A clinical trial to evaluate duration of caffeine therapy for apnea of prematurity in preterm newborn.
Not Applicable
- Conditions
- Health Condition 1: P284- Other apnea of newborn
- Registration Number
- CTRI/2023/09/057347
- Lead Sponsor
- ikhil Kumar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All babies with birth gestation between 28 to 32 weeks on caffeine therapy.
Exclusion Criteria
antenatally detected congenital anomalies
parents not giving consent
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To estimate the proportion of infants between 28 to 32 weeks of gestational age who have clinically significant apnea on stopping caffeine after an apnea free period of 7 days. <br/ ><br>Clinically Significant Apnea defined as drop in saturation below 80% and any one of the following: <br/ ><br>(a) decrease in heart rate below 100/min. <br/ ><br>(b) Poor respiratory effort requiring PPV. <br/ ><br>(C)Need for o2 supplementation,HHFNC,CPAP,MV.(d)Restart of caffeine therpy by clinical team.Timepoint: From birth to 7 days of apnea free and off respiratory support.
- Secondary Outcome Measures
Name Time Method 1. To study the adverse effects related to caffeine among neonates. <br/ ><br> <br/ ><br>2.To study the factors associated with clinically significant apnea after an apnea free period of 7 dayTimepoint: From birth till rooming in.