Donor Breast Milk and Serum Ferritin Levels in Very Preterm Infants
NCT ID: NCT06843278
Last Updated: 2025-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
34 participants
OBSERVATIONAL
2022-08-17
2024-10-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Very preterm infants receiving breast milk
maternal breast milk
Very preterm infants receiving maternal breast milk
Very preterm infants receiving donor breast milk
Donor breast milk
Very preterm infants receiving donor breast milk
Interventions
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maternal breast milk
Very preterm infants receiving maternal breast milk
Donor breast milk
Very preterm infants receiving donor breast milk
Eligibility Criteria
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Inclusion Criteria
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
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
2 Weeks
4 Weeks
ALL
No
Sponsors
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AdventHealth
OTHER
Responsible Party
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Principal Investigators
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Anoop Pulickal, MD
Role: PRINCIPAL_INVESTIGATOR
AdvenHealth
Locations
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AdventHealth
Orlando, Florida, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
American Academy of Pediatrics Policy Statement. Breastfeeding and the use of breast milk. Pediatrics 2012; 129:e827-841
Other Identifiers
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1878559
Identifier Type: -
Identifier Source: org_study_id
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