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

August 13, 2024 updated by: CHRISTUS Health

Pilot Non-inferiority Study Investigating Daily Versus Every Other Day Dosing of Oral Iron in Premature Infants.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Dietary supplement: 6 mg/kg of oral iron as ferrous sulfate administered every day.
6 mg/kg of oral iron as daily ferrous sulfate instead of 6mg/kg of oral iron supplementation administered every other day.
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.
Dietary supplement: 6 mg/kg of oral iron as ferrous sulfate administered every other day.
6mg/kg of oral iron as ferrous sulfate administered every other day instead of 6 mg/kg of oral iron daily supplementation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 Week-36 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterize Ret-Hb levels in preterm infants.
Time Frame: 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.
12-24 Months
Identify the number of blood transfusions received between enrollment and 36 weeks' PMA between two groups.
Time Frame: 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.
12-24 Months
Determine prevalence of bronchopulmonary dysplasia between two groups.
Time Frame: 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.
12-24 Months
Identify the number of subjects with sepsis between two groups.
Time Frame: 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.
12-24 Months
Identify the number with necrotizing enterocolitis (NEC)/gastrointestinal perforations between two groups.
Time Frame: 12-24 Months
A chart review of medical records will be used to identify which participants developed necrotizing enterocolitis and/or gastrointestinal perforations.
12-24 Months
Characterize growth between two groups.
Time Frame: 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.
12-24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHRISTUS Health

Investigators

  • Principal Investigator: Pratik K Parikh, MD, CHRISTUS Health
  • Principal Investigator: Richelle L Homo, MD, CHRISTUS Health; Brooke Army Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

March 28, 2026

Study Completion (Estimated)

March 28, 2026

Study Registration Dates

First Submitted

July 31, 2024

First Submitted That Met QC Criteria

August 13, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-091

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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