Study of the Effect of Hydrocortisone Administered for the Prevention of Pulmonary Bronchodysplasia (PREMILOC Trial) on the Determinants of Systemic Blood Pressure in Children (PREMILOCAP)

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05451264
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 5.3

Study Details

Study Description

Brief Summary

The risk of Arterial Hypertension (HTA) is increased in very premature infants and hydrocortisone administered in the neonatal period could modify this risk.

The main objective is to assess whether the administration of hydrocortisone in the perinatal period in children born prematurely is associated with an increase in Pulse Wave Velocity (PWV) by comparing the future of children included in the PREMILOC trial (hydrocortisone versus placebo) at the age of 7-13 years. The primary endpoint will be the carotid-femoral pulse wave velocity in m/s.

Condition or Disease	Intervention/Treatment	Phase
Infant, Premature, Diseases	Diagnostic Test: blood pressure measurement	N/A

Detailed Description

Descriptive cross-sectional study of the subjects included in the double-blind, monocentric randomized controlled trial (children included and followed up at the Robert Debré hospital in the PREMILOC trial): follow-up of these children approximately 10 years later on vascular parameters.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Descriptive cross-sectional study of the subjects included in the double-blind, monocentric randomized controlled trial (children included and followed up at the Robert Debré hospital in the PREMILOC trial): follow-up of these children approximately 10 years later on vascular parametersDescriptive cross-sectional study of the subjects included in the double-blind, monocentric randomized controlled trial (children included and followed up at the Robert Debré hospital in the PREMILOC trial): follow-up of these children approximately 10 years later on vascular parameters
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: The treatment having been received previously in the PREMILOC trial, no one knows which treatment the patients received.
• Primary Purpose: Prevention
• Official Title: Study of the Effect of Hydrocortisone Administered for the Prevention of Pulmonary Bronchodysplasia (PREMILOC Trial) on the Determinants of Systemic Blood Pressure in Children
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hydrocortisone During the PREMILOC trial, patients received hydrocortisone (0.5mg/kg/12h for 7 days and 0.5mg/kg/24h for 3 days).	Diagnostic Test: blood pressure measurement; Completion of the physical activity and quality of life questionnaire (PedSQL adapted to the age of the child), measurement of weight and height; Measurement of VOP (Pulse wave velocity), AI (increase index) and ECG (electro cardiogram) collection at rest lying down; Stimulation test by slow breathing at 6 cycles/min for three minutes; Continuation of the measurements in a standing position for 5 minutes; Installation of blood pressure holter (MAPA) which will be kept for 24 hours and then returned by post.
Placebo Comparator: Placebo During the PREMILOC trial, patients received placebo (0.5mg/kg/12h for 7 days and 0.5mg/kg/24h for 3 days).	Diagnostic Test: blood pressure measurement; Completion of the physical activity and quality of life questionnaire (PedSQL adapted to the age of the child), measurement of weight and height; Measurement of VOP (Pulse wave velocity), AI (increase index) and ECG (electro cardiogram) collection at rest lying down; Stimulation test by slow breathing at 6 cycles/min for three minutes; Continuation of the measurements in a standing position for 5 minutes; Installation of blood pressure holter (MAPA) which will be kept for 24 hours and then returned by post.

Outcome Measures

Primary Outcome Measures

1. Velocity of the carotid-femoral pulse wave in m/s (VOP) [Inclusion]

   Velocity of the carotid-femoral pulse wave in m/s measured by the SphygmoCor device.

Secondary Outcome Measures

1. Index increase of VOP [Inclusion]

   Index increase measured by the SphygmoCor device

2. Cardio-Radial Pulse Wave Velocity [Inclusion]

   Cardio-Radial Pulse Wave Velocity in m/s (Biopac device); 3 measures: supine, standing and deep breaths

3. Sensitivity of the baroreflex [Inclusion]

   Sensitivity of the baroreflex (up and down measurement, average; standing versus lying down: Biopac device) in ms/mmHg; 3 measures: supine, standing and deep breaths

4. High Frequence bare of the sympatho-vagal balance [Inclusion]

   in ms^2; 3 measures: supine, standing and deep breaths

5. High Frequence bare of the sympatho-vagal balance [Inclusion]

   in percent; 3 measures: supine, standing and deep breaths

6. Low frequence bare of the sympatho-vagal balance [Inclusion]

   in percent; 3 measures: supine, standing and deep breaths

7. Low frequence bare of the sympatho-vagal balance [Inclusion]

   in ms^2; 3 measures: supine, standing and deep breaths

8. Low Frequence/High Frequence ratio of the sympatho-vagal balance [Inclusion]

   Low Frequence/High Frequence ratio of the sympatho-vagal balance

9. Parameters from ambulatory blood pressure measurement (ABPM) [During 24 hours]

   Parameters from ambulatory blood pressure measurement (ABPM) (Spacelabs device) 24-hour systolic and diastolic average, day, night, systolic and diastolic nocturnal dipping

10. Other factors associated with the risk of early hypertension: quality of life [Data retrieved on inclusion]

    quality of life: PedsQL quizz

11. Other factors associated with the risk of early hypertension: presence of overweight [Data retrieved on inclusion]

    presence of overweight (yes/no)

12. Other factors associated with the risk of early hypertension: etnicity [Data retrieved on inclusion]

    ethnicity

13. Other factors associated with the risk of early hypertension: daily physical activity [Data retrieved on inclusion]

    daily physical activity: number of hours of physical activity per day

14. Other factors associated with the risk of early hypertension: Fetal growth restriction [Data retrieved on inclusion]

    Fetal growth restriction during the pregnancy (yes/no)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 13 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Child included in the PREMILOC trial on the Robert Debré site

• Age from 7 to 13 years old (eve of 14 years old)

• Consent of the holders of parental authority and agreement of the child

Exclusion Criteria:

• Absence of affiliation to a social security scheme

• Patient under state medical aid

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Robert Debre Hospital	Paris		France	75019

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Chérine Chérine, MD PhD, APHP

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT05451264
• Other Study ID Numbers: APHP211326
• First Posted: Jul 11, 2022
• Last Update Posted: Jul 11, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infant, Premature, Diseases

Study Results

No Results Posted as of Jul 11, 2022