Patent Ductus Arteriosus
Conditions
Keywords
Prematurity, patent ductus arteriosus, ibuprofen
Brief summary
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.
Interventions
DRUGIbuprofen
Very premature infants with a large ductus, selected by an early echocardiogram, will receive ibuprofen before 12 hours of life
DRUGPlacebo
Very premature infants with a large ductus, selected by an early echocardiogram, will receive placebo before 12 hours of life
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 28 Weeks
Healthy volunteers
No
Inclusion criteria
* Gestational less than 28 weeks * Postnatal age less than 12 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year survival without cerebral palsy | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ASQ (Ages and Stages Questionnaire) score at 2 years | 2 years | — |
| Incidence of other prematurity-related morbidities (pulmonary, digestive, neurological, renal) | 2 years | To compare the outcome between the large and the small ductus groups |
| Comparison of outcome according to the McNamara stage at surgical ligation | 2 years | — |
Countries
France
Contacts
STUDY_CHAIRJean-Christophe ROZE, Professor
Nantes University Hospital
Outcome results
None listed