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Lung function has never been assessed during kangaroo mother care (KMC) in preterm infants. We measured lung (rSO2L) and cerebral (rSO2C) oxygenation by near-infrared spectroscopy (NIRS) in infants born at less than 32 weeks of gestation or weighing ≤ 1500 g during KMC. rSO2L, rSO2C, and pulmonary (FOEL) and cerebral (FOEC) tissue oxygen extraction fraction were measured in 20 preterm infants before, during, and after a 2-h period of KMC at a mean postnatal age of 36 ± 21 days of life. We found that rSO2L, rSO2C, FOEL, and FOEC did not change in our patients. After 120 min of KMC, rSO2L was lower (71.3 ± 1.4 vs. 76.7 ± 4.6%; P = 0.012) in infants with BPD (n = 6; 30%) than in infants without BPD (n = 14 = 60%), while FOEL was higher (0.26 ± 0.02 vs. 0.20 ± 0.05; P = 0.012).Conclusion: Cerebral and lung oxygenation did not change in preterm infants during KMC. A transient decrease in lung oxygenation was offset by the increase in oxygen extraction, but these changes were clinically insignificant. These results confirm the safety of KMC in preterm infants who are in stable clinical conditions. What is Known ⢠Kangaroo mother care (KMC) is widely used to improve the care of preterm newborns since it improves their outcome. ⢠KMC is safe as patients' vital parameters, are not negatively affected, but lung function has never been directly assessed. What is New ⢠Cerebral and lung oxygenation measured by near-infrared spectroscopy did not change during KMC. ⢠A transient decrease in lung oxygenation compensated for by the increase in oxygen extraction occurred only in infants with BPD, but these changes were clinically insignificant.
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Microsystems represent an alternative but proficient approach of analysis outside the laboratory, and their use could help in reducing the impact of pre-analytical errors, in particular in challenging newborn samples. The study purpose is to compare the Horiba Microsemi CRP LC-767G system for rapid 3-part complete blood count (CBC) and C-reactive protein (CRP) determination with the laboratory reference systems (respectively Sysmex XN-9100™ and Roche Cobas® c702) in samples of adult patients and newborns hospitalized in the neonatal intensive care unit (NICU) samples. The comparison between the analyzers was performed through Passing-Bablok regression analysis and Bland-Altman plot. One hundred eighty-three blood samples were analyzed. The regression analysis results, performed in the newborn (n = 70) and in adult (n = 113) populations, showed a good agreement between the instruments. The evaluation of the Bland-Altman plots showed comparable values of bias < 10% for most of the parameters, but not for MPV, lymphocyte, and monocyte count. CONCLUSION: The comparison between the Microsemi CRP LC-767G system and the laboratory instrumentations demonstrated comparable results. The Microsemi CRP LC-767G system provides reliable analytical data and faster turnaround time, particularly useful in NICU. WHAT IS KNOWN: ⢠Microsystems for point-of-care testing (POCT) represent an alternative but proficient approach of analysis outside the laboratory, in order to perform a rapid, safe, and exhaustive evaluation for critical patients' management, acting as a valid support for treatment in acute care. WHAT IS NEW: ⢠The Microsemi CRP LC-767G system can represent an alternative but effective testing approach outside the laboratory, particularly in NICU, to reduce the impact of pre-analytical errors on newborn samples.
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BACKGROUND: Spinal muscular atrophy (SMA) is due to the homozygous absence of SMN1 in around 97% of patients, independent of the severity (classically ranked into types I-III). The high genetic homogeneity, coupled with the excellent results of presymptomatic treatments of patients with each of the three disease-modifying therapies available, makes SMA one of the golden candidates to genetic newborn screening (NBS) (SMA-NBS). The implementation of SMA in NBS national programmes occurring in some countries is an arising new issue that the scientific community has to address. We report here the results of the first Italian SMA-NBS project and provide some proposals for updating the current molecular diagnostic scenario. METHODS: The screening test was performed by an in-house-developed qPCR assay, amplifying SMN1 and SMN2. Molecular prognosis was assessed on fresh blood samples. RESULTS: We found 15 patients/90885 newborns (incidence 1:6059) having the following SMN2 genotypes: 1 (one patient), 2 (eight patients), 2+c.859G>C variant (one patient), 3 (three patients), 4 (one patient) or 6 copies (one patient). Six patients (40%) showed signs suggestive of SMA at birth. We also discuss some unusual cases we found. CONCLUSION: The molecular diagnosis of SMA needs to adapt to the new era of the disease with specific guidelines and standard operating procedures. In detail, SMA diagnosis should be felt as a true medical urgency due to therapeutic implications; SMN2 copy assessment needs to be standardised; commercially available tests need to be improved for higher SMN2 copies determination; and the SMN2 splicing-modifier variants should be routinely tested in SMA-NBS.
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Atrofia Muscular Espinal , Tamizaje Neonatal , Humanos , Recién Nacido , Proyectos Piloto , Tamizaje Neonatal/métodos , Atrofia Muscular Espinal/diagnóstico , Atrofia Muscular Espinal/genética , Genotipo , ItaliaRESUMEN
AIM: We developed the Promotion of Breastfeeding (PROBREAST) programme and evaluated what effect it had on the breastfeeding rate in infants born at less than 32 weeks of gestation or weighing ≤1500 grams. METHODS: We compared the breastfeeding rate in two cohorts of patients who were born before (n = 72; January 2017 to June 2018) and after (n = 80; July 2018 to December 2019) the application of the programme. Moreover, we compared the correlation between type of feeding at discharge and post-discharge breastfeeding rate, between exclusive breastfeeding, postnatal growth and neurodevelopment. RESULTS: Infants in the PROBREAST group had an exclusive breastfeeding rate at discharge higher (42 vs. 16%, p < 0.001) than that in the historical control group. Exclusive breastfeeding was negatively correlated with weight z-score at discharge, but not at 12 and 24 months corrected age, and was positively correlated with cognitive score at 24 months corrected age. CONCLUSION: The application of a structured programme for the promotion of breastfeeding improved the breastfeeding rate in very preterm infants. We demonstrated that exclusive breastfeeding at discharge improved their neurodevelopment without impairing growth.
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Lactancia Materna , Alta del Paciente , Humanos , Lactancia Materna/estadística & datos numéricos , Recién Nacido , Femenino , Masculino , Promoción de la Salud/métodos , Recien Nacido Prematuro/crecimiento & desarrollo , Desarrollo Infantil , Recien Nacido Extremadamente Prematuro/crecimiento & desarrolloRESUMEN
OBJECTIVES: To assess the feasibility, accuracy, and reproducibility of tissue-tracking mitral annular displacement (TMAD) compared with other measures of left ventricular systolic function in healthy preterm and term neonates in the transitional period. METHODS: This was a prospective observational study. Two echocardiograms were performed at 24 and 48 hours of life. TMAD, shortening fraction (SF), ejection fraction (EF), s', and global longitudinal strain (GLS) were measured offline. Accuracy to detect impaired GLS was tested by ROC curve analysis. DeLong test was used to compare AUCs. Intra and interobserver reproducibility of the off-line analysis was calculated. RESULTS: Mean ± SD gestational age and weight were 34.2 ± 3.8 weeks and 2162 ± 833 g, respectively. TMAD was feasible in 168/180 scans (93%). At 24 hours the AUC (95% CI) of SF, EF, s', and TMAD (%) was 0.51 (0.36-0.67), 0.68 (0.54-0.82), 0.63 (0.49-0.77), and 0.89 (0.79-0.99) respectively. At 48 hours the AUC (95% CI) of SF, EF, s', and TMAD (%) was 0.64 (0.51-0.77), 0.59 (0.37-0.80), 0.70 (0.54-0.86), and 0.96 (0.91-1.00), respectively. The AUC of TMAD was superior to the AUC of SF, EF, s', at both timepoints (P < .02). Intraclass correlation coefficients (95% CI) of intra and interobserver reproducibility of TMAD were 0.97 (0.95-0.99) and 0.94 (0.88-0.97), respectively. CONCLUSION: TMAD showed improved accuracy and optimal reproducibility in neonates in the first 48 hours of life.
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Ecocardiografía , Función Ventricular Izquierda , Recién Nacido , Humanos , Reproducibilidad de los Resultados , Válvula Mitral/diagnóstico por imagen , Sístole , Volumen SistólicoRESUMEN
OBJECTIVES: to describe the results of a pilot population-based perinatal mortality surveillance system, with regards to stillbirths; to study maternal, obstetric, and foetal characteristics, evaluating risk factors and understanding causes. DESIGN: a cross-sectional study was conducted on incident cases of stillbirths collected by the surveillance system from July 2017 to June 2019 in three Italian Regions (Lombardy, Tuscany, and Sicily). SETTING AND PARTICIPANTS: data on stillbirths, resulting from the in-hospital multidisciplinary audits, organised using the Significant Event Audit methodology, were analysed. According to the World Health Organization (WHO) definitions, the project identified stillbirths as foetuses born dead >=28 weeks of gestation. The WHO International Classification of Diseases-Perinatal Mortality was used to categorise the causes of foetal death. MAIN OUTCOMES MEASURES: maternal characteristics, obstetric and foetal findings were investigated. Unadjusted relative risks and 95% confidence intervals were computed with respect to the background population. Finally, causes of death and contributing maternal conditions have been considered. RESULTS: the maternity and neonatal units of the three participating Regions notified 520 stillbirths, of which 435 cases underwent to the multidisciplinary audit (83.7%); 40.0% of cases occurred in the gestational age range between 36 and 39 weeks. The risk of stillbirth was significantly increased in mothers with foreign citizenship (RR: 1.39; 95%CI: 1.13-1.71), multiple pregnancies (RR: 1.59; 95%CI 1.05-2.42), and pregnancies conceived with assisted reproductive technologies (RR: 2.15; 95%CI 1.45-3.19). The rate of congenital malformations was 6.0%. A diagnosis of foetal growth restriction was reported in 10.3% of cases, although the percentage of dead foetuses weighting <10° centile was at least twice in almost all gestational age periods. Post-mortem and placental histological examinations were carried out in more than 70% and more than 90% of cases, respectively. CONCLUSIONS: the implementation of a population-based surveillance system with high participation rate of maternity units and the use of universally accepted definitions could improve the identification of stillbirth avoidable risk factors and potentially modifiable predisposing maternal conditions, highlighting issues of perinatal assistance in need of improvement.
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Mortalidad Perinatal , Mortinato , Humanos , Femenino , Italia/epidemiología , Proyectos Piloto , Estudios Transversales , Mortinato/epidemiología , Embarazo , Recién Nacido , Adulto , Factores de Riesgo , Vigilancia de la Población , Edad Gestacional , Causas de Muerte , Muerte FetalRESUMEN
AIM: To investigate the association between morphine exposure in the neonatal period and neurodevelopment at 2 and 5 years of age while controlling for potential confounders. METHOD: We performed a retrospective, single-centre cohort study on 106 infants (60 males, 46 females; mean gestational age 26 weeks [SD 1]) born extremely preterm (gestational age < 28 weeks). Morphine administration was expressed as cumulative dose (mg/kg) until term-equivalent age. Neurodevelopmental outcome was assessed at 2 years with the Bayley Scales of Infant and Toddler Development, Third Edition, Dutch version and at 5 years with the Wechsler Preschool and Primary Scale of Intelligence, Third Edition, Dutch version. Multiple linear regression analysis was used to assess the association between morphine exposure and outcome. RESULTS: Sixty-four out of 106 (60.4%) infants included in the study received morphine. Morphine exposure was not associated with poorer motor, cognitive, and language subscores of the Bayley Scales of Infant and Toddler Development, Third Edition, Dutch version at 2 years. Morphine exposure was associated with lower Full-Scale IQ scores (p = 0.008, B = -9.3, 95% confidence interval [CI] = -15.6 to -3.1) and Performance IQ scores (p = 0.005, B = -17.5, 95% CI = -27.9 to -7) at 5 years of age. INTERPRETATION: Morphine exposure in infants born preterm is associated with poorer Full-Scale IQ and Performance IQ at 5 years. Individualized morphine administration is advised in infants born extremely preterm.
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Desarrollo Infantil , Recien Nacido Extremadamente Prematuro , Recién Nacido , Masculino , Femenino , Preescolar , Humanos , Lactante , Estudios de Cohortes , Morfina/efectos adversos , Estudios RetrospectivosRESUMEN
Neonatal SOFA score was reported as an accurate predictor of mortality while the prognostic accuracy of SIRS criteria is unknown. The aim was to compare neonatal SOFA and SIRS criteria for the prediction of late onset sepsis-related mortality in preterm newborns. Newborns ≤ 32 weeks with late onset sepsis were retrospectively studied. Neonatal SOFA and SIRS criteria were calculated at onset of sepsis (T0), and after 6 ± 1 (T1), 12 ± 3 (T2) and 24 ± 3 h (T3). Outcome was death during antibiotic treatment for late onset sepsis. We studied 112 newborns with gestational age 26.9 ± 2.3 weeks; 11% met the study outcome. Neonatal SOFA was significantly higher in non-survivors vs. survivors at all time intervals; SIRS criteria were significantly higher in non-survivors vs. survivors at T1, T2 and T3. Neonatal SOFA increased over time in non-survivors (p = 0.003). At T0, the area under receiver operating characteristics curve was significantly higher for neonatal SOFA score than SIRS criteria (0.950 vs. 0.569; p = 0.0002), and the best calculated cut-off for T0 neonatal SOFA score was 4. In multivariate analysis T0 and T1 neonatal SOFA were predictors of late onset sepsis-related mortality (p = 0.048 and p < 0.001). Conclusion: Neonatal SOFA score showed greater discriminatory capacity for mortality than SIRS criteria and might be helpful to plan management for patients at higher risk of death. What is Known: ⢠Neonatal SOFA score may be an accurate prognostic tool. ⢠No prognostic score has been fully standardized for septic newborns in NICU. What is New: ⢠Neonatal SOFA score outperformed SIRS criteria for the prediction of prognosis in preterm infants with late onset sepsis. ⢠Neonatal SOFA score assessed at onset of sepsis and 6 hrs later is a predictor of mortality.
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Sepsis , Síndrome de Respuesta Inflamatoria Sistémica , Lactante , Humanos , Recién Nacido , Síndrome de Respuesta Inflamatoria Sistémica/diagnóstico , Pronóstico , Puntuaciones en la Disfunción de Órganos , Estudios Retrospectivos , Recien Nacido Prematuro , Sepsis/diagnóstico , Mortalidad Hospitalaria , Curva ROCRESUMEN
Carboxyhemoglobin (COHb) is considered a biomarker of oxidative stress and previous studies reported an increase in COHb levels in preterm infants who develop late-onset sepsis (LOS). Our aim was to assess the correlation between COHb levels and the risk for LOS development. We retrospectively studied 100 preterm infants, 50 in the LOS and 50 in the no LOS group. COHb levels were measured on the day of diagnosis of the first episode of LOS, 3, 2, and 1 days before and 1 and 4 days after the onset of LOS. Logistic regression analysis showed that a higher level of COHb 2 days before the diagnosis of LOS increases the risk for LOS development (OR 12.150, 95% Cl 1.311-12.605; P = 0.028). A COHb level of 1.55% measured 2 days before the diagnosis of LOS is the best predictive threshold for LOS with a sensitivity of 70% and a specificity of 70%. Conclusion: Increased levels of COHb may predict the diagnosis of LOS in very preterm infants with a good accuracy. If further studies confirm our findings, this easy-to-measure biomarker could provide neonatologists with another tool for monitoring and early diagnosis of sepsis in high-risk patients. What is Known: ⢠Carboxyhemoglobin (COHb) is a biomarker of oxidative stress. ⢠Previous studies reported an increase in COHb levels in preterm infants who develop late-onset sepsis (LOS). What is New: ⢠COHb levels increased two days before the diagnosis of LOS and this increase was associated with the risk for developing LOS. ⢠ROC curve analysis for COHb measured two days before the diagnosis of LOS showed that 1.55% is the best predictive threshold for LOS with a sensitivity of 70% and a specificity of 70%.
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Recien Nacido Prematuro , Sepsis , Lactante , Femenino , Recién Nacido , Humanos , Carboxihemoglobina , Estudios Retrospectivos , Sepsis/diagnóstico , BiomarcadoresRESUMEN
Lung ultrasound (LU) has emerged as the imaging technique of choice for the assessment of neonates with respiratory distress syndrome (RDS) at the bedside. Scoring systems were developed to quantify RDS severity and to predict the need for surfactant administration. There is no data on the comparison of the three main LU scores (LUS) proposed by Brat, Raimondi and Rodriguez-Fanjul. Moreover, there is not enough evidence to recommend which score and which cut-off has the best ability to predict surfactant need. The three LUS were compared in terms of ability to predict the need for surfactant and reproducibility in a cohort of very preterm infants. This was an observational, retrospective, multicenter study. Neonates below 32 weeks of gestational age with RDS, on non-invasive ventilation with a LU performed prior to surfactant administration (1-3 h of life) were included. Brat, Raimondi, and Rodriguez-Fanjul's scores were calculated for each patient. Receiver-operating characteristic (ROC) curve analysis was used to assess the ability to predict surfactant administration. K-Cohen test, Bland-Altman, and intraclass correlation coefficients were used to assess the intra and interobserver variability. Fifty-four preterm infants were enrolled. Brat, Raimondi, and Rodriguez-Fanjul scores showed a strong ability to predict the need for surfactant: the AUCs were 0.85 (95% CI 0.74-0.96), 0.85 (95% CI 0.75-0.96), and 0.79 (95% CI 0.67-0.92), respectively. No significant differences have been found between the AUCs using the DeLong test. Brat and Raimondi's scores had an optimal cut-off value > 8, while the Rodriguez-Fanjul's score > 10. The k-Cohen values of intraobserver agreement for Brat, Raimondi, and Rodriguez-Fanjul's scores were 0.896 (0.698-1.000), 1.000 (1.000-1.000), and 0.922 (0.767-1.000), respectively. The k-Cohen values of interobserver agreement were 0.896 (0.698-1.000), 0.911 (0.741-1.000), and 0.833 (0.612-1.000), respectively.Conclusions: The three LUS had an excellent ability to predict the need for surfactant and an optimal intra and interobserver agreement. The differences found between the three scores are minimal with negligible clinical implications. Since the optimal cut-off value differed, the same score should be used consistently within the same center. What is Known: ⢠Lung ultrasound is a useful bedside imaging tool that should be used in the assessment of neonates with RDS ⢠Scoring systems or lung ultrasound scores allow to quantify the severity of the pulmonary disease and to predict the need for surfactant replacement therapy What is New: ⢠The three lung ultrasound scores by Brat, Raimondi and Rodriguez-Fanjul have an excellent ability to predict the need for surfactant replacement therapy, although with different cut-off values ⢠All three lung ultrasound scores had an excellent intra and interobserver reproducibility.
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Surfactantes Pulmonares , Síndrome de Dificultad Respiratoria del Recién Nacido , Recién Nacido , Humanos , Recien Nacido Prematuro , Estudios Retrospectivos , Reproducibilidad de los Resultados , Pulmón/diagnóstico por imagen , Surfactantes Pulmonares/uso terapéutico , Síndrome de Dificultad Respiratoria del Recién Nacido/terapia , Ultrasonografía , Tensoactivos/uso terapéuticoRESUMEN
INTRODUCTION: Fetal lower urinary tract obstruction (LUTO) can be mild or severe with oligohydramnios, renal dysplasia and pulmonary hypoplasia. Fetal urine biochemical markers correlate with fetal prognosis and, if favorable, surgical intervention is feasible. METHODS: We report a patient in her 18th gestational week whose fetus was diagnosed with LUTO and underwent fetal urine sampling for calcium, sodium, chloride, beta2-microglobulin and total protein of the routine LUTO panel, with the addition of creatinine, glucose, phosphate, urea, ammonia, albumin, and NGAL. RESULTS: Although the routine fetal urine biochemistry seemed to be favorably trending favorably, sodium, beta2-microglobulin, glucose, and urea did not decrease to the reference ranges, and ammonia and creatinine were lower than the reference ranges. Ultrasound demonstrated no improvement of the obstruction. CONCLUSIONS: This case highlights the need to acquire further experience with biochemical fetal urine markers in order to better manage LUTO.
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Obstrucción Uretral , Sistema Urinario , Humanos , Embarazo , Femenino , Creatinina , Amoníaco , Obstrucción Uretral/diagnóstico , Obstrucción Uretral/etiología , Obstrucción Uretral/cirugía , Feto , Biomarcadores , Sodio , Urea , Glucosa , Ultrasonografía PrenatalRESUMEN
OBJECTIVE: To investigate the efficacy and safety of nebulized poractant alfa (at 200 and 400 mg/kg doses) delivered in combination with nasal continuous positive airway pressure compared with nasal continuous positive airway pressure alone in premature infants with diagnosed respiratory distress syndrome. STUDY DESIGN: This randomized, controlled, multinational study was conducted in infants at 280/7 to 326/7 weeks of gestation. The primary outcome was the incidence of respiratory failure in the first 72 hours of life, defined as needing endotracheal surfactant and/or mechanical ventilation owing to prespecified criteria. Secondary outcomes included the time to respiratory failure in the first 72 hours, duration of ventilation, mortality, incidence of bronchopulmonary dysplasia, and major associated neonatal comorbidities. In addition, the safety and tolerability of the treatments were assessed reporting the number and percentage of infants with treatment-emergent adverse events and adverse drug reactions during nebulization. RESULTS: In total, 129 infants were randomized. No significant differences were observed for the primary outcome: 24 (57%), 20 (49%), and 25 (58%) infants received endotracheal surfactant and/or mechanical ventilation within 72 hours in the poractant alfa 200 mg/kg, poractant alfa 400 mg/kg, and nasal continuous positive airway pressure groups, respectively. Similarly, secondary respiratory outcomes did not differ among groups. Enrollment was halted early owing to a change in the benefit-risk balance of the intervention. Nebulized poractant alfa was well-tolerated and safe, and no serious adverse events were related to the study treatment. CONCLUSIONS: The intervention did not decrease the likelihood of respiratory failure within the first 72 hours of life. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03235986.
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Enfermedades del Prematuro , Surfactantes Pulmonares , Síndrome de Dificultad Respiratoria del Recién Nacido , Insuficiencia Respiratoria , Productos Biológicos , Presión de las Vías Aéreas Positiva Contínua , Humanos , Recién Nacido , Enfermedades del Prematuro/epidemiología , Fosfolípidos , Surfactantes Pulmonares/uso terapéutico , Síndrome de Dificultad Respiratoria del Recién Nacido/tratamiento farmacológico , Síndrome de Dificultad Respiratoria del Recién Nacido/epidemiología , Insuficiencia Respiratoria/tratamiento farmacológico , Tensoactivos/uso terapéuticoRESUMEN
AIM: To explore whether continuous somatosensory evoked potentials (SEPs) monitoring and video electroencephalograms (VEEG) accurately predict lesions observed on brain magnetic resonance imaging (MRI) in neonates with hypoxic-ischaemic encephalopathy (HIE) receiving therapeutic hypothermia. METHOD: This prospective study included 31 neonates (16 males, 15 females; mean [SD] gestational age 39 weeks [1.67]) who received therapeutic hypothermia for HIE. Therapeutic hypothermia was provided for 72 hours, with a target temperature of 33.0°C to 34.0°C and this was followed by a rewarming rate of approximately 0.5°C per hour, up to 36.5°C. SEPs and VEEG were evaluated simultaneously and continuously for 1 hour under normothermic conditions. MRI was carried out at a mean (SD) age of 6 (2) days. RESULTS: Our results showed a statistically significant correlation between continuous SEP and MRI scores (r=0.37, p=0.03), but not between the VEEG and MRI scores (r=0.30, p=0.09). Receiver operating characteristic analysis confirmed that continuous SEPs were highly specific and sensitive at predicting MRI abnormalities, whereas the VEEG had high specificity but low sensitivity. INTERPRETATION: Continuous monitoring of SEPs could provide early and important prognostic information in neonates with HIE. WHAT THIS PAPER ADDS: Early continuous somatosensory evoked potential (SEP) monitoring is correlated with hypoxic-ischaemic encephalopathy (HIE) lesions. Video electroencephalograms (VEEGs) are associated with lesions diagnosed after magnetic resonance imaging. Both showed high specificity, but VEEGs did not show high sensitivity. Continuously monitoring SEPs provides important information about HIE.
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Lesiones Encefálicas , Hipotermia Inducida , Hipotermia , Hipoxia-Isquemia Encefálica , Lesiones Encefálicas/complicaciones , Potenciales Evocados Somatosensoriales , Femenino , Humanos , Hipotermia/complicaciones , Hipotermia/terapia , Hipotermia Inducida/métodos , Hipoxia-Isquemia Encefálica/complicaciones , Hipoxia-Isquemia Encefálica/diagnóstico por imagen , Hipoxia-Isquemia Encefálica/terapia , Lactante , Recién Nacido , Imagen por Resonancia Magnética/métodos , Masculino , Estudios ProspectivosRESUMEN
Late preterm infants (LPIs) represent a significant percentage of all neonates (6-8%), but there are limited published data on their postnatal management. Our aim was to compare the frequency of neonatal intensive care unit (NICU) admission and the breastfeeding rate of LPIs born at 35+0-36+6 weeks of gestation who were cared for by initial rooming in strategy rather than directly admitted to the special care unit (SCU) and, eventually, to the NICU. We carried out a retrospective study in the perinatal centers of Careggi University Hospital (CUH) and San Giovanni di Dio Hospital in Florence, Italy, where the first and second strategies were applied, respectively. Main outcomes were LPIs admission rate at SCU/NICU and breastfeeding rate at discharge. We studied 190 LPIs born at SGDH and 240 born at CUH. The admission rate in SCU (81 vs. 43%; P < 0.001) and NICU (20 vs. 10%; P = 0.008) was higher in SGDH than in CUH, as was the exclusive breastfeeding rate (36 vs. 22%; P < 0.001). However, infants who were assisted in rooming-in at CUH and infants with similar clinical characteristics at SGDH had similar mixed (60 vs. 69%) and exclusive (35 vs. 31%) breastfeeding rates. Conclusion: Postnatal assistance of LPIs in rooming-in, eventually followed by admission in SCU/NICU based on their clinical conditions, allowed to safely halve their hospitalization. The assistance of infants in rooming-in did not negatively affect their breastfeeding rate. These results support the possibility of assisting LPIs in rooming-in. What is Known: ⢠Late preterm infants represent a significant percentage of all neonates. ⢠Early rooming-in and breastfeeding is recommended for late preterm infants. What is New: ⢠Postnatal assistance of late preterm infants in rooming-in, followed when necessary by admission in neonatal units based on clinical conditions, allowed to safely avoid about half the number of hospitalizations in comparison with direct admission in neonatal units. ⢠This strategy did not affect breastfeeding rate. Infants who were admitted to SCU/NICU after initial rooming-in had worst breastfeeding rate.
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Recien Nacido Prematuro , Unidades de Cuidado Intensivo Neonatal , Lactancia Materna , Femenino , Hospitalización , Humanos , Lactante , Recién Nacido , Embarazo , Estudios RetrospectivosRESUMEN
Bilirubin (BR) is the final product of haem catabolism. Disruptions along BR metabolic/transport pathways resulting from inherited disorders can increase plasma BR concentration (hyperbilirubinaemia). Unconjugated hyperbilirubinemia may induce BR accumulation in brain, potentially causing irreversible neurological damage, a condition known as BR encephalopathy or kernicterus, to which newborns are especially vulnerable. Numerous pharmaceutical strategies, mostly based on hemoperfusion, have been proposed over the last decades to identify new valid, low-risk alternatives for BR removal from plasma. On the other hand, accumulating evidence indicates that BR produces health benefits due to its potent antioxidant, anti-inflammatory and immunomodulatory action with a significant potential for the treatment of a multitude of diseases. The present manuscript reviews both such aspects of BR pharmacology, gathering literature data on applied pharmaceutical strategies adopted to: (i) reduce the plasma BR concentration for preventing neurotoxicity; (ii) produce a therapeutic effect based on BR efficacy in the treatment of many disorders.
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Antiinflamatorios/farmacología , Antioxidantes/farmacología , Bilirrubina/farmacología , Enfermedades Neuroinflamatorias/tratamiento farmacológico , Antiinflamatorios/sangre , Antiinflamatorios/química , Antioxidantes/química , Bilirrubina/sangre , Bilirrubina/química , HumanosRESUMEN
BACKGROUND: Enteral feeding induces mesenteric hemodynamic changes in preterm infants, which may vary according to the milk used. Our aim in this study was to evaluate changes of splanchnic regional oxygenation (rSO2S) measured by near-infrared spectroscopy (NIRS) in infants fed with mother's own milk (MOM), fortified human milk (FHM), or preterm formula (PTF). METHODS: Infants born at 25-31 weeks of gestational age (n = 54) received a bolus of MOM, FHM, or PTF. rSO2S and splanchnic fractional oxygen extraction ratio (FOES) were recorded 60 min before (T0), and 30 min (T1) and 120 min (T2) after the beginning of bolus feeding. RESULTS: In the MOM group, rSO2S and FOES did not change during the study period. In the FBM group, rSO2S decreased from T0 to T1 and increased from T1 to T2, while FOES changed in reverse. In the PTF group, rSO2S decreased from T0 to T1 and from T1 to T2, while FOES changed in reverse. CONCLUSIONS: Splanchnic oxygenation was not affected by MOM feeding, was transiently decreased by FBM feeding, and was persistently decreased by PTF. These results suggest that preterm infants who received PTF has higher splanchnic tissue oxygen extraction compared to those who received MOM or FBM. IMPACT: Human milk feeding is associated to a lower splanchnic energy expenditure than preterm formula feeding. Fortified human milk transiently increases splanchnic energy expenditure. Preterm formula should be used only in the absence of human milk.
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Alimentación con Biberón , Lactancia Materna , Alimentos Fortificados , Fórmulas Infantiles , Recien Nacido Prematuro , Leche Humana , Oxígeno/sangre , Circulación Esplácnica , Metabolismo Energético , Edad Gestacional , Humanos , Recién Nacido , Italia , Leche Humana/metabolismo , Oximetría , Estudios Prospectivos , Espectroscopía Infrarroja Corta , Factores de TiempoRESUMEN
Our aim was to assess the efficacy and safety of intravenous (i.v.) paracetamol vs. i.v. ibuprofen for the treatment of hemodynamically significant patent ductus arteriosus (hsPDA) in preterm infants. This is a multicenter randomized controlled study. Infants with a gestational age of 25+0-31+6 weeks were randomized to receive i.v. paracetamol (15 mg/kg/6 h for 3 days) or i.v. ibuprofen (10-5-5 mg/kg/day). The primary outcome was the closure rate of hsPDA after the first treatment course with paracetamol or ibuprofen. Secondary outcomes included the constriction rate of hsPDA, the re-opening rate, and the need for surgical closure. Fifty-two and 49 infants received paracetamol or ibuprofen, respectively. Paracetamol was less effective in closing hsPDA than ibuprofen (52 vs. 78%; P = 0.026), but the constriction rate of the ductus was similar (81 vs. 90%; P = 0.202), as confirmed by logistic regression analysis. The re-opening rate, the need for surgical closure, and the occurrence of adverse effects were also similar.Conclusions: Intravenous paracetamol was less effective in closing hsPDA than ibuprofen, but due to a similar constriction effect, its use was associated with the same hsPDA outcome. These results can support the use of i.v. paracetamol as a first-choice drug for the treatment of hsPDA.Trial registration: Clinicaltrials.gov : NCT02422966, Date of registration: 04/09/2015; EudraCT no: 2013-003883-30. What is Known: ⢠The successful closure of patent ductus arteriosus with oral paracetamol has been recently reported in several preterm infants, but only one randomized controlled study investigated the efficacy of intravenous paracetamol. What is New: ⢠Intravenous paracetamol is less effective in closing hsPDA than ibuprofen, but have a similar constriction effect. ⢠These results can support the use of i.v. paracetamol as a first-choice drug for the treatment of hsPDA.
Asunto(s)
Conducto Arterioso Permeable , Ibuprofeno , Acetaminofén , Conducto Arterioso Permeable/tratamiento farmacológico , Edad Gestacional , Humanos , Lactante , Recién Nacido , Recien Nacido PrematuroRESUMEN
AIM: To assess the effect of midwife-to-infant ratio on healthy term infant outcome. METHODS: Infants were enrolled in an inhospital midwife-led centre and an obstetrician-led centre with different midwife-to-infant ratios (1:2.5-1:5 vs 1:7-1:15). The primary endpoint was exclusive breastfeeding rate; secondary endpoints were neonatal admission in neonatal care unit rate and length of hospital stay. RESULTS: One hundred and ten infants were enrolled in both midwife- and obstetrician-led centre. Exclusive breastfeeding rate at discharge was higher (88% vs 78%, P = .048) in infants born in the midwife- than in the obstetrician-led centre. Admission rate in neonatal care units (9% vs 2%, P = .017) and stay in hospital duration (3.1 ± 1.8 vs 2.6 ± 0.8 days, P = .008) were higher in the obstetrician- than in the midwife-led centre. Birth in the midwife-led centre increased the likelihood of exclusive breastfeeding (OR: 2.04, 1.07-3.92), while newborns' admission in neonatal care units decreased it (OR : 0.17, 0.07-0.43). CONCLUSION: Healthy term infants' neonatal outcome is negatively associated with a low midwife-to-infant ratio which decreases exclusive breastfeeding rate and is associated with a higher likelihood of admission in neonatal care units and longer stay in hospital.
Asunto(s)
Partería , Lactancia Materna , Femenino , Hospitalización , Humanos , Lactante , Mortalidad Infantil , Recién Nacido , Unidades de Cuidado Intensivo Neonatal , Parto , EmbarazoRESUMEN
OBJECTIVE: To investigate recombinant human insulin-like growth factor 1 complexed with its binding protein (rhIGF-1/rhIGFBP-3) for the prevention of retinopathy of prematurity (ROP) and other complications of prematurity among extremely preterm infants. STUDY DESIGN: This phase 2 trial was conducted from September 2014 to March 2016. Infants born at a gestational age of 230/7 weeks to 276/7 weeks were randomly allocated to rhIGF-1/rhIGFBP-3 (250 µg/kg/ 24 hours, continuous intravenous infusion from <24 hours of birth to postmenstrual age 296/7 weeks) or standard neonatal care, with follow-up to a postmenstrual age of 404/7 weeks. Target exposure was ≥70% IGF-1 measurements within 28-109 µg/L and ≥70% intended therapy duration. The primary endpoint was maximum severity of ROP. Secondary endpoints included time to discharge from neonatal care, bronchopulmonary dysplasia, intraventricular hemorrhage, and growth measures. RESULTS: Overall, 61 infants were allocated to rhIGF-1/rhIGFBP-3, 60 to standard care (full analysis set); 24 of 61 treated infants achieved target exposure (evaluable set). rhIGF-1/rhIGFBP-3 did not decrease ROP severity or ROP occurrence. There was, however, a 53% decrease in severe bronchopulmonary dysplasia in the full analysis set (21.3% treated vs 44.9% standard care), and an 89% decrease in the evaluable set (4.8% vs 44.9%; P = .04 and P = .02, respectively) for severity distribution between groups. There was also a nonsignificant trend toward decrease in grades 3-4 intraventricular hemorrhage in the full analysis set (13.1% vs 23.3%) and in the evaluable set (8.3% vs 23.3%). Fatal serious adverse events were reported in 19.7% of treated infants (12/61) and 11.7% of control infants (7/60). No effect was observed on time to discharge from neonatal care/growth measures. CONCLUSIONS: rhIGF-1/rhIGFBP-3 did not affect development of ROP, but decreased the occurrence of severe bronchopulmonary dysplasia, with a nonsignificant decrease in grades 3-4 intraventricular hemorrhage. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01096784.
Asunto(s)
Hemorragia Cerebral/prevención & control , Factor I del Crecimiento Similar a la Insulina/uso terapéutico , Proteínas Recombinantes/uso terapéutico , Retinopatía de la Prematuridad/prevención & control , Displasia Broncopulmonar/prevención & control , Hemorragia Cerebral/terapia , Femenino , Edad Gestacional , Humanos , Recien Nacido Extremadamente Prematuro , Recién Nacido , Recien Nacido Prematuro , Infusiones Intravenosas , Proteína 3 de Unión a Factor de Crecimiento Similar a la Insulina/uso terapéutico , Masculino , Retinopatía de la Prematuridad/mortalidad , Retinopatía de la Prematuridad/terapia , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
Efficacy and safety profiles of different pharmacological interventions used to treat patent ductus arteriosus (PDA) are relatively unexplored. Integrating the findings of randomized clinical trials (RCTs) with those from observational studies may provide key evidence on this important issue. We aimed at estimating the relative likelihood of failure to close the PDA, need for surgical closure, and occurrence of adverse events among preterm and full-term infants treated with indomethacin, ibuprofen, or acetaminophen, placebo, or no treatment including both RCTs and observational studies. We searched PubMed, Embase, and the Register of Controlled Trials from inception to October 30, 2018. We first estimated proportions of subjects with failure to close the PDA, subjects in whom surgical closure was performed after pharmacological treatment, death, and subjects with selected adverse events (AEs). These estimates were obtained using frequentist random-effect meta-analysis of arm-specific proportions. We then compared active drugs with each other and with control (either placebo or no treatment) by summarizing results at the end of treatment reported in the papers, regardless of number of administration(s), dose, route and type of administration, and study design and quality. We also summarized primary outcome results separately at first, second and third cycles of treatment. These estimates were obtained using Bayesian random-effects network meta-analysis for mixed comparisons, and frequentist random-effect pairwise meta-analysis for direct comparisons. We included 64 RCTs and 24 observational studies including 14,568 subjects (5339 in RCTs and 9229 in observational studies, 8292 subjects received indomethacin, 4761 ibuprofen, 574 acetaminophen, and 941 control (including placebo or no intervention).The proportion of subjects with failure to close the PDA was 0.24 (95% Confidence Interval, CI: 0.20, 0.29) for indomethacin, 0.18 (0.14, 0.22) for ibuprofen, 0.19 (0.09, 0.30) for acetaminophen, and 0.59 (0.48, 0.69) for control. At end of treatment, compared to control, we found inverse associations between all active drugs and failure to close PDA (for indomethacin Odds Ratio, OR, was 0.17 [95% Credible Interval, CrI: 0.11-0.24], ibuprofen 0.19 [0.12-0.28], and acetaminophen 0.15 [0.09-0.26]), without differences among active drugs. We showed inverse associations between effective drugs and need for surgical closure, as compared to control (for indomethacin OR was 0.28 [0.15-0.50], ibuprofen 0.30 [0.16-0.54], and acetaminophen 0.19 [0.07-0.46]), without differences among drugs. Indomethacin was directly associated with intraventricular hemorrhage (IVH) (1.27; 1.00, 1.62) compared to ibuprofen, and to oliguria as compared to ibuprofen (3.92; 1.69, 9.82) or acetaminophen (10.8; 1.86, 93.1). In conclusion, active pharmacological treatment, with indomethacin, ibuprofen, or acetaminophen, is inversely associated with failure to close the PDA compared to non-treatment. Ibuprofen should be preferred to indomethacin to avoid occurrence of IVH or oliguria, acetaminophen should be preferred to indomethacin to avoid oliguria.