Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates

Bronchopulmonary Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00208039
• Other study ID #: 2004-9-3983
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: November 19, 2007
• Start date: September 2004
• Est. completion date: November 2007

Study information

• Verified date: November 2007
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 10 Days

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• Infasurf
Infasurf 3 cc/kg instilled via endotracheal tube, repeated 3 and 7 days later if infant stable and continues to meet criteria

Locations

Country	Name	City	State
n/a

Sponsors (8)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Alta Bates Summit Medical Center, Children's Hospital & Research Center Oakland, Children's Mercy Hospital Kansas City, Long Island Jewish Medical Center, St. Louis Children's Hospital, University of Pennsylvania, Women & Children's Hospital of Buffalo

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		28 days