p16Ink4a in Bronchopulmonary Dysplasia in Children (DBP16)

Case-control Study Evaluating the Impact of 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bronchopulmonary Dysplasia
• Intervention / Treatment: Other: Blood punction

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Créteil, France, 94000
    • Centre Hospitalier Intercommunal de Creteil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 15 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil
• Investigators: Principal Investigator: Ralph EPAUD, MD, CHI Creteil

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2018
• Primary Completion (Actual): March 7, 2022
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: May 17, 2018
• First Submitted That Met QC Criteria: May 29, 2018
• First Posted (Actual): May 30, 2018

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Bronchopulmonary Dysplasia
• Other Study ID Numbers: DBP16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No