Pediatric Outcomes and Recovery With Peri-Operative Iron Supplement Evaluation

NCT07095244 | Recruiting

• 1 other identifier: H25-00010
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Varus-derotation osteotomy; Anemia; Iron deficiency; Nutrition; Perioperative blood management

Outcome Measures

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.

  From surgery start time to discharge from hospital.

Secondary Outcomes (4)

• Resolution of anemia

  From baseline to 12 months post-op.

• Increased Iron Levels

  From baseline to 12 months post-op.

• Lower incidence of surgical site infection and pressure wounds

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

• Decreased hospital length of stay

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

Study Arms (3)

Prospective (Iron Supplementation)

EXPERIMENTAL

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.

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

Historical

NO INTERVENTION

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

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.

Dietary Supplement: Comprehensive Nutrition Management

Interventions

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).

Also known as: Standard Nutrition Care

Prospective (Iron Supplementation); Prospective (No Iron Supplementation)

Iron Supplement DIETARY_SUPPLEMENT

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

Prospective (Iron Supplementation)

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• BC Children's Hospital Research Institute: collaborator

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

Related Publications (17)

• Luo J, West NC, Pang S, Robillard JM, Page P, Chadha NK, Gan H, Correll LR, Ridgway R, Broemling N, Gorges M; Pediatric Pain Prediction Collaboration. Parental Perspectives on Pediatric Surgical Recovery: Narrative Analysis of Free-Text Comments From a Postoperative Survey. JMIR Perioper Med. 2024 Dec 20;7:e65198. doi: 10.2196/65198.

  PMID: 39705676 BACKGROUND

• Lin Y. Preoperative anemia-screening clinics. Hematology Am Soc Hematol Educ Program. 2019 Dec 6;2019(1):570-576. doi: 10.1182/hematology.2019000061.

  PMID: 31808909 BACKGROUND

• Tan GM, Murto K, Downey LA, Wilder MS, Goobie SM. Error traps in Pediatric Patient Blood Management in the Perioperative Period. Paediatr Anaesth. 2023 Aug;33(8):609-619. doi: 10.1111/pan.14683. Epub 2023 May 5.

  PMID: 37144721 BACKGROUND

• Faraoni D, DiNardo JA, Goobie SM. Relationship Between Preoperative Anemia and In-Hospital Mortality in Children Undergoing Noncardiac Surgery. Anesth Analg. 2016 Dec;123(6):1582-1587. doi: 10.1213/ANE.0000000000001499.

  PMID: 27870741 BACKGROUND

• Hartfield D. Iron deficiency is a public health problem in Canadian infants and children. Paediatr Child Health. 2010 Jul;15(6):347-50. doi: 10.1093/pch/15.6.347. No abstract available.

  PMID: 21731416 BACKGROUND

• Goobie SM, Faraoni D. Perioperative paediatric patient blood management: a narrative review. Br J Anaesth. 2025 Jan;134(1):168-179. doi: 10.1016/j.bja.2024.08.034. Epub 2024 Oct 24.

  PMID: 39455307 BACKGROUND

• Goel R, Cushing MM, Tobian AA. Pediatric Patient Blood Management Programs: Not Just Transfusing Little Adults. Transfus Med Rev. 2016 Oct;30(4):235-41. doi: 10.1016/j.tmrv.2016.07.004. Epub 2016 Aug 1.

  PMID: 27559005 BACKGROUND

• DiFazio RL, Glader LJ, Tombeno R, Lawler K, Friel K, Brustowicz RM, Shore BJ. Team Approach: The Perioperative Management of Reconstructive Hip Surgery for the Non-Ambulatory Child with Cerebral Palsy and Spastic Hip Disease. JBJS Rev. 2020 Jul;8(7):e1900185. doi: 10.2106/JBJS.RVW.19.00185.

  PMID: 32678539 BACKGROUND

• Butler LR, Dominy CL, White CA, Mengsteab P, Lin E, Allen AK, Ranade SC. Risk factors for 90-day readmission and prolonged length of stay after hip surgery in children with cerebral palsy. J Orthop. 2023 Mar 2;38:14-19. doi: 10.1016/j.jor.2023.03.002. eCollection 2023 Apr.

  PMID: 36925762 BACKGROUND

• Fontanals M, O'Leary JD, Zaarour C, Skelton T, Faraoni D. Preoperative anemia increases the risk of red blood cell transfusion and prolonged hospital length of stay in children undergoing spine arthrodesis surgery. Transfusion. 2019 Feb;59(2):492-499. doi: 10.1111/trf.15055. Epub 2018 Nov 30.

  PMID: 30499592 BACKGROUND

• Papadopoulos A, Ntaios G, Kaiafa G, Girtovitis F, Saouli Z, Kontoninas Z, Diamantidis MD, Savopoulos C, Hatzitolios A. Increased incidence of iron deficiency anemia secondary to inadequate iron intake in institutionalized, young patients with cerebral palsy. Int J Hematol. 2008 Dec;88(5):495-497. doi: 10.1007/s12185-008-0191-3. Epub 2008 Nov 11.

  PMID: 18991057 BACKGROUND

• Le Roy C, Barja S, Sepulveda C, Guzman ML, Olivarez M, Figueroa MJ, Alvarez M. Vitamin D and iron deficiencies in children and adolescents with cerebral palsy. Neurologia (Engl Ed). 2021 Mar;36(2):112-118. doi: 10.1016/j.nrl.2017.11.005. Epub 2018 Jan 17. English, Spanish.

  PMID: 29342407 BACKGROUND

• Jevsevar DS, Karlin LI. The relationship between preoperative nutritional status and complications after an operation for scoliosis in patients who have cerebral palsy. J Bone Joint Surg Am. 1993 Jun;75(6):880-4. doi: 10.2106/00004623-199306000-00008.

  PMID: 8314827 BACKGROUND

• Ruzbarsky JJ, Beck NA, Baldwin KD, Sankar WN, Flynn JM, Spiegel DA. Risk factors and complications in hip reconstruction for nonambulatory patients with cerebral palsy. J Child Orthop. 2013 Dec;7(6):487-500. doi: 10.1007/s11832-013-0536-1. Epub 2013 Oct 15.

  PMID: 24432112 BACKGROUND

• Nazareth A, Shymon SJ, Andras L, Goldstein RY, Kay RM. Impact of tranexamic acid use on blood loss and transfusion rates following femoral varus derotational osteotomy in children with cerebral palsy. J Child Orthop. 2019 Apr 1;13(2):190-195. doi: 10.1302/1863-2548.13.180143.

  PMID: 30996744 BACKGROUND

• Compton E, Goldstein RY, Nazareth A, Shymon SJ, Andras L, Kay RM. Tranexamic acid use decreases transfusion rate in children with cerebral palsy undergoing proximal femoral varus derotational osteotomy. Medicine (Baltimore). 2022 Jan 14;101(2):e28506. doi: 10.1097/MD.0000000000028506.

  PMID: 35029205 BACKGROUND

• Bouwhuis CB, van der Heijden-Maessen HC, Boldingh EJ, Bos CF, Lankhorst GJ. Effectiveness of preventive and corrective surgical intervention on hip disorders in severe cerebral palsy: a systematic review. Disabil Rehabil. 2015;37(2):97-105. doi: 10.3109/09638288.2014.908961. Epub 2014 Apr 14.

  PMID: 24731007 BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Cerebral Palsy; Anemia; Iron Deficiencies

Interventions

Iron-Dextran Complex

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Teresa Skelton, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine L Mason, BSc

CONTACT

604-875-2000; katherine.mason@bcchr.ca

Steffanie M Fisher, MSc

CONTACT

604-875-2000; steffanie.fisher@bcchr.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: All participants who are enrolled prospectively will receive comprehensive nutrition management, which includes a blood test. Participants will have their blood work done prior to initiating nutrition intervention for iron-deficiency (two tubes containing 1 to 2 ml each). If patients are determined to be iron-deficient or anemic, they will be prescribed iron supplementation. All patients will receive comprehensive nutrition management from a clinical dietician during the months leading up to their procedure (up to 12 months preoperatively). Patients will have their blood re-tested in the operating room before surgery (after the induction of anesthesia).

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: July 31, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)