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NCT Number: NCT05451264

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)

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.

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Key information

Conditions

Infant, Premature, Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases

Age range

7 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Robert Debre Hospital

Paris, 75019, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood pressure measurement

Diagnostic Test

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.

Primary outcomes

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

    Time frame: Inclusion

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

Secondary outcomes

  1. Index increase of VOP

    Time frame: Inclusion

    Index increase measured by the SphygmoCor device

  2. Cardio-Radial Pulse Wave Velocity

    Time frame: Inclusion

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

  3. Sensitivity of the baroreflex

    Time frame: 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

    Time frame: Inclusion

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

  5. High Frequence bare of the sympatho-vagal balance

    Time frame: Inclusion

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

  6. Low frequence bare of the sympatho-vagal balance

    Time frame: Inclusion

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

  7. Low frequence bare of the sympatho-vagal balance

    Time frame: Inclusion

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

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

    Time frame: Inclusion

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

  9. Parameters from ambulatory blood pressure measurement (ABPM)

    Time frame: 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

    Time frame: Data retrieved on inclusion

    quality of life: PedsQL quizz

  11. Other factors associated with the risk of early hypertension: presence of overweight

    Time frame: Data retrieved on inclusion

    presence of overweight (yes/no)

  12. Other factors associated with the risk of early hypertension: etnicity

    Time frame: Data retrieved on inclusion

    ethnicity

  13. Other factors associated with the risk of early hypertension: daily physical activity

    Time frame: 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

    Time frame: Data retrieved on inclusion

    Fetal growth restriction during the pregnancy (yes/no)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: PREMILOCAP

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 11, 2022
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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