An interventional study of 6 mg/kg of oral iron as ferrous sulfate administered every other day. and 6 mg/kg of oral iron as ferrous sulfate administered every day. in Very Low Birth Weight Infant, Premature Infants and Anemia of Prematurity, sponsored by CHRISTUS Health. Status unknown at 1 site in United States. Open to participants aged 26 Weeks to 32 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by CHRISTUS Health · Not applicable, Interventional, and Supportive care
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
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.
2,610 studies on the registry are indexed under Premature Birth; 507 are open to participants now.
This study's planned enrollment of 100 is above the median of 84 across 1,722 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →CHRISTUS Health is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
6 mg/kg of oral iron as daily ferrous sulfate instead of 6mg/kg of oral iron supplementation administered every other day.
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
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
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
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
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
Identify the number with necrotizing enterocolitis (NEC)/gastrointestinal perforations between two groups.
A chart review of medical records will be used to identify which participants developed necrotizing enterocolitis and/or gastrointestinal perforations.
Time frame: 12-24 Months
Characterize growth between two groups.
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.
Time frame: 12-24 Months
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Started Aug 2024 (actual). Primary completion is estimated for Mar 2026, 19 months after the start.
Of 753 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 19 months is below that.
Counting every sponsor, half of 775 studies reached it within 24 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
CHRISTUS Health