COMPARISON OF USING AIR VERSUS 100% OXYGEN FOR MANAGING NEWLY BORN BABIES IN THE DELIVERY ROOM

Not Applicable

Conditions: Health Condition 1: null- The oxidative stress levels, by measuring plasma 15-F2t-isoprostane levels with and without exposure to 100% oxygen

Registration Number: CTRI/2012/04/002593

Lead Sponsor: PGIMER

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 124

Inclusion Criteria

1) Preterm neonates 28 to 33 6/7 weeks gestation born between 8 AM to 9PM , Monday to Saturday in delivery room or operation theatre (Note: These timings have been chosen to ensure the availability of the research team for all eligible deliveries ), and

2) Needing bag and mask ventilation as per Neonatal Resuscitation Program (NRP) i.e. apnea or gasping respiration, and/or heart rate < 100/min after 30 seconds of initial steps

Exclusion criteria:

1)Life threatening congenital malformations diagnosed antenatally or soon after birth

2)Antenatally diagnosed congenital heart defects

3)Concurrent delivery where the research team is already involved with delivery of another woman already enrolled in the trial.

Exclusion Criteria

a)Life threatening congenital malformations diagnosed antenatally or soon after birth

b)Antenatally diagnosed congenital heart defects

c)Concurrent delivery where the research team is already involved with delivery of another woman already enrolled in the trial.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma 15-F2t-isoprostane levelsTimepoint: At 4 hours of life

Secondary Outcome Measures

Name	Time	Method
a)Biochemical : Plasma 15-F2t-isoprostane levels, plasma MDA levels, blood gas parameters (pH, pO2, pCO2, SBE)<br>b)Physiologic : Apgar scores at 5, 10, 15 and 20 minutes of life, Time to normalization of heart rate (>100/minute), heart rate and SpO2 changes <br>c)Clinical : Time to first breath, Time to achieve regular respiration, Mortality, Incidences of hypoxic ischemic encephalopathy (HIE), Bronchopulmonary dysplasia (BPD), and retinopathy of prematurity (ROP), duration of oxygen, duration of ventilation, abnormal neurological examination <br>Timepoint: Biochemical - 1, 4, 12, 24 and 72 hours<br>Physiologic - 30 minutes<br>Clinical - 40 weeks or earlier