RecruitingPhase 2ACTRN12607000532404

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


Sponsor

Dr David Knight

Enrollment

90 participants

Start Date

Aug 10, 2007

Study Type

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

Sex: Both males and femalesMin Age: 2 DayssMax Age: 28 Weekss

Plain Language Summary

Simplified for easier understanding

This study is looking at whether treating a common heart condition in very premature babies — called patent ductus arteriosus (PDA) — actually improves their outcomes. A PDA is when a small blood vessel near the heart that normally closes at birth stays open. Although this is routinely treated with a drug called indomethacin, there is limited evidence that treatment actually helps. This pilot study will help determine if a larger international study to answer this question is feasible. You may be eligible if: - Your baby was born weighing less than 1,250 grams OR at less than 28 weeks of pregnancy - Your baby has been found by ultrasound (echocardiography) to have a large patent ductus arteriosus at 3 days of age You may NOT be eligible if: - Your baby has significant birth defects - Your baby's condition is considered life-threatening in the next few hours - Your baby has already received indomethacin - There is a medical reason your baby cannot receive indomethacin Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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

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)

Auckland, New Zealand

New Zealand

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12607000532404


Related Trials