NCT00165074

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2003

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

November 22, 2007

Status Verified

November 1, 2007

First QC Date

September 9, 2005

Last Update Submit

November 19, 2007

Conditions

Respiratory Distress Syndrome

Keywords

PrematurityLung DiseaseHyaline MembraneSurfactant

Outcome Measures

Primary Outcomes (1)

  • 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

    72 hours

Interventions

Infasurf (drug)DRUG

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

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

Eligibility Criteria

Age7 Days - 10 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Less than 1250 gm birthweight
  • Day 5-21 of life

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.1203/01.PDR.0000145565.45490.D9. Epub 2004 Oct 20.

    PMID: 15496605BACKGROUND

MeSH Terms

Conditions

Respiratory Distress SyndromePremature BirthLung Diseases

Interventions

calfactantPharmaceutical Preparations

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesRespiration DisordersObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Michael Posencheg, MD

    University of Pennsylvania/Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

  • Roberta A Ballard, MD

    University of California, San Francisco Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

June 1, 2003

Study Completion

June 1, 2007

Last Updated

November 22, 2007

Record last verified: 2007-11