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Pilot Trial of Surfactant Therapy For Preterm Neonates 5-21 Days Old With Respiratory Decompensation
This study has been completed.

First Received on September 9, 2005.   Last Updated on November 19, 2007   History of Changes
Sponsor: Children's Hospital of Philadelphia
Collaborators: University of Pennsylvania
Women & Children's Hospital of Buffalo
Information provided by: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00165074
  Purpose

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 Intervention
Respiratory Distress Syndrome
Drug: Infasurf (drug)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Trial of Surfactant Therapy For Preterm Neonates 5-21 Days Old With

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • 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 ]

Enrollment: 11
Study Start Date: June 2003
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
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.

  Eligibility

Ages Eligible for Study:   up to 10 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00165074

Sponsors and Collaborators
Children's Hospital of Philadelphia
University of Pennsylvania
Women & Children's Hospital of Buffalo
Investigators
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00165074     History of Changes
Other Study ID Numbers: 2002-9-2968
Study First Received: September 9, 2005
Last Updated: November 19, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital of Philadelphia:
Prematurity
Lung Disease
Hyaline Membrane
Surfactant

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pulmonary Surfactants
Calfactant
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012