Clinical trial NCT00165074: Pilot Trial of Surfactant Therapy For Preterm Neonates 5-21 Days Old With Respiratory Decompensation
Official title: Pilot Trial of Surfactant Therapy For Preterm Neonates 5-21 Days Old With
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome
Keywords: Prematurity
Lung Disease
Hyaline Membrane
Surfactant
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: Women & Children's Hospital of Buffalo
First posted: 2005-09-14
Enrollment: 11
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: 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
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Pennsylvania/Children's Hospital of Philadelphia
name: Michael Posencheg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco Medical Center
name: Roberta A Ballard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1203/01.PDR.0000145565.45490.D9. Epub 2004 Oct 20.