Gastrin-Releasing Peptide and Bronchopulmonary Dysplasia

NCT01748565 | Completed DMC

• 1 other identifier: Pro00025462
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to identify biological markers that might predict premature infants who are at a higher risk for developing BPD, and to correlate the presence of these markers with infant symptoms and lung function in the first year after discharge from the hospital.

Conditions

Bronchopulmonary Dysplasia; Prematurity

Keywords

biomarkers; oxidative stress; BPD; prematurity

Outcome Measures

Primary Outcomes (6)

• urine GRP levels

  Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD

  day-of-life 1-4

• urine GRP levels

  Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD

  36 weeks post-menstrual age

• urine GRP levels

  Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD

  4-6 months corrected age

• urine GRP levels

  Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD

  12-14 months corrected age

• infant pulmonary function tests

  The association of urine GRP levels and the severity of lung disease as determined by pulmonary function tests in infants with and without BPD

  4-6 months corrected age

• infant pulmonary function tests

  The association of urine GRP levels and the severity of lung disease as determined by pulmonary function tests in infants with and without BPD

  12-14 months corrected age

Study Arms (1)

premature infants

Infants born prematurely between 23-0/7 and 27-6/7 weeks post-menstrual age with and without bronchopulmonary dysplasia

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients in the neonatal intensive care unit at Duke Medical Center or Riley Children's Hospital

You may qualify if:

• Gestational age at birth 23-0/7 to 27-6/7 weeks post-menstrual age

You may not qualify if:

• Are not considered to be viable (decision made not to provide life-saving therapies)
• Have congenital heart disease (not including PDA and hemodynamically insignificant VSD or ASD)
• Have structural abnormalities of the upper airway, lungs or chest wall
• Have other congenital malformations or syndromes that adversely affect life expectancy or cardio-pulmonary development
• Unlikely to return to the clinic for follow-up visits

Sponsors & Collaborators

• Duke University: lead
• Indiana University: collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (2)

Riley Children's Hospital

Indianapolis, Indiana, 46202-5225, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

urine specimens and saliva with DNA

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Charles M Cotten, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: December 12, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: April 12, 2024

Record last verified: 2016-08

Locations

US (2)