Health Condition 1: null- The oxidative stress levels, by measuring plasma 15-F2t-isoprostane levels with and without exposure to 100% oxygen
Conditions
Interventions
Intervention1: 100% oxygen: Administered in delivery room if resuscitation is warranted till the babys pulse saturation is within the normal range for that age
Control Intervention1: Room air: 21% of
Sponsors
PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: 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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma 15-F2t-isoprostane levelsTimepoint: At 4 hours of life | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Biochemical : Plasma 15-F2t-isoprostane levels, plasma MDA levels, blood gas parameters (pH, pO2, pCO2, SBE) 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 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 Timepoint: Biochemical - 1, 4, 12, 24 and 72 hours Physiologic - 30 minutes Clinical - 40 weeks or earlier | — |
Countries
India
Contacts
Public ContactPraveen Kumar
PGIMER
Outcome results
None listed