Comparison of different doses of caffeine (respiratory stimulant) to prevent intermittent episodes of cessation of breathing and low saturation/heart rate in preterm babies
Phase 3
- Conditions
- Health Condition 1: P284- Other apnea of newborn
- Registration Number
- CTRI/2023/10/058930
- Lead Sponsor
- Dr Anu Thukral
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All neonates who receive caffeine prophylactically ( <28 weeks of gestation) or for treatment of apnea of prematurity in <32 weeks gestation would be included once the treating clinical team initiates caffeine
Exclusion Criteria
1. Major congenital malformations
2. Antenatally diagnosed chromosomal disorders
3. Infants with airway anomalies
4. Neonates on mechanical ventilation at the time of initiation of caffeine citrate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the incidence of caffeine therapy failure between two maintenance doses in the first 2 weeks post initiation of therapy for apnea of prematurityTimepoint: First 2 weeks post initiation of caffeine
- Secondary Outcome Measures
Name Time Method 1. Number of investigative workups done for evaluation of secondary causes of apnea while on maintenance caffeine therapy till death/discharge/caffeine stoppage <br/ ><br>2. No of episodes of hypoxemia(Spo2 <90%) in the first 24-72 hours after the initiation of maintenance caffeine therapy <br/ ><br>3. Cumulative dose in mg of caffeine the neonate received till death/discharge/caffeine stoppage <br/ ><br>4. Duration of respiratory support <br/ ><br>5. Duration of hospital stay <br/ ><br>6. Incidence of al cause failure of caffeine therapy in the first 2 weeks of initiation of therapy for apnea of prematurityTimepoint: Till death/discharge/ caffeine stoppage