p16Ink4a in Bronchopulmonary Dysplasia in Children

Study Overview
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Brief Summary
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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.

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

Conditions
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Bronchopulmonary Dysplasia

Intervention / Treatment
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* Other: Blood punction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Term newborns (≥37GA)<br>Blood punction on the cordon | Other: Blood punction<br>* 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.<br>|
| Other: Premature newborns<br>Blood punction on the cordon | Other: Blood punction<br>* 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.<br>|
| Other: Child between 7 and 15 years old with BPD<br>Blood punction | Other: Blood punction<br>* 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.<br>|
| Other: Child between 7 and 15 years old without BPD<br>Blood punction | Other: Blood punction<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| p16 expression | p16 expression measured by qPCR in newborns cord blood cells and in circulating leukocytes of children aged from 7 to 15 | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Telomeres length | Telomeres length of circulating leukocytes | Day 1 | 
| Genetic expression of p21, p53, H2Ax | Genetic expression of p21, p53, H2Ax of circulating leukocytes | Day 1 |