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

University of North Carolina System

Status and phase: Unknown; Phase 2

Conditions: Bronchopulmonary Dysplasia

Treatments: Other: Sham; Drug: Infasurf; Drug: Pulmicort

Study type: Interventional

Funder types: Other

Identifiers

NCT01268215

UMCIRB # 10-0250

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 24 to 28 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 3 patient groups

A (two study drugs group)

Experimental group

Description:

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

Treatment:

Drug: Pulmicort

Drug: Infasurf

B (one study drug group)

Active Comparator group

Description:

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

Treatment:

Drug: Infasurf

C (no study drug group)

Sham Comparator group

Description:

The standard management only.

Treatment:

Other: Sham