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Pilot Trial of Surfactant Therapy For Preterm Neonates 5-21 Days Old With Respiratory Decompensation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00165074
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : November 22, 2007
University of Pennsylvania
Women & Children's Hospital of Buffalo
Information provided by:
Children's Hospital of Philadelphia

Brief Summary:
The purpose of the study is to determine whether additional surfactant(Infasurf) doses at 7 to 10 days of life time will improve lung function in premature infants, allowing a decrease in required oxygen concentration and ventilator settings.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome Drug: Infasurf (drug) Not Applicable

Detailed Description:
Pulmonary surfactant is required for normal lung function. Preliminary data from previous trials suggest that more than half of chronically ventilated premature infants, greater than 1 week of age, have at least one episode of surfactant dysfunction, as measured in vitro, associated with a low surfactant protein B content. We propose to enroll premature infants less than 1250 gm birthweight, between days 5 and 21 of life who are intubated, mechanically ventilated, with a respiratory decompensation, defined as a severity score (mean airway pressure x FIO2) rising from a baseline of < 1.8 to > 3.5, sustained for > 24 hours. Infants will receive two doses of Infasurf surfactant, 12-24 hours apart, at the standard dose of 3 ml/kg. Primary outcome is the change in respiratory severity score at 72 hours post surfactant treatment compared to pre-treatment. Sample size is 31 infants, study duration is 3 years, and recruitment of study patients will occur at the Hospital of the University of Pennsylvania, and Women and Children's Hospital of Buffalo.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Trial of Surfactant Therapy For Preterm Neonates 5-21 Days Old With
Study Start Date : June 2003
Actual Study Completion Date : June 2007

Intervention Details:
  • Drug: Infasurf (drug)
    Infasurf 3 cc/kg instilled via endotracheal tube q 12-24 hours x 2 doses
    Other Name: Infasurf (calfactant, manufactured for Forest Pharmaceuticals, Inc. St. Louis, MO, by ONY Inc., Amherst, NY

Primary Outcome Measures :
  1. We hypothesize that at least 25% of treated infants will have a 50% or greater reduction in respiratory severity score at 72 hours compared to pre-treat [ Time Frame: 72 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 10 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Less than 1250 gm birthweight
  • Day 5-21 of life
  • Intubated and mechanically ventilated, with respiratory decompensation, defined as the majority of daily severity scores (calculated every 6 hr from average of respiratory settings over 3-4 hour period) rising from baseline < 1.8, to > 3.5, sustained for >24hr. Note: Prior surfactant therapy at birth is neither an inclusion nor exclusion criterion.

Exclusion Criteria:

  • Serious congenital malformations
  • Life expectancy < 7 days from enrollment
  • Patent ductus arteriosus at time of decompensation
  • Pulmonary hemorrhage as cause of respiratory decompensation
  • Active air leak syndrome at time of decompensation
  • Postnatal steroid therapy for lung disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00165074

Sponsors and Collaborators
Children's Hospital of Philadelphia
University of Pennsylvania
Women & Children's Hospital of Buffalo
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Principal Investigator: Michael Posencheg, MD University of Pennsylvania/Children's Hospital of Philadelphia
Principal Investigator: Roberta A Ballard, MD University of California, San Francisco Medical Center
Layout table for additonal information Identifier: NCT00165074    
Other Study ID Numbers: 2002-9-2968
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: November 22, 2007
Last Verified: November 2007
Keywords provided by Children's Hospital of Philadelphia:
Lung Disease
Hyaline Membrane
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pulmonary Surfactants
Respiratory System Agents