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p16Ink4a in Bronchopulmonary Dysplasia in Children

Case-control Study Evaluating the Impact of p16Ink4a in Bronchopulmonary Dysplasia in Children

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03540680
Acronym
DBP16
Enrollment
80
Registered
2018-05-30
Start date
2018-03-07
Completion date
2023-12-30
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchopulmonary Dysplasia

Brief 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.

Interventions

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.

Sponsors

Centre Hospitalier Intercommunal Creteil
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 15 Years
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

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

Design outcomes

Primary

MeasureTime frameDescription
p16 expressionDay 1p16 expression measured by qPCR in newborns cord blood cells and in circulating leukocytes of children aged from 7 to 15

Secondary

MeasureTime frameDescription
Telomeres lengthDay 1Telomeres length of circulating leukocytes
Genetic expression of p21, p53, H2AxDay 1Genetic expression of p21, p53, H2Ax of circulating leukocytes

Countries

France

Contacts

PRINCIPAL_INVESTIGATORRalph EPAUD, MD

CHI Créteil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026