NCT07816601

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
14mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
May 2026Dec 2027

Study Start

First participant enrolled

May 6, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 11, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

September 11, 2026

Status Verified

July 1, 2026

Enrollment Period

1.5 years

First QC Date

September 8, 2026

Last Update Submit

September 8, 2026

Conditions

Iron Deficiency Anemia

Keywords

preterm infantneonateferritiniron supplementationdonor breast milkmaternal breast milklow birth weight

Outcome Measures

Primary Outcomes (2)

  • To determine the serum ferritin(ng/ml) level in very preterm infants receiving DBM with an early iron supplementation protocol.

    To determine the serum ferritin(ng/ml) level in very preterm infants receiving DBM with an early iron supplementation protocol.

    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

    To determine the hematocrit level(%) in very preterm infants receiving DBM with an early iron supplementation protocol

    At 14 days of life(+/- 4 days) and at 28 days of life(+/- 4 days)

Study Arms (1)

Very preterm infants

EXPERIMENTAL
Drug: Ferrous Sulfate Oral Product

Interventions

Ferrous Sulfate Oral ProductDRUG

Dietary Supplement

Very preterm infants

Eligibility Criteria

Age29 Weeks - 33 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \. 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AdventHealth Orlando

Orlando, Florida, 32803, United States

RECRUITING

Related Publications (10)

  • Kc A, Rana N, Malqvist M, Jarawka Ranneberg L, Subedi K, Andersson O. Effects of Delayed Umbilical Cord Clamping vs Early Clamping on Anemia in Infants at 8 and 12 Months: A Randomized Clinical Trial. JAMA Pediatr. 2017 Mar 1;171(3):264-270. doi: 10.1001/jamapediatrics.2016.3971.

    PMID: 28114607BACKGROUND

  • Mercer JS, Erickson-Owens DA, Deoni SCL, Dean DC 3rd, Collins J, Parker AB, Wang M, Joelson S, Mercer EN, Padbury JF. Effects of Delayed Cord Clamping on 4-Month Ferritin Levels, Brain Myelin Content, and Neurodevelopment: A Randomized Controlled Trial. J Pediatr. 2018 Dec;203:266-272.e2. doi: 10.1016/j.jpeds.2018.06.006. Epub 2018 Jul 6.

    PMID: 30473033BACKGROUND

  • German KR, Vu PT, Comstock BA, Ohls RK, Heagerty PJ, Mayock DE, Georgieff M, Rao R, Juul SE; PENUT Consortium. Enteral Iron Supplementation in Infants Born Extremely Preterm and its Positive Correlation with Neurodevelopment; Post Hoc Analysis of the Preterm Erythropoietin Neuroprotection Trial Randomized Controlled Trial. J Pediatr. 2021 Nov;238:102-109.e8. doi: 10.1016/j.jpeds.2021.07.019. Epub 2021 Jul 27.

    PMID: 34324880BACKGROUND

  • Mohd-Taufek N, Cartwright D, Davies M, Hewavitharana AK, Koorts P, McConachy H, Shaw PN, Sumner R, Whitfield K. The effect of pasteurization on trace elements in donor breast milk. J Perinatol. 2016 Oct;36(10):897-900. doi: 10.1038/jp.2016.88. Epub 2016 Jun 2.

    PMID: 27253894BACKGROUND

  • Mannel R, Peck JD. Outcomes Associated With Type of Milk Supplementation Among Late Preterm Infants. J Obstet Gynecol Neonatal Nurs. 2018 Jul;47(4):571-582. doi: 10.1016/j.jogn.2017.11.005. Epub 2017 Dec 27.

    PMID: 29287170BACKGROUND

  • Stoltz Sjostrom E, Ohlund I, Tornevi A, Domellof M. Intake and macronutrient content of human milk given to extremely preterm infants. J Hum Lact. 2014 Nov;30(4):442-9. doi: 10.1177/0890334414546354. Epub 2014 Aug 12.

    PMID: 25117506BACKGROUND

  • Hard AL, Nilsson AK, Lund AM, Hansen-Pupp I, Smith LEH, Hellstrom A. Review shows that donor milk does not promote the growth and development of preterm infants as well as maternal milk. Acta Paediatr. 2019 Jun;108(6):998-1007. doi: 10.1111/apa.14702. Epub 2019 Jan 25.

    PMID: 30565323BACKGROUND

  • Quigley M, Embleton ND, McGuire W. Formula versus donor breast milk for feeding preterm or low birth weight infants. Cochrane Database Syst Rev. 2019 Jul 19;7(7):CD002971. doi: 10.1002/14651858.CD002971.pub5.

    PMID: 31322731BACKGROUND

  • Arslanoglu S, Ziegler EE, Moro GE; World Association of Perinatal Medicine Working Group On Nutrition. Donor human milk in preterm infant feeding: evidence and recommendations. J Perinat Med. 2010 Jul;38(4):347-51. doi: 10.1515/jpm.2010.064.

    PMID: 20443660BACKGROUND

  • Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics. 2012 Mar;129(3):e827-41. doi: 10.1542/peds.2011-3552. Epub 2012 Feb 27.

    PMID: 22371471BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-DeficiencyPremature Birth

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Anoop Pulickal, MD, PhD

CONTACT

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

Deborah Ruth, RN

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2026

First Posted

September 11, 2026

Study Start

May 6, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

September 11, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)