- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00165074
Pilot Trial of Surfactant Therapy For Preterm Neonates 5-21 Days Old With Respiratory Decompensation
November 19, 2007 updated by: Children's Hospital of Philadelphia
Pilot Trial of Surfactant Therapy For Preterm Neonates 5-21 Days Old With
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 week to 1 week (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2003
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (Estimate)
September 14, 2005
Study Record Updates
Last Update Posted (Estimate)
November 22, 2007
Last Update Submitted That Met QC Criteria
November 19, 2007
Last Verified
November 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2002-9-2968
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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