Suitable oxygen levels to help small babies to breathe at birth
- Conditions
- Newborn affected by maternal complication of pregnancy, unspecified,
- Registration Number
- CTRI/2023/01/048958
- Brief Summary
Aim of the study:
To compare the effect of two different oxygen concentrations, i.e., 30% vs. 60% for initiation of delivery room stabilization in preterm neonates.
Hypothesis:
The present study is planned with a hypothesis that initiating delivery room stabilization with an oxygen concentration of 60% might increase the proportion of preterm neonates achieving a target oxygen saturation of ≥80% at 5 minutes, compared to an oxygen concentration of 30%, and lead to a better outcome. The present study may help to generate evidence for the use of optimal initial oxygen concentration for stabilizing preterm neonates at birth.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 150
Inborn preterm neonates with gestational age less than 34 weeks requiring respiratory support for delivery room stabilization as per American Heart Association Neonatal Resuscitation Program (AHA-NRP) 2020 guidelines.
-
- Neonates with birth weight <500 grams and gestational age <25 weeks 2. Non availability of oxygen blender at delivery area 3. Major congenital anomalies 4. Inability to obtain parental consent 5. Parental decision.
- not to resuscitate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of neonates achieving a target oxygen saturation of ≥80%. At 5 minutes of life.
- Secondary Outcome Measures
Name Time Method 1. Time to achieve HR100/min 2. Time to achieve SpO2 85%
Trial Locations
- Locations (1)
All India Institute of Medical Sciences, Rishikesh
🇮🇳Dehradun, UTTARANCHAL, India
All India Institute of Medical Sciences, Rishikesh🇮🇳Dehradun, UTTARANCHAL, IndiaSriparna BasuPrincipal investigator9935340260sriparna.neonat@aiimsrishikesh.edu.in