Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Bronchopulmonary Dysplasia

Intervention / Treatment
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* Drug: Exosurf
* Drug: Survanta


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 6 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surfactant 1<br>Exosurf Neonatal (Burroughs Wellcome Co.) | Drug: Exosurf<br>* Infants received up to four intratracheal doses of the surfactant.<br>* Other names: Exosurf Neonatal (Burroughs Wellcome Co.);|
| Active Comparator: Surfactant 2<br>Survanta (Ross Laboratories) | Drug: Survanta<br>* Infants received up to four intratracheal doses of the surfactant.<br>* Other names: Survanta (Ross Laboratories);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death or bronchopulmonary dysplasia |  | 28 days of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average fraction of inspired oxygen (FIO2) |  | 72 hours after treatment | 
| Mean airway pressure (MAP) |  | 72 hours after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Prematurity, Respiratory distress syndrome, Surfactant