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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: September 9, 2005   Last Updated: November 19, 2007   History of Changes
Sponsor: Children's Hospital of Philadelphia
Collaborators: University of Pennsylvania
Woman and Children’s Hospital of Buffalo, NY
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: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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
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
Woman and Children’s Hospital of Buffalo, NY
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:
Study ID Numbers: 2002-9-2968
Study First Received: September 9, 2005
Last Updated: November 19, 2007
ClinicalTrials.gov Identifier: NCT00165074     History of Changes
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 System Agents
Pathologic Processes
Disease
Respiratory Tract Diseases
Therapeutic Uses
Lung Diseases
Syndrome
Respiration Disorders
Respiratory Distress Syndrome, Adult
Calfactant
Pharmacologic Actions
Pulmonary Surfactants

ClinicalTrials.gov processed this record on November 30, 2009