Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates

This study has been completed.
Sponsor:
Collaborators:
University of Pennsylvania
Women & Children's Hospital of Buffalo
Children's Mercy Hospital Kansas City
St. Louis Children's Hospital
Children's Hospital & Research Center Oakland
Alta Bates Summit Medical Center
Long Island Jewish Medical Center
Information provided by:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00208039
First received: September 13, 2005
Last updated: November 19, 2007
Last verified: November 2007
  Purpose

A research study that will evaluate if giving surfactant medication to premature babies weighing < 1250 gm at birth during the second and third weeks of life will help their lungs. We are enrolling those premature babies who continue to require the breathing tube and the mechanical ventilator at days 7-10 of life.


Condition Intervention
Respiratory Distress Syndrome
Bronchopulmonary Dysplasia
Drug: Infasurf

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 Booster Prophylaxis For Ventilated Preterm Neonates Less Than or Equal to 1250 gm Birthweight Ver 4.0

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Surfactant therapy will decrease the mean area under the curve(of the plots of daily respiratory severity scores between days 7 and 28 of life), by 33% from historic controls. [ Time Frame: 28 days ]

Enrollment: 89
Study Start Date: September 2004
Study Completion Date: November 2007
Intervention Details:
    Drug: Infasurf
    Infasurf 3 cc/kg instilled via endotracheal tube, repeated 3 and 7 days later if infant stable and continues to meet criteria
    Other Name: Infasurf (calfactant, manufactured for INOTherapeutics, Clinton NJ by ONY Inc., Amherst, NY)
Detailed Description:

Pulmonary surfactant is required for normal lung function. Data from a previous study suggest that as many as 75% of chronically ventilated extremely low birthweight premature infants have at least one episode of surfactant dysfunction beyond the first week of life, as measured in vitro, associated with a low surfactant protein B content. Furthermore, episodes of surfactant dysfunction are significantly associated with clinically significant respiratory decompensations. We hypothesize that booster doses of surfactant given during the second and third week of life to extremely low birth weight premature infants requiring persistent intubation and mechanical ventilation will improve their respiratory status during the first 28 days of life. We propose to enroll premature infants < 1250 gm birthweight, between days 7 and 10 of life who are intubated, and mechanically ventilated. Infants requiring persistent intubation and mechanical ventilation for respiratory support at 7-10 days of life will receive a total of 3 doses of Infasurf surfactant, 3 days apart, at the standard dose of 3 ml/kg. Primary outcome is the change in area under the respiratory severity score curve between days 7 and 28 of life. Total sample size is 88 infants, study duration is 36 months, and recruitment of study patients will occur at The Hospital of the University of Pennsylvania, in Philadelphia PA, Women and Children's Hospital in Buffalo, St. Louis Children's Hospital in St. Louis MO, Mercy Children's Hospital in Kansas City, Oakland Children's and Alta Bates Medical Center in Berkeley, CA and Long Island Jewish Medical Center, NY.

  Eligibility

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

Inclusion Criteria:

  • Less than or equal to1250 gm birthweight
  • Day 7-10 of life
  • Intubated and mechanically ventilated at day 7-10 of life

Exclusion Criteria:

  • Infants intubated solely for apnea
  • Serious congenital malformations
  • Life expectancy < 7 days from enrollment
  • Pulmonary hemorrhage at time of enrollment
  • Active air leak syndrome at time of enrollment
  • Bilateral grade IV intracranial hemorrhage
  • Postnatal systemic steroid therapy for lung disease

Note: Prior surfactant therapy at birth is neither an inclusion nor exclusion criterion.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208039

Sponsors and Collaborators
Children's Hospital of Philadelphia
University of Pennsylvania
Women & Children's Hospital of Buffalo
Children's Mercy Hospital Kansas City
St. Louis Children's Hospital
Children's Hospital & Research Center Oakland
Alta Bates Summit Medical Center
Long Island Jewish Medical Center
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: NCT00208039     History of Changes
Other Study ID Numbers: 2004-9-3983
Study First Received: September 13, 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:
Bronchopulmonary Dysplasia
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Respiration Disorders
Pulmonary Surfactants
Calfactant
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014