Comparison of the Rate of Preoperative Haemoglobin After Administration of Epoetin Alpha Associated With an Oral Medical Supplementation Versus Intravenous Before Surgery of Craniosynostosis at the Child (IRON KID)
Craniosynostosis
About this trial
This is an interventional treatment trial for Craniosynostosis focused on measuring Craniosynostosis, hemoglobin, iron peros, iron intravenous
Eligibility Criteria
Inclusion Criteria:
- Craniosynostosis Surgery
- Age: between 4 and 24 months inclusive
- Weight: less than 12kg
- Hemoglobin: 10 g / dl ≤ Hb 14 ≤ g / dl
- Affiliated patients or beneficiaries of a Social Security scheme
- Signature of the consent of the patient's parents
Exclusion Criteria:
- Generalized infection
- Time for consultation of anesthesia with respect to the date of surgery greater than 5 weeks or less than 22 days.
- Initial biological assessment dating more than 3 months before the consultation of anesthesia
- Parents do not understand French
- BMI greater than 20 kg.m-2
- Contraindications to EPO
- Contraindications to ferric carboxymaltose and to ferrous fumarate
Sites / Locations
- University Hospital of AngersRecruiting
- University Hospital of MontpellierRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Ferrous fumarate or ferrostrane
Ferric carboxymaltose
The oral treatment should begin 21 days before surgery. Recommended Dosage ferrous fumarate according to the SPC in force: 5 to 8 kg: 2 cd rases / d or 200mg of ferrous fumarate 8 to 10 kg: 3 cd rases / d or 300mg of ferrous fumarate 10 to 12kg: 4 cd rases / d or 400mg of ferrous fumarate Ferrostrane ® (syrup) Laboratory TEOFARMA SRL Either 34mg of iron per teaspoon Recommended dosage according to the SPC in force: Infant 5 to 8 kg (about 1 to 6 months): 2 teaspoons a day, Infant from 8 to 12 kg (about 6 to 30 months): 3 teaspoons a day.
The single intravenous treatment the day of the inclusion. Dosage according to: 15mg / kg iron (to dilute in 3 ml / kg of Nacl 0.9% (SSI), to pass in 15 minutes.