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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age26-32
SponsorCHRISTUS Health

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children (Minor < 18 years of age)

Neonates

Hospitalized

Premature infants who are on full enteral feeds and are started on oral iron

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 6 mg/kg of oral iron as ferrous sulfate administered every other day.

    Dietary supplement

    6mg/kg of oral iron as ferrous sulfate administered every other day instead of 6 mg/kg of oral iron daily supplementation.

  • 6 mg/kg of oral iron as ferrous sulfate administered every day.

    Dietary supplement

    6 mg/kg of oral iron as daily ferrous sulfate instead of 6mg/kg of oral iron supplementation administered every other day.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Control GroupOther 1 intervention
Group B: Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

The iron replete status will be measured by reticulocyte hemoglobin (Ret-Hb) between EOD and daily iron supplementation.

Time frame
1 Week-36 Weeks

Secondary outcomes

1

Characterize Ret-Hb levels in preterm infants.

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.

Time frame
12-24 Months
2

Identify the number of blood transfusions received between enrollment and 36 weeks' PMA between two groups.

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.

Time frame
12-24 Months
3

Determine prevalence of bronchopulmonary dysplasia between two groups.

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.

Time frame
12-24 Months
4

Identify the number of subjects with sepsis between two groups.

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.

Time frame
12-24 Months

Other outcomes

Sponsors and contacts

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