Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06555315
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Pilot Trial Investigating Every Other Day Dosing of Oral Iron in Premature Infants IQONic
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Non-inferiority Study Investigating Daily Versus Every Other Day Dosing of Oral Iron in Premature Infants
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None