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

NCT ID: NCT01268215

Last Updated: 2010-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Bronchopulmonary Dysplasia

Keywords

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Bronchopulmonary Dysplasia Budesonide Infasurf

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A (two study drugs group)

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

Group Type EXPERIMENTAL

Infasurf

Intervention Type DRUG

Endotracheal instillation of Infasurf once per week for three weeks

Pulmicort

Intervention Type DRUG

Endotracheal instillation, once per week for three weeks

B (one study drug group)

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

Group Type ACTIVE_COMPARATOR

Infasurf

Intervention Type DRUG

Endotracheal instillation of Infasurf once per week for three weeks

C (no study drug group)

The standard management only.

Group Type SHAM_COMPARATOR

Sham

Intervention Type OTHER

None instilled through the endotracheal tube

Interventions

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Infasurf

Endotracheal instillation of Infasurf once per week for three weeks

Intervention Type DRUG

Pulmicort

Endotracheal instillation, once per week for three weeks

Intervention Type DRUG

Sham

None instilled through the endotracheal tube

Intervention Type OTHER

Other Intervention Names

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Calfactant Budesonide Air Sham

Eligibility Criteria

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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
Minimum Eligible Age

24 Weeks

Maximum Eligible Age

28 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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East Carolina University

OTHER

Sponsor Role lead

Responsible Party

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Neonatology Section, Pediatric Department, Brody School of Medicine at East Carolina University

Principal Investigators

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Waleed M Maamoun, MD

Role: PRINCIPAL_INVESTIGATOR

Pitt County Memorial Hospital/Brody School of Medicine at East Carolina University

James Cummings, MD

Role: STUDY_DIRECTOR

Pitt County Memorial Hospital/Brody School of Medicine at East Carolina University

Scott MacGilvray, MD

Role: STUDY_CHAIR

Pitt County Memorial Hospital/Brody School of Medicine at East Carolina University

Karl Kaminski, RRT-NPS

Role: STUDY_CHAIR

Pitt County Memorial Hospital/Brody School of Medicine at East Carolina University

Locations

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NICU-Pitt County Memorial Hospital

Greenville, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Waleed Maamoun, MD

Role: CONTACT

Phone: 1-252-744-3945

Email: [email protected]

James Cummings, MD

Role: CONTACT

Phone: 1-252-744-4787

Email: [email protected]

Other Identifiers

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UMCIRB # 10-0250

Identifier Type: -

Identifier Source: org_study_id