CTRI/2015/06/005904
Recruiting
Phase 2
Population Pharmacokinetic and Pharmacodynamic study of Aminophylline and Caffeine in premature newborns with Apnea
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kasturba Medical College
- Enrollment
- 402
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Not specified
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