NCT00000494

Brief Summary

To evaluate the effects (up to one year of age) of indomethacin on the clinical course of patent ductus arteriosus (PDA) in premature infants (24 hours old or less) and to assess the relative merits of indomethacin and surgery in infants with persistent respiratory distress who were not treated early with indomethacin. Two concurrent trials were performed.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Sep 1978

Shorter than P25 for phase_3 cardiovascular-diseases

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1978

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 1982

Completed
17.7 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

December 13, 2013

Status Verified

April 1, 2012

First QC Date

October 27, 1999

Last Update Submit

December 12, 2013

Conditions

Cardiovascular DiseasesDefect, Congenital HeartDuctus Arteriosus, PatentHeart Diseases

Interventions

indomethacinDRUG
surgery, cardiovascularPROCEDURE

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Boy and girl premature infants with patent ductus arteriosus. Birth weight of 1,750 grams or less. Admitted to participating institution within first 24 hours of life.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (3)

  • Gersony WM, Peckham GJ, Ellison RC, Miettinen OS, Nadas AS. Effects of indomethacin in premature infants with patent ductus arteriosus: results of a national collaborative study. J Pediatr. 1983 Jun;102(6):895-906. doi: 10.1016/s0022-3476(83)80022-5.

    PMID: 6343572BACKGROUND

  • Ellison RC, Peckham GJ, Lang P, Talner NS, Lerer TJ, Lin L, Dooley KJ, Nadas AS. Evaluation of the preterm infant for patent ductus arteriosus. Pediatrics. 1983 Mar;71(3):364-72.

    PMID: 6338474BACKGROUND

  • Irawati Y, Natalia MER, Gondhowiardjo TD, Dachlan I, Soebono H. Modified tarsorrhaphy versus gold weight implant technique for paralytic lagophthalmos treatment in patients with leprosy: One-year observation of a randomized controlled trial study. Front Med (Lausanne). 2023 Jan 4;9:941082. doi: 10.3389/fmed.2022.941082. eCollection 2022.

    PMID: 36687442DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesHeart Defects, CongenitalDuctus Arteriosus, PatentHeart Diseases

Interventions

IndomethacinCardiovascular Surgical Procedures

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsSurgical Procedures, Operative

Study Officials

  • Alexander Nadas

    Children's Hospital & Medical Center

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

September 1, 1978

Study Completion

March 1, 1982

Last Updated

December 13, 2013

Record last verified: 2012-04