MedPath

p16Ink4a in Bronchopulmonary Dysplasia in Children

Not Applicable
Active, not recruiting
Conditions
Bronchopulmonary Dysplasia
Interventions
Other: Blood punction
Registration Number
NCT03540680
Lead Sponsor
Centre Hospitalier Intercommunal Creteil
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
80
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Premature newbornsBlood punctionBlood punction on the cordon
Term newborns (≥37GA)Blood punctionBlood punction on the cordon
Child between 7 and 15 years old with BPDBlood punctionBlood punction
Child between 7 and 15 years old without BPDBlood punctionBlood punction
Primary Outcome Measures
NameTimeMethod
p16 expressionDay 1

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

Secondary Outcome Measures
NameTimeMethod
Telomeres lengthDay 1

Telomeres length of circulating leukocytes

Genetic expression of p21, p53, H2AxDay 1

Genetic expression of p21, p53, H2Ax of circulating leukocytes

Trial Locations

Locations (1)

Centre Hospitalier Intercommunal de Créteil

🇫🇷

Créteil, France

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