Impact of the COVID-19 Pandemic on a Clinical Trial: A Quantitative Report on Study Engagement and Strategies.

INTRODUCTION: The COVID-19 pandemic impacted clinical research worldwide potentially altering research findings. The study purpose was to measure the effect of the pandemic on recruitment, retention, assessment, and intervention completion rates. METHODS: Enrollment and participation data from a clinical trial evaluating efficacy of a physical therapy intervention for high-risk preterm infants were compared across 3 pandemic periods (February 2019 through November 2021). RESULTS: Recruitment, retention, assessment, and intervention completion rates were lowest during the peak pandemic period. CONCLUSIONS: In compliance with the Human Subjects Review Board, and for the participants' and staff safety, transition from in-person to telehealth or hybrid visits was required to continue this longitudinal study. Despite the negative effect of the pandemic, parental resilience and commitment to the study was clear. Flexibility, quick action, dedication, and efficiency of the research team were key elements enabling study continuation with successful transition to telehealth assessments/interventions during the peak pandemic period.

Discussions of miscarriage and preterm births on Twitter.

BACKGROUND: Experiences typically considered private, such as, miscarriages and preterm births are being discussed publicly on social media and Internet discussion websites. These data can provide timely illustrations of how individuals discuss miscarriages and preterm births, as well as insights into the wellbeing of women who have experienced a miscarriage. OBJECTIVES: To characterise how users discuss the topic of miscarriage and preterm births on Twitter, analyse trends and drivers, and describe the perceived emotional state of women who have experienced a miscarriage. METHODS: We obtained 291 443 Twitter postings on miscarriages and preterm births from January 2017 through December 2018. Latent Dirichlet Allocation (LDA) was used to identify major topics of discussion. We applied time series decomposition methods to assess temporal trends and identify major drivers of discussion. Furthermore, four coders labelled the emotional content of 7282 personal miscarriage disclosure tweets into the following non-mutually exclusive categories: grief/sadness/depression, anger, relief, isolation, annoyance, and neutral. RESULTS: Topics in our data fell into eight groups: celebrity disclosures, Michelle Obama's disclosure, politics, healthcare, preterm births, loss and anxiety, flu vaccine and ectopic pregnancies. Political discussions around miscarriages were largely due to a misunderstanding between abortions and miscarriages. Grief and annoyance were the most commonly expressed emotions within the miscarriage self-disclosures; 50.6% (95% confidence interval [CI] 49.1, 52.2) and 16.2% (95% CI 15.2, 17.3). Postings increased with celebrity disclosures, pharmacists' refusal of prescribed medications and outrage over the high rate of preterm births in the United States. Miscarriage disclosures by celebrities also led to disclosures by women who had similar experiences. CONCLUSIONS: This study suggests that increase in discussions of miscarriage on social media are associated with several factors, including celebrity disclosures. Additionally, there is a misunderstanding of the potential physical, emotional and psychological impacts on individuals who lose a pregnancy due to a miscarriage.

Supporting play exploration and early developmental intervention versus usual care to enhance development outcomes during the transition from the neonatal intensive care unit to home: a pilot randomized controlled trial.

BACKGROUND: While therapy services may start in the Neonatal Intensive Care Unit (NICU) there is often a gap in therapy after discharge. Supporting Play Exploration and Early Development Intervention (SPEEDI) supports parents, helping them build capacity to provide developmentally supportive opportunities starting in the NICU and continuing at home. The purpose of this single blinded randomized pilot clinical trial was to evaluate the initial efficacy of SPEEDI to improve early reaching and exploratory problem solving behaviors. METHODS: Fourteen infants born very preterm or with neonatal brain injury were randomly assigned to SPEEDI or Usual Care. The SPEEDI group participated in 5 collaborative parent, therapist, and infant interventions sessions in the NICU (Phase 1) and 5 at home (Phase 2). Parents provided daily opportunities designed to support the infants emerging motor control and exploratory behaviors. Primary outcome measures were assessed at the end of the intervention, 1 and 3 months after the intervention ended. Reaching was assessed with the infant supported in an infant chair using four 30 s trials. The Early Problem Solving Indicator was used to evaluate the frequency of behaviors during standardized play based assessment. Effect sizes are including for secondary outcomes including the Test of Infant Motor Performance and Bayley Scales of Infant and Toddler Development. RESULTS: No group differences were found in the duration of toy contact. There was a significant group effect on (F1,8 = 4.04, p = 0.08) early exploratory problem-solving behaviors with infants in the SPEEDI group demonstrating greater exploration with effect sizes of 1.3, 0.6, and 0.9 at the end of the intervention, 1 and 3 months post-intervention. CONCLUSIONS: While further research is needed, this initial efficacy study showed promising results for the ability of SPEEDI to impact early problem solving behaviors at the end of intervention and at least 3 months after the intervention is over. While reaching did not show group differences, a ceiling effect may have contributed to this finding. This single blinded pilot RCT was registered prior to subject enrollment on 5/27/14 at ClinicalTrials.Gov with number NCT02153736.

Oral Feeding Outcome after Analgesic and Sedative Exposure in VLBW Preterm Infant.

OBJECTIVE: The objective of this study was to assess the association of analgesics and sedatives on oral feeding function and need for feeding tube at discharge in the very low birth weight (VLBW) (<1,500 g) preterm infant. STUDY DESIGN: A retrospective review of surviving inborn infants < 1,500 g and < 32 weeks' gestation (n = 209), discharged between January 1, 2012, and December 31, 2014, from the neonatal intensive care unit identified exposure to analgesic and sedative medications, demographics, medical course, and nasogastric or gastrostomy tube (GT) feeding at discharge. Predictive modeling with logistic regression to identify independent factors associated with discharge on tube feedings. RESULTS: Out of 209, 45 (21.5%) infants received an analgesic/sedative with 23 out of 45 (51.1%) discharged with tube feedings. Infants discharged with tube feedings were born smaller, of younger gestation, with greater SNAPPE-II scores, periventricular leukomalacia, chronic lung disease, postnatal glucocorticoids, lansoprazole, and longer time intubated. After adjusting for covariates, exposure to analgesic/sedatives (fentanyl, midazolam, or morphine) was independently predictive of discharge on tube feedings. CONCLUSION: Analgesic and sedative exposure in VLBW infants is highly associated with poor oral feeding and need for tube feedings at discharge.

Early Detection Tool of Intestinal Dysfunction: Impact on Necrotizing Enterocolitis Severity.

OBJECTIVE: The aim of this study is to determine the use of an early clinical signs and symptoms warning tool in early identification of intestinal dysfunction as a clinical strategy to decrease necrotizing enterocolitis (NEC) severity. DESIGN: Using signs and symptoms of 297 infants, of which 33 infants were diagnosed with stage II and III EC intestinal dysfunction, a five clinical category scoring tool (Neonatal Necrotizing Enterocolitis Early Detection Score [NeoNEEDS]) and strategy with abdominal X-ray alert was developed. The categories included behavior, cardiac, respiratory, gastrointestinal, and feeding tolerance. The strategy was tested in a prospective cohort of 72 infants < 1,500 g, utilizing 532 observations between 10/2012 and 9/1/2013. The statistical analysis utilized the Statistical Analysis Software (SAS). RESULTS: The earliest signs and symptoms of intestinal dysfunction (Stage I NEC) were cardiorespiratory baseline changes, p < 0.001. Abdominal distension and/or feeding intolerance were late findings associated with stage II or III NEC. Tool scores ≥ 5 predicted intestinal dysfunction (p < 0.00). Sensitivity was high (95%) with specificity of 82% and positive and negative predictive values of 76% and 95%, respectively. Use of the tool during the study period was associated with decreased NEC severity rates (Bell NEC stage II and III). CONCLUSION: Cardiorespiratory symptoms precede gastrointestinal symptoms of intestinal dysfunction. Targeting signs and symptoms in an early warning tool to identify intestinal dysfunction can impact NEC severity progression.

Skin-to-Skin Care and the Development of the Preterm Infant Oral Microbiome.

OBJECTIVE: The oral cavity represents an initial entry way for oral and gut indigenous colonization. Skin-to-skin (STS) care, in which the mother holds the diaper clad naked preterm (PT) infant between her breasts, is associated with improved digestive function, decreased stress, and improved survival. This study evaluated the development of oral microbial colonization repertoires and health characteristics in PT infants with or without STS exposure. METHODS: Saliva from 42 PT infants (<32 weeks of gestation at birth) was collected prospectively at 1 month and/or at discharge. High-throughput 16S rRNA sequencing identified microbial diversity and prevalence of bacterial signatures correlated with clinical STS or non-STS care. RESULTS: Corrected for gestational age (CGA) at sampling, bacterial taxa demonstrated increased Streptococcus as a signature of oral repertoire maturation. STS was associated with increased Streptococcus (p < 0.024), while non-STS was associated with greater Corynebacterium (p < 0.023) and Pseudomonas (p < 0.019) in infants ≤ 32 weeks CGA. In infants > 32 weeks CGA, Neisseria and Acinetobacter were more prevalent, 50 vs. 16.7% and 40 vs. 0%, respectively. STS care was associated with shorter hospitalization (p < 0.039). CONCLUSION: STS care during earlier gestation was associated with a distinct microbial pattern and an accelerated pace of oral microbial repertoire maturity.

Supporting Play Exploration and Early Development Intervention From NICU to Home: A Feasibility Study.

PURPOSE: To determine the feasibility of completing a clinical trial of Supporting Play Exploration and Early Development Intervention (SPEEDI) that blends early and intense intervention with family support during the transition from the neonatal intensive care unit (NICU) to home and the community. METHODS: Ten infants born preterm were randomly assigned to intervention or usual care groups. Data on intervention frequency and parent feedback were used to determine the feasibility of SPEEDI. Effect sizes were calculated for motor and problem-solving outcome measures at the end of the intervention, 3 months adjusted age. RESULTS: Infants received on average 96.4% and 100.3% of anticipated NICU and home intervention. Only 28% of infants were receiving early intervention services during the SPEEDI period. Effect sizes were large and in the anticipated direction. CONCLUSIONS: SPEEDI is a feasible intervention and appropriate for future clinical trials. VIDEO ABSTRACT: For more insights from the authors, see Supplemental Digital Content 1, available at http://links.lww.com/PPT/A83.

A neonatal nurse training program in kangaroo mother care (KMC) decreases barriers to KMC utilization in the NICU.

OBJECTIVE: This study assessed the impact of a nurse simulation training program on perception of kangaroo mother care (KMC) value and transfer skill competency. STUDY DESIGN: An 8-item Likert scale skill survey tool and a 24-item Likert developmental care survey tool were used in a prospective cohort study to analyze perceptions of 30 neonatal nurses who underwent a comprehensive KMC simulation-based training program. Competency skills were evaluated pretraining and tracked by direct observation for 6 months posttraining. Pre- and postsurvey data were analyzed and KMC utilization for preterm infants born at ≤ 34 weeks' gestation was determined. RESULTS: Nurses' competency in infant transfer improved, especially in infants receiving nasal continuous positive airway pressure or ventilator support, from 30 to 93% or 10 to 50%, respectively, p < 0.0001. Neonatal nurses' perceived KMC value increased from 50 to 100%, p < 0.001, and parent KMC utilization increased from 26.5 to 85.9%, p < 0.0001. Nurses' support for parental visitation improved from 38 to 73%, p < 0.001; discussion of KMC with parents on the 1st day increased from 5 to 45%, p < 0.001; and initial day of KMC provision improved from 18.0 ± 2.7 to 5.6 ± 1.2 days, p < 0.001. CONCLUSIONS: A comprehensive simulation-based KMC education program improved nurses' perception of KMC value, their competency and comfort in infant transfer for KMC care, and successfully promoted KMC parent utilization for the preterm infant in the neonatal intensive care unit.

Cerebral, renal, and splanchnic tissue oxygen saturation values in healthy term newborns.

OBJECTIVE: To determine cerebral regional tissue oxygen saturation (CrSO2), renal regional tissue oxygen saturation (RrSO2), and splanchnic regional tissue oxygen saturation (SrSO2) values in healthy term infants. STUDY DESIGN: Near-infrared spectroscopy was used to simultaneously measure CrSO2, RrSO2, and SrSO2 continuously for a 1-hour period on the first and second days of life. RESULTS: A total of 41 subjects were monitored out of which complete data were available for 38 subjects. Mean CrSO2 was 78.2 ± 7.9% on first day; 78.3 ± 6.1% on second day (p = 0.95). Mean RrSO2 was 92.1 ± 5.3% on first day; 88.9 ± 5.9% on second day (p < 0.01). Mean SrSO2 was 69.9 ± 12.1% on first day and 75.3 ± 12.4% on second day (p = 0.02). CONCLUSION: There appears to be consistency in rSO2 values in healthy newborns. CrSO2 was similar on both days. Differences observed in RrSO2 and SrSO2 between days may represent a shift in somatic blood flow distribution taking place during the first day of life.

Association of Right Ventricular Dysfunction with Risk of Neurodevelopmental Impairment in Infants with Pulmonary Hypertension.

(1) Background: Pulmonary hypertension (PH) increases pulmonary vascular resistance and right ventricular (RV) afterload. Assessment of RV systolic function in PH using RV fractional area change (RV FAC) as a marker directly correlates with mortality and the need for extracorporeal membrane oxygenation (ECMO). However, few studies have assessed neurodevelopmental outcomes. We hypothesize that cardiac RV systolic dysfunction with lower RV FAC is associated with worse neurodevelopmental impairment (NI). (2) Methods: Retrospective study of 42 subjects with PH to evaluate neurodevelopmental outcomes in the first two years of life based on (i) subjective assessment of RV systolic function and (ii) RV FAC, a specific echocardiographic marker for RV function. (3) Results: Subjects from the initial study cohort (n = 135) with PH who had long-term follow-up were divided into RV dysfunction (study, n = 20) and non-RV dysfunction (control, n = 22) groups. RV FAC in the study vs. control group (0.18 vs. 0.25) was lower (p = 0.00017). There was no statistically significant difference in NI either with RV dysfunction or lower RV FAC. Although not significant, RV dysfunction was associated with longer mean duration of mechanical ventilation, time on ECMO, and length of stay. In the initial cohort (135), mortality was 16.3% and the percentage of NI was 62%. (4) Conclusions: Neonatal pulmonary hypertension is associated with a high degree of neurodevelopment impairment. Early RV systolic dysfunction, as identified by RV FAC, was not an optimal predictive biomarker for infants with PH and neurodevelopmental impairment.

Incidence and etiology of late preterm admissions to the neonatal intensive care unit and its associated respiratory morbidities when compared to term infants.

OBJECTIVE: To determine etiology of neonatal intensive care unit (NICU) admission and acute morbidities in late preterm (LPT) neonates. METHODS: Neonates admitted at New York University Langone Medical Center's NICU were grouped as follows: period 1: all LPT neonates with gestational age between 34(0)/(7) and 36(6)/(7) weeks and born between January 2006 and June 2007; period 2: all term neonates born between January 2007 and June 2008. Neonatal and maternal data were collected from both the groups and compared. RESULTS: Thirty-three percent of LPT births were admitted to the NICU, compared with 7% of term births (p < 0.05). LPT neonates had an increased incidence of low birth weight, hypoglycemia, hypothermia, and hyperbilirubinemia as an admission diagnosis (p < 0.001). The overall incidence of respiratory distress syndrome (RDS) was 9%, 4%, 3%, 0.7%, 0.2% and 0% in 34-week, 35-week, 36-week, 37-week, 38- to 39-week, and 40-week gestational age neonates (p < 0. 001).There was an increased incidence of RDS and persistent pulmonary hypertension, along with an increased need for surfactant replacement therapy, continuous positive airway pressure, and ventilator support in the LPT group when compared with the term neonates (p < 0.001). CONCLUSIONS: LPT neonates are at increased risk for hypothermia, hypoglycemia, hyperbilirubinemia, and respiratory morbidity requiring increased respiratory support when compared with term neonates.

Maternal antenatal treatments influence initial oral microbial acquisition in preterm infants.

OBJECTIVE: The purpose of this study was to analyze the association of maternal antenatal therapy on initial preterm infant oral microbial acquisition of gut metabolically important bacteria: Firmicutes, Bacteroidetes, Lactobacillus, Bifidobacterium, and Bacteroides species. STUDY DESIGN: Infant oral samples were collected prefeeding at 24 hours and analyzed using group-specific primers by real-time 16S rRNA quantitative polymerase chain reaction with analysis of variance and logistic regression to evaluate effect of antenatal exposure. RESULTS: Sixty-five infants < 34 weeks' gestational age (GA) were evaluated; mean GA was 28.6 ± 2.6 (standard deviation) weeks. Infants unexposed to antenatal treatment (n = 5) acquired < 1% Firmicutes, which was composed of 100% Lactobacillus species with no detectable Bifidobacterium, Bacteroidetes, or Bacteroides species. Infants exposed to antibiotics (n = 7), acquired fivefold less total bacterial density (TBD) with 45% Firmicutes 1.3% Lactobacillus species, 23.5% Bacteroidetes and rare Bacteroides. Compared with unexposed infants, steroids (n = 26) or steroid and antibiotics (n = 27) exposure led to an eightfold increase in TBD with < 1% Lactobacillus species and Bacteroides species 100% and 30%, respectively (p < 0.04). Bifidobacterium was undetectable in all groups. CONCLUSION: Preterm infant exposure to routine maternal antenatal treatments influence early oral microbial acquisition during the primary hours related to establishment of gut commensal bacteria.

Maternal and neonatal nurse perceived value of kangaroo mother care and maternal care partnership in the neonatal intensive care unit.

BACKGROUND: Kangaroo Mother Care (KMC) enhances infant and maternal well-being and requires maternal-care partnerships (MCP) for implementation. OBJECTIVE: To examine maternal and neonatal nurse provider perspectives on the value of KMC and MCP. STUDY DESIGN: Prospective cohort design of neonatal nurses and mothers of preterm infants self-report anonymous questionnaire. Analyses of categorical independent variables and continuous variables were calculated. RESULTS: In all, 82.3% of nurses (42) and 100% (143) of mothers participated in the survey. compared with 18% of nurses, 63% of mothers believed "KMC should be provided daily" and 90% of mothers compared with 40% of nurses strongly believed "mothers should be partners in care." In addition, 61% of nonwhite mothers identified that "KMC was not something they were told they could do for their infant" compared with 39% of white mothers. Nonwhite and foreign-born nurses were 2.8 and 3.1 times more likely to encourage MCP and KMC. CONCLUSION: Mothers held strong positive perceptions of KMC and MCP value compared with nurses. Nonwhite mothers perceived they received less education and access to KMC. Barriers to KMC and MCP exist among nurses, though less in nonwhite, foreign-born, and/or nurses with their own children, identifying important provider educational opportunities to improve maternal KMC access in the NICU.

Splanchnic-cerebral oxygenation ratio (SCOR) values in healthy term infants as measured by near-infrared spectroscopy (NIRS).

PURPOSE: The splanchnic-cerebral oxygenation ratio (SCOR) is a measurement comparing regional tissue oxygen saturation of splanchnic organs and brain tissue. SCOR has been previously proposed as a marker of clinical conditions associated with gut ischemia. Our goal was to determine SCOR values in healthy neonates in their first and second days of life. METHODS: Prospective observational study measuring SCOR in term neonates in the nursery using near-infrared spectroscopy (NIRS). RESULTS: Forty-five subjects with a mean gestational age of 39.4 ± 1.3 weeks were included. Mean SCOR on the first day was 0.90 ± 0.16 and 0.97 ± 0.16 on the second day, p = 0.02 (n = 45). No correlation was found between SCOR and gestational age; however, we did find a positive correlation between hour of life and SCOR values (r = 0.28, r(2) = 0.08, p < 0.01, two tails); SCOR appears to stabilize by 36 h. CONCLUSIONS: Our findings demonstrate SCOR values in healthy neonates consistent with those previously theorized and help to validate it as a diagnostic measure. In addition, we have demonstrated that SCOR values may normally be lower in infants during their first days of life, and this information may be helpful to clinicians using NIRS as a diagnostic tool.

Resonance Raman Spectroscopy Tissue Oxygenation Measurements in Neonates.

INTRODUCTION: Current oxygen monitoring by pulse oximetry has limitations and cannot provide estimates of the oxygen content in the microvasculature, where oxygen is used. Resonance Raman spectroscopy (RRS) provides noninvasive microvascular oxygen measurement. The objectives of this study were to (i) measure the correlation between preductal RRS microvascular oxygen saturations (RRS-StO2) and central venous oxygen saturation (SCVO2), (ii) develop normative data for RRS-StO2 measurements in healthy preterm infants, and (iii) determine the effect of blood transfusion on RRS-StO2. METHODS: Thirty-three buccal and thenar RRS-StO2 measurements were performed in 26 subjects to correlate RRS-StO2 with SCVO2. Thirty-one measurements were performed in 28 subjects to develop normative RRS-StO2 values, and eight subjects were enrolled in the transfusion group to assess changes in RRS-StO2 with blood transfusion. RESULTS: There were good correlations for buccal (r = 0.692) and thenar (r = 0.768) RRS-StO2 versus SCVO2. The median RRS-StO2 in healthy subjects was 76% (IQR 68.7-80.8). There was a significant increase of 7.8 ± 4.6% in the thenar RRS-StO2 after blood transfusion. CONCLUSIONS: RRS appears to be a safe and noninvasive means of monitoring microvascular oxygenation. Thenar RRS-StO2 measurements are more feasible and practical to use than buccal. In healthy preterm infants, the median RRS-StO2 was calculated based on measurements across various gestational age and gender. More studies evaluating the effects of gestational age of RRS-StO2 in various critical clinical settings are needed to confirm the findings.

Peripartum Traumas and Mental Health Outcomes in a Low-Income Sample of NICU Mothers: A Call for Family-Centered, Trauma-Informed Care.

Postpartum depression (PPD), postpartum anxiety (PPA), and post-traumatic stress disorder (PTSD) among birthing people have increased substantially, contributing to adverse maternal/infant dyad outcomes, with a high prevalence in the neonatal intensive care unit (NICU). Despite calls for trauma-informed care in the NICU and high rates of post-traumatic stress, little research has examined the rates of or the relationships between peripartum mood and adverse child experiences (ACEs) in NICU mothers or evaluated which peripartum traumas are most distressing. This study employed structural equation modeling (SEM) to explore whether peripartum-related traumas and NICU-related stressors mediated the associations between ACEs and mental health outcomes in 119 lower-income, racially diverse mothers in a Level IV NICU. Mental health concerns were prevalent and highly comorbid, including 51.3% PPA, 34.5% PPD, 39.5% post-traumatic stress, and 37% with ≥4 ACEs. The majority (53.8%) of mothers endorsed multiple peripartum traumas; NICU admission was the most common trauma (61%), followed by birth (19%), pregnancy (9%), and a medical event in the NICU (9%). Our SEMs had good fit and demonstrated that ACEs predicted peripartum distress. Trauma-informed care efforts should employ transdiagnostic approaches and recognize that women commonly present to the NICU with childhood trauma history and cumulative peripartum traumas.

Lactation Support as a Proxy Measure of Family-Centered Care Quality in Neonates with Life-Limiting Conditions-A Comparative Study.

BACKGROUND: Lactation support is an important measure of Family-Centered Care (FCC) in the Neonatal Intensive Care Unit (NICU). Life-limiting conditions (LLCs) raise complex ethical care issues for providers and parents in the NICU and represent a key and often overlooked population for whom FCC is particularly important. We investigated healthcare disparities in FCC lactation support quality in infants with LLCs. METHODS: A retrospective cohort of inborn infants with or without LLCs admitted to the NICU between 2015-2023 included 395 infants with 219 LLC infants and 176 matched non-LLC infants and were compared on LLC supports. RESULTS: The LLC cohort experienced greater skin-to-skin support, but less lactation specialist visits, breast pumps provided, and human milk oral care use. LLC infants also experienced less maternal visitation, use of donor milk (LLC: 15.5%, non-LLC: 33.5%), and breastfeeds (LLC: 24.2%, non-LLC: 43.2%), with lower mean human milk provision (LLC: 36.6%, non-LLC: 67.1%). LLC infants who survived to discharge had similar human milk use as non-LLC infants (LLC: 49.8%, non-LLC: 50.6%). CONCLUSION: Lactation support was significantly absent for families and infants who presented with LLCs in the NICU, suggesting that policies can be altered to increase lactation support FCC quality for this population.