study for optimizing appropriate dosage of Caffeine and Aminophylline in premature new born babies with pause of breathing lasting atleast for 20 seconds
Not Applicable
- Conditions
- Health Condition 1: null- Premature neonates with apnea of prematurityHealth Condition 2: P073- Preterm [premature] newborn [other]
- Registration Number
- CTRI/2017/10/010132
- Lead Sponsor
- Science and Engineering Research Board
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Preterms (<= 34wk gestation) with > 6 apneic episodes within 24hr of life, who will be receiving Methylxanthines for AOP.
Exclusion Criteria
Congenital anomalies, secondary causes of apnea (sepsis, significant Patent Ductus Arteriosus, Glucose, electrolytes abnormality), receiving drugs with enzyme inducing or inhibiting property, previously receiving Methylxanthine.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clearance and volume of distributionTimepoint: Time of dosing and exact time of blood sampling will be recorded. Every 6th month of sampling (in bulk), plasma samples will be evaluated by LCMS technique to obtain drug clearance and volume of distribution
- Secondary Outcome Measures
Name Time Method Apnea count, desaturations, Bradycardia, Heart rate, duration of NICU stay, type of and duration of ventilator support, full feed attainment and adverse events.Timepoint: Apnea counts, desaturations, Bradycardia will be noted at every 24 hours. The frequency of individual event will be summed up at the intervals of 1 to 3 days, 4 to 7 days and 8th to 14 days of methylxanthine adminsitration for statistical analysis. Heart rate will be recorded at every 24 hours.Duration of NICU stay, type of and duration of ventilator support, full feed attainment and adverse events will be monitored till discharge from NICU.