Pilot Non-inferiority Study Investigating Daily Versus Every Other Day Dosing of Oral Iron in Premature Infants.
Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Study focuses on determining if daily versus every-other-day (EOD) oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks post-menstrual age in premature neonates
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 7 months
Healthy Volunteers: t
View:
• Children (Minor \< 18 years of age)
• Neonates
• Hospitalized
• Premature infants who are on full enteral feeds and are started on oral iron
• Premature infants who completed 26 0/7 to 32 6/7 weeks' gestation at birth
Locations
United States
Texas
CHRISTUS Children's
RECRUITING
San Antonio
Contact Information
Primary
Rosario Ocampo
rosario.ocampo@christushealth.org
210-704-4996
Backup
Donna Rodney
donna.rodney@christushealth.org
(210) 683-7746
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2026-03-28
Participants
Target number of participants: 100
Treatments
Other: Control Group
After the infant achieves full enteral feeds, the infant is started on 6 mg/kg of oral iron daily supplementation. The dose of 6 mg/kg of enteral iron was chosen based on the aforementioned recommendations with evidence of its safety, while minimizing the need to increase the enteral iron dosage if an infant were to be started on ESAs where a dose of 6 mg/kg of enteral iron supplementation is the standard practice. Phlebotomy to obtain a complete blood count, reticulocyte count, and reticulocyte hemoglobin count is pursued the Monday after starting iron supplementation and every 2 weeks thereafter to weeks to monitor hematocrit or hemoglobin levels and iron status.
Experimental: Intervention Group
After the infant achieves full enteral feeds, the infant is started on 6mg/kg of oral iron supplementation administered every other day. The dose of 6 mg/kg of enteral iron was chosen based on the aforementioned recommendations with evidence of its safety, while minimizing the need to increase the enteral iron dosage if an infant were to be started on ESAs where a dose of 6 mg/kg of enteral iron supplementation is the standard practice. Phlebotomy to obtain a complete blood count, reticulocyte count, and reticulocyte hemoglobin count is pursued the Monday after starting iron supplementation and every 2 weeks thereafter to weeks to monitor hematocrit or hemoglobin levels and iron status.
Related Therapeutic Areas
Sponsors
Leads: CHRISTUS Health