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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07342686
Enrollment
500
Registered
2026-01-15
Start date
2023-12-01
Completion date
2023-12-30
Last updated
2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniopharyngioma, Growth Hormone Deficiency (GHD)

Keywords

Hypothalamic Injury, Neuropsychological Development, Stratified Nursing Pathway, Multicenter Retrospective Study

Brief summary

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.

Interventions

None listed

Sponsors

West China Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of growth hormone deficiency (GHD) at 2 years post-surgery2 yearsdefined as peak GH \< 10 ng/mL on stimulation testing plus age-/sex-adjusted IGF-1 below reference range

Secondary

MeasureTime frame
Change in height standard-deviation score (Δ-height SDS) from baseline to final follow-up.2 years
Proportion of patients who initiate recombinant human GH (rhGH) therapy2 years
Normalized IGF-1 level (age-/sex-adjusted z-score) at final follow-up.2 years
Mean full-scale IQ score (WISC-IV) and rate of cognitive impairment (IQ < 85).2 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026