Comparing Ibuprofen And Indomethacin For The Treatment Of The Patent Ductus Arteriosus in Very Premature Babies

• Status: Withdrawn
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine the safety and efficacy of ibuprofen, compared with indomethacin, in the treatment for the closure of the patent ductus arteriosus in premature babies born under 29 weeks gestation

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: KK Women's and Children's Hospital
• Collaborators: Cumberland Pharmaceuticals; National University Hospital, Singapore
• Treatments: Ibuprofen; Indomethacin

Criteria

Inclusion Criteria:

• Infants <29 weeks gestation with a PDA diameter of >= 1.5 mm on 2Dechocardiogram

• Parental written informed consent - Parent agrees to the subject's participation in the study as indicated by parent's signature on the consent form

• Parent is willing to comply with procedures/treatment and is able to keep to scheduled study assessments

Exclusion criteria:

• Major congenital malformations in the opinion of the investigator

• Necrotising enterocolitis

• Gastrointestinal Perforation

• Systemic illness other than PDA, not fit for the trial in the opinion of the investigator

• The parent is in the opinion of the investigator, mentally or legally incapacitated

• The parent is unwilling/unable to comply to study procedures