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Trial record 1 of 13 for:    bronchopulmonary dysplasia OR neonatal chronic lung disease | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed
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Genes Associated With Bronchopulmonary Dysplasia and Retinopathy of Prematurity

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ClinicalTrials.gov Identifier: NCT01780155
Recruitment Status : Recruiting
First Posted : January 30, 2013
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) )

January 29, 2013
January 30, 2013
September 20, 2018
January 29, 2013
July 15, 2019   (Final data collection date for primary outcome measure)
Bronchopulmonary dysplasia; retinopathy of prematurity [ Time Frame: 6 years ]
Same as current
Complete list of historical versions of study NCT01780155 on ClinicalTrials.gov Archive Site
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Genes Associated With Bronchopulmonary Dysplasia and Retinopathy of Prematurity
Candidate Genes Associated With Susceptibility to Bronchopulmonary Dysplasia and Retinopathy of Prematurity

Background:

- Some premature babies develop bronchopulmonary dysplasia (BPD) and retinopathy of prematurity (ROP). BPD and ROP are long-term chronic diseases of the lungs and eyes, respectively. BPD is associated with receiving mechanical ventilation to treat respiratory distress syndrome, and causes lung inflammation and scarring. ROP is caused by poor development of blood vessels in the eyes, and may lead to blindness. Because not all premature babies develop BPD or ROP, researchers want to study the genes that could be associated with these diseases. They will look at both premature infants and their parents to see if there is a genetic component to BPD and ROP.

Objectives:

- To study genes that may be associated with BPD and ROP.

Eligibility:

  • Premature babies born with a weight less than or equal to 1,250 grams.
  • Parents of the premature babies.

Design:

  • Parents will answer questions about the mother s health and pregnancy.
  • Delivery and medical information will be collected during the baby s hospitalization for the first month after birth.
  • Parents will provide a saliva sample from the inside of the cheek.
  • A saliva sample will also be collected from the baby within 28 days of birth. If the baby needs tracheal aspiration (removal of fluid from the throat), tracheal fluid samples will also be collected.
  • Parents will have followup interviews about their child s health 6 months, 12 months, and yearly for up to 6 years after birth.
  • This is a genetic study only. Treatment will not be provided as part of this study.
Understanding the role of susceptibility genes for risk of BPD and ROP may lead to immediate identification of populations who require personalized medical care, and to the assessment of innovative prophylactic and therapeutic interventions in the future. Our purpose is to establish in our hospital network a prospective cohort of triads composed of premature newborns with a birth weight less than or equal to 1250 g and their parents, to examine the role of candidate susceptibility genes in the development of BPD and ROP. Our hypothesis is that the presence of single-nucleotide polymorphisms in candidate genes is associated with differential susceptibility to BPD and ROP. As an initial model, a loss-of-function substitution at position -617 of the NRF2 promoter region is hypothesized to be associated with a greater risk of severe BPD and prethreshold ROP in premature infants with a birth weight less than or equal to 1250 g.
Observational
Time Perspective: Prospective
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  • Bronchopulmonary Dysplasia
  • Retinopathy of Prematurity
  • Prematurity
  • Pulmonary Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3600
Same as current
July 15, 2019
July 15, 2019   (Final data collection date for primary outcome measure)
  • INCLUSION CRITERIA:

Premature newborns with a birth weight less than or equal to 1250 g and their parents from the participating institutions that comprise the Fundacion Infant hospital network will be enrolled in this study after signing the informed consent.

EXCLUSION CRITERIA:

Premature newborns with a birth weight less than or equal to 1250 g with cyanotic congenital heart disease, congenital anomalies of the respiratory tract (for example, tracheoesophageal fistula, pulmonary hypoplasia, diaphragmatic hernia), eye malformations, or congenital immunodeficiencies. Newborns from parents (mother and/or father) who used in vitro fertilization products from donor banks will also be excluded from participating in the study.

Sexes Eligible for Study: All
Child, Adult, Older Adult
Yes
Contact: Steven R Kleeberger, Ph.D. (919) 541-3540 kleeber1@niehs.nih.gov
Argentina,   United States
 
 
NCT01780155
999913031
13-E-N031
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National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) )
National Institute of Environmental Health Sciences (NIEHS)
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Principal Investigator: Steven R Kleeberger, Ph.D. National Institute of Environmental Health Sciences (NIEHS)
National Institutes of Health Clinical Center (CC)
December 29, 2017