Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome (Surfactant 1)

NICHD Neonatal Research Network

Status and phase: Completed; Phase 3; Phase 2

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

Treatments: Drug: Survanta; Drug: Exosurf

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01203358

NICHD-NRN-0003

U10HD021415 (U.S. NIH Grant/Contract)

U10HD021373 (U.S. NIH Grant/Contract)

U10HD027853 (U.S. NIH Grant/Contract)

U01HD019897 (U.S. NIH Grant/Contract)

U10HD021364 (U.S. NIH Grant/Contract)

U10HD027880 (U.S. NIH Grant/Contract)

U10HD027856 (U.S. NIH Grant/Contract)

U10HD027851 (U.S. NIH Grant/Contract)

U10HD027881 (U.S. NIH Grant/Contract)

U10HD021397 (U.S. NIH Grant/Contract)

U10HD021385 (U.S. NIH Grant/Contract)

U10HD027871 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 617 patients

Sex: All

Ages: Under 6 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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617 participants in 2 patient groups

Surfactant 1

Active Comparator group

Description:

Exosurf Neonatal (Burroughs Wellcome Co.)

Treatment:

Drug: Exosurf

Surfactant 2

Active Comparator group

Description:

Survanta (Ross Laboratories)

Treatment:

Drug: Survanta