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

Not Applicable

Recruiting

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

• 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.

Study Timeline

• Study First Submitted: 2024-07-31
• Status Verified: 2024-08
• Study Start: 2024-08-01
• Study First Submitted QC: 2024-08-13
• Last Update Submitted: 2024-08-13
• Study First Posted: 2024-08-15
• Last Update Posted: 2024-08-15
• Primary Completion: 2026-03-28
• Study Completion: 2026-03-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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