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

University of British Columbia

Status: Not yet enrolling

Conditions: Varus-Derotation Osteotomy Surgery; Pelvic Osteotomy Surgery; Cerebral Palsy; Iron-deficiency Anemia

Treatments: Dietary Supplement: Comprehensive Nutrition Management; Dietary Supplement: Iron Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT07095244

H25-00010

Details and patient eligibility

About

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.

Full description

Purpose:

The investigators aim to establish a multidisciplinary pathway for all patients scheduled for varus-derotation osteotomy (VDRO) surgery that incorporates comprehensive nutrition management and iron deficiency anemia assessment and management. The goal is to determine whether patients with nutritional optimization will experience improved care, including a decreased risk of adverse outcomes and improved surgical outcomes.

Hypothesis:

The primary hypothesis is that a comprehensive nutritional prehabilitation intervention for iron deficiency anemia before pediatric varus-derotational osteotomy (VDRO) surgery will decrease the risk blood transfusion, as shown by a lower incidence of blood transfusions, during the preoperative period. The investigators also aim to show that this program will improve other perioperative surgical outcomes and will be feasible and acceptable to families.

Justification:

VDRO, a surgical procedure designed to prevent or address hip displacement, is a lengthy procedure (>4 hours), with risk of blood transfusion from 10-25%. VDRO patients often present with complex medical conditions and require multidisciplinary care. Malnutrition contributes to morbidity but is rarely highlighted by the perioperative team. Similarly, while patient blood management programs are standard perioperative care for adults, their implementation in pediatrics is limited. Estimates of iron-deficiency anemia in Canadian children range from 12-64%, without considering medically complex patients at high risk of malnutrition. Preoperative anemia raises the risk of in-hospital mortality for pediatric surgical patients. BC Children's Hospital treats 30-35 VDRO patients annually. The investigators aim to establish a multidisciplinary nutritional and prehabilitation program for elective VDRO patients (with and without neuromotor conditions) that includes comprehensive nutrition and iron deficiency anemia management.

Objectives:

(1) Study the integration of blood management into the nutritional care of patients having VDRO surgery and determine whether it improves perioperative outcomes; (2) evaluate the program's operational feasibility and its acceptability among patients' families; (3) apply the findings to other elective surgical interventions, such as neuromuscular scoliosis surgery.

Research Design:

The investigators will conduct a prospective observational study to evaluate this comprehensive nutritional prehabilitation program over a 24-month period and compare outcomes against a historical cohort from February 2022 to December 2024 using propensity score matching. The primary outcome will be the percentage of patients transfused during the perioperative stay. Secondary perioperative outcomes will include anemia, iron levels, length of hospital stay, and surgical complications such as pressure sores. The investigators will recruit all patients 0-18 years scheduled to undergo VDRO and/or pelvic osteotomy, unless they have undergone a surgical intervention or received a nutritional intervention that includes iron within the previous 3 months. All patients will be evaluated by the dietitian and have screening lab work to evaluate for iron deficiency at initial consultation. If required, patients will receive a prescription for iron supplementation and education on non-pharmacological methods to enhance iron intake. Longitudinal online surveys will assess compliance/tolerance and family satisfaction with the program. Further feedback will be obtained in optional semi-structured interviews.

Iron Supplementation Intevntion:

Feramax (or other iron polysaccharide complex) will be prescribed as it is most used in practice due to its fewer gastrointestinal side effects, ability to be taken with food, and lack of requirement for stomach acid for absorption, making it suitable for patients receiving gastrojejunostomy feedings. The typical dose of iron for pediatric patients with deficiency is 3-6 mg/kg, up to a maximum of 150 mg/day. Other possible nutritional interventions may include recommending supplements (most commonly calcium/Vitamin D and occasionally a multivitamin), optimizing tube feeds, and providing dietary education.

Standard Nutrition Intervention:

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 components of the following non-exhaustive list.

1. Diet education regarding general healthy diet and nutrition for bone health (for generally healthy orally fed patients).
2. Recommendations for vitamin and mineral supplements as needed (based on estimated intake from diet or tube feeds. This may include a multivitamin, calcium and/or Vitamin D.
3. Optimization of tube feeds (if the child is tube fed).
4. High protein or high energy diet education if the child is underweight, but capable of achieving their nutritional needs by increasing oral intake.
5. Addition of oral nutrition supplements (i.e., Pediasure or Ensure) to promote weight gain in orally fed children.
6. Discussion surrounding enteral feeding (for children who are orally fed, but severely malnourished and cannot meet their nutritional needs by mouth). The orthopedic surgeon may refer the patient to general surgery, or the family may ask their pediatrician for a referral.

Statistical Analysis The investigators will recruit a convenience sample of participants over a two-year period (n~50); the investigators will propensity-score match each prospective participant to two historical controls based on age, sex, gross motor function classification system score, ASA physical status score, and procedure booking code. Transfusion rates between the baseline period and the intervention period will be compared using Fisher's exact test. Semi-structured interviews will be analyzed using a grounded theory-based qualitative approach.

Enrollment: 180 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

Prospective (Iron Supplementation)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Iron Supplement

Dietary Supplement: Comprehensive Nutrition Management

Historical

No Intervention group

Description:

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.

Prospective (No Iron Supplementation)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Comprehensive Nutrition Management