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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 : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) )

Brief Summary:

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.

Condition or disease
Bronchopulmonary Dysplasia Retinopathy of Prematurity Prematurity Pulmonary Disease

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 3600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Candidate Genes Associated With Susceptibility to Bronchopulmonary Dysplasia and Retinopathy of Prematurity
Actual Study Start Date : June 24, 2013
Estimated Primary Completion Date : September 26, 2022
Estimated Study Completion Date : September 26, 2022


Group/Cohort
1
Parents and premature newborns with a birth weight less than or equal to1250 g from member institutions of the hospital network will be invited to participate in this study.



Primary Outcome Measures :
  1. Bronchopulmonary dysplasia; retinopathy of prematurity [ Time Frame: 6 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited irrespective of gender, ethnicity, race, or socio-economic status. Parents and premature newborns with a birth weight less than or equal to1250 g from member institutions of the hospital network will be invited to participate in this study.@@@
Criteria
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01780155


Contacts
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Contact: Steven R Kleeberger, Ph.D. (919) 541-3540 kleeber1@niehs.nih.gov

Locations
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United States, North Carolina
NIEHS, Research Triangle Park Recruiting
Research Triangle Park, North Carolina, United States, 27709
Argentina
Clinica Y Maternidad Recruiting
Buenos Aires, Argentina
Contact: Mariana Sorgetti, MD    Not Listed    msorgetti@gmail.com   
Fundacion Infant Recruiting
Buenos Aires, Argentina
Contact: Fernando Polack    541146340060      
Hospital Italiano de Buenos Aires Recruiting
Buenos Aires, Argentina
Contact: Gonzalo Mariani, M.D.    Not Listed    gonzalo.mariani@gmail.com   
Instituto Medico de Obstretricia (IMO) Recruiting
Buenos Aires, Argentina
Contact: Ang(SqrRoot)(Copyright)lica Grillo, M.D.    Not Listed    angelicagrillo@hotmail.com   
Sanatario de los Arcos Recruiting
Buenos Aires, Argentina
Contact: Elba Lopez Turconi    Not Listed      
Sanatorio de la Trinidad Recruiting
Buenos Aires, Argentina
Contact: Jorge Digregorio    Not Listed    jhdigre@gmail.com   
Sanatorio Otamendi y Miroli Recruiting
Buenos Aires, Argentina
Contact: Christian Osio, M.D.    Not Listed    christian.osio@gmail.com   
Sponsors and Collaborators
National Institute of Environmental Health Sciences (NIEHS)
Investigators
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Principal Investigator: Steven R Kleeberger, Ph.D. National Institute of Environmental Health Sciences (NIEHS)
Publications:
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Responsible Party: National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier: NCT01780155    
Other Study ID Numbers: 999913031
13-E-N031
First Posted: January 30, 2013    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 16, 2019
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) ):
Oxidative Stress
Hyperoxia
Brochopulmonary Dysplasia
Retinopathy of Prematurity
Very Low Birth Rate
Additional relevant MeSH terms:
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Retinal Diseases
Lung Diseases
Respiratory Tract Diseases
Eye Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Bronchopulmonary Dysplasia
Retinopathy of Prematurity
Premature Birth
Hyperplasia
Pathologic Processes
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Ventilator-Induced Lung Injury
Lung Injury