Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01203358

Acronym

Surfactant 1

Enrollment

617

Registered

2010-09-16

Start date

1991-01-31

Completion date

1992-01-31

Last updated

2019-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Prematurity, Respiratory distress syndrome, Surfactant

Brief summary

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

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.

Interventions

DRUGExosurf

Infants received up to four intratracheal doses of the surfactant.

DRUGSurvanta

Infants received up to four intratracheal doses of the surfactant.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 6 Hours

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

Design outcomes

Primary

Measure	Time frame
Death or bronchopulmonary dysplasia	28 days of life

Secondary

Measure	Time frame
Average fraction of inspired oxygen (FIO2)	72 hours after treatment
Mean airway pressure (MAP)	72 hours after treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026