Genes Associated With Bronchopulmonary Dysplasia and Retinopathy of Prematurity

August 4, 2021 updated by: National Institute of Environmental Health Sciences (NIEHS)

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1068

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

  • Argentina
      • Buenos Aires, Argentina
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Argentina
        • Sanatorio Otamendi y Miroli
      • Buenos Aires, Argentina
        • Sanatorio de la Trinidad
      • Buenos Aires, Argentina
        • Clinica Y Maternidad
      • Buenos Aires, Argentina
        • Fundacion INFANT
      • Buenos Aires, Argentina
        • Instituto Medico de Obstretricia (IMO)
      • Buenos Aires, Argentina
        • Sanatario de los Arcos
  • United States
    • North Carolina
      • Research Triangle Park, North Carolina, United States, 27709
        • NIEHS, Research Triangle Park

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.@@@

Description

  • 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.

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

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bronchopulmonary dysplasia; retinopathy of prematurity
Time Frame: 6 years
6 years

Collaborators and Investigators

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

Sponsor

National Institute of Environmental Health Sciences (NIEHS)

Investigators

  • Principal Investigator: Steven R Kleeberger, Ph.D., National Institute of Environmental Health Sciences (NIEHS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

June 24, 2013

Primary Completion (ACTUAL)

July 20, 2020

Study Completion (ACTUAL)

August 1, 2020

Study Registration Dates

First Submitted

January 29, 2013

First Submitted That Met QC Criteria

January 29, 2013

First Posted (ESTIMATE)

January 30, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 5, 2021

Last Update Submitted That Met QC Criteria

August 4, 2021

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999913031
  • 13-E-N031

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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