Pediatric Outcomes and Recovery With Peri-Operative Iron Supplement Evaluation
A legfontosabb adatok
- Ki végzi
- University of British Columbia
- Hol
- Vancouver (Kanada)A helyszín megnézése
- Azonosító
- Állapot
- Toboroz
- Résztvevők
- 180 fő, tervezett
- Kezdés
- 2025. szept. 1.
- Várható befejezés
- 2027. dec. 31.
- A vizsgálat típusa
- Beavatkozással járó, 3 csoportAz egyik csoport nem kap vizsgálati kezelést, összehasonlításként.
- A vizsgált kezelések
- Iron Supplement
- Comprehensive Nutrition Management
- A regiszteradat frissítve
- 2026. május 14.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
The trial is looking for children and teens scheduled for VDRO and/or pelvic osteotomy hip surgery, with or without a neuromotor condition such as cerebral palsy. Children who had this surgery between February 2022 and December 2024 can also join as a comparison group.
- Életkor
- 0 to 18 years
- Nem
- All sexes
- A betegség stádiuma
- Scheduled for VDRO (a thigh bone surgery for hip displacement) and/or pelvic osteotomy surgery, or had it between February 2022 and December 2024.
- Korábbi kezelés
- No major surgery in the last 3 months. No nutrition program with iron testing and treatment in the last 3 months. Not taking erythropoietin.
- Biomarker vagy leletérték
- Blood tests check iron levels. Low iron leads to the iron supplement group; normal iron leads to the group without iron.
A részvétel fő kizáró okai
- Major surgery in the last 3 months
- Nutrition program with iron testing and treatment in the last 3 months
- Iron taken by mouth or feeding tube is not allowed for medical reasons
- A bleeding disorder or taking erythropoietin
- Patient and family cannot read and understand English
A regiszter feltételei, szó szerint
Mind a 9 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- 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 who have a bleeding disorder
- Patients in whom oral/enteral iron supplementation is contraindicated
- 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
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 0 és 18 év között vagy?
Helyszínek itt: Kanada
- BC Children ' s HospitalVancouver, KanadaContact: Katherine L Mason, BScRésztvevőt keres
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A vizsgálat 3 csoportja
- Prospective (Iron Supplementation)A vizsgált kezelés
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.
Kezelés: Iron Supplement és Comprehensive Nutrition Management
- HistoricalNincs vizsgálati kezelés, összehasonlításként
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)A vizsgált kezelés
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.
Kezelés: Comprehensive Nutrition Management
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Pediatric Outcomes and Recovery With Peri-Operative Iron Supplement Evaluation (PORPOISE)
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
- Illeszkedési kérdések
- Forrás: NCT07095244: ki vehet részt
- A regiszteradat frissítve
- 2026. május 14.