Recruiting
Phase 2

Topical Steroid

Sponsor:

East Carolina University

Code:

NCT01268215

Conditions

Bronchopulmonary Dysplasia

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Infasurf

Pulmicort

Sham

Study Details

Brief summary:

A Pilot study to evaluate the safety and the efficacy of endotracheal instillation of pulmonary surfactant, with or without topical steroid (Budesonide), as a prophylactic treatment for Bronchopulmonary Dysplasia (a form of chronic lung disease) in extremely low birth weight infants. Cytokines (a group of inflammatory mediators) are measured in the tracheal aspirate before and after instillation of the study drugs.

Conditions

Bronchopulmonary Dysplasia

Study ID

NCT01268215

Start date

Jul, 2010

Status verified date

Jul, 2010

Completion date

Dec, 2013

Anticipated

Primary completion date

Jun, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Birth weight 501-1000 g and ≤ 28 weeks gestational age
2. Diagnosed as RDS requiring mechanical ventilation and surfactant therapy during the first 4 hours after birth
3. Still ventilated on day 5-9 of life.
4. An interval of at least 24 hours' duration between the last dose of indomethacin and the endotracheal instillation of study drug.

Exclusion Criteria:

1. Congenital or chromosomal anomalies
2. Occurrence of perinatal sepsis
3. Use of intravenous steroids > 7 days

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: A (two study drugs group)

The standard management + two study drugs (endotracheal instillation of a mixture containing budesonide and Infasurf)

active comparator: B (one study drug group)

The standard management + one study drug (endotracheal instillation of Infasurf only).

sham comparator: C (no study drug group)

The standard management only.

Interventions

Infasurf

Endotracheal instillation of Infasurf once per week for three weeks

Pulmicort

Endotracheal instillation, once per week for three weeks

Sham

None instilled through the endotracheal tube

Primary outcome measure

  • To measure the effect of surfactant with and without Budesonide on the development of BPD in ELBW infants. [ Time Frame: Supplemental oxygen requirement at 36 weeks' postmenstrual age (PMA) ]

Central Contacts and Locations

Central contacts

Waleed Maamoun, MD

1-252-744-3945maamounw@ecu.edu

James Cummings, MD

1-252-744-4787CummingsJ@ecu.edu

Locations

NICU-Pitt County Memorial Hospital

Recruiting

Greenville, North Carolina, United States, 27834

More Information

Sponsor

East Carolina University

Last update posted

Dec 29, 2010

Last verified

Jul, 2010

Keywords

  • Bronchopulmonary Dysplasia
  • Budesonide
  • Infasurf

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by East Carolina University on 2010-12-29.