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

December 28, 2010 updated by: East Carolina University

The Effect of Endotracheal Instillation of Surfactant With and Without Budesonide on the Development of Bronchopulmonary Dysplasia in Ventilator-dependent, Extremely Low Birth Weight Infants: A Pilot Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • NICU-Pitt County Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A (two study drugs group)
The standard management + two study drugs (endotracheal instillation of a mixture containing budesonide and Infasurf)
Drug: Infasurf
Endotracheal instillation of Infasurf once per week for three weeks
Other Names:
  • Calfactant
Drug: Pulmicort
Endotracheal instillation, once per week for three weeks
Other Names:
  • Budesonide
Active Comparator: B (one study drug group)
The standard management + one study drug (endotracheal instillation of Infasurf only).
Drug: Infasurf
Endotracheal instillation of Infasurf once per week for three weeks
Other Names:
  • Calfactant
Sham Comparator: C (no study drug group)
The standard management only.
Other: Sham
None instilled through the endotracheal tube
Other Names:
  • Air Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
Supplemental oxygen requirement at 36 weeks' postmenstrual age (PMA)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure the effect of surfactant with and without Budesonide on the inflammatory cytokines in tracheal aspirates.
Time Frame: 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
The measurement of cytokines in tracheal aspirate samples will be done at the end of the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

East Carolina University

Investigators

  • Principal Investigator: Waleed M Maamoun, MD, Pitt County Memorial Hospital/Brody School of Medicine at East Carolina University
  • Study Director: James Cummings, MD, Pitt County Memorial Hospital/Brody School of Medicine at East Carolina University
  • Study Chair: Scott MacGilvray, MD, Pitt County Memorial Hospital/Brody School of Medicine at East Carolina University
  • Study Chair: Karl Kaminski, RRT-NPS, Pitt County Memorial Hospital/Brody School of Medicine at East Carolina University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

June 1, 2012

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

December 28, 2010

First Submitted That Met QC Criteria

December 28, 2010

First Posted (Estimate)

December 29, 2010

Study Record Updates

Last Update Posted (Estimate)

December 29, 2010

Last Update Submitted That Met QC Criteria

December 28, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCIRB # 10-0250

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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