Bronchopulmonary DysplasiaNCT01780155
Genes Associated With Bronchopulmonary Dysplasia and Retinopathy of Prematurity
An observational study of Bronchopulmonary Dysplasia and Retinopathy of Prematurity, run by National Institute of Environmental Health Sciences (NIEHS) at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bronchopulmonary Dysplasia, Retinopathy of Prematurity, Prematurity
- How many people
- 1,068 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 24 Jun 2013to 1 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.@@@
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Argentina7 sites
Clinica Y Maternidad
Buenos Aires
Fundacion Infant
Buenos Aires
Hospital Italiano de Buenos Aires
Buenos Aires
Instituto Medico de Obstretricia (IMO)
Buenos Aires
Sanatario de los Arcos
Buenos Aires
Sanatorio de la Trinidad
Buenos Aires
Sanatorio Otamendi y Miroli
Buenos Aires
United States1 site
NIEHS, Research Triangle Park
Research Triangle Park, North Carolina, 27709
About this study
Official title: 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.
Read more
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.
Read the 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.
- Keywords
- Oxidative Stress, Hyperoxia, Brochopulmonary Dysplasia, Retinopathy of Prematurity, Very Low Birth Rate
- Medical subject headings
- Bronchopulmonary Dysplasia, Retinopathy of Prematurity, Premature Birth, Lung Diseases, Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Bronchopulmonary dysplasia; retinopathy of prematurity
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study start24 Jun 2013
- Primary completion20 Jul 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,068 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Steven R Kleeberger, Ph.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780155
- Sponsor's protocol ID
- 999913031
- Other IDs
- 13-E-N031
- Status last verified
- Aug 2019
- First submitted
- 29 Jan 2013
- Last updated
- 5 Aug 2021
- Results posted
- No
Publications
Anderson CG, Benitz WE, Madan A. Retinopathy of prematurity and pulse oximetry: a national survey of recent practices. J Perinatol. 2004 Mar;24(3):164-8. doi: 10.1038/sj.jp.7211067.
PubMed 14999216Asikainen TM, Huang TT, Taskinen E, Levonen AL, Carlson E, Lapatto R, Epstein CJ, Raivio KO. Increased sensitivity of homozygous Sod2 mutant mice to oxygen toxicity. Free Radic Biol Med. 2002 Jan 15;32(2):175-86. doi: 10.1016/s0891-5849(01)00776-6.
PubMed 11796207Clyman R. Oxygen-saturation targets and outcomes in extremely preterm infants. J Pediatr. 2004 Mar;144(3):408. No abstract available.
PubMed 15032225
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Candidate Genes Associated With Susceptibility to Bronchopulmonary Dysplasia and Retinopathy of Prematurity
- ClinicalTrials.gov ID
- NCT01780155
- Acronym / sponsor ID
- 999913031
- Keywords
- Oxidative Stress, Hyperoxia, Brochopulmonary Dysplasia, Retinopathy of Prematurity, Very Low Birth Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,068 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 24 Jun 2013 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 30 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.@@@
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bronchopulmonary dysplasia; retinopathy of prematurity
Time frame: 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Background: PubMed 14999216Anderson CG, Benitz WE, Madan A. Retinopathy of prematurity and pulse oximetry: a national survey of recent practices. J Perinatol. 2004 Mar;24(3):164-8. doi: 10.1038/sj.jp.7211067.
- Background: PubMed 11796207Asikainen TM, Huang TT, Taskinen E, Levonen AL, Carlson E, Lapatto R, Epstein CJ, Raivio KO. Increased sensitivity of homozygous Sod2 mutant mice to oxygen toxicity. Free Radic Biol Med. 2002 Jan 15;32(2):175-86. doi: 10.1016/s0891-5849(01)00776-6.
- Background: PubMed 15032225Clyman R. Oxygen-saturation targets and outcomes in extremely preterm infants. J Pediatr. 2004 Mar;144(3):408. No abstract available.
Related trials for Bronchopulmonary Dysplasia
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Recruiting
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven R Kleeberger, Ph.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchopulmonary Dysplasia and Retinopathy of Prematurity, run by National Institute of Environmental Health Sciences (NIEHS) at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Argentina, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchopulmonary dysplasia; retinopathy of prematurity (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01780155, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.