Skip to main content
OpenTrials
Completed

NCT Number: NCT07342686

Hypothalamic-Stratified Nursing Pathway for Pediatric Craniopharyngioma

The goal of this multicenter retrospective cohort study is to determine whether MRI-graded hypothalamic injury severity predicts growth-hormone deficiency (GHD) and neuropsychological morbidity in 500 children and adolescents (≤ 18 y) who underwent craniopharyngioma resection at six Chinese pediatric centers between 2013 and 2023 and were followed ≥ 2 years. The main questions it aims to answer are:

1. Does increasing hypothalamic injury grade (Grade 0 = uninvolved, Grade 1 = mild compression, Grade 2 = significant invasion) independently correlate with higher incidence of GHD, lower IGF-1 levels, greater height SDS decline, and increased need for recombinant human GH therapy? 2. Is higher injury grade associated with worse neuropsychological outcomes-lower IQ, impaired executive function, emotional disorders, and obesity-after adjustment for age, tumor size, and extent of resection?

Researchers compared the three injury-grade groups to quantify endocrine and neuro-behavioral outcomes and to catalog differentiated nursing needs (growth monitoring frequency, dietary-behavioral plans, psychological support intensity, comorbidity surveillance). Participants underwent pre- and post-operative MRI grading by blinded neuroradiologists, standardized endocrine stimulation tests, annual neuropsychological testing (WISC-IV, BRIEF, CBCL), and detailed nursing-documentation review; all data were analyzed with Spearman correlation, ANOVA, and multivariable logistic regression.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≤18 years at the time of craniopharyngioma resection;
  • Pathologically confirmed craniopharyngioma;
  • Postoperative follow-up duration ≥2 years;
  • Complete preoperative and postoperative MRI data, endocrine test results, neuropsychological assessment records, and nursing documentation;
  • No preoperative GHD, neuropsychological disorders, or other systemic diseases affecting growth or neurodevelopment.

Exclusion criteria

  • Preoperative diagnosis of GHD, cognitive impairment, or emotional disorders;
  • Concurrent intracranial tumors or systemic diseases (e.g., congenital growth hormone deficiency, Down syndrome);
  • Loss to follow-up or incomplete clinical data;
  • Tumor recurrence requiring reoperation during follow-up.

Treatment and study plan

Primary outcomes

  1. Incidence of growth hormone deficiency (GHD) at 2 years post-surgery

    Time frame: 2 years

    defined as peak GH < 10 ng/mL on stimulation testing plus age-/sex-adjusted IGF-1 below reference range

Secondary outcomes

  1. Change in height standard-deviation score (Δ-height SDS) from baseline to final follow-up.

    Time frame: 2 years

  2. Proportion of patients who initiate recombinant human GH (rhGH) therapy

    Time frame: 2 years

  3. Normalized IGF-1 level (age-/sex-adjusted z-score) at final follow-up.

    Time frame: 2 years

  4. Mean full-scale IQ score (WISC-IV) and rate of cognitive impairment (IQ < 85).

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

A Hypothalamic Injury-Stratified Nursing Care Pathway for Pediatric Craniopharyngioma Survivors: Advancing Nursing Leadership in Complex Chronic Disease Management

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 15, 2026
Registry last updated
Jan 15, 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.

Published trials that share one or more normalized conditions with this study.