NCT01630278

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
363

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2012

Longer than P75 for phase_3

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

7.3 years

First QC Date

June 11, 2012

Last Update Submit

July 5, 2019

Conditions

Patent Ductus Arteriosus

Keywords

Prematuritypatent ductus arteriosusibuprofen

Outcome Measures

Primary Outcomes (1)

  • 2-year survival without cerebral palsy

    2 years

Secondary Outcomes (3)

  • ASQ (Ages and Stages Questionnaire) score at 2 years

    2 years

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

    2 years

  • Comparison of outcome according to the McNamara stage at surgical ligation

    2 years

Study Arms (3)

Small ductus

NO INTERVENTION

Large ductus ibuprofen

EXPERIMENTAL

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

Drug: Ibuprofen

Large ductus placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

IbuprofenDRUG

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

Large ductus ibuprofen
PlaceboDRUG

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

Large ductus placebo

Eligibility Criteria

AgeUp to 28 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University Hopsital

Angers, France

Location

University Hopsital

Bordeaux, France

Location

University Hospital

Créteil, France

Location

University Hospital

Grenoble, France

Location

University Hospital

Lille, France

Location

University Hospital

Marseille, France

Location

Univesity Hospital

Montpellier, France

Location

University Hospital

Nantes, France

Location

University Hospital (AP-HP Groupe hospitalier)

Paris, France

Location

University Hospital

Rennes, France

Location

University Hospital

Tours, France

Location

Related Publications (2)

  • Roze JC, Cambonie G, Le Thuaut A, Debillon T, Ligi I, Gascoin G, Patkai J, Beuchee A, Favrais G, Flamant C, Durrmeyer X, Clyman R. Effect of Early Targeted Treatment of Ductus Arteriosus with Ibuprofen on Survival Without Cerebral Palsy at 2 Years in Infants with Extreme Prematurity: A Randomized Clinical Trial. J Pediatr. 2021 Jun;233:33-42.e2. doi: 10.1016/j.jpeds.2020.12.008. Epub 2020 Dec 9.

    PMID: 33307111DERIVED

  • Mitra S, Scrivens A, von Kursell AM, Disher T. Early treatment versus expectant management of hemodynamically significant patent ductus arteriosus for preterm infants. Cochrane Database Syst Rev. 2020 Dec 10;12(12):CD013278. doi: 10.1002/14651858.CD013278.pub2.

    PMID: 33301630DERIVED

MeSH Terms

Conditions

Ductus Arteriosus, PatentPremature Birth

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Jean-Christophe ROZE, Professor

    Nantes University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2012

First Posted

June 28, 2012

Study Start

March 1, 2012

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

July 8, 2019

Record last verified: 2019-07

Locations

FR(11)