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Completed

NCT Number: NCT01203358

Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome

The purpose of this study is to compare the efficacy of two surfactants, Exosurf Neonatal (Burroughs Wellcome Co.) and Survanta (Ross Laboratories), for the treatment of neonatal respiratory distress syndrome.

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Key information

Conditions

Infant, Newborn Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Low Birth Weight Infant, Newborn, Diseases Infant, Premature Infant, Premature, Diseases Infant, Small for Gestational Age Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury

Age range

Up to 6 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Stanford University, Palo Alto, California, United States

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About this study

The NICHD Neonatal Research Network conducted a randomized trial at 11 centers comparing the efficacy of two surfactants -- Exosurf Neonatal (Burroughs Wellcome Co.) and Survanta (Ross Laboratories) -- for the treatment of neonatal respiratory distress syndrome. Newborn infants with birth weights of 501-1500g with respiratory distress syndrome who were receiving assisted ventilation with 30% oxygen or more within 6 hours of birth were enrolled between January 1991 and January 1992. Infants were randomly assigned to receive up to four intratracheal doses of either Exosurf Neonatal or Survanta.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Newborn infants weighing 501 to 1500 gm with respiratory distress syndrome were receiving assisted ventilation with 30% oxygen or more

Exclusion criteria

  • Less than 6 hours of age

Treatment and study plan

Exosurf

Drug

Infants received up to four intratracheal doses of the surfactant.

Other names: Exosurf Neonatal (Burroughs Wellcome Co.)

Survanta

Drug

Infants received up to four intratracheal doses of the surfactant.

Other names: Survanta (Ross Laboratories)

Primary outcomes

  1. Death or bronchopulmonary dysplasia

    Time frame: 28 days of life

Secondary outcomes

  1. Average fraction of inspired oxygen (FIO2)

    Time frame: 72 hours after treatment

  2. Mean airway pressure (MAP)

    Time frame: 72 hours after treatment

Sponsors and collaborators

Lead sponsor

NICHD Neonatal Research Network

Network

Registry information

Official study title

Efficacy and Safety of Exosurf Neonatal and Survanta for the Treatment of Respiratory Distress Syndrome

Acronym: Surfactant 1

Important dates

Study start
1991
Primary completion
1992
Study completion
1992
First posted
Sep 16, 2010
Registry last updated
Mar 22, 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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