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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
BC Children's Hospital
RECRUITING
Vancouver
Contact Information
Primary
Steffanie Fisher, MSc
steffanie.fisher@bcchr.ca
604-875-2000
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 180
Treatments
Experimental: Prospective (Iron Supplementation)
Patients scheduled for VDRO and/or pelvic osteotomy surgery who are aged 0 to 18 years old (n = 50-60). Note that the investigators will include patients who do or do not have a diagnosis of a neuromotor condition. All patients will be evaluated by the dietitian and have screening lab work to evaluate for iron deficiency at initial consultation. If lab results show that iron supplementation is required, patients will be allocated to the iron supplementation arm and will receive a prescription for iron supplementation, education on non-pharmacological methods to enhance iron intake and comprehensive nutrition management.
No_intervention: Historical
All patients who had VDRO and/or pelvic osteotomy surgery between February 2022 and December 2024 who are aged 0 to 18 years old (n = 100-120). These participants will be enrolled as comparators and receive no intervention, as their surgery has passed.
Experimental: Prospective (No Iron Supplementation)
Patients scheduled for VDRO and/or pelvic osteotomy surgery who are aged 0 to 18 years old (n = 50-60). Note that the investigators will include patients who do or do not have a diagnosis of a neuromotor condition. All patients will be evaluated by the dietitian and have screening lab work to evaluate for iron deficiency at initial consultation. If lab results show adequate iron levels, patients will be allocated to the no iron supplementation arm and will only receive comprehensive nutrition management, without an iron supplementation prescription.
Sponsors
Collaborators: BC Children's Hospital Research Institute
Leads: University of British Columbia

This content was sourced from clinicaltrials.gov