Abstract

Background: Preterm infants are commonly supported with 5–8 cmH2O CPAP. However, animal studies demonstrate that high initial CPAP levels (12–15 cmH2O) which are then reduced (termed physiological based (PB)-CPAP), improve lung aeration without adversely affecting cardiovascular function. We investigated the feasibility of PB-CPAP and the effect in preterm infants at birth.Methods: Preterm infants (24–30 weeks gestation) were randomized to PB-CPAP or 5–8 cmH2O CPAP for the first 10 min after birth. PB-CPAP consisted of 15 cmH2O CPAP that was decreased when infants were stabilized (heart rate ≥100 bpm, SpO2 ≥85%, FiO2 ≤ 0.4, spontaneous breathing) to 8 cmH2O with steps of ~2/3 cmH2O/min. Primary outcomes were feasibility and SpO2 in the first 5 min after birth. Secondary outcomes included physiological and breathing parameters and short-term neonatal outcomes. Planned enrollment was 42 infants.Results: The trial was stopped after enrolling 31 infants due to a low inclusion rate and recent changes in the local resuscitation guideline that conflict with the study protocol. Measurements were available for analysis in 28 infants (PB-CPAP n = 8, 5–8 cmH2O n = 20). Protocol deviations in the PB-CPAP group included one infant receiving 3 inflations with 15 cmH2O PEEP and two infants in which CPAP levels were decreased faster than described in the study protocol. In the 5–8 cmH2O CPAP group, three infants received 4, 10, and 12 cmH2O CPAP. During evaluations, caregivers indicated that the current PB-CPAP protocol was difficult to execute. The SpO2 in the first 5 min after birth was not different [61 (49–70) vs. 64 (47–74), p = 0.973]. However, infants receiving PB-CPAP achieved higher heart rates [121 (111–130) vs. 97 (82–119) bpm, p = 0.016] and duration of mask ventilation was shorter [0:42 (0:34–2:22) vs. 2:58 (1:36–6:03) min, p = 0.020]. Infants in the PB-CPAP group required 6:36 (5:49-11:03) min to stabilize, compared to 9:57 (6:58–15:06) min in the 5–8 cmH2O CPAP group (p = 0.256). There were no differences in short-term outcomes.Conclusion: Stabilization of preterm infants with PB-CPAP is feasible but tailoring CPAP appeared challenging. PB-CPAP did not lead to higher SpO2 but increased heart rate and shortened the duration of mask ventilation, which may reflect faster lung aeration.

Highlights

  • Elective intubation and mechanical ventilation were standard care in the delivery room (DR), but respiratory support is primarily given non-invasively to minimize risk of injury [1,2,3]

  • One hundred and twenty-seven eligible infants were born in the Leiden University Medical Center (LUMC) during the study enrolment period from October 2019 until March 2021, with the study being halted from March 2020 until May 2020 due to COVID-19 restrictions

  • We found no effect on oxygenation in this study, the effect of Physiological based (PB)-continuous positive airway pressure (CPAP) on Oxygen Saturation (SpO2) could have been diminished by the large difference in gestational age, high Fraction of inspired Oxygen (FiO2) levels in both groups and the fact that the power requirements with respect to sample size could not be met

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Summary

Introduction

Elective intubation and mechanical ventilation were standard care in the delivery room (DR), but respiratory support is primarily given non-invasively to minimize risk of injury [1,2,3]. The effectiveness of non-invasive support is dependent on infants having a patent airway since the larynx of newborn infants closes during apnea [4,5,6,7,8]. Recent studies showed that breathing effort can be stimulated by adequate oxygenation, repetitive tactile stimulation and caffeine [10,11,12]. Respiratory support in the DR can further be optimized by improving lung aeration. Preterm infants are commonly supported with 5–8 cmH2O CPAP. Animal studies demonstrate that high initial CPAP levels (12–15 cmH2O) which are reduced (termed physiological based (PB)-CPAP), improve lung aeration without adversely affecting cardiovascular function. We investigated the feasibility of PB-CPAP and the effect in preterm infants at birth

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