Recruiting

Iron Supplementation

Sponsor:

AdventHealth

Code:

NCT07816601

Conditions

Iron Deficiency Anemia

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Ferrous Sulfate Oral Product

Study Details

Brief summary:

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

Conditions

Iron Deficiency Anemia

Study ID

NCT07816601

Start date

May 6, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

17 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Very preterm infants

Interventions

Ferrous Sulfate Oral Product

Dietary Supplement

Primary outcome measure

  • To determine the serum ferritin(ng/ml) level in very preterm infants receiving DBM with an early iron supplementation protocol. [ Time Frame: At 14 days of life(+/- 4 days) and at 28 days of life(+/- 4 days) ]
  • To determine the hematocrit level(%) in very preterm infants receiving DBM with an early iron supplementation protocol [ Time Frame: At 14 days of life(+/- 4 days) and at 28 days of life(+/- 4 days) ]

Central Contacts and Locations

Central contacts

Anoop Pulickal, MD, PhD

407-303-2528Anoop.Pulickal.MD@adventhealth.com

Deborah Ruth, RN

407-303-9186deborah.ruth@adventhealth.com

Locations

AdventHealth Orlando

Recruiting

Orlando, Florida, United States, 32803

More Information

Sponsor

AdventHealth

Last update posted

Sep 11, 2026

Last verified

Jul, 2026

Keywords

  • preterm infant
  • neonate
  • ferritin
  • iron supplementation
  • donor breast milk
  • maternal breast milk
  • low birth weight

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by AdventHealth on 2026-09-11.