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CompletedNCT06843278Updated Feb 24, 2025

Donor Breast Milk and Serum Ferritin Levels in Very Preterm Infants

An observational study in Ferritin Levels in Very Preterm Infants, sponsored by AdventHealth. Completed at 1 site in United States. Open to participants aged 2 Weeks to 4 Weeks. Per ClinicalTrials.gov, last updated 2025-02-24.

Sponsored by AdventHealth · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
34
Ages
2 Weeks to 4 Weeks
Sex
All
01

Study summary

This study compares the iron levels in very preterm infants receiving donor breast (DBM) milk to very preterm infants receiving maternal breast milk (MBM).

02

Conditions studied

  • Ferritin Levels in Very Preterm Infants

Browse trials for

Keywords

  • Breast milk
  • Donor breast milk
  • Ferritin level
  • very preterm infants
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 34 is below the median of 112 across 777 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

AdventHealth is the lead sponsor of 107 studies on the registry; 25 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Weeks to 4 Weeks
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Very preterm infants

Inclusion criteria

  1. All preterm infants born between 29 weeks and 0 days -32 weeks and 6 days of gestational age and admitted to the NICU at Advent Health for Children

  2. Received either MBM or DBM starting between 5 to10 days of life

    a. Infants receiving >50% feeding volume by DBM for the first 14 days of life will be considered to have received predominantly DBM. The comparison group will be infants who received > 50% of MBM for the first 14 days of life.

  3. Parent able to read and write in the English language.

Exclusion criteria

Exclusion Criteria:

  1. Death prior to completion of participation
  2. Extremis with likelihood of death prior to completion of participation in the study
  3. Blood transfusion as determined by clinical team during the study
  4. Major congenital anomaly or genetic syndrome and
  5. Major surgical GI conditions that preclude feeding
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
34 participants (actual)
Patient registry
No

Groups and cohorts

  • Very preterm infants receiving breast milk

    Other: maternal breast milk

  • Very preterm infants receiving donor breast milk

    Other: Donor breast milk

Interventions

  • Othermaternal breast milk

    Very preterm infants receiving maternal breast milk

  • OtherDonor breast milk

    Very preterm infants receiving donor breast milk

06

What researchers measure

Primary outcomes

  1. The Average Serum ferritin level in very preterm infants

    The average serum ferritin level (ng/ml) in very preterm infants receiving donor breast milk or maternal breast milk

    Time frame: Until four weeks of age or discharge

Secondary outcomes

  1. The Average Hemoglobin levels (g/dl) in very preterm infants

    The average Hemoglobin levels (g/dL) in very preterm infants receiving donor breast milk or maternal breast milk

    Time frame: Until four weeks of age or discharge

  2. The Average Bilirubin Levels (mg/dL) in very preterm infants

    The average Hemoglobin levels (g/dL) in very preterm infants receiving donor breast milk or maternal breast milk

    Time frame: until four weeks of age or discharge

07

Study locations

1 site
  • AdventHealth
    Orlando, Florida 32803, United States
08

References and documents

Publications

  • Gao C, Miller J, Middleton PF, Huang YC, McPhee AJ, Gibson RA. Changes to breast milk fatty acid composition during storage, handling and processing: A systematic review. Prostaglandins Leukot Essent Fatty Acids. 2019 Jul;146:1-10. doi: 10.1016/j.plefa.2019.04.008. Epub 2019 May 1. PubMed 31186148 ↗
  • Maisels MJ, Gifford K. Breast-feeding, weight loss, and jaundice. J Pediatr. 1983 Jan;102(1):117-8. doi: 10.1016/s0022-3476(83)80305-9. No abstract available. PubMed 6848709 ↗
  • Joy R, Krishnamurthy S, Bethou A, Rajappa M, Ananthanarayanan PH, Bhat BV. Early versus late enteral prophylactic iron supplementation in preterm very low birth weight infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F105-9. doi: 10.1136/archdischild-2013-304650. Epub 2013 Dec 3. PubMed 24302687 ↗
  • 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. PubMed 28114607 ↗
  • 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. PubMed 30473033 ↗
  • 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. PubMed 34324880 ↗
  • Taufek NM, Cartwright D, Hewavitharana A, Koorts P, McConachy H, Shaw N, Whitfield K, Davies M. TO INVESTIGATE THE EFFECT OF THE PASTEURISATION PROCESS ON TRACE ELEMENTS IN DONOR BREAST MILK. Arch Dis Child. 2016 Sep;101(9):e2. doi: 10.1136/archdischild-2016-311535.27. PubMed 27540206 ↗
  • 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. PubMed 27253894 ↗
  • 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. PubMed 29287170 ↗
  • 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. PubMed 25117506 ↗
  • 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. PubMed 30565323 ↗
  • 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. PubMed 31322731 ↗
  • 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. PubMed 20443660 ↗
  • American Academy of Pediatrics Policy Statement. Breastfeeding and the use of breast milk. Pediatrics 2012; 129:e827-841

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06843278
Lead sponsor
AdventHealth
Responsible party
Sponsor
First posted
Feb 24, 2025
Start date
Aug 17, 2022
Primary completion
Oct 17, 2024
Completion
Oct 17, 2024
Last update
Feb 24, 2025

Study contacts

Anoop Pulickal, MD
principal investigator · AdvenHealth

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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