Clinical trial NCT00208039: Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates
Official title: Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates Less Than or Equal to 1250 gm Birthweight Ver 4.0
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome
Bronchopulmonary Dysplasia
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
name: Children's Mercy Hospital Kansas City
name: St. Louis Children's Hospital
name: UCSF Benioff Children's Hospital Oakland
name: Alta Bates Summit Medical Center
name: Long Island Jewish Medical Center
First posted: 2005-09-21
Enrollment: 89
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: 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.

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 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.

Primary outcomes:
measure: 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.
timeFrame: 28 days
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.