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Clinical efficacy of t piece resuscitator versus selfinflating bag for resuscitation in preterm neonates requiring positive pressure ventilation at birth.

Clinical efficacy of t piece resuscitator versus selfinflating bag for resuscitation in preterm neonates requiring positive pressure ventilation at birth: a randomized controlled trial - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094959
Enrollment
170
Registered
2025-09-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P229- Respiratory distress of newborn, unspecified

Interventions

Intervention1: T piece resuscitator: As per NRP protocol positive pressure ventilation will be provided till the end of NICU Stay Control Intervention1: Self Inflating bag: As per NRP protocol positiv

Sponsors

Government Institute of Medical Sciences Greater Noida
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonates born in this tertiary care irrespective of mode of delivery will be eligible for enrolment if they fulfil the following inclusion criteria: Neonates with gestational age of less than 1. not breathing apneic or gasping. 2. Neonates with Heart Rate less than 100 beats per minute after completion of initial steps of neonatal resuscitation.

Exclusion criteria

Exclusion criteria: Neonates with any of the following conditions will be excluded: 1.Major congenital malformation for example congenital diaphragmatic hernia, central cleft lip, Cleft Palate 2.Major CNS malformations For example Meningomyelocele 3. Twin gestation

Design outcomes

Primary

MeasureTime frame
Delivery room intubation rateTimepoint: At the time of enrollment day 1

Secondary

MeasureTime frame
Duration of NICU stay -Need of surfactant -Neonates developing bronchopulmonary dysplasia at 36 weeksTimepoint: From Base line to till end of the NICU stay

Countries

India

Contacts

Public ContactDr Gaurangi Jaiswal

Government Institute of Medical Sciences

gaurangijaiswal08@gmail.com6388431180

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026