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Clinical Trials/NCT03540680
NCT03540680
Active, not recruiting
Not Applicable

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

Centre Hospitalier Intercommunal Creteil1 site in 1 country80 target enrollmentMarch 7, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bronchopulmonary Dysplasia
Sponsor
Centre Hospitalier Intercommunal Creteil
Enrollment
80
Locations
1
Primary Endpoint
p16 expression
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 7, 2018
End Date
December 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

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

  • Telomeres length(Day 1)
  • Genetic expression of p21, p53, H2Ax(Day 1)

Study Sites (1)

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