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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000532404

Acronym

INDUCE trial

Enrollment

Registered

2007-10-17

Start date

2007-08-10

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

2 Days to 28 Weeks

Healthy volunteers

Inclusion criteria

Birthweight <1250g or gestational age <28 weeks. Large patent ductus arterisous diagnosed by echocardiography at 3 days of age.

Exclusion criteria

Significant congenital anomalies, likely death within hours, previous indomethacin, contraindication to indomethacin.

Outcome results