Protocol of randomized controlled trial comparing T piece resuscitator versus self-inflating bag for resuscitation in the delivery room in preterm neonates

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dc.contributor.authorKumar, Harshiten_US
dc.contributor.authorJain, Sukshamen_US
dc.contributor.authorKhurana, Supreeten_US
dc.contributor.authorChawla, Deepaken_US
dc.date.accessioned2024-09-24T07:20:17Z
dc.date.available2024-09-24T07:20:17Z
dc.date.issued2023-09
dc.description.abstractBackground: 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). SpO2 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.en_US
dc.identifier.affiliationsDepartment of Neonatology, Government Medical College and Hospital, Chandigarh, Indiaen_US
dc.identifier.affiliationsDepartment of Neonatology, Government Medical College and Hospital, Chandigarh, Indiaen_US
dc.identifier.affiliationsDepartment of Neonatology, Government Medical College and Hospital, Chandigarh, Indiaen_US
dc.identifier.affiliationsDepartment of Neonatology, Government Medical College and Hospital, Chandigarh, Indiaen_US
dc.identifier.citationKumar Harshit, Jain Suksham, Khurana Supreet, Chawla Deepak. Protocol of randomized controlled trial comparing T piece resuscitator versus self-inflating bag for resuscitation in the delivery room in preterm neonates. International Journal of Clinical Trials. 2023 Jul. 10(3). 233-242en_US
dc.identifier.issn349-3240
dc.identifier.issn2349-3259
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/228782
dc.languageenen_US
dc.relation.issuenumber3en_US
dc.relation.volume10en_US
dc.source.urihttps://doi.org/10.18203/2349-3259.ijct20232196en_US
dc.subjectTPRen_US
dc.subjectSIBen_US
dc.subjectDelivery room resuscitationen_US
dc.subjectDelivery room intubationen_US
dc.titleProtocol of randomized controlled trial comparing T piece resuscitator versus self-inflating bag for resuscitation in the delivery room in preterm neonatesen_US
dc.typeJournal Articleen_US
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