Genes Associated With Bronchopulmonary Dysplasia and Retinopathy of Prematurity

Completed

Conditions studied: Bronchopulmonary Dysplasia, Retinopathy of Prematurity, Prematurity, Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT01780155

Run by

National Institute of Environmental Health Sciences (NIEHS)

People needed

1068

Starts

2013-06-24

Expected to finish

2020-08-01

Last updated by the study team

2021-08-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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