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

NCT01268215 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2010-12-29

No results posted yet for this study

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

Interventions

DRUG

Infasurf

Endotracheal instillation of Infasurf once per week for three weeks

DRUG

Pulmicort

Endotracheal instillation, once per week for three weeks

OTHER

Sham

None instilled through the endotracheal tube

Sponsors & Collaborators

  • East Carolina University

    lead OTHER

Principal Investigators

  • Waleed M Maamoun, MD · Pitt County Memorial Hospital/Brody School of Medicine at East Carolina University

  • James Cummings, MD · Pitt County Memorial Hospital/Brody School of Medicine at East Carolina University

  • Scott MacGilvray, MD · Pitt County Memorial Hospital/Brody School of Medicine at East Carolina University

  • Karl Kaminski, RRT-NPS · Pitt County Memorial Hospital/Brody School of Medicine at East Carolina University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
24 Weeks
Max Age
28 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2012-06-30
Completion
2013-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01268215 on ClinicalTrials.gov