Donor Breast Milk with Early Iron Supplementation in Very Preterm Infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study in very preterm infants compares an earlier iron supplementation protocol to a standard approach by starting ferrous sulfate when enteral feeds reach 80 ml/kg/day, rather than waiting for full feeds. Ferritin and hematocrit will be measured at roughly two timepoints (day 14 and day 28 or discharge) to see if earlier iron improves iron status. The trial involves donors’ breast milk as the primary nutrition and is conducted at AdventHealth Orlando with infants born 29 to 32.6 weeks gestation who receive DBM. Results will inform whether earlier iron can optimize iron stores in DBM-fed preterm infants.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\. All preterm infants born between 29.0-32.6 weeks of gestational age and admitted to the NICU at Advent Health for Children 2. Infants likely to be receiving DBM between 5 to 14 days of life 3. Infants receiving \>50% of the feeding volume by DBM will be considered to have received DBM.

Exclusion Criteria:

1. Death prior to completion of participation or extremis with likelihood of death prior to completion of participation in the study
2. Blood transfusion as determined by clinical team during the study
3. Major congenital anomaly or genetic syndrome and major surgical GI conditions that preclude feeding

Where it's running

• AdventHealth Orlando
  Orlando, Florida, United States Recruiting

Study contacts

• Study coordinator: Anoop Pulickal, MD, PhD
• Email: Anoop.Pulickal.MD@adventhealth.com
• Phone: 407-303-2528

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.