Early Ibuprofen Treatment of Patent Ductus Arteriosus (PDA) in Premature Infants (TRIOCAPI)

Nantes University Hospital (NUH)

Status and phase: Completed; Phase 3

Conditions: Patent Ductus Arteriosus

Treatments: Drug: Placebo; Drug: Ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT01630278

BRD/10/06-O

Details and patient eligibility

About

Very premature infants with a large ductus, selected by an early echocardiogram, will receive either ibuprofen or placebo before 12 hours of life. Follow-up will include repeated echocardiograms and cranial ultrasound at 36 hours, 14 days and 36 weeks of postconceptional age. The primary outcome will be survival without cerebral palsy at years.

Enrollment: 363 patients

Sex: All

Ages: Under 28 weeks old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Gestational less than 28 weeks
• Postnatal age less than 12 hours

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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363 participants in 3 patient groups, including a placebo group

Small ductus

No Intervention group

Large ductus ibuprofen

Experimental group

Description:

Very premature infants with a large ductus, selected by an early echocardiogram, will receive ibuprofen before 12 hours of life

Treatment:

Drug: Ibuprofen

Large ductus placebo

Placebo Comparator group

Description:

Very premature infants with a large ductus, selected by an early echocardiogram, will receive placebo before 12 hours of life

Treatment:

Drug: Placebo