p16Ink4a in Bronchopulmonary Dysplasia in Children (DBP16)

Centre Hospitalier Intercommunal Creteil

Status: Active, not recruiting

Conditions: Bronchopulmonary Dysplasia

Treatments: Other: Blood punction

Study type: Interventional

Funder types: Other

Identifiers

NCT03540680

DBP16

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: Under 15 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Term newborns (≥37GA)

Other group

Description:

Blood punction on the cordon

Treatment:

Other: Blood punction

Premature newborns

Other group

Description:

Blood punction on the cordon

Treatment:

Other: Blood punction

Child between 7 and 15 years old with BPD

Other group

Description:

Blood punction

Treatment:

Other: Blood punction

Child between 7 and 15 years old without BPD

Other group

Description:

Blood punction

Treatment:

Other: Blood punction