Targeted Fortification of Donor Breast Milk in Preterm Infants

NCT04294368 | Recruiting

• 1 other identifier: AAAS6625
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized controlled trial comparing standard fortification of donor breast milk to targeted fortification of donor breast milk in preterm infants. The purpose of the study is to determine if there is a benefit to target fortifying donor breast milk in the preterm population. The investigators hypothesize that infants receiving targeted fortification of donor breast milk will have improved growth compared to infants receiving standard fortification of donor breast milk.

Conditions

Prematurity; Extreme; Failure to Thrive in Newborn; Growth Retardation; Growth Failure; Infant Nutrition Disorders

Keywords

Human Milk Analyzer; Miris; Target Fortification; Targeted Fortification; Donor Breast Milk

Outcome Measures

Primary Outcomes (3)

• Change in weight

  Weight change in g/kg/day, z-score value, and change in z-score from week-to-week

  Up to 11 weeks

• Change in length

  Length change in cm/kg/day, z-score value, and change in z-score from week-to-week

  Up to 11 weeks

• Head circumference

  Head circumference change in cm/kg/day, z-score value, and change in z-score from week-to-week

  Up to 11 weeks

Secondary Outcomes (7)

• Total Number of Days of Length of Stay in NICU

  Up to 1 year

• Rate of Mortality

  Up to one year

• Number of Feeding Intolerance Events

  Up to 34 weeks corrected gestational age

• Number of Necrotizing Enterocolitis Events

  Up to 1 year of age

• Incidence of Bronchopulmonary dysplasia

  Up to 1 year of age

Study Arms (2)

Control

OTHER

Standard fortification of breast milk

Dietary Supplement: Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid; Dietary Supplement: Similac Liquid Protein Fortifier; Dietary Supplement: Nestle Microlipid; Dietary Supplement: Medica Nutrition SolCarb; Other: Analysis with Miris (AB) Human Milk Analyzer

Experimental

EXPERIMENTAL

Targeted fortification of breast milk

Dietary Supplement: Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid (Targeted Fortification); Dietary Supplement: Similac Liquid Protein Fortifier (Targeted Fortification); Dietary Supplement: Nestle Microlipid (Targeted Fortification); Dietary Supplement: Medica Nutrition SolCarb (Targeted Fortification); Other: Analysis with Miris (AB) Human Milk Analyzer

Interventions

Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid DIETARY_SUPPLEMENT

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.

Control

Similac Liquid Protein Fortifier DIETARY_SUPPLEMENT

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.

Control

Nestle Microlipid DIETARY_SUPPLEMENT

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.

Control

Medica Nutrition SolCarb DIETARY_SUPPLEMENT

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.

Control

Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid (Targeted Fortification) DIETARY_SUPPLEMENT

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.

Experimental

Similac Liquid Protein Fortifier (Targeted Fortification) DIETARY_SUPPLEMENT

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.

Experimental

Nestle Microlipid (Targeted Fortification) DIETARY_SUPPLEMENT

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

Experimental

Medica Nutrition SolCarb (Targeted Fortification) DIETARY_SUPPLEMENT

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

Experimental

Analysis with Miris (AB) Human Milk Analyzer OTHER

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.

Control; Experimental

Eligibility Criteria

• Age: 1 Day - 21 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Premature infants born \</= 30 weeks gestational age
• Birth Weight \</= 1500 grams

You may not qualify if:

• Parents do no consent to donor milk
• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center/ New York - Presbyterian

New York, New York, 10032, United States

RECRUITING

Related Publications (13)

• 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.

  PMID: 30968003 BACKGROUND

• 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.

  PMID: 26037506 BACKGROUND

• 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.

  PMID: 30985203 BACKGROUND

• 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.

  PMID: 24912866 BACKGROUND

• 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.

  PMID: 25174435 BACKGROUND

• 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.

  PMID: 26101360 BACKGROUND

• 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.

  PMID: 30682200 BACKGROUND

• 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.

  PMID: 27370649 BACKGROUND

• 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.

  PMID: 21707744 BACKGROUND

• 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.

  PMID: 25769062 BACKGROUND

• 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.

  PMID: 31268194 BACKGROUND

• 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.

  PMID: 23769498 BACKGROUND

• 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.

  PMID: 26914990 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Failure to Thrive; Infant Nutrition Disorders

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Marianne Garland, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianne Garland, MD

CONTACT

212 305 0952; mg71@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control group to receive standard fortification of donor breast milk. Experimental group to receive targeted fortification of donor breast milk.

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 4, 2020
• Study Start: March 9, 2020
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)