Clinical trial · Observational
Hypothalamic-Stratified Nursing Pathway for Pediatric Craniopharyngioma
A Hypothalamic Injury-Stratified Nursing Care Pathway for Pediatric Craniopharyngioma Survivors: Advancing Nursing Leadership in Complex Chronic Disease Management
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Craniopharyngioma | Craniopharyngioma | ONTOLOGY_EXACT | 0.90 |
| Growth Hormone Deficiency (GHD) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Grade 0
- description
- Hypothalamic Injury Uninvolved (n=100)
- label
- Grade 1
- description
- Mild Compression (n=250)
- label
- Grade 2
- description
- Significant Invasion (n=150)
Primary outcomes (1)
- measure
- Incidence of growth hormone deficiency (GHD) at 2 years post-surgery
- timeFrame
- 2 years
- description
- defined as peak GH \< 10 ng/mL on stimulation testing plus age-/sex-adjusted IGF-1 below reference range
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available