Clinical trial NCT06555315: Pilot Trial Investigating Every Other Day Dosing of Oral Iron in Premature Infants (IQONic)
Official title: Pilot Non-inferiority Study Investigating Daily Versus Every Other Day Dosing of Oral Iron in Premature Infants.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Very Low Birth Weight Infant
Premature Infants
Anemia of Prematurity
Iron Deficiency, Anaemia in Children
Extremely Low Birth Weight
Keywords: Premature infants
Iron
anemia of prematurity
iron deficiency
Lead sponsor: CHRISTUS Health
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 100
Sex: ALL
Minimum age (years): 26
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 1 Week-36 Weeks
Secondary outcomes:
measure: Characterize Ret-Hb levels in preterm infants.
timeFrame: 12-24 Months
measure: Identify the number of blood transfusions received between enrollment and 36 weeks' PMA between two groups.
timeFrame: 12-24 Months
measure: Determine prevalence of bronchopulmonary dysplasia between two groups.
timeFrame: 12-24 Months
measure: Identify the number of subjects with sepsis between two groups.
timeFrame: 12-24 Months
measure: Identify the number with necrotizing enterocolitis (NEC)/gastrointestinal perforations between two groups.
timeFrame: 12-24 Months
measure: Characterize growth between two groups.
timeFrame: 12-24 Months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: CHRISTUS Children's
state: Texas
Study officials:
affiliation: CHRISTUS Health
name: Pratik K Parikh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRISTUS Health; Brooke Army Medical Center
name: Richelle L Homo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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