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

Purpose

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.

Condition	Intervention
Respiratory Distress Syndrome	Drug: Infasurf (drug)

Drug Information available for:

Calfactant

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	Pilot Trial of Surfactant Therapy For Preterm Neonates 5-21 Days Old With

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:

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 [ Time Frame: 72 hours ]

Enrollment:	11
Study Start Date:	June 2003
Study Completion Date:	June 2007

Intervention Details:

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

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

Ages Eligible for Study:	up to 10 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165074

Sponsors and Collaborators

Children's Hospital of Philadelphia

University of Pennsylvania

Woman and Children’s Hospital of Buffalo, NY

Investigators


Principal Investigator:	Michael Posencheg, MD	University of Pennsylvania/Children's Hospital of Philadelphia

Principal Investigator:	Roberta A Ballard, MD	University of California, San Francisco Medical Center

More Information

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.

Study ID Numbers:	2002-9-2968
First Received:	September 9, 2005
Last Updated:	November 19, 2007
ClinicalTrials.gov Identifier:	NCT00165074
Health Authority:	United States: Food and Drug Administration

Keywords provided by Children's Hospital of Philadelphia:

Prematurity

Lung Disease

Hyaline Membrane

Surfactant

Study placed in the following topic categories:

Lung Diseases

Calfactant

Additional relevant MeSH terms:

Respiratory System Agents

Pathologic Processes

Disease

Therapeutic Uses

Syndrome

Pharmacologic Actions

Pulmonary Surfactants

ClinicalTrials.gov processed this record on October 23, 2008

Sponsors and Collaborators:	Children's Hospital of Philadelphia University of Pennsylvania Woman and Children’s Hospital of Buffalo, NY
Information provided by:	Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:	NCT00165074