T-Piece resuscitator versus self-inflating bag for delivery room resuscitation in preterm neonates: a randomized...

The establishment of adequate ventilation is the cornerstone of neonatal resuscitation in the delivery room (DR). This parallel-group, accessor-blinded randomized controlled trial compared the changes in peripheral oxygen saturation (SpO₂), heart rate (HR), and cerebral regional oxygen saturation (crSO₂) with the use of a T-piece resuscitator (TPR) versus self-inflating bag (SIB) as a mode of providing positive pressure ventilation (PPV) during DR resuscitation in preterm neonates. Seventy-two preterm neonates were randomly allocated to receive PPV with TPR (n = 36) or SIB (n = 36). The primary outcome was SpO₂ (%) at 5 min. The secondary outcomes included the time to achieve a SpO₂ ≥ 80% and > 85%, HR > 100/min, fractional-inspired oxygen (FiO₂) requirement, minute-specific SpO₂, HR and FiO₂ trends for the first 5 min of life, need for DR-intubation, crSO₂, need and duration of respiratory support, and other in-hospital morbidities. Mean SpO₂ at 5 min was 74.5 ± 17.8% and 69.4 ± 22.4%, in TPR and SIB groups, respectively [Mean difference, 95% Confidence Interval 5.08 (-4.41, 14.58); p = 0.289]. No difference was observed in the time to achieve a SpO₂ ≥ 80% and > 85%, HR > 100/min, the requirement of FiO₂, DR-intubation, and the need and duration of respiratory support. There was no significant difference in the minute-specific SpO₂, HR, and FiO₂ requirements for the first 5 min. CrSO₂ (%) at one hour was lower by 5% in the TPR group compared to SIB; p = 0.03. Other complications were comparable.

TPR and SIB resulted in comparable SpO₂ at 5 min along with similar minute-specific SpO₂, HR, and FiO₂ trends.

Clinical trial registry of India, Registration no: CTRI/2021/10/037384, Registered prospectively on: 20/10/2021, https://ctri.icmr.org.in/ .

• Compared to self-inflating bags (SIB), T-piece resuscitators (TPR) provide more consistent inflation pressure and tidal volume as shown in animal and bench studies. • There is no strong recommendation for one device over the other in view of low certainty evidence.

• TPR and SIB resulted in comparable peripheral oxygen saturation (SpO2) at 5 min along with similar minute-specific SpO2, heart rate, and fractional-inspired oxygen requirement trends. • Short-term complications and mortality rates were comparable with both devices.