Objective To evaluate the effectiveness and safety of a T-piece resuscitator compared with a self-inflating bag for providing mask ventilation to newborns at birth. Study design Newborns at ≥26 weeks ...gestational age receiving positive-pressure ventilation at birth were included in this multicenter cluster-randomized 2-period crossover trial. Positive-pressure ventilation was provided with either a self-inflating bag (self-inflating bag group) with or without a positive end-expiratory pressure valve or a T-piece with a positive end-expiratory pressure valve (T-piece group). Delivery room management followed American Academy of Pediatrics and International Liaison Committee on Resuscitation guidelines. The primary outcome was the proportion of newborns with heart rate (HR) ≥100 bpm at 2 minutes after birth. Results A total of 1027 newborns were included. There was no statistically significant difference in the incidence of HR ≥100 bpm at 2 minutes after birth between the T-piece and self-inflating bag groups: 94% (479 of 511) and 90% (466 of 516), respectively (OR, 0.65; 95% CI, 0.41-1.05; P = .08). A total of 86 newborns (17%) in the T-piece group and 134 newborns (26%) in the self-inflating bag group were intubated in the delivery room (OR, 0.58; 95% CI, 0.4-0.8; P = .002). The mean ± SD maximum positive inspiratory pressure was 26 ± 2 cm H2 O in the T-piece group vs 28 ± 5 cm H2 O in the self-inflating bag group ( P < .001). Air leaks, use of drugs/chest compressions, mortality, and days on mechanical ventilation did not differ significantly between groups. Conclusion There was no difference between the T-piece resuscitator and a self-inflating bag in achieving an HR of ≥100 bpm at 2 minutes in newborns ≥26 weeks gestational age resuscitated at birth. However, use of the T-piece decreased the intubation rate and the maximum pressures applied.
Objective To determine whether very low birth weight infants (VLBWIs), initially supported with continuous positive airway pressure (CPAP) and then selectively treated with the INSURE (intubation, ...surfactant, and extubation to CPAP; CPAP/INSURE) protocol, need less mechanical ventilation than those supported with supplemental oxygen, surfactant, and mechanical ventilation if required (Oxygen/mechanical ventilation MV). Study design In a multicenter randomized controlled trial, spontaneously breathing VLBWIs weighing 800-1500 g were allocated to receive either therapy. In the CPAP/INSURE group, if respiratory distress syndrome (RDS) did not occur, CPAP was discontinued after 3-6 hours. If RDS developed and the fraction of inspired oxygen (FiO2 ) was >0.35, the INSURE protocol was indicated. Failure criteria included FiO2 >0.60, severe apnea or respiratory acidosis, and receipt of more than 2 doses of surfactant. In the Oxygen/MV group, in the presence of RDS, supplemental oxygen without CPAP was given, and if FiO2 was >0.35, surfactant and mechanical ventilation were provided. Results A total of 256 patients were randomized to either the CPAP/INSURE group (n = 131) or the Oxygen/MV group (n = 125). The need for mechanical ventilation was lower in the CPAP/INSURE group (29.8% vs 50.4%; P = .001), as was the use of surfactant (27.5% vs 46.4%; P = .002). There were no differences in death, pneumothorax, bronchopulmonary dysplasia, and other complications of prematurity between the 2 groups. Conclusion CPAP and early selective INSURE reduced the need for mechanical ventilation and surfactant in VLBWIs without increasing morbidity and death. These results may be particularly relevant for resource-limited regions.
Objective To determine the relationship between Pa co2 in the first 4 days of life and neurodevelopment at 18 to 22 months. Study design Stepwise regression and exhaustive CHAID (Chi-squared ...Automatic Interaction Detector) analyses were done for neurodevelopmental impairment (NDI), mental developmental index (MDI), and psychomotor developmental index (PDI) using clinical variables in combination with the maximum (max), time-weighted average (avg), and max-minimum (max-min) Pa co2 in 400 infants of 401 to 1000 g birth weight (BW). Results By regression, NDI predictors were male sex, non-Caucasian race, premature prolonged rupture of membranes (PPROM), lower BW, IVH 3 to 4, and lower 1-minute Apgar score. For lower MDI, predictors were male sex, non-Caucasian race, PPROM, IVH 3 to 4, sepsis, and higher max-min Pa co2 . For lower PDI, predictors were male sex, PPROM, lower BW, IVH 3 to 4, sepsis, and higher avg Pa co2 . By CHAID, the most important predictor of NDI was sex. For MDI, sex was most important followed by max-min Pa co2 >42 mm Hg in boys. For PDI, IVH was most important, followed by max-min Pa co2 >42 mm Hg for grade ≤2 IVH. Conclusions Extreme fluctuations in Pa co2 and higher max Pa co2 are associated with worse neurodevelopmental outcomes and may indicate either a greater severity of illness or contribution of Pa co2 to pathophysiology of adverse neurodevelopment.
