Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide

PHASE3CompletedINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

January 31, 2008

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2012

Conditions
Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction)Bronchopulmonary Dysplasia
Interventions
DRUG

Infasurf (ONY Inc.)

Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14, if remains intubated.

DRUG

Sham

Sham instillation (no treatment) will be given to study infants on days 0, 3, 7, 10, and 14, if remains intubated.

Trial Locations (9)

11794

Stony Brook University Medical Center, Stony Brook

14222

Women and Children's Hospital of Buffalo, Buffalo

60611

Northwestern Memorial Hospital, Chicago

60614

Children's Memorial Hospital, Chicago

64108

Children's Mercy Hospital, Kansas City

77030

Texas Children's Hospital, Houston

94143

University of California, San Francisco, San Francisco

94609

Children's Hospital Oakland, Oakland

94705

Alta Bates Summit Medical Center, Berkeley

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Mallinckrodt

INDUSTRY

collaborator

ONY

INDUSTRY

lead

Roberta Ballard

OTHER