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CompletedNCT03540680DBP16Updated Jun 15, 2026

p16Ink4a in Bronchopulmonary Dysplasia in Children

An interventional study of Blood punction in Bronchopulmonary Dysplasia, sponsored by Centre Hospitalier Intercommunal Creteil. Completed at 1 site in France. Open to participants aged Up to 15 Years. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by Centre Hospitalier Intercommunal Creteil · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
Up to 15 Years
Sex
All
01

Study 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 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.

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Conditions studied

  • Bronchopulmonary Dysplasia
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In context

Bronchopulmonary Dysplasia

339 studies on the registry are indexed under Bronchopulmonary Dysplasia; 80 are open to participants now.

This study's enrollment of 80 is above the median of 70 across 228 interventional studies indexed under Bronchopulmonary Dysplasia.

Browse Bronchopulmonary Dysplasia studies →

Lead sponsor

Centre Hospitalier Intercommunal Creteil is the lead sponsor of 131 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

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

Exclusion criteria

Exclusion Criteria:

Premature (\< 28 GA) and term neonates:

-Congenital malformation

Child from 7 to 15 years old with BPD:

  • Cystic fibrosis
  • Evolutive cancer
  • Chronic inflammatory disease
  • 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
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Other
    Term newborns (≥37GA)

    Blood punction on the cordon

    Other: Blood punction

  • Other
    Premature newborns

    Blood punction on the cordon

    Other: Blood punction

  • Other
    Child between 7 and 15 years old with BPD

    Blood punction

    Other: Blood punction

  • Other
    Child between 7 and 15 years old without BPD

    Blood punction

    Other: Blood punction

Interventions

  • OtherBlood punction

    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.

06

What researchers measure

Primary outcomes

  1. p16 expression

    p16 expression measured by qPCR in newborns cord blood cells and in circulating leukocytes of children aged from 7 to 15

    Time frame: Day 1

Secondary outcomes

  1. Telomeres length

    Telomeres length of circulating leukocytes

    Time frame: Day 1

  2. Genetic expression of p21, p53, H2Ax

    Genetic expression of p21, p53, H2Ax of circulating leukocytes

    Time frame: Day 1

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Study locations

1 site
  • Centre Hospitalier Intercommunal de Créteil
    Créteil, 94000, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03540680
Lead sponsor
Centre Hospitalier Intercommunal Creteil
Responsible party
Sponsor
First posted
May 30, 2018
Start date
Mar 7, 2018
Primary completion
Mar 7, 2022
Completion
Dec 30, 2023
Last update
Jun 15, 2026

Study contacts

Ralph EPAUD, MD
principal investigator · CHI Créteil

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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