Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates

NCT00208039 | Completed

• 1 other identifier: 2004-9-3983
• Study Type: interventional
• Target: 89
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Respiratory Distress Syndrome; Bronchopulmonary Dysplasia

Keywords

Prematurity; Lung Disease; Hyaline Membrane; Surfactant

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Infasurf DRUG

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

Also known as: Infasurf (calfactant, manufactured for INOTherapeutics, Clinton NJ by ONY Inc., Amherst, NY)

Eligibility Criteria

• Age: 7 Days - 10 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Less than or equal to1250 gm birthweight
• Day 7-10 of life
• Intubated and mechanically ventilated at day 7-10 of life

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• University of Pennsylvania: collaborator
• Women & Children's Hospital of Buffalo: collaborator
• Children's Mercy Hospital Kansas City: collaborator
• St. Louis Children's Hospital: collaborator
• UCSF Benioff Children's Hospital Oakland: collaborator
• Alta Bates Summit Medical Center: collaborator
• Long Island Jewish Medical Center: collaborator

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: 15496605 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome; Bronchopulmonary Dysplasia; Premature Birth; Lung Diseases

Interventions

calfactant

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiration Disorders; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital 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 13, 2005
• First Posted: September 21, 2005
• Study Start: September 1, 2004
• Study Completion: November 1, 2007
• Last Updated: November 22, 2007

Record last verified: 2007-11