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Genes Associated With Bronchopulmonary Dysplasia and Retinopathy of Prematurity

NCT01780155 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1068

Last updated 2021-08-05

No results posted yet for this study

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.

Conditions

  • Bronchopulmonary Dysplasia
  • Retinopathy of Prematurity
  • Prematurity
  • Pulmonary Disease

Sponsors & Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)

    lead NIH

Principal Investigators

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

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-24
Primary Completion
2020-07-20
Completion
2020-08-01

Countries

  • United States
  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01780155 on ClinicalTrials.gov