Search > Iron-Deficiency Anemia
17 Participants NeededMy employer runs this trial

Ferrous Sulfate for Preterm Infants

DR
AP
Overseen ByAnoop Pulickal, MD, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: AdventHealth
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to determine the serum ferritin level and hematocrit level in very preterm infants receiving donor breast milk(DBM) with an early iron supplementation protocol . The main questions it aims to answer are: Does earlier iron supplementation provide increased ferritin levels at 14 and 28 days of life in subjects fed primarily donor breast milk?

Iron supplementation will be implemented when the infant achieves 80ml/kg/day of enteral feeds, as contrasted to the current protocol of full feeds (140 to 160ml/kg/day), the latter usually by Day 14 of life.

At day of life(DOL) 14 (± 4 days), a blood sample will be obtained for serum ferritin determination. Similarly, a second blood draw would be performed at day of life 28 (± 4 days) or prior to discharge, whichever comes earlier

Are You a Good Fit for This Trial?

This trial is for very preterm infants who are mainly fed donor breast milk. It focuses on babies at risk of iron-deficiency anemia and does not specify other major exclusions.

Inclusion Criteria

My baby is expected to get donor breast milk between days 5 and 14 of life.
Infants receiving >50% of the feeding volume by DBM will be considered to have received DBM
My baby was born between 29 and 32 weeks and admitted to Advent Health for Children NICU.

Exclusion Criteria

I may receive a blood transfusion if my doctor decides it's needed during the study.
Death prior to completion of participation or extremis with likelihood of death prior to completion of participation in the study
I have a major birth defect or genetic syndrome that affects my ability to eat.

What Are the Treatments Tested in This Trial?

Interventions

  • Ferrous Sulfate Oral Product

Trial Overview

The study compares starting oral iron supplements (ferrous sulfate) earlier versus the usual later start in very preterm infants receiving donor breast milk, to see if early supplementation improves iron levels after birth.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Very preterm infantsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AdventHealth

Lead Sponsor

Trials
118
Recruited
31,800+

Unbiased Results

We believe in providing patients with all the options.

Your Data Stays Your Data

We only share your information with the clinical trials you're trying to access.

Verified Trials Only

All of our trials are run by licensed doctors, researchers, and healthcare companies.