Aminophylline in Neonates with Moderate to Severe Asphyxia undergoing Therapeutic Hypothermia: A Randomized Controlled Clinical Trial.
Phase 1
- Conditions
- Health Condition 1: P039- Newborn affected by complication of labor and delivery, unspecified
- Registration Number
- CTRI/2022/10/046291
- Lead Sponsor
- BLDEDU SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER VIJAYAPURA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All neonates born above 36 weeks of gestation with evidence of intrapartum asphyxia (APGAR score: <5 at 10 min, Continued need for PPV at 10 min, Cord or postnatal pH before 1 hr <7.00, Cord or postnatal base deficit before 1hr >12mmmol/L) and presence of moderate or severe hypoxic-ischemic encephalopathy as per modified Sarnat and Sarnat staging undergoing Therapeutic Hypothermia are included.
Exclusion Criteria
Neonates < 36 weeks and birth weight <1.8 kg with evidence of intrapartum asphyxia are excluded from the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the efficacy of aminophylline in neonates with moderate to severe encephalopathy undergoing Therapeutic Hypothermia. <br/ ><br>Timepoint: at 12 Hours of Life <br/ ><br> <br/ ><br>at 72 Hours of Life
- Secondary Outcome Measures
Name Time Method 2.To assess optimal dosing strategies, importance of timing and duration of exposure of aminophylline, in neonates with moderate to severe encephalopathy during Therapeutic Hypothermia.Timepoint: at 12 Hours of Life <br/ ><br> <br/ ><br>at 72 Hours of Life