International Journal of Clinical Trials | July-September 2023 | Vol 10 | Issue 3 Page 233 International Journal of Clinical Trials Kumar H et al. Int J Clin Trials. 2023 Aug;10(3):233-242 http://www.ijclinicaltrials.com pISSN 2349-3240 | eISSN 2349-3259 Protocol Protocol of randomized controlled trial comparing T piece resuscitator versus self-inflating bag for resuscitation in the delivery room in preterm neonates Harshit Kumar, Suksham Jain*, Supreet Khurana, Deepak Chawla INTRODUCTION The vast majority of newborns, approximately 90% need little assistance to successful transition from intrauterine to extrauterine life. Approximately 10% of infants require some assistance for normal transition at birth. Of these, roughly 3-6% need assisted ventilation, and less than 1% require extensive resuscitation. 1,2 The most important action in resuscitation of a newborn in the delivery room is to establish effective ventilation. Most widely used devices for manual ventilation are SIB and TPR, flow inflating bag is another device with uncommon usage. To date, there is insufficient evidence regarding the optimal device for establishing effective ventilation in newborns at birth. Current ILCOR and American academy of paediatrics (AAP)/American heart association (AHA) recommendations state that ventilation of neonates can be performed effectively with a flow-inflating bag, a SIB, or TPR. 3 TPR have an intrinsic ability to provide positive end expiratory pressure (PEEP). In addition, it has been shown to deliver more accurate and consistent peak inspiratory pressure (PIP) when compared with SIB. 4 It is ABSTRACT Background: Neonatal resuscitation is a critical process for a newborn with effective ventilation as its key component. Three manual ventilation devices, including self-inflating bags (SIB), flow-inflating bags (FIB), and T- piece resuscitator (TPR) are recommended for positive pressure ventilation (PPV) in the delivery room. To date, there is insufficient evidence regarding the optimal device for establishing effective ventilation in newborns. This study is planned to compare the effectiveness of TPR and SIB during resuscitation. Methods: This will be a single centre, open-label, randomized controlled trial. Study participants will be preterm ≤34 of gestation needing PPV at birth as per NRP algorithm. Newborns will be randomly assigned to two groups (TPR or SIB). SpO 2 at 2 and 5 min, time to reach heart rate >100/min by pulse oximetry, and duration of PPV will be recorded. Primary outcome is need of delivery room intubation. Intention to treat analysis will be done using STATA version 17.0. A priori defined subgroup for purpose of analysis will be gestation ≤30 and 31-34 weeks. Trial will be done as per good clinical practice guidelines. Conclusions: If PPV with TPR is proven to be more efficacious in terms of less delivery room intubation, there would be a way towards finalizing the TPR as primary device for providing PPV during delivery room resuscitation at birth. This study has potential to bring down need of delivery room intubation with less duration of mechanical ventilation and morbidity in form of IVH, BPD and composite outcome of BPD and death. Trial registration: CTRI number: CTRI/2023/01/048660. Keywords: TPR, SIB, Delivery room resuscitation, Delivery room intubation Department of Neonatology, Government Medical College and Hospital, Chandigarh, India Received: 02 April 2023 Revised: 13 July 2023 Accepted: 17 July 2023 *Correspondence: Dr. Suksham Jain, E-mail: dr.sukshamj@gmail.com Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. DOI: https://dx.doi.org/10.18203/2349-3259.ijct20232196