Pilot Trial of Surfactant Therapy For Preterm Neonates 5-21 Days Old With Respiratory Decompensation

NCT ID: NCT00165074

Last Updated: 2007-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2007-06-30

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.

Conditions

Respiratory Distress Syndrome

Keywords

Prematurity; Lung Disease; Hyaline Membrane; Surfactant

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Infasurf (drug)

Infasurf 3 cc/kg instilled via endotracheal tube q 12-24 hours x 2 doses

Intervention Type: DRUG

Other Intervention Names

Infasurf (calfactant, manufactured for Forest Pharmaceuticals, Inc. St. Louis, MO, by ONY Inc., Amherst, NY

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

• Minimum Eligible Age: 7 Days
• Maximum Eligible Age: 10 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Women & Children's Hospital of Buffalo

OTHER

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Principal Investigators

Michael Posencheg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania/Children's Hospital of Philadelphia

Roberta A Ballard, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco Medical Center

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15496605 (View on PubMed)

Other Identifiers

2002-9-2968

Identifier Type: -

Identifier Source: org_study_id