Preterm neonates were initially managed with either nCPAP or PS with rapid extubation to nCPAP had similar clinical outcomes to those treated with PS followed by a period of mechanical ventilation. An approach that uses early nCPAP leads to a reduction in the number of infants who are intubated and given surfactant.
Objective To compare early routine pharmacologic treatment of moderate-to-large patent ductus arteriosus (PDA) at the end of week 1 with a conservative approach that requires prespecified respiratory and hemodynamic criteria before treatment can be given. Study design A total of 202 neonates of <28 weeks of gestation age (mean, 25.8 ± 1.1 weeks) with moderate-to-large PDA shunts were enrolled between age 6 and 14 days (mean, 8.1 ± 2.2 days) into an exploratory randomized controlled trial. Results At enrollment, 49% of the patients were intubated and 48% required nasal ventilation or continuous positive airway pressure. There were no differences between the groups in either our primary outcome of ligation or presence of a PDA at discharge (early routine treatment [ERT], 32%; conservative treatment [CT], 39%) or any of our prespecified secondary outcomes of necrotizing enterocolitis (ERT, 16%; CT, 19%), bronchopulmonary dysplasia (BPD) (ERT, 49%; CT, 53%), BPD/death (ERT, 58%; CT, 57%), death (ERT,19%; CT, 10%), and weekly need for respiratory support. Fewer infants in the ERT group met the rescue criteria (ERT, 31%; CT, 62%). In secondary exploratory analyses, infants receiving ERT had significantly less need for inotropic support (ERT, 13%; CT, 25%). However, among infants who were ≥26 weeks gestational age, those receiving ERT took significantly longer to achieve enteral feeding of 120 mL/kg/day (median: ERT, 14 days [range, 4.5-19 days]; CT, 6 days [range, 3-14 days]), and had significantly higher incidences of late-onset non-coagulase-negative Staphylococcus bacteremia (ERT, 24%; CT,6%) and death (ERT, 16%; CT, 2%). Conclusions In preterm infants age <28 weeks with moderate-to-large PDAs who were receiving respiratory support after the first week, ERT did not reduce PDA ligations or the presence of a PDA at discharge and did not improve any of the prespecified secondary outcomes, but delayed full feeding and was associated with higher rates of late-onset sepsis and death in infants born at ≥26 weeks of gestation. Trial registration ClinicalTrials.gov: NCT01958320.
IMPORTANCE Umbilical cord milking as an alternative to delayed umbilical cord clamping may provide equivalent benefits to preterm infants, but without delaying resuscitation. OBJECTIVE To determine whether the rates of death or severe intraventricular hemorrhage differ among preterm infants receiving placental transfusion with umbilical cord milking vs delayed umbilical cord clamping. DESIGN, SETTING, AND PARTICIPANTS Noninferiority randomized clinical trial of preterm infants (born at 23-31 weeks' gestation) from 9 university and private medical centers in 4 countries were recruited and enrolled between June 2017 and September 2018. Planned enrollment was 750 per group. However, a safety signal comprising an imbalance in the number of severe intraventricular hemorrhage events by study group was observed at the first interim analysis; enrollment was stopped based on recommendations from the data and safety monitoring board. The planned noninferiority analysis could not be conducted and a post hoc comparison was performed instead. Final date of follow-up was December 2018. INTERVENTIONS Participants were randomized to umbilical cord milking (n = 236) or delayed umbilical cord clamping (n = 238). MAIN OUTCOMES AND MEASURES The primary outcome was a composite of death or severe intraventricular hemorrhage to determine noninferiority of umbilical cord milking with a 1% noninferiority margin. RESULTS Among 540 infants randomized, 474 (88%) were enrolled and completed the trial (mean gestational age of 28 weeks; 46% female). Twelve percent (29/236) of the umbilical cord milking group died or developed severe intraventricular hemorrhage compared with 8% (20/238) of the delayed umbilical cord clamping group (risk difference, 4% [95% CI, −2% to 9%]; P = .16). Although there was no statistically significant difference in death, severe intraventricular hemorrhage was statistically significantly higher in the umbilical cord milking group than in the delayed umbilical cord clamping group (8% [20/236] vs 3% [8/238], respectively; risk difference, 5% [95% CI, 1% to 9%]; P = .02). The test for interaction between gestational age strata and treatment group was significant for severe intraventricular hemorrhage only (P = .003); among infants born at 23 to 27 weeks' gestation, severe intraventricular hemorrhage was statistically significantly higher with umbilical cord milking than with delayed umbilical cord clamping (22% [20/93] vs 6% [5/89], respectively; risk difference, 16% [95% CI, 6% to 26%]; P = .002). CONCLUSIONS AND RELEVANCE In this post hoc analysis of a prematurely terminated randomized clinical trial of umbilical cord milking vs delayed umbilical cord clamping among preterm infants born at less than 32 weeks' gestation, there was no statistically significant difference in the rate of a composite outcome of death or severe intraventricular hemorrhage, but there was a statistically significantly higher rate of severe intraventricular hemorrhage in the umbilical cord milking group. The early study termination and resulti...
Rational, consensus periviability guidelines are well accepted and can be used by all neonatologists, obstetricians, and nurses who provide care to pregnant women and infants at extremely early gestational ages. Pregnant women see these guidelines as highly understandable, useful, consistent, and respectful. When encouraged to participate with attending staff in discussions involving morbidity and mortality outcomes of premature infants and consensus medical practice recommendations, a substantial proportion of parents will choose palliative comfort care for their extremely premature infant up through 25 weeks' postmenstrual age. We believe the choice of neonatal intensive care versus palliative comfort care in extremely premature infants rightfully belongs to medically informed parents. More research is needed to examine how these decisions are made under diverse conditions of culture, religion, and technology.
Objective: Strategies to reduce Retinopathy of Prematurity (ROP) have focused primarily on respiratory management. Hyperglycemia (HG) and insulin use, risk factors for adult diabetic retinopathy, as well as growth rates may be modifiable variables useful to reduce ROP. ) done in the first 29 days of life were collected for analysis.Result: BGs were done at least every 3 to 6 h for the first 48 to 96 h of life, then every 6 to 24 h thereafter, as long as infants remained on hyperalimentation. Hyperglycemia was defined as mild (BG 151 to 180), moderate (181 to 210) or severe (>210). Insulin use (given if BG>180 to 210) was also noted for each simultaneous BG. ROP was classified as none, mild (stage 1 to 2) or severe (stage 3 to 4). Growth velocity (g kg À1 per day), length and head circumference were also analyzed. In all, 372 infants mean (s.d.) gestational age 27.6 (1.4) weeks, mean (s.d.) birth weight 994 (242) g had 18 649 BGs analyzed. 103 (28%) of the infants had mild ROP and 29 (8%) had severe ROP. 137 (37%) of the infants received at least 1 day of exogenous insulin (median days 9, range 1 to 26). Higher cumulative mean BG, more episodes of HG, and more insulin exposure were associated with an increased incidence and severity of ROP. Ordinal logistic regression identified lower gestational age, male gender, fetal growth restriction, slower NICU growth velocity, and higher BG as predictors for severity of ROP. However, insulin use was a stronger predictor than BG, and replaced it in the risk model. Conclusion:After adjusting for important risk factors, HG and especially insulin use in premature infants may increase the risk of ROP. In addition, slower NICU growth velocity, but not rates of head or length growth, was predictive of ROP.
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