Bronchopulmonary DysplasiaDBP16NCT03540680
p16Ink4a in Bronchopulmonary Dysplasia in Children
A study testing Blood punction in people with Bronchopulmonary Dysplasia, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
The bronchopulmonary dysplasia (BPD) is a respiratory disease of the premature child which lead to a reduction of gas exchange surface and to a prolonged respiratory failure. This disease has morphologic and functional consequences at adulthood and is today considered to be an early determinant of respiratory diseases… Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- Blood punction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 7 Mar 2018to 30 Dec 2023
- Phase
- Interventional
- 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 Up to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature(< 28 GA) neonates
- Alive neonate born at less than 28 gestational age
- Signed inform consent
- Term neonates:
- Alive neonate born at least at 37 GA or more
- Signed inform consent
Show all 14Show fewer
- Child from 7 to 15 years old with BPD:
- Child from 7 to 15 years old
- Child with a BPD diagnosed
- Signed inform consent
- Child from 7 to 15 years old without BPD:
- Child from 7 to 15 years old
- Child receiving a blood test
- Signed inform consent
Who cannot join
- Premature (< 28 GA) and term neonates:
- -Congenital malformation
- Child from 7 to 15 years old with BPD:
- Cystic fibrosis
- Evolutive cancer
- Chronic inflammatory disease
Show all 14Show fewer
- Known anemia
- Refusal of participation of child or parental authority
- Child from 7 to 15 years old without BPD:
- Other respiratory disease: severe asthma, cystic fibrosis, deficit AAT, bronchial dilatation
- Evolutive cancer
- Chronic inflammatory disease
- Known anemia
- Refusal of participation of child or parental authority
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Case-control Study Evaluating the Impact of p16Ink4a in Bronchopulmonary Dysplasia in Children
The bronchopulmonary dysplasia (BPD) is a respiratory disease of the premature child which lead to a reduction of gas exchange surface and to a prolonged respiratory failure. This disease has morphologic and functional consequences at adulthood and is today considered to be an early determinant of respiratory diseases at adulthood.
The physiopathology of BPD is not well known. Several mechanisms could be involved especially a reparation failure favored by an increase of cellular senescence which is a permanent stop of cellular proliferation. The transcription factor 16 Ink4a, considered as a marker of aging, is one of the essential markers of senescence. Its increase during prematurity was shown at the blood cells of the cordon, but its involvement in BPD and its evolution in child are not yet studied.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- Blood punction
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood punctionOther
For the arms "Term newborns (≥37GA)" and "Premature newborns" the only intervention is a blood punction on the cordon.
For the arms "Child between 7 and 15 years old" with or without BPD the only intervention is a blood punction on peripheral blood.
| Study group | Role | What they receive |
|---|---|---|
| Term newborns (≥37GA) | Other | Blood punction on the cordon Receives: Other: Blood punction |
| Premature newborns | Other | Blood punction on the cordon Receives: Other: Blood punction |
| Child between 7 and 15 years old with BPD | Other | Blood punction Receives: Other: Blood punction |
| Child between 7 and 15 years old without BPD | Other | Blood punction Receives: Other: Blood punction |
What is being measured
The primary outcome is the main question the study is designed to answer.
p16 expression
p16 expression measured by qPCR in newborns cord blood cells and in circulating leukocytes of children aged from 7 to 15
Measured: Day 1
Secondary outcomes (2)
Telomeres length
Telomeres length of circulating leukocytes
Measured: Day 1
Genetic expression of p21, p53, H2Ax
Genetic expression of p21, p53, H2Ax of circulating leukocytes
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start7 Mar 2018
- Primary completion7 Mar 2022
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ralph EPAUD, MD, Principal investigator, CHI Créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540680
- Sponsor's protocol ID
- DBP16
- Acronym
- DBP16
- Status last verified
- Jun 2026
- First submitted
- 17 May 2018
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case-control Study Evaluating the Impact of p16Ink4a in Bronchopulmonary Dysplasia in Children
- ClinicalTrials.gov ID
- NCT03540680
- Acronym / sponsor ID
- DBP16 / DBP16
- Conditions
- Bronchopulmonary Dysplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 7 Mar 2022 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 30 May 2018 (actual)
- 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.
The bronchopulmonary dysplasia (BPD) is a respiratory disease of the premature child which lead to a reduction of gas exchange surface and to a prolonged respiratory failure. This disease has morphologic and functional consequences at adulthood and is today considered to be an early determinant of respiratory diseases at adulthood.
The physiopathology of BPD is not well known. Several mechanisms could be involved especially a reparation failure favored by an increase of cellular senescence which is a permanent stop of cellular proliferation. The transcription factor 16 Ink4a, considered as a marker of aging, is one of the essential markers of senescence. Its increase during prematurity was shown at the blood cells of the cordon, but its involvement in BPD and its evolution in child are not yet studied.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Term newborns (≥37GA) | Other | Other: Blood punctionBlood punction on the cordon |
| Premature newborns | Other | Other: Blood punctionBlood punction on the cordon |
| Child between 7 and 15 years old with BPD | Other | Other: Blood punctionBlood punction |
| Child between 7 and 15 years old without BPD | Other | Other: Blood punctionBlood punction |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Premature(< 28 GA) neonates
- Alive neonate born at less than 28 gestational age
- Signed inform consent
- Alive neonate born at least at 37 GA or more
- Signed inform consent
Key exclusion criteria (14 listed)
- -Congenital malformation
- Cystic fibrosis
- Evolutive cancer
- Chronic inflammatory disease
- Known anemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood punctionFor the arms "Term newborns (≥37GA)" and "Premature newborns" the only intervention is a blood punction on the cordon. For the arms "Child between 7 and 15 years old" with or without BPD the only intervention is a blood punction on peripheral blood. | Other | Child between 7 and 15 years old with BPD, Child between 7 and 15 years old without BPD, Premature newborns, Term newborns (≥37GA) |
Primary outcome
p16 expression
Time frame: Day 1
p16 expression measured by qPCR in newborns cord blood cells and in circulating leukocytes of children aged from 7 to 15
2 secondary outcomes
Telomeres length
Time frame: Day 1
Genetic expression of p21, p53, H2Ax
Time frame: Day 1
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 15 Jun 2026.
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.
Ralph EPAUD, MD principal investigator
CHI Créteil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood punction in people with Bronchopulmonary Dysplasia, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
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 14 inclusion and 14 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 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
p16 expression (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2026.