Clinical trial NCT01203358: Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome
Official title: Efficacy and Safety of Exosurf Neonatal and Survanta for the Treatment of Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Infant, Newborn
Infant, Low Birth Weight
Infant, Small for Gestational Age
Infant, Premature
Bronchopulmonary Dysplasia
Keywords: NICHD Neonatal Research Network
Extremely Low Birth Weight (ELBW)
Prematurity
Respiratory distress syndrome
Surfactant
Lead sponsor: NICHD Neonatal Research Network
Sponsor class: NETWORK
First posted: 2010-09-16
Enrollment: 617
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Death or bronchopulmonary dysplasia
timeFrame: 28 days of life
Secondary outcomes:
measure: Average fraction of inspired oxygen (FIO2)
timeFrame: 72 hours after treatment
measure: Mean airway pressure (MAP)
timeFrame: 72 hours after treatment
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Cincinnati
country: United States
facility: Cincinnati Children's Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve University, Rainbow Babies and Children's Hospital
state: Ohio
city: Memphis
country: United States
facility: University of Tennessee
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: University of Vermont
name: Jeffrey D. Horbar, MD
role: STUDY_DIRECTOR
affiliation: George Washington University
name: Elizabeth C. Wright, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Case Western Reserve University
name: Avroy A. Fanaroff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tennessee
name: Sheldon B. Korones, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University
name: Seetha Shankaran, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Charles R. Bauer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas
name: Jon E. Tyson, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: James A. Lemons, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Edward F. Donovan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Barbara J. Stoll, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: David K. Stevenson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of New Mexico
name: LuAnn Papile, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Horbar JD, Wright LL, Soll RF, Wright EC, Fanaroff AA, Korones SB, Shankaran S, Oh W, Fletcher BD, Bauer CR, et al. A multicenter randomized trial comparing two surfactants for the treatment of neonatal respiratory distress syndrome. National Institute of Child Health and Human Development Neonatal Research Network. J Pediatr. 1993 Nov;123(5):757-66. doi: 10.1016/s0022-3476(05)80856-x.