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p16Ink4a in Bronchopulmonary Dysplasia in Children (DBP16)

Primary Purpose

Bronchopulmonary Dysplasia

Status

Active

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Blood punction

About this trial

This is an interventional basic science trial for Bronchopulmonary Dysplasia

Eligibility Criteria

undefined - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre Hospitalier Intercommunal de Créteil

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Arm Label

Term newborns (≥37GA)

Premature newborns

Child between 7 and 15 years old with BPD

Child between 7 and 15 years old without BPD

Arm Description

Blood punction on the cordon

Blood punction

Outcomes

Primary Outcome Measures

p16 expression

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

Secondary Outcome Measures

Telomeres length

Telomeres length of circulating leukocytes

Genetic expression of p21, p53, H2Ax

Genetic expression of p21, p53, H2Ax of circulating leukocytes

Full Information

NCT ID

NCT03540680

First Posted

May 17, 2018

Last Updated

June 6, 2023

Sponsor

Centre Hospitalier Intercommunal Creteil

1. Study Identification

Unique Protocol Identification Number

NCT03540680

Brief Title

p16Ink4a in Bronchopulmonary Dysplasia in Children

Acronym

DBP16

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 7, 2018 (Actual)

Primary Completion Date

March 7, 2022 (Actual)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Intercommunal Creteil

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bronchopulmonary Dysplasia

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Term newborns (≥37GA)

Arm Type

Other

Arm Description

Blood punction on the cordon

Arm Title

Premature newborns

Arm Type

Other

Arm Description

Blood punction on the cordon

Arm Title

Child between 7 and 15 years old with BPD

Arm Type

Other

Arm Description

Blood punction

Arm Title

Child between 7 and 15 years old without BPD

Arm Type

Other

Arm Description

Blood punction

Intervention Type

Other

Intervention Name(s)

Blood punction

Intervention Description

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 Outcome Measure Information:

Title

p16 expression

Description

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

Time Frame

Day 1

Secondary Outcome Measure Information:

Title

Telomeres length

Description

Telomeres length of circulating leukocytes

Time Frame

Day 1

Title

Genetic expression of p21, p53, H2Ax

Description

Genetic expression of p21, p53, H2Ax of circulating leukocytes

Time Frame

Day 1

10. Eligibility

Sex

All

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ralph EPAUD, MD

Organizational Affiliation

CHI Créteil

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Hospitalier Intercommunal de Créteil

City

Créteil

ZIP/Postal Code

94000

Country

France

12. IPD Sharing Statement

Learn more about this trial

p16Ink4a in Bronchopulmonary Dysplasia in Children

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