p16Ink4a in Bronchopulmonary Dysplasia in Children

Bronchopulmonary Dysplasia Clinical Trial

— DBP16  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03540680
• Other study ID #: DBP16
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 7, 2018
• Est. completion date: December 30, 2023

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 30, 2023
• Est. primary completion date: March 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal de Créteil	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Telomeres length	Telomeres length of circulating leukocytes	Day 1
Secondary	Genetic expression of p21, p53, H2Ax	Genetic expression of p21, p53, H2Ax of circulating leukocytes	Day 1