Comparing Different Caffeine Amounts to Prevent Breathing Problems in Premature Babies: A Study (HI-CAF Trial)
Phase 2
- Conditions
- Health Condition 1: P073- Preterm [premature] newborn [other]
- Registration Number
- CTRI/2024/03/063926
- Lead Sponsor
- Dr Asha M
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All neonates less than 30 weeks of gestation and
Neonates between 30+1 to 31+6 who develop recurrent apnoea.
Exclusion Criteria
Major Congenital anomaly or Chromosomal abnormalities and
Parents who do not consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of apnoea of prematurityTimepoint: Upto 28 days of life
- Secondary Outcome Measures
Name Time Method BPD <br/ ><br>Timepoint: anytime during hospital stay.;Duration of respiratory support.Timepoint: anytime during hospital stay. <br/ ><br>;Growth velocities( average weekly weight gain in first month of life and average weight gain during NICU stay) <br/ ><br>Timepoint: anytime during hospital stay.;Incidence of PDA, NEC, IVH, PVL, ROP and AKI. <br/ ><br>Timepoint: anytime during hospital stay. <br/ ><br>;Mortality <br/ ><br>Timepoint: anytime during hospital stay.;Number of NPO hoursTimepoint: anytime during hospital stay.;Severe adverse events. <br/ ><br>Timepoint: anytime during hospital stay.;The incidence of Hypertension. <br/ ><br>Timepoint: anytime during hospital stay.;The incidence of Seizures. <br/ ><br>Timepoint: anytime during hospital stay.;The rates of failure of extubation.Timepoint: anytime during hospital stay.;The time to reach full enteral feeding.Timepoint: anytime during hospital stay.