A study to determine whether closure of Patent ductus arteriosus with indomethacin on the basis of size in the first 24 hrs of life in preterm babies between 28-32 weeks having respiratory difficulty is required or not.
Phase 4
Completed
- Registration Number
- CTRI/2009/091/000041
- Lead Sponsor
- Anil Batra
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Preterm 28 - 32 weeks admitted to NICU within 12 hrs of birth
Ventilatory support for respiratory distress
PDA more than or equal to 2 mm in size in the first 24 hrs of life
Exclusion Criteria
Babies with major congenital malformations
Any contraindication of giving indomethacin
Babies with severe asphyxia as defined by Apgar score, <3 at 5 min of life with cord/with in 1 hour of life pH< 7.0 or base excess >16
Shock requiring pressor support at time of randomization
Refusal to obtain consent
Gestation below 28 weeks
Presence of other cardiac malformations including ASD, VSD, any cause of left ventricular dysfunction and mitral valve abnormalities
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Closure of PDA at 7 days of lifeTimepoint: 7 days
- Secondary Outcome Measures
Name Time Method Duration of assisted ventilation <br>Hemodynamically significant PDA at 3 days of age<br>Pulmonary hemorrhage<br>Intraventricular haemorrhage <br>Duration of oxygen dependence <br>Duration of hospital stay<br>Sepsis <br>Side effects related to indomethacin<br>Timepoint: 3 days<br>Nursery stay