Pediatric Outcomes and Recovery With Peri-Operative Iron Supplement Evaluation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-18
SponsorUniversity of British Columbia

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Iron Supplement

    Dietary supplement

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

  • Comprehensive Nutrition Management

    Dietary supplement

    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).

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Prospective (Iron Supplementation)Experimental treatment 2 interventions
Group B: HistoricalNo intervention 0 interventions
Group C: Prospective (No Iron Supplementation)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Decreased incidence of blood transfusion

A comprehensive nutritional prehabilitation intervention for iron deficiency anemia before pediatric VDRO surgery will decrease the risk of requiring a blood transfusion, as shown by a decreased incidence of blood transfusions, in the perioperative period.

Time frame
From surgery start time to discharge from hospital.

Secondary outcomes

1

Resolution of anemia

As per the Government of British Columbia guidelines, the investigators will consider iron supplementation for blood Ferritin \< 20 mcg/L for participants aged 0 to 2 years old and \< 30 mcg/L for participants aged 3 years or older. Cases where Ferritin is \< 100 mcg/L, but Transferrin saturation is \<20% will also be considered for iron supplementation. Participants who fall into the above categories at the time of their initial nutrition consultation, but no longer do at the time of surgery, will have their anemia considered "resolved".

Time frame
From baseline to 12 months post-op.
2

Increased Iron Levels

Iron supplementation (if prescribed/necessary) will increase iron levels as proven by a comparison between the blood test at the time of the nutrition consultation and the time of surgery, as shown by Ferritin levels.

Time frame
From baseline to 12 months post-op.
3

Lower incidence of surgical site infection and pressure wounds

The investigators will compare the number and type of adverse outcomes (including surgical site infection and pressure wounds) between the retrospective (no intervention) and prospective (iron supplementation and/or nutrition management) groups.

Time frame
From the day of surgery to 30 days post-op.
4

Decreased hospital length of stay

Acute inpatient length of stay (days) between retrospective (no intervention) and prospective (iron supplementation and/or nutrition management) groups.

Time frame
From the date of surgery until the date of hospital discharge.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of British Columbia

Lead sponsor

BC Children's Hospital Research Institute

Collaborator