A clinical trial to evaluate the duration of caffeine therapy for apnea of prematurity
Not Applicable
Active, not recruiting
- Conditions
- Health Condition 1: null- Apnea of Prematurity
- Registration Number
- CTRI/2016/12/007559
- Lead Sponsor
- Kerala Institute of Medical Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All babies with birth gestation between 26 â?? 32 weeks, on caffeine therapy.
Indications for caffeine therapy:
1)As treatment for apnea of prematurity.
2)Prophylactic caffeine therapy in extremely low birth weight infants (birth weight below 1000 g) to avoid intubation and mechanical ventilation, or to enhance extubation.
3)Periextubation caffeine for infants less than 32 weeks and those intubated for RDS.
Exclusion Criteria
â?¿Major congenital anomalies
â?¿Grade 111 or 1V Intraventricular Hemorrhage (IVH).
â?¿On drugs that can cause central nervous system depression â?? morphine, midazolam, antiepileptic drugs (AED)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of babies having clinically significant apnea from randomization till transfer to room in each of the two groups.Timepoint: till rooming in.
- Secondary Outcome Measures
Name Time Method