care (SC). Bayley Scales of Infant Development III (Bayley-III) were assessed for 76 infants (SC, n = 31; FNI, n = 45); the Child Behavior Checklist (CBCL) for 57 infants (SC, n = 31; FNI, n = 26); and the Modified Checklist for Autism in Toddlers (M-CHAT) was obtained for 59 infants (SC, n = 33; FNI, n = 26). RESULTS: Family Nurture Intervention significantly improved Bayley-III cognitive (p = .039) and language (p = .008) scores for infants whose scores were greater than 85. FNI infants had fewer attention problems on the CBCL (p < .02). FNI improved total M-CHAT scores (p < .02). Seventy-six percent of SC infants failed at least one of the M-CHAT items, compared to 27% of FNI infants (p < .001). In addition, 36% of SC infants versus 0% of FNI infants failed at least one social-relatedness M-CHAT item (p < .001). CONCLUSIONS: Family Nurture Intervention is the first NICU intervention to show significant improvements in preterm infants across multiple domains of neurodevelopment, social-relatedness, and attention problems. These gains suggest that an intervention that facilitates emotional interactions between mothers and infants in the NICU may be key to altering developmental trajectories of preterm infants.
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Desarrollo Infantil/fisiología , Enfermedades del Prematuro/prevención & control , Recien Nacido Prematuro/psicología , Unidades de Cuidado Intensivo Neonatal , Relaciones Madre-Hijo/psicología , Psicoterapia/métodos , Adulto , Femenino , Humanos , Lactante , Recién Nacido , Masculino , Resultado del TratamientoRESUMEN
OBJECTIVE: To assess the impact of Family Nurture Intervention (FNI) on electroencephalogram (EEG) activity in preterm infants (26-34 weeks gestation). METHODS: Two groups were tested in a single, level IV neonatal intensive care unit (NICU; standard care or standard care plus FNI) using a randomized controlled trial design. The intervention consists of sessions designed to achieve mutual calm and promote communication of affect between infants and their mothers throughout the NICU stay. EEG recordings were obtained from 134 infants during sleep at â¼35 and â¼40 weeks postmenstrual age (PMA). Regional brain activity (power) was computed for 10 frequency bands between 1 and 48 Hz in each of 125 electrodes. RESULTS: Near to term age, compared to standard care infants, FNI infants showed robust increases in EEG power in the frontal polar region at frequencies 10 to 48 Hz (20% to 36% with p-values <0.0004). Effects were significant in both quiet and active sleep, regardless of gender, singleton-twin status, gestational age (26-30 or 30-35 weeks) or birth weight (<1500 or >1500 g). CONCLUSION: FNI leads to increased frontal brain activity during sleep, which other investigators find predictive of better neurobehavioral outcomes. SIGNIFICANCE: FNI may be a practicable means of improving outcomes in preterm infants.
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Encéfalo/fisiología , Electroencefalografía , Recien Nacido Prematuro/fisiología , Relaciones Madre-Hijo , Sueño/fisiología , Niño , Femenino , Edad Gestacional , Humanos , Lactante , Recién Nacido , Unidades de Cuidado Intensivo Neonatal , Masculino , Madres , Resultado del TratamientoRESUMEN
BACKGROUND: While survival rates for preterm infants have increased, the risk for adverse long-term neurodevelopmental and behavioral outcomes remains very high. In response to the need for novel, evidence-based interventions that prevent such outcomes, we have assessed Family Nurture Intervention (FNI), a novel dual mother-infant intervention implemented while the infant is in the Neonatal Intensive Care Unit (NICU). Here, we report the first trial results, including the primary outcome measure, length of stay in the NICU and, the feasibility and safety of its implementation in a high acuity level IV NICU. METHODS: The FNI trial is a single center, parallel-group, randomized controlled trial at Morgan Stanley Children's Hospital for mothers and their singleton or twin infants of 26-34 weeks gestation. Families were randomized to standard care (SC) or (FNI). FNI was implemented by nurture specialists trained to facilitate affective communication between mother and infant during specified calming interactions. These interactions included scent cloth exchange, sustained touch, vocal soothing and eye contact, wrapped or skin-to-skin holding, plus family-based support interactions. RESULTS: A total of 826 infants born between 26 and 34 weeks during the 3.5 year study period were admitted to the NICU. After infant and mother screening plus exclusion due to circumstances that prevented the family from participating, 373 infants were eligible for the study. Of these, we were unable to schedule a consent meeting with 56, and consent was withheld by 165. Consent was obtained for 150 infants from 115 families. The infants were block randomized to groups of N = 78, FNI and N = 72, SC. Sixteen (9.6%) of the randomized infants did not complete the study to home discharge, 7% of those randomized to SC and 12% of FNI infants. Mothers in the intervention group engaged in 3 to 4 facilitated one- to two-hour sessions/week. Intent to treat analyses revealed no significant difference between groups in medical complications. The mean length of stay was not significantly affected by the intervention. CONCLUSION: There was no significant effect demonstrated with this intervention amount on the primary short-term outcome, length of stay. FNI can be safely and feasibly implemented within a level IV NICU. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01439269.
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Recien Nacido Prematuro/crecimiento & desarrollo , Unidades de Cuidado Intensivo Neonatal/organización & administración , Cuidado Intensivo Neonatal/métodos , Tiempo de Internación/estadística & datos numéricos , Conducta Materna/psicología , Relaciones Madre-Hijo/psicología , Madres/educación , Relaciones Familiares , Estudios de Factibilidad , Femenino , Humanos , Recién Nacido , Recien Nacido Prematuro/psicología , Análisis de Intención de Tratar , Masculino , Madres/psicología , Seguridad del PacienteRESUMEN
A range of efficacies have been reported for biomedical HIV prevention interventions, including antiretroviral treatment, male circumcision, preexposure prophylaxis, microbicides, and preventive vaccines. This range of efficacies probably results from the influence of multiple inputs and processes during trials, including the strength and target of the intervention, host factors, target population characteristics, level of HIV exposure, and intervention dose. Expertise in social and behavioral sciences, in conjunction with basic science, clinical research, epidemiology, biostatistics, and community, is needed to understand the influence of these inputs and processes on intervention efficacy, improve trial design and implementation, and enable interpretation of trial results. In particular, social and behavioral sciences provide the means for investigating and identifying populations suitable for recruitment into and retention in trials and for developing and improving measures of HIV exposure and intervention dose, all within the larger sociocultural context. Integration of social and behavioral sciences early in idea generation and study design is imperative for the successful conduct of biomedical trials and for ensuring optimal data collection approaches necessary for the interpretation of findings, particularly in cases of unexpected results.
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Vacunas contra el SIDA , Antirretrovirales/uso terapéutico , Infecciones por VIH/prevención & control , Antirretrovirales/administración & dosificación , Investigación Conductal , Investigación Biomédica , Circuncisión Masculina , Ensayos Clínicos como Asunto , Prestación Integrada de Atención de Salud , Femenino , Infecciones por VIH/inmunología , Infecciones por VIH/terapia , Humanos , Masculino , Cumplimiento de la Medicación , Ciencias Sociales , Resultado del TratamientoRESUMEN
BACKGROUND: The stress that results from preterm birth, requisite acute care and prolonged physical separation in the Neonatal Intensive Care Unit (NICU) can have adverse physiological/psychological effects on both the infant and the mother. In particular, the experience compromises the establishment and maintenance of optimal mother-infant relationship, the subsequent development of the infant, and the mother's emotional well-being. These findings highlight the importance of investigating early interventions that are designed to overcome or reduce the effects of these environmental insults and challenges. METHODS: This study is a randomized controlled trial (RCT) with blinded assessment comparing Standard Care (SC) with a novel Family Nurture Intervention (FNI). FNI targets preterm infants born 26-34 weeks postmenstrual age (PMA) and their mothers in the NICU. The intervention incorporates elements of mother-infant interventions with known efficacy and organizes them under a new theoretical context referred to collectively as calming activities. This intervention is facilitated by specially trained Nurture Specialists in three ways: 1) In the isolette through calming interactions between mother and infant via odor exchange, firm sustained touch and vocal soothing, and eye contact; 2) Outside the isolette during holding and feeding via the Calming Cycle; and 3) through family sessions designed to engage help and support the mother. In concert with infant neurobehavioral and physiological assessments from birth through 24 months corrected age (CA), maternal assessments are made using standard tools including anxiety, depression, attachment, support systems, temperament as well as physiological stress parameters. Quality of mother-infant interaction is also assessed. Our projected enrolment is 260 families (130 per group). DISCUSSION: The FNI is designed to increase biologically important activities and behaviors that enhance maternally-mediated sensory experiences of preterm infants, as well as infant-mediated sensory experiences of the mother. Consequently, we are enlarging the testing of preterm infant neurodevelopment beyond that of previous research to include outcomes related to mother-infant interactions and mother-infant co-regulation. Our primary objective is to determine whether repeated engagement of the mother and her infant in the intervention's calming activities will improve the infant's developmental trajectory with respect to multiple outcomes. Our secondary objective is to assess the effectiveness of FNI in the physiological and psychological co-regulation of the mother and infant. We include aspects of neurodevelopment that have not been comprehensively measured in previous NICU interventions. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01439269.
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Cuidado del Lactante/métodos , Recien Nacido Prematuro , Relaciones Madre-Hijo , Madres/psicología , Desarrollo Infantil , Protocolos Clínicos , Femenino , Humanos , Conducta del Lactante , Recién Nacido , Recien Nacido Prematuro/fisiología , Recien Nacido Prematuro/psicología , Unidades de Cuidado Intensivo Neonatal , Apego a Objetos , Pruebas Psicológicas , Proyectos de Investigación , Método Simple Ciego , Apoyo Social , Estrés Fisiológico , Estrés Psicológico/etiología , Estrés Psicológico/prevención & controlRESUMEN
OBJECTIVE: Policy, regulation, training, and support for cadres adopting tasks and roles outside their historical domain have lagged behind the practical shift in service-delivery on the ground. The Health Systems Strengthening for Equity (HSSE) project sought to assess the alignment between national policy and regulation, preservice training, district level expectations, and clinical practice of cadres providing some or all components of emergency obstetric care (EmOC) in Malawi and Tanzania. METHODS: A mixed methods approach was used, including key informant interviews, a survey of District Health Management Teams, and a survey of health providers employed at a representative sample of health facilities. RESULTS: A lack of alignment between national policy and regulation, training, and clinical practice was observed in both countries, particularly for cadres with less preservice training; a closer alignment was found between district level expectations and reported clinical practice. There is ineffective use of cadres that are trained and authorized to provide EmOC, but who are not delivering care, especially assisted vaginal delivery. CONCLUSION: Better alignment between policy and practice, and support and training, and more efficient utilization of clinical staff are needed to achieve the quality health care for which the Malawian and Tanzanian health ministries and governments are accountable.
Asunto(s)
Atención a la Salud/organización & administración , Servicios Médicos de Urgencia/organización & administración , Servicios de Salud Materna/organización & administración , Calidad de la Atención de Salud , Recolección de Datos , Atención a la Salud/legislación & jurisprudencia , Atención a la Salud/normas , Parto Obstétrico/métodos , Servicios Médicos de Urgencia/legislación & jurisprudencia , Servicios Médicos de Urgencia/normas , Femenino , Política de Salud , Humanos , Malaui , Servicios de Salud Materna/legislación & jurisprudencia , Servicios de Salud Materna/normas , Embarazo , TanzaníaRESUMEN
BACKGROUND: Despite the serious consequences of conflict for reproductive health, populations affected by conflict and its aftermath face tremendous barriers to accessing reproductive health services, due to insecurity, inadequate numbers of trained personnel and lack of supplies. Family planning is often particularly neglected. METHODS: In six conflict-affected areas in Sudan, northern Uganda and the Democratic Republic of Congo, household surveys of married or in-union women of reproductive age were conducted to determine baseline measures of family planning knowledge, attitudes and behaviors regarding contraception. Health facility assessments were carried out to assess baseline measures of family planning services availability. Data were double-entered into CSPro 3.2 and exported to SAS 9.2, which was used to calculate descriptive statistics. The studies' purposes were to guide program activities and to serve as a baseline against which program accomplishments could be measured. RESULTS: Knowledge of modern contraceptive methods was low relative to other sub-Saharan African countries, and use of modern methods was under 4% in four sites; in two sites with prior family planning services it was 12% and 16.2%. From 30% to 40% of women reported they did not want a child within two years, however, and an additional 12% to 35% wanted no additional children, suggesting a clear need for family planning services. The health facilities assessment showed that at most only one-third of the facilities mandated to provide family planning had the necessary staff, equipment and supplies to do so adequately; in some areas, none of the facilities were prepared to offer such services. CONCLUSIONS: Family planning services are desired by women living in crisis situations when offered in a manner appropriate to their needs, yet services are rarely adequate to meet these needs. Refugee and internally displaced women must be included in national and donors' plans to improve family planning in Africa.
RESUMEN
In February 2008, trained female interviewers collected data on sexual violence and use of medical services following sexual assault from 607 women in the Democratic Republic of the Congo (DRC). Exposure to sexual violence during the DRC's civil war was reported by 17.8% of the women; 4.8% of the women reported exposure to sexual violence after the war. Few sexual-assault survivors accessed timely medical care. Facility assessments showed that this care was rarely available. Clinical care for sexual-assault survivors must be integrated into primary health care for DRC women.
Asunto(s)
Aceptación de la Atención de Salud/estadística & datos numéricos , Delitos Sexuales/estadística & datos numéricos , Sobrevivientes/psicología , Adolescente , Adulto , República Democrática del Congo , Femenino , Humanos , Persona de Mediana Edad , Atención Primaria de Salud/estadística & datos numéricos , Investigación Cualitativa , Factores de Tiempo , Violencia , Guerra , Adulto JovenRESUMEN
BACKGROUND: Prolonged exposure to war has severely impacted the provision of health services in the Democratic Republic of the Congo (DRC). Health infrastructure has been destroyed, health workers have fled and government support to health care services has been made difficult by ongoing conflict. Poor reproductive health (RH) indicators illustrate the effect that the prolonged crisis in DRC has had on the on the reproductive health (RH) of Congolese women. In 2007, with support from the RAISE Initiative, the International Rescue Committee (IRC) and CARE conducted baseline assessments of public hospitals to evaluate their capacities to meet the RH needs of the local populations and to determine availability, utilization and quality of RH services including emergency obstetric care (EmOC) and family planning (FP). METHODS: Data were collected from facility assessments at nine general referral hospitals in five provinces in the DRC during March, April and November 2007. Interviews, observation and clinical record review were used to assess the general infrastructure, EmOC and FP services provided, and the infection prevention environment in each of the facilities. RESULTS: None of the nine hospitals met the criteria for classification as an EmOC facility (either basic or comprehensive). Most facilities lacked any FP services. Shortage of trained staff, essential supplies and medicines and poor infection prevention practices were consistently documented. All facilities had poor systems for routine monitoring of RH services, especially with regard to EmOC. CONCLUSIONS: Women's lives can be saved and their well-being improved with functioning RH services. As the DRC stabilizes, IRC and CARE in partnership with the local Ministry of Health and other service provision partners are improving RH services by: 1) providing necessary equipment and renovations to health facilities; 2) improving supply management systems; 3) providing comprehensive competency-based training for health providers in RH and infection prevention; 4) improving referral systems to the hospitals; 5) advocating for changes in national RH policies and protocols; and 6) providing technical assistance for monitoring and evaluation of key RH indicators. Together, these initiatives will improve the quality and accessibility of RH services in the DRC - services which are urgently needed and to which Congolese women are entitled by international human rights law.