Evolution of the Quality of Life of Short Statured Children Treated With Growth Hormone : Evaluation at Adult Size

NCT ID: NCT05195437

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-08

Study Completion Date

2024-10-12

Brief Summary

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Short stature can lead to emotional and social stress in children and adolescents, as well as their parents. Children and their parents want to be able to identify the cause of stunted growth and address it with treatment. Mitigating the impact of short stature on quality of life is one of the main goals of treatment. The quality of life in children can be measured using adapted self-questionnaires.

The investigative team published in 2019 the results of a preliminary study which shows that after one year of treatment with growth hormone, the quality of life improves in children, in particular on the scales emotional and social. These evaluations were carried out in particular thanks to the general questionnaire of quality of life: Pediatric Quality of Life Inventory (PedsQL) 4.0, but also via a specific questionnaire of the size: Quality of Life of Short Stature Youth questionnaire (QoLiSSY).

50 of the 74 patients who participated in this study have now reached their final height. The objective of the present study is to reassess this cohort using the QoLiSSY and PedsQL 4.0 questionnaires. The patient will be his own witness.

Detailed Description

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Short stature can lead to emotional and social stress in children and adolescents, as well as their parents. Children and their parents want to be able to identify the cause of stunted growth and address it with treatment. Mitigating the impact of short stature on quality of life is one of the main goals of treatment. The quality of life in children can be measured using adapted self-questionnaires.

The investigative team published in 2019 the results of a preliminary study which shows that after one year of treatment with growth hormone, the quality of life improves in children, in particular on the scales emotional and social. These evaluations were carried out in particular thanks to the general questionnaire of quality of life: Pediatric Quality of Life Inventory (PedsQL) 4.0, but also via a specific questionnaire of the size: Quality of Life of Short Stature Youth questionnaire (QoLiSSY).

50 of the 74 patients who participated in this study have now reached their final height. The objective of the present study is to reassess this cohort using the QoLiSSY and PedsQL 4.0 questionnaires. The patient will be his own witness.

Conditions

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Growth Hormone Treatment

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Growth hormone treatment

Adolescents and young adults followed or having been followed by the endocrinology, gynecology and pediatric diabetology department of the Necker Enfants Malades hospital, who reached their final height and who have been treated with growth hormone due to short stature.

QoLiSSY and PedsQL 4.0 questionnaires

Intervention Type OTHER

Patients have been reaching adult size complete the two questionnaires of the study :

Quality of Life of Short Stature Youth questionnaire (QoLiSSY), assessing health-related quality of life in short stature youth.

Pediatric Quality of Life Inventory (PedsQL) 4.0 : general health-related quality of life.

The patients have previously completed the PedsQL 4.0 and QoLiSSY questionnaires when starting their growth hormone therapy and after one year of growth hormone therapy.

Interventions

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QoLiSSY and PedsQL 4.0 questionnaires

Patients have been reaching adult size complete the two questionnaires of the study :

Quality of Life of Short Stature Youth questionnaire (QoLiSSY), assessing health-related quality of life in short stature youth.

Pediatric Quality of Life Inventory (PedsQL) 4.0 : general health-related quality of life.

The patients have previously completed the PedsQL 4.0 and QoLiSSY questionnaires when starting their growth hormone therapy and after one year of growth hormone therapy.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adolescents and young adults followed or having been followed by the endocrinology, gynecology and pediatric diabetology department of the Necker Enfants Malades hospital and treated with growth hormone because of their short stature.
* Patient who participated in the initial study.
* Patient having reached the final height during the last consultation (growth rate less than 1 cm / year and / or bone age ≥ 15 years for girls, ≥ 17 years for boys).
* Holders of parental authority, minor patients and adult patients informed and not opposed to their participation in the study.

Exclusion Criteria

\- Refusal to participate in the study.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michel Polak, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hôpital Necker-Enfants Malades

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2024-A01272-45

Identifier Type: OTHER

Identifier Source: secondary_id

APHP211523

Identifier Type: -

Identifier Source: org_study_id

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