p16Ink4a in Bronchopulmonary Dysplasia in Children

NCT ID: NCT03540680

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-07
• Study Completion Date: 2023-12-30

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.

Conditions

Bronchopulmonary Dysplasia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Term newborns (≥37GA)

Blood punction on the cordon

Group Type: OTHER

Blood punction

Intervention Type: OTHER

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.

Premature newborns

Blood punction on the cordon

Group Type: OTHER

Blood punction

Intervention Type: OTHER

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 BPD

Blood punction

Group Type: OTHER

Blood punction

Intervention Type: OTHER

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 without BPD

Blood punction

Group Type: OTHER

Blood punction

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ralph EPAUD, MD

Role: PRINCIPAL_INVESTIGATOR

CHI Créteil

Locations

Centre Hospitalier Intercommunal de Créteil

Créteil, , France

Countries

France

Other Identifiers

DBP16

Identifier Type: -

Identifier Source: org_study_id