Pilot Trial Investigating Every Other Day Dosing of Oral Iron in Premature Infants (IQONic)
- Conditions
- Extremely Low Birth WeightVery Low Birth Weight InfantPremature InfantsAnemia of PrematurityIron Deficiency, Anaemia in Children
- Interventions
- Dietary Supplement: 6 mg/kg of oral iron as ferrous sulfate administered every day.Dietary Supplement: 6 mg/kg of oral iron as ferrous sulfate administered every other day.
- Registration Number
- NCT06555315
- Lead Sponsor
- CHRISTUS Health
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
• 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group 6 mg/kg of oral iron as ferrous sulfate administered every day. 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 Group 6 mg/kg of oral iron as ferrous sulfate administered every other day. 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 Measures
Name Time Method 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. 1 Week-36 Weeks The iron replete status will be measured by reticulocyte hemoglobin (Ret-Hb) between EOD and daily iron supplementation.
- Secondary Outcome Measures
Name Time Method Identify the number of subjects with sepsis between two groups. 12-24 Months Microbiology data obtained from a query of medical records will be used to identify which participants developed blood, urine, or cerebrospinal fluid culture positive sepsis.
Characterize Ret-Hb levels in preterm infants. 12-24 Months Laboratory data obtained from a query of the medical records will be used to characterize reticulocyte-hemoglobin (Ret-Hb) levels. The units used for Ret-Hb is "pg" or picograms.
Identify the number with necrotizing enterocolitis (NEC)/gastrointestinal perforations between two groups. 12-24 Months A chart review of medical records will be used to identify which participants developed necrotizing enterocolitis and/or gastrointestinal perforations.
Characterize growth between two groups. 12-24 Months A query of medical records will be conducted to identify weight (grams), height (centimeters), and head circumference (centimeters) percentiles and velocity for the infants at birth up until 36 weeks' postmenstrual age.
Identify the number of blood transfusions received between enrollment and 36 weeks' PMA between two groups. 12-24 Months Blood bank data obtained from a query of the medical records will be used to identify the number of blood transfusions received by each study participant.
Determine prevalence of bronchopulmonary dysplasia between two groups. 12-24 Months A chart review of medical records will be used to identify which participants developed a diagnosis of bronchopulmonary dysplasia (BPD), clinically defined as the study participant requiring supplemental oxygen and/or respiratory support either at 28 days postnatal age or 36 weeks' postmenstrual age. The severity of BPD will be defined as that outlined by the 2019 Jensen guidelines.
Trial Locations
- Locations (1)
CHRISTUS Children's
🇺🇸San Antonio, Texas, United States