RecruitingNot ApplicableNCT06555315

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

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


Sponsor

CHRISTUS Health

Enrollment

100 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 26 WeeksMax Age: 32 Weeks

Inclusion Criteria5

  • 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 Criteria1

  • • 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

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Interventions

DIETARY_SUPPLEMENT6 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.

DIETARY_SUPPLEMENT6 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.


Locations(1)

CHRISTUS Children's

San Antonio, Texas, United States

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NCT06555315


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