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Completed

NCT Number: NCT03540680

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.

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Key information

Conditions

Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Respiratory Tract Diseases Ventilator-Induced Lung Injury

Age range

Up to 15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Intercommunal de Créteil

Créteil, 94000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood punction

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Telomeres length

    Time frame: Day 1

    Telomeres length of circulating leukocytes

  2. Genetic expression of p21, p53, H2Ax

    Time frame: Day 1

    Genetic expression of p21, p53, H2Ax of circulating leukocytes

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Registry information

Official study title

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

Acronym: DBP16

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
May 30, 2018
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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