Setting of appropriate dosage and comparing the effectiveness of Caffeine and Aminophylline in premature babies with pause of breathing for 15 to 20 seconds
Phase 2
- Conditions
- Health Condition 1: null- Neonates with Apnea of Prematurity
- Registration Number
- CTRI/2015/06/005904
- Lead Sponsor
- Kasturba Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 402
Inclusion Criteria
1. Less than or equal to 34 completed weeks of gestation with less than or equal to 6 apneas in 24 hours , or
2. Any preterm newborn with apneic episode requiring bag and mask ventilation for termination of apnea.
Exclusion Criteria
1.Neonates with secondary causes of apnea ( hypoglycemia , hypocalcemia , hypothermia, seizures , sepsis , Intra Ventricular Hemorrhage , depression from medications)
2.Neonates who are on other drugs that potentiates the toxicity of Methylxanthines
3.Preterm neonates with major congenital anomalies
4.Significant PDA as a cause of apnea (defined as - ductus diameter of 1.5mm and absent/ retrograde diastolic flow in the post-ductal aorta)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method