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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by East Carolina University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
East Carolina University
ClinicalTrials.gov Identifier:
NCT01268215
First received: December 28, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Bronchopulmonary Dysplasia
Drug: Infasurf
Drug: Pulmicort
Other: Sham
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by East Carolina University:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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:
  • 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. ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 45
Study Start Date: July 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Calfactant
Drug: Pulmicort
Endotracheal instillation, once per week for three weeks
Other Name: 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 Name: Calfactant
Sham Comparator: C (no study drug group)
The standard management only.
Other: Sham
None instilled through the endotracheal tube
Other Name: Air Sham

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.

  Eligibility

Ages Eligible for Study:   24 Weeks to 28 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01268215

Contacts
Contact: Waleed Maamoun, MD 1-252-744-3945 maamounw@ecu.edu
Contact: James Cummings, MD 1-252-744-4787 CummingsJ@ecu.edu

Locations
United States, North Carolina
NICU-Pitt County Memorial Hospital Recruiting
Greenville, North Carolina, United States, 27834
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Waleed Mohammed Maamoun, MD, Neonatology Section, Pediatric Department, Brody School of Medicine at East Carolina University
ClinicalTrials.gov Identifier: NCT01268215     History of Changes
Other Study ID Numbers: UMCIRB # 10-0250
Study First Received: December 28, 2010
Last Updated: December 28, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by East Carolina University:
Bronchopulmonary Dysplasia
Budesonide
Infasurf

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Lung Injury
Respiratory Tract Diseases
Ventilator-Induced Lung Injury
Budesonide
Calfactant
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Pulmonary Surfactants
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014