Pilot Trial Investigating Every Other Day Dosing of Oral Iron in Premature Infants (IQONic)

Part of paid clinical trials in San Antonio, Texas.

Sponsor
CHRISTUS Health
Study ID
NCT06555315
Status
Recruiting
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Conditions

  • Anemia of Prematurity
  • Extremely Low Birth Weight
  • Iron Deficiency, Anaemia in Children
  • Premature Infants
  • Very Low Birth Weight Infant

Eligibility Criteria

Sex
ALL
Age
26 Weeks - 32 Weeks
Healthy Volunteers
Accepted

Interventions

  • 6 mg/kg of oral iron as ferrous sulfate administered every other day. — DIETARY_SUPPLEMENT
    6mg/kg of oral iron as ferrous sulfate administered every other day instead of 6 mg/kg of oral iron daily supplementation.
  • 6 mg/kg of oral iron as ferrous sulfate administered every day. — DIETARY_SUPPLEMENT
    6 mg/kg of oral iron as daily ferrous sulfate instead of 6mg/kg of oral iron supplementation administered every other day.

Study Details

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

Key Dates

Start date
Aug 1, 2024
Status verified
Aug 2024
Primary completion
Mar 28, 2026
Completion
Mar 28, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Determine if daily versus EOD oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks PMA. [ Time Frame: 1 Week-36 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
CHRISTUS Children'sSan AntonioTexas78207
Rosario Ocampo
[email protected]
210-639-3157
Richelle Homo, MD (SUB_INVESTIGATOR)

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By research site
CHRISTUS Children's· San Antonio, TX

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