Page 121 - Physiological based CPAP for preterm infants at birth Tessa Martherus

Feasibility and effect of physiological based CPAP in preterm infants at birth
PB-CPAP has so far only been investigated in a preclinical setting. Preterm rabbit (25) and sheep (26) studies demonstrated that initially, 15 cmH2O CPAP improves lung aeration, facilitates cardiovascular stability and better supports spontaneous breathing compared to the currently used CPAP levels. Lung aeration and breathing rates could be maintained if CPAP was gradually decreased to at least 8 cmH2O but did increase oxygen requirements. Overall, there were no indications that PB-CPAP impedes the cardiovascular system or increases the risk on pneumothorax, CPAP belly or intraventricular haemorrhages.
This is the first clinical study that investigates PB-CPAP in preterm infants and we aimed to test the feasibility of using this strategy in the DR and evaluate the effect on physiological parameters.
Methods
P
This single-blinded randomized controlled trial was conducted at the Leiden University Medical Center (LUMC). Preterm infants born between 24+0 and 29+6 weeks gestation were eligible for inclusion. Exclusion criteria were congenital malformations or abnormalities (observed during pregnancy) that affect the transition at birth. Parents were not approached for study participation if there was a language barrier, if there was no time to acquire informed consent or if it was considered inappropriate.
Infants were randomized to PB-CPAP or 5-8 cmH2O CPAP using an electronic data capture
system (Castor EDC, Amsterdam, the Netherlands). While allocation was initially solely 5 stratified by gestational age (24+0-26+6 and 27+0-29+6 weeks, variable block sizes (4-6)), the stratification number of infants per pregnancy (single and twin pregnancies) was added after randomizing twenty-three infants in November 2020 and documented in a protocol amendment.
Infants randomized to PB-CPAP received 15 cmH2O CPAP until they reached predefined stabilization criteria (heart rate ≥100 bpm, SpO2 ≥85%, FiO2 ≤0.4, spontaneous breathing), then CPAP was decreased to 8 cmH2O in three steps (2-2-3 cmH2O/min). The decrease in CPAP only continued if the infant still met the stabilization criteria. If infants became apneic, intermittent positive pressure ventilation (iPPV) was initiated with a PEEP of 8 cmH2O. Once infants continued on CPAP after a period of iPPV, the pressure was increased back to the CPAP level that had been used prior to the ventilation period. After completing the 10 min study duration, all infants continued with CPAP levels conforming to local protocols. An escape strategy was provided for infants who were breathing sufficiently prior to the start of respiratory support. We assumed that these infants had already established lung aeration and that continuous 8 cmH2O CPAP is sufficient to maintain aeration. Infants randomized to the control group, received 5 to 8 cmH2O CPAP. Remaining procedures were executed in line with the local protocol, with exception of infants who participated in the ABC3 study (NCT0380851) and were randomized to physiological based cord clamping.
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