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

Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00165074
• Other study ID #: 2002-9-2968
• Status: Completed
• Phase: N/A
• First received: September 9, 2005
• Last updated: November 19, 2007
• Start date: June 2003
• Est. completion date: June 2007

Study information

• Verified date: November 2007
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 10 Days

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• Infasurf (drug)
Infasurf 3 cc/kg instilled via endotracheal tube q 12-24 hours x 2 doses

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	University of Pennsylvania, Women & Children's Hospital of Buffalo

References & 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. Epub 2004 Oct 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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