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Completed

NCT Number: NCT01630278

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

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.

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Key information

Conditions

Patent Ductus Arteriosus Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ductus Arteriosus, Patent Female Urogenital Diseases and Pregnancy Complications Heart Defects, Congenital Heart Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 28 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hopsital, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Ibuprofen

Drug

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

Placebo

Drug

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

Primary outcomes

  1. 2-year survival without cerebral palsy

    Time frame: 2 years

Secondary outcomes

  1. ASQ (Ages and Stages Questionnaire) score at 2 years

    Time frame: 2 years

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

    Time frame: 2 years

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

  3. Comparison of outcome according to the McNamara stage at surgical ligation

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Impact of Early Targeted Ibuprofene Treatment of Patent Ductus Arteriosus (PDA) on Long Term Neurodevelopmental Outcome in Very Premature Infants (TRIOCAPI)

Acronym: TRIOCAPI

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Jun 28, 2012
Registry last updated
Jul 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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