Early pharmacological treatment with supportive care versus supportive care alone in preterm infants with a patent ductus arteriosus

Phase 4

Completed

• Conditions: patent ductus arteriosus; preterm infants; Reproductive Health and Childbirth - Complications of newborn; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12616000195459
• Lead Sponsor: Hunter Medical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-15
• Study Completion: 2019-06-01
• Last Update Posted: 13 September 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

Preterm infants less than 29 weeks gestation
PDA diameter > 1.5 mm
<72 hours of age

Exclusion Criteria

significant active haemorrhage (pulmonary, IVH grade 3 or 4, other) at randomization
major congenital heart disease
significant other congenital abnormalities
absolute contraindications for indomethacin or ibuprofen

Study & Design

• Study Type: Interventional
• Study Design: Not specified