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

Nantes University Hospital363 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

363

Conditions

Patent Ductus Arteriosus

Interventions

IbuprofenDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMax age: 28 Weeks

Medical Language ↔ Plain English

Inclusion Criteria: * Gestational less than 28 weeks * Postnatal age less than 12 hours

Locations (11)

University Hopsital

Angers, France

University Hopsital

Bordeaux, France

University Hospital

Créteil, France

University Hospital

Grenoble, France

Outcomes

Primary Outcomes

2-year survival without cerebral palsy

Time frame: 2 years

Secondary Outcomes

ASQ (Ages and Stages Questionnaire) score at 2 years

Time frame: 2 years

Incidence of other prematurity-related morbidities (pulmonary, digestive, neurological, renal)

To compare the outcome between the large and the small ductus groups

Time frame: 2 years

Comparison of outcome according to the McNamara stage at surgical ligation

Time frame: 2 years

Data from ClinicalTrials.gov

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