Management of Patent Ductus in Premature Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

1978-09-30

Study Completion Date

1982-03-31

Brief Summary

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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.

Detailed Description

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BACKGROUND:

The incidence of patent ductus arteriosus is higher in premature infants than in full-term infants and is highest in premature infants who have respiratory distress syndrome. It is generally agreed that intervention in an asymptomatic infant with a small left-to-right shunt is unnecessary, since the patent ductus almost invariably closes spontaneously and thus does not require surgery. A few infants will demonstrate signs of a large shunt during the course of respiratory distress syndrome. Many of these infants will improve with medical management of congestive heart failure, but others require surgical closure. A third group of babies with respiratory distress have severe progressive pulmonary disease requiring ventilatory support. There was disagreement as to whether elimination of the patent ductus in these infants resulted in decreased mortality. A variety of therapeutic approaches was being used, and there was no convincing evidence of the superiority of one treatment over another.

DESIGN NARRATIVE:

Trial A was a randomized, double-blind trial in which indomethacin plus usual medical therapy was compared with a placebo plus medical therapy. Where this regimen was unsuccessful, the code was broken, and infants who received indomethacin were treated surgically. Infants who had received placebo in Trial A were entered, if there were no contraindications to indomethacin, into Trial B. In Trial B, infants were randomized to surgery or indomethacin therapy. Those in whom indomethacin treatment was unsuccessful were treated surgically. The Recruitment and Intervention Phase began in April 1979. All patients were enrolled by March 31, 1981, and followed for one year after enrollment.

Conditions

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Cardiovascular Diseases Defect, Congenital Heart Ductus Arteriosus, Patent Heart Diseases

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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indomethacin

Intervention Type DRUG

surgery, cardiovascular

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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.

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Alexander Nadas

Role:

Children's Hospital & Medical Center

References

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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.

Reference Type BACKGROUND

PMID: 6343572 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 6338474 (View on PubMed)

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.

Reference Type DERIVED

PMID: 36687442 (View on PubMed)

Other Identifiers

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R01HL023121

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

13

Identifier Type: -

Identifier Source: org_study_id