NCT03540680

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2022

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

June 7, 2023

Status Verified

June 1, 2023

Enrollment Period

4 years

First QC Date

May 17, 2018

Last Update Submit

June 6, 2023

Conditions

Bronchopulmonary Dysplasia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Telomeres length

    Day 1

  • Genetic expression of p21, p53, H2Ax

    Day 1

Study Arms (4)

Term newborns (≥37GA)

OTHER

Blood punction on the cordon

Other: Blood punction

Premature newborns

OTHER

Blood punction on the cordon

Other: Blood punction

Child between 7 and 15 years old with BPD

OTHER

Blood punction

Other: Blood punction

Child between 7 and 15 years old without BPD

OTHER

Blood punction

Other: Blood punction

Interventions

Blood punctionOTHER

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.

Child between 7 and 15 years old with BPDChild between 7 and 15 years old without BPDPremature newbornsTerm newborns (≥37GA)

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Intercommunal de Créteil

Créteil, 94000, France

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Ralph EPAUD, MD

    CHI Créteil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2018

First Posted

May 30, 2018

Study Start

March 7, 2018

Primary Completion

March 7, 2022

Study Completion

December 30, 2023

Last Updated

June 7, 2023

Record last verified: 2023-06

Locations

FR(1)