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NCT01780155
Genes Associated With Bronchopulmonary Dysplasia and Retinopathy of Prematurity
trial in Bronchopulmonary Dysplasia in 1,068 participants. Completed in 1 August 2020.
20 July 2020
Quick facts
| Lead sponsor | National Institute of Environmental Health Sciences (NIEHS) |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,068 |
| Start date | 24 June 2013 |
| Primary completion | 20 July 2020 |
| Estimated completion | 1 August 2020 |
| Sites | 8 locations across Argentina, United States |
Conditions studied
- Bronchopulmonary Dysplasia — all drugs for Bronchopulmonary Dysplasia →
- Retinopathy of Prematurity — all drugs for Retinopathy of Prematurity →
- Prematurity — all drugs for Prematurity →
- Pulmonary Disease — all drugs for Pulmonary Disease →
Sponsor
National Institute of Environmental Health Sciences (NIEHS)
Who can join
Eligibility, any sex, with Bronchopulmonary Dysplasia or Retinopathy of Prematurity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01780155
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Related trials
Other recruiting trials for Bronchopulmonary Dysplasia
Currently open trials in the same condition.
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- NCT06808997 — Prospective Multicentre Mixed Methods Study to Explore Extubation Practices and Respiratory Outcomes in Extremely Preter · recruiting
- NCT06897839 — Efficacy and Safety of Zelpultide Alfa in Preterm Neonates at High Risk of Developing Bronchopulmonary Dysplasia (BPD) · Phase 2, PHASE3 · recruiting
Other National Institute of Environmental Health Sciences (NIEHS) trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01780155 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Environmental Health Sciences (NIEHS)
- Last refreshed: 5 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01780155.
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