A randomised trial to see if closing the arterial duct improves outcome in very premature babies
Double blind randomised trial of the effect indomethacin for closure of patent ductus arteriosus on death and chronic lung disease in very preterm infants. The Indomethacin Ductus Closure Effect trial: The INDUCE trial
Dr David Knight
90 participants
Aug 10, 2007
Interventional
Conditions
Summary
Patent ductus arteriosus is a common complication in very preterm infants. Although it is treated aggressively with indomethacin, there is little or no evidence that this treatment improves outcome in these infants. This is a pilot study to investigate if outcome is improved. If the pilot is successful, a large international trial will be organised.
Eligibility
Inclusion Criteria1
- Birthweight <1250g or gestational age <28 weeks. Large patent ductus arterisous diagnosed by echocardiography at 3 days of age.
Exclusion Criteria1
- Significant congenital anomalies, likely death within hours, previous indomethacin, contraindication to indomethacin.
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Interventions
Intravenous indomethacin 200mcg/kg x1 then 100mcg/kg x5, all at 24 hourly intervals. Prepared as standard dilution so 0.4ml/kg given for 1st dose then 0.2ml/kg
Locations(2)
View Full Details on ANZCTR
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ACTRN12607000532404