RecruitingNot ApplicableNCT07095244

Pediatric Outcomes and Recovery With Peri-Operative Iron Supplement Evaluation

Pediatric Outcomes and Recovery With Peri-Operative Iron Supplement Evaluation (PORPOISE)

Sponsor

University of British Columbia

Enrollment

180 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Cerebral Palsy Iron-Deficiency Anemia Varus-Derotation Osteotomy Surgery Pelvic Osteotomy Surgery

Summary

Varus-derotation osteotomy (VDRO) is a surgery to prevent or address hip displacement in children. Many children having this surgery have cerebral palsy or other neuromotor disorders, who have a higher rate of malnutrition, including low iron or anemia. This can affect their surgical outcomes, such as increasing their need for blood transfusions. This project aims to develop a preoperative nutritional program for VDRO patients, to improve their surgical outcomes and decrease their need for transfusions. This may include taking iron supplementation for patient with low iron or anemia. Participants will undergo a nutrition program before their surgery.

Eligibility

Min Age: 0 YearsMax Age: 18 Years

Inclusion Criteria4

All patients scheduled for VDRO and/or pelvic osteotomy surgery (prospective cohort)
All patients who had VDRO and/or pelvic osteotomy surgery between February 2022 and December 2024 (historical cohort)
Ages 0-18 years old
Note that the investigators will include patients who do or do not have a diagnosis of a neuromotor condition. The investigators may not include patients who are enrolled in other conflicting research studies.

Exclusion Criteria7

Patients who have undergone a major surgical intervention in the last 3 months
Patients who have received a nutritional intervention that includes iron testing and treatment within the last 3 months
Patients in whom oral/enteral iron supplementation is contraindicated
Patients who have a bleeding disorder
Patients taking erythropoietin
Patients who cannot read and understand English*
Patients and their families who cannot read and understand English will be excluded from the study because the surveys and interviews are conducted in English. These patients will still have access to the same nutrition management and interventions as study participants.

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Interventions

DIETARY_SUPPLEMENTIron Supplement

FeraMAX Pd powder 15: NPN 80109337 FeraMAX Pd Therapeutic 150 capsules: NPN 80075623 (for an adolescent that can swallow capsules)

DIETARY_SUPPLEMENTComprehensive Nutrition Management

Standard nutrition care will depend on the results of the nutrition assessment, as well as underlying conditions, and will be performed regardless of iron supplementation. The intervention will be at the discretion of the dietician but may include; diet education, recommendations for vitamin and mineral supplements, optimization of tube feeds (if the child is tube fed), high protein or high energy diet education if the child is underweight, dddition of oral nutrition supplements (i.e., Pediasure or Ensure) to promote weight gain in orally fed children, discussion surrounding enteral feeding (for children who are orally fed, but severely malnourished and cannot meet their nutritional needs by mouth).