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

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

November 19, 2007

Start Date ^ICMJE

June 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00165074 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Respiratory Distress Syndrome

Intervention ^ICMJE

Drug: Infasurf (drug)

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 10 Days

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00165074

Responsible Party

Study ID Numbers ^ICMJE

2002-9-2968

Study Sponsor ^ICMJE

Children's Hospital of Philadelphia

Collaborators ^ICMJE

University of Pennsylvania
Woman and Children’s Hospital of Buffalo, NY

Investigators ^ICMJE

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

Information Provided By

Children's Hospital of Philadelphia

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP