Infant, Premature, DiseasesPREMILOCAPNCT05451264
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)
A study testing blood pressure measurement in people with Infant, Premature, Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Infant, Premature, Diseases
- What is being tested?
- blood pressure measurement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jan 2023to 11 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Absence of affiliation to a social security scheme
- Patient under state medical aid
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Infant, Premature, Diseases
- Being tested
- blood pressure measurement
- Medical subject headings
- Infant, Premature, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood pressure measurementDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Hydrocortisone | Experimental | During the PREMILOC trial, patients received hydrocortisone (0.5mg/kg/12h for 7 days and 0.5mg/kg/24h for 3 days). Receives: Diagnostic Test: blood pressure measurement |
| Placebo | Placebo comparator | During the PREMILOC trial, patients received placebo (0.5mg/kg/12h for 7 days and 0.5mg/kg/24h for 3 days). Receives: Diagnostic Test: blood pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Velocity of the carotid-femoral pulse wave in m/s (VOP)
Velocity of the carotid-femoral pulse wave in m/s measured by the SphygmoCor device.
Measured: Inclusion
Secondary outcomes (14)
Index increase of VOP
Index increase measured by the SphygmoCor device
Measured: Inclusion
Cardio-Radial Pulse Wave Velocity
Cardio-Radial Pulse Wave Velocity in m/s (Biopac device); 3 measures: supine, standing and deep breaths
Measured: Inclusion
Sensitivity of the baroreflex
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
Measured: Inclusion
High Frequence bare of the sympatho-vagal balance
in ms^2; 3 measures: supine, standing and deep breaths
Measured: Inclusion
High Frequence bare of the sympatho-vagal balance
in percent; 3 measures: supine, standing and deep breaths
Measured: Inclusion
Low frequence bare of the sympatho-vagal balance
in percent; 3 measures: supine, standing and deep breaths
Measured: Inclusion
Low frequence bare of the sympatho-vagal balance
in ms^2; 3 measures: supine, standing and deep breaths
Measured: Inclusion
Low Frequence/High Frequence ratio of the sympatho-vagal balance
Low Frequence/High Frequence ratio of the sympatho-vagal balance
Measured: Inclusion
Parameters from ambulatory blood pressure measurement (ABPM)
Parameters from ambulatory blood pressure measurement (ABPM) (Spacelabs device) 24-hour systolic and diastolic average, day, night, systolic and diastolic nocturnal dipping
Measured: During 24 hours
Other factors associated with the risk of early hypertension: quality of life
quality of life: PedsQL quizz
Measured: Data retrieved on inclusion
Other factors associated with the risk of early hypertension: presence of overweight
presence of overweight (yes/no)
Measured: Data retrieved on inclusion
Other factors associated with the risk of early hypertension: etnicity
ethnicity
Measured: Data retrieved on inclusion
Other factors associated with the risk of early hypertension: daily physical activity
daily physical activity: number of hours of physical activity per day
Measured: Data retrieved on inclusion
Other factors associated with the risk of early hypertension: Fetal growth restriction
Fetal growth restriction during the pregnancy (yes/no)
Measured: Data retrieved on inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start23 Jan 2023
- Primary completion11 Jul 2024
- Study completion11 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant, Premature, DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 parameters
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chérine Chérine, MD PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451264
- Sponsor's protocol ID
- APHP211326
- Acronym
- PREMILOCAP
- Status last verified
- Feb 2026
- First submitted
- 17 Jun 2022
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benzouid C, Bokov P, Coste P, Azonaha S, Diallo K, Guilmin-Crepon S, Baud O, Biran V, Delclaux C. Hydrocortisone administration in preterm infants is not associated with adverse cardiovascular outcomes in childhood. Pediatr Res. 2026 Jan 9. doi: 10.1038/s41390-025-04732-4. Online ahead of print.
PubMed 41513980
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05451264
- Acronym / sponsor ID
- PREMILOCAP / APHP211326
- Conditions
- Infant, Premature, Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 11 Jul 2024 (actual)
- Study completion
- 11 Jul 2024 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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 parameters
| Arm | Type | Receives |
|---|---|---|
| Hydrocortisone | Experimental | Diagnostic Test: blood pressure measurementDuring the PREMILOC trial, patients received hydrocortisone (0.5mg/kg/12h for 7 days and 0.5mg/kg/24h for 3 days). |
| Placebo | Placebo comparator | Diagnostic Test: blood pressure measurementDuring the PREMILOC trial, patients received placebo (0.5mg/kg/12h for 7 days and 0.5mg/kg/24h for 3 days). |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Absence of affiliation to a social security scheme
- Patient under state medical aid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood pressure measurementCompletion 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. | Diagnostic test | Hydrocortisone, Placebo |
Primary outcome
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.
14 secondary outcomes
Index increase of VOP
Time frame: Inclusion
Cardio-Radial Pulse Wave Velocity
Time frame: Inclusion
Sensitivity of the baroreflex
Time frame: Inclusion
High Frequence bare of the sympatho-vagal balance
Time frame: Inclusion
High Frequence bare of the sympatho-vagal balance
Time frame: Inclusion
Low frequence bare of the sympatho-vagal balance
Time frame: Inclusion
Low frequence bare of the sympatho-vagal balance
Time frame: Inclusion
Low Frequence/High Frequence ratio of the sympatho-vagal balance
Time frame: Inclusion
Parameters from ambulatory blood pressure measurement (ABPM)
Time frame: During 24 hours
Other factors associated with the risk of early hypertension: quality of life
Time frame: Data retrieved on inclusion
Other factors associated with the risk of early hypertension: presence of overweight
Time frame: Data retrieved on inclusion
Other factors associated with the risk of early hypertension: etnicity
Time frame: Data retrieved on inclusion
Other factors associated with the risk of early hypertension: daily physical activity
Time frame: Data retrieved on inclusion
Other factors associated with the risk of early hypertension: Fetal growth restriction
Time frame: Data retrieved on inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Results publication: PubMed 41513980Benzouid C, Bokov P, Coste P, Azonaha S, Diallo K, Guilmin-Crepon S, Baud O, Biran V, Delclaux C. Hydrocortisone administration in preterm infants is not associated with adverse cardiovascular outcomes in childhood. Pediatr Res. 2026 Jan 9. doi: 10.1038/s41390-025-04732-4. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chérine Chérine, MD PhD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood pressure measurement in people with Infant, Premature, Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Velocity of the carotid-femoral pulse wave in m/s (VOP) (time frame: Inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05451264, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.