Pilot Study of Topical Steroid for Prevention of Chronic Lung Disease in Extremely Premature Infants.

Phase 2

• Conditions: Bronchopulmonary Dysplasia
• Interventions: Other: Sham; Drug: Infasurf; Drug: Pulmicort

• Registration Number: NCT01268215
• Lead Sponsor: East Carolina University

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.

Detailed Description

Bronchopulmonary Dysplasia (BPD) is still one of the most common complications of ventilated premature infants. Lung inflammation plays a major role in its pathogenesis. Systemic steroids can be given to control this inflammatory process but their widespread use is limited by their systemic side effects and concerns for long neurodevelopmental adverse sequelae. Delivering steroids by inhalation which has been proven to be effective in young infants with asthma has been shown to be unsatisfactory for ELBW infants with BPD. This may be due to the fact that current delivery devices do not meet the requirements of the specific anatomical and physiologic characteristics of the airways and breathing patterns in this special group of patients. A novel approach to facilitate delivery directly to the lungs, thereby avoiding systemic concerns has been demonstrated in a recent study in which budesonide ( a topical steroid) was given to ventilated preterm infants using surfactant as a vehicle.

Study Timeline

• Status Verified: 2010-07
• Study Start: 2010-07
• Study First Submitted: 2010-12-28
• Study First Submitted QC: 2010-12-28
• Last Update Submitted: 2010-12-28
• Study First Posted: 2010-12-29
• Last Update Posted: 2010-12-29
• Primary Completion: 2012-06
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C (no study drug group)	Sham	The standard management only.
A (two study drugs group)	Infasurf	The standard management + two study drugs (endotracheal instillation of a mixture containing budesonide and Infasurf)
A (two study drugs group)	Pulmicort	The standard management + two study drugs (endotracheal instillation of a mixture containing budesonide and Infasurf)
B (one study drug group)	Infasurf	The standard management + one study drug (endotracheal instillation of Infasurf only).

Primary Outcome Measures

Name	Time	Method
To measure the effect of surfactant with and without Budesonide on the development of BPD in ELBW infants.	Supplemental oxygen requirement at 36 weeks' postmenstrual age (PMA)	The main goal of the study is to determine whether endotracheal instillation of surfactant (Infasurf) with or without potent topical steroid (Budesonide) reduces the development of Bronchopulmonary Dysplasia (BPD) in Extremely Low Birth Weight (ELBW) infants at high risk of BPD.

Secondary Outcome Measures

Name	Time	Method
To measure the effect of surfactant with and without Budesonide on the inflammatory cytokines in tracheal aspirates.	The measurement of cytokines in tracheal aspirate samples will be done at the end of the study.	Tracheal aspirate samples will be collected before instillation of each dose of the study drug, 7 days after the last dose if the infant is still intubated, and prior to elective extubation regardless of when extubation occurs. Tracheal aspirate samples will be obtained from the control (standard management) group in the same way and using the same time frame as the treatment groups

Trial Locations

Locations (1)

NICU-Pitt County Memorial Hospital; 🇺🇸 Greenville, North Carolina, United States