Pilot Non-inferiority Study Investigating Daily Versus Every Other Day Dosing of Oral Iron in Premature Infants.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- CHRISTUS Health
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief 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
Detailed Description
Iron is an important component of hemoglobin, and an essential part of erythropoiesis. It is also a necessary micronutrient for rapidly proliferating and differentiating cells and tissues especially in the brain. Iron deficiency in infancy has been associated with anemia and impaired neurodevelopmental outcomes that extend into childhood. Premature infants are at highest risk for iron deficiency because they are deprived of the iron accretion that occurs in the third trimester of pregnancy, are born with lower iron stores compared to their term counterparts, and have increased utilization and depletion of iron stores with their rapid growth rate.
In older populations, EOD iron supplementation is as effective as daily iron supplementation in the treatment of iron deficiency anemia, with studies revealing significantly fewer gastrointestinal side effects in those who are on EOD iron. Adults regulate their iron status through a feedback pathway involving hepcidin whereby iron-sufficient individuals will have upregulated hepcidin, which leads to decreased iron absorption and availability. Recent studies have revealed that pediatric patients and premature neonates regulate iron absorption through hepcidin in a similar fashion. Though the regulation of iron status through hepcidin has been studied in extremely premature neonates, the clinical effect of EOD dosing of iron has not yet been examined in this population.
This is a non-inferiority, blinded, randomized control trial designed to investigate if EOD iron is comparable to daily iron dosing in achieving iron replete status by reticulocyte hemoglobin measurements in premature infants.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
A statistician who is blinded to the study allocation will analyze the data.
Eligibility Criteria
- Ages
- 26 Weeks to 32 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Children (Minor < 18 years of age)
- •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
Exclusion Criteria
- •Infants with known congenital anomalies or chromosomal abnormalities (such as Trisomy 18 or Trisomy 21), conditions that affect iron metabolism (such as thalassemia or hemochromatosis), bleeding disorders or coagulopathy, and received iron parenterally prior to randomization
Arms & Interventions
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.
Intervention: 6 mg/kg of oral iron as ferrous sulfate administered every day. (Dietary Supplement)
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.
Intervention: 6 mg/kg of oral iron as ferrous sulfate administered every other day. (Dietary Supplement)
Outcomes
Primary Outcomes
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
The iron replete status will be measured by reticulocyte hemoglobin (Ret-Hb) between EOD and daily iron supplementation.
Secondary Outcomes
- Characterize Ret-Hb levels in preterm infants.(12-24 Months)
- Identify the number with necrotizing enterocolitis (NEC)/gastrointestinal perforations between two groups.(12-24 Months)
- Identify the number of subjects with sepsis between two groups.(12-24 Months)
- Characterize growth between two groups.(12-24 Months)
- Identify the number of blood transfusions received between enrollment and 36 weeks' PMA between two groups.(12-24 Months)
- Determine prevalence of bronchopulmonary dysplasia between two groups.(12-24 Months)