NCT07026812

Brief Summary

Short stature is defined as a height less than -2 Standard Deviations (SD) for age and a slowing of growth velocity by a loss of 1 SD/year. The causes of short stature are multiple (chronic diseases, growth hormone deficiency, hypothyroidism, hyperadrenocorticism, genetic syndromes, etc.). However, nearly 30% are considered idiopathic, with no identified etiology (Naccache et al., unpublished). Growth hormone (GH) is secreted in a pulsatile manner with maximum peaks primarily at night, raising questions about the relationship between sleep disturbances and short stature. In children, one of the main causes of sleep disturbances in the digital age is screen use, which is becoming increasingly important, particularly in the pediatric population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 18, 2025

Completed
Last Updated

June 18, 2025

Status Verified

January 1, 2025

Enrollment Period

2 years

First QC Date

June 10, 2025

Last Update Submit

June 10, 2025

Conditions

Keywords

Growth hormone

Outcome Measures

Primary Outcomes (6)

  • Screen consumption on sleep

    Evaluation of the Impact of Screen Consumption on Sleep by Answers to the Questionnaire Given to the Child and/or Parent(s) (Depending on Age)

    At enrollment visit

  • Screen consumption on sleep

    Sleep assessment by responses to the questionnaire given to the child and/or the parent(s) (depending on age) in order to assess the duration of sleep

    At enrollment visit

  • Screen consumption on sleep

    Evaluation of the Impact of Screen Consumption on Sleep by Answers to the Questionnaire Given to the Child and/or Parent(s) (Depending on Age) in Order to Evaluate child's physical activity

    At enrollment visit

  • Impact of sleep on idiopathic growth disorder

    Collection of auxological data at the time of the day hospital consultation (height) noted in the health record and/or in the hospital medical file

    At enrollment visit

  • Impact of sleep on idiopathic growth disorder

    Collection of auxological data at the time of the day hospital consultation (weight) noted in the health record and/or in the hospital medical file

    At enrollment visit

  • Impact of sleep on idiopathic growth disorder

    Collection of auxological data at the time of the day hospital consultation (age) noted in the health record and/or in the hospital medical file

    At enrollment visit

Secondary Outcomes (1)

  • Impact of screens on body size (BMI)

    At enrollment visit

Study Arms (1)

Growth hormone stimulation test group

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Any patient coming to the day hospital for a growth hormone stimulation test and/or for an oral provocation test in the context of an allergy,

You may qualify if:

  • Children aged 6 to 16 years old coming to the day hospital for a growth hormone stimulation test or an oral provocation test (without growth disorders)
  • Not opposed to participating in the study
  • Patients affiliated with the Social Security system

You may not qualify if:

  • Growth hormone deficiency confirmed by 2 tests
  • Hypothyroidism
  • Hypercorticism
  • All chronic diseases
  • Skeletal pathologies: Turner syndrome, constitutional bone disease Intrauterine growth retardation
  • Pubertal delay defined by absence of puberty onset \>13 years in girls and 14 years in boys
  • Patient under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Rouen

Rouen, 76031, France

Location

MeSH Terms

Conditions

Growth Disorders

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mireille MC CASTANET, Professor

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR
  • Mireille MC CASTANET, Professor

    University Hospital, Rouen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2025

First Posted

June 18, 2025

Study Start

September 26, 2022

Primary Completion

September 11, 2024

Study Completion

June 1, 2025

Last Updated

June 18, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

The data provided will be the property of the sponsor and will be used solely for its own research activities.

Locations