Pilot Trial of Surfactant Therapy For Preterm Neonates 5-21 Days Old With Respiratory Decompensation
Information source: Children's Hospital of Philadelphia
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Respiratory Distress Syndrome
Intervention: Infasurf (drug) (Drug)
Phase: N/A
Status: Completed
Sponsored by: Children's Hospital of Philadelphia Official(s) and/or principal investigator(s):
Michael Posencheg, MD, Principal Investigator, Affiliation: University of Pennsylvania/Children's Hospital of Philadelphia
Roberta A Ballard, MD, Principal Investigator, Affiliation: University of California, San Francisco Medical Center
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.
Clinical Details
Official title: Pilot Trial of Surfactant Therapy For Preterm Neonates 5-21 Days Old With
Study design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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
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
Minimum age: N/A.
Maximum age: 10 Days.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Related publications: Merrill JD, Ballard RA, Cnaan A, Hibbs AM, Godinez RI, Godinez MH, Truog WE, Ballard PL. Dysfunction of pulmonary surfactant in chronically ventilated premature infants. Pediatr Res. 2004 Dec;56(6):918-26. Epub 2004 Oct 20.
Starting date: June 2003
Ending date: June 2007
Last updated: November 19, 2007
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