Targeted Fortification of Donor Breast Milk in Preterm Infants
NCT ID: NCT04294368
Last Updated: 2025-05-14
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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RECRUITING
NA
50 participants
INTERVENTIONAL
2020-03-09
2026-03-31
Brief Summary
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Detailed Description
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The study design involves measurement of macronutrient and calorie content of donor breast milk using a point-of-care human milk analyzer (Miris, AB). The individual macronutrient (protein, fat, and carbohydrate) concentrations will be targeted in the intervention group such that the infant will receive protein of 4 g/kg/day, fat of 6.6 g/kg/day, and carbohydrates of 11.6-13.2 g/kg/day. Fortification will be added in a step-wise fashion daily over a 3-4 day period starting when the infant reaches about 80 ml/kg/day in feeding volume. Fortifiers that may be used in this study include: Abbott Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid, Abbott Liquid Protein, Nestle Microlipid, and Medica Nutrition SolCarb. Participants in the control arm will receive donor milk that is fortified in the standard fashion at this institution; that is, 4 packets of Human Milk Fortifier will be added to 100 ml of donor breast milk. Additional fortification such as liquid protein or microlipid may be added to the donor milk and mom's own milk in response to poor growth for participants in both groups, as is standard of care in this Neonatal Intensive Care Unit (NICU). Patients in both experimental and control groups will always receive mom's own milk first when it is available. Mom's own milk will not be analyzed and will always be fortified in the standard fashion for both groups. The participants will be studied until they reach 34 weeks corrected gestational age.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Control
Standard fortification of breast milk
Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid
The control group will receive mother's breast milk when it is available. Mother's breast milk will be fortified with 4 packets of Similac Human Milk Fortifier (HMF) per 100 mL. When mother's breast milk is not available, participants will be fed donor breast milk with 4 packets of HMF.
Similac Liquid Protein Fortifier
For participants in the control group, additional fortification can be added to the milk for patients in this group in response to poor growth, as is standard of care in the NICU. The standard dose is 1 ml per 30 ml of breast milk.
Nestle Microlipid
For participants in the control group, additional fortification can be added to the milk for patients in this group in response to poor growth, as is standard of care in the NICU. The standard dose is 1 ml per 30 ml of breast milk.
Medica Nutrition SolCarb
For participants in the control group, additional fortification can be added to the milk for patients in this group in response to poor growth, as is standard of care in the NICU.
Analysis with Miris (AB) Human Milk Analyzer
For participants in both the control and the experimental arms, each batch of donor milk will be analyzed using the Miris Human Milk Analyzer. Manufacturer recommendations for milk analysis will be strictly followed.
Experimental
Targeted fortification of breast milk
Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid (Targeted Fortification)
The experimental group will receive mother's breast milk when it is available. Mother's breast milk will be fortified with 4 packets of Similac Human Milk Fortifier (HMF) per 100 mL. When mother's breast milk is not available, participants will be fed donor breast milk with 4 packets of HMF. For participants in the experimental group, the investigators will continue to add fortification. Two packets of HMF per day will be added until goal fortification is reached.
Similac Liquid Protein Fortifier (Targeted Fortification)
Participants in the experimental group will receive a dose that will vary depending on the base protein content in the donor breast milk for each particular batch of donor breast milk.
Nestle Microlipid (Targeted Fortification)
Participants in the experimental group will receive a dose that will vary depending on the base fat content in the donor breast milk for each particular batch of donor breast milk
Medica Nutrition SolCarb (Targeted Fortification)
Participants in the experimental group will receive a dose that will vary depending on the base carbohydrate content in the donor breast milk for each particular batch of donor breast milk
Analysis with Miris (AB) Human Milk Analyzer
For participants in both the control and the experimental arms, each batch of donor milk will be analyzed using the Miris Human Milk Analyzer. Manufacturer recommendations for milk analysis will be strictly followed.
Interventions
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Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid
The control group will receive mother's breast milk when it is available. Mother's breast milk will be fortified with 4 packets of Similac Human Milk Fortifier (HMF) per 100 mL. When mother's breast milk is not available, participants will be fed donor breast milk with 4 packets of HMF.
Similac Liquid Protein Fortifier
For participants in the control group, additional fortification can be added to the milk for patients in this group in response to poor growth, as is standard of care in the NICU. The standard dose is 1 ml per 30 ml of breast milk.
Nestle Microlipid
For participants in the control group, additional fortification can be added to the milk for patients in this group in response to poor growth, as is standard of care in the NICU. The standard dose is 1 ml per 30 ml of breast milk.
Medica Nutrition SolCarb
For participants in the control group, additional fortification can be added to the milk for patients in this group in response to poor growth, as is standard of care in the NICU.
Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid (Targeted Fortification)
The experimental group will receive mother's breast milk when it is available. Mother's breast milk will be fortified with 4 packets of Similac Human Milk Fortifier (HMF) per 100 mL. When mother's breast milk is not available, participants will be fed donor breast milk with 4 packets of HMF. For participants in the experimental group, the investigators will continue to add fortification. Two packets of HMF per day will be added until goal fortification is reached.
Similac Liquid Protein Fortifier (Targeted Fortification)
Participants in the experimental group will receive a dose that will vary depending on the base protein content in the donor breast milk for each particular batch of donor breast milk.
Nestle Microlipid (Targeted Fortification)
Participants in the experimental group will receive a dose that will vary depending on the base fat content in the donor breast milk for each particular batch of donor breast milk
Medica Nutrition SolCarb (Targeted Fortification)
Participants in the experimental group will receive a dose that will vary depending on the base carbohydrate content in the donor breast milk for each particular batch of donor breast milk
Analysis with Miris (AB) Human Milk Analyzer
For participants in both the control and the experimental arms, each batch of donor milk will be analyzed using the Miris Human Milk Analyzer. Manufacturer recommendations for milk analysis will be strictly followed.
Eligibility Criteria
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Inclusion Criteria
* Birth Weight \</= 1500 grams
Exclusion Criteria
* Confounders for poor growth such as congenital heart disease, GI diagnoses such as gastroschisis and omphalocele, and or major congenital anomalies
* Grade III or IV intraventricular hemorrhage diagnoses prior to randomization
* Small for gestational age (\<3% on Fenton Growth Curve)
* Failure to initiate fortified feeds prior to 3 weeks of life
* Diagnosis of necrotizing entercolitis prior to randomization
* Diagnosis of early onset sepsis confirmed with positive culture
1 Day
21 Days
ALL
No
Sponsors
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Columbia University
OTHER
Responsible Party
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Principal Investigators
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Marianne Garland, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Columbia University Medical Center/ New York - Presbyterian
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Arslanoglu S, Boquien CY, King C, Lamireau D, Tonetto P, Barnett D, Bertino E, Gaya A, Gebauer C, Grovslien A, Moro GE, Weaver G, Wesolowska AM, Picaud JC. Fortification of Human Milk for Preterm Infants: Update and Recommendations of the European Milk Bank Association (EMBA) Working Group on Human Milk Fortification. Front Pediatr. 2019 Mar 22;7:76. doi: 10.3389/fped.2019.00076. eCollection 2019.
Billard H, Simon L, Desnots E, Sochard A, Boscher C, Riaublanc A, Alexandre-Gouabau MC, Boquien CY. Calibration Adjustment of the Mid-infrared Analyzer for an Accurate Determination of the Macronutrient Composition of Human Milk. J Hum Lact. 2016 Aug;32(3):NP19-27. doi: 10.1177/0890334415588513. Epub 2015 Jun 2.
Fusch C. Avoiding Postnatal Growth Retardation by Individualized Fortification of Breast Milk: Implications for Somatic and Neurodevelopmental Outcomes. Breastfeed Med. 2019 Apr;14(S1):S15-S17. doi: 10.1089/bfm.2019.0031. No abstract available.
Fusch G, Rochow N, Choi A, Fusch S, Poeschl S, Ubah AO, Lee SY, Raja P, Fusch C. Rapid measurement of macronutrients in breast milk: How reliable are infrared milk analyzers? Clin Nutr. 2015 Jun;34(3):465-76. doi: 10.1016/j.clnu.2014.05.005. Epub 2014 May 17.
Gidrewicz DA, Fenton TR. A systematic review and meta-analysis of the nutrient content of preterm and term breast milk. BMC Pediatr. 2014 Aug 30;14:216. doi: 10.1186/1471-2431-14-216.
Horbar JD, Ehrenkranz RA, Badger GJ, Edwards EM, Morrow KA, Soll RF, Buzas JS, Bertino E, Gagliardi L, Bellu R. Weight Growth Velocity and Postnatal Growth Failure in Infants 501 to 1500 Grams: 2000-2013. Pediatrics. 2015 Jul;136(1):e84-92. doi: 10.1542/peds.2015-0129.
John A, Sun R, Maillart L, Schaefer A, Hamilton Spence E, Perrin MT. Macronutrient variability in human milk from donors to a milk bank: Implications for feeding preterm infants. PLoS One. 2019 Jan 25;14(1):e0210610. doi: 10.1371/journal.pone.0210610. eCollection 2019.
Morlacchi L, Mallardi D, Gianni ML, Roggero P, Amato O, Piemontese P, Consonni D, Mosca F. Is targeted fortification of human breast milk an optimal nutrition strategy for preterm infants? An interventional study. J Transl Med. 2016 Jul 1;14(1):195. doi: 10.1186/s12967-016-0957-y.
Montjaux-Regis N, Cristini C, Arnaud C, Glorieux I, Vanpee M, Casper C. Improved growth of preterm infants receiving mother's own raw milk compared with pasteurized donor milk. Acta Paediatr. 2011 Dec;100(12):1548-54. doi: 10.1111/j.1651-2227.2011.02389.x. Epub 2011 Jul 14.
O'Connor DL, Ewaschuk JB, Unger S. Human milk pasteurization: benefits and risks. Curr Opin Clin Nutr Metab Care. 2015 May;18(3):269-75. doi: 10.1097/MCO.0000000000000160.
Quan M, Wang D, Gou L, Sun Z, Ma J, Zhang L, Wang C, Schibler K, Li Z. Individualized Human Milk Fortification to Improve the Growth of Hospitalized Preterm Infants. Nutr Clin Pract. 2020 Aug;35(4):680-688. doi: 10.1002/ncp.10366. Epub 2019 Jul 3.
Rochow N, Fusch G, Choi A, Chessell L, Elliott L, McDonald K, Kuiper E, Purcha M, Turner S, Chan E, Xia MY, Fusch C. Target fortification of breast milk with fat, protein, and carbohydrates for preterm infants. J Pediatr. 2013 Oct;163(4):1001-7. doi: 10.1016/j.jpeds.2013.04.052. Epub 2013 Jun 12.
Zhu M, Yang Z, Ren Y, Duan Y, Gao H, Liu B, Ye W, Wang J, Yin S. Comparison of macronutrient contents in human milk measured using mid-infrared human milk analyser in a field study vs. chemical reference methods. Matern Child Nutr. 2017 Jan;13(1):10.1111/mcn.12248. doi: 10.1111/mcn.12248. Epub 2016 Feb 23.
Other Identifiers
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AAAS6625
Identifier Type: -
Identifier Source: org_study_id
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