Comparison of different devices to establish respiration at birth in tiny babies

Not Applicable

Completed

• Conditions: Health Condition 1: P289- Respiratory condition of newborn,unspecified

• Registration Number: CTRI/2021/10/037384
• Lead Sponsor: All India Institute of Medical Sciences Rishikesh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-02-23
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 72

Inclusion Criteria

Inborn preterm neonates (gestational age <37 weeks) requiring positive pressure ventilation in delivery room.

Exclusion Criteria

1. Major congenital anomalies

2. Inability to attain parental consent

3. Parental decision - not to resuscitate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peripheral oxygen saturation (SpO2).Timepoint: At 5 minutes of life.

Secondary Outcome Measures

Name	Time	Method
1. Time to achieve HR100/min <br/ ><br>2. Time to achieve SpO2 85% <br/ ><br>3. Minute specific HR and SpO2 trends <br/ ><br>4. Cerebral regional oxygen saturation (crSO2) trends till 1 hour <br/ ><br>5. Need for delivery room intubation <br/ ><br>6. Need for surfactant use <br/ ><br>7. Need and duration of respiratory support <br/ ><br>8. Duration of supplemental oxygen therapy <br/ ><br>9. Duration of hospital stay <br/ ><br>10. Incidence of adverse eventsTimepoint: During hospital stay and at discharge.