Human Milk Cream as a Caloric Supplement in Pre-Term Infants

NCT01487928 | Completed

• 1 other identifier: H-29743
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

Brief Summary

Human milk is commonly considered to have 20 calories per ounce (kcal/oz). However, studies show that up to 65% of human milk may be less than the expected 20 kcal/oz which can greatly affect an infant's growth. The investigators now have the ability to measure caloric density of human milk and add human milk cream to any human milk (mother's own or donor human milk) that is less than 20 kcal/oz to bring it up to that amount.

Conditions

Prematurity

Keywords

breastfed; human milk cream; human milk fat; caloric supplement

Outcome Measures

Primary Outcomes (1)

• Caloric content of human milk

  Human milk samples will be analyzed for macronutrients and total caloric content.

  Daily until 36 weeks corrected gestational age

Secondary Outcomes (1)

• Growth

  Weekly until 36 weeks corrected age

Study Arms (2)

Human Milk Cream Group

EXPERIMENTAL

For infants randomized to the human milk cream group, the human milk (either mother's own or donor) being provided to the infant will be tested each time a new container is used to prepare feedings. The test will be for the caloric content of the milk using a commercially available device provided for this purpose. If the caloric level falls below 20 kcal/oz for any test, then an appropriate amount of human milk cream will be added to the milk to bring the content as close as possible to 20 kcal/oz. The amount added will be calculated to the nearest mL rounding down for 0.1-0.4mL and up for 0.5-0.9 mL to avoid imprecision due to the measuring device used in the nutrition preparation area.

Dietary Supplement: Human Milk Cream

Control Group

NO INTERVENTION

For infants randomized to the Control group, human milk and human milk derived fortifier will be provided according to the institutional standard of care and there will be no use of the milk analysis (mother's own or donor), which is typical for the vast majority of neonatal intensive care units.

Interventions

Human Milk Cream DIETARY_SUPPLEMENT

If the caloric level of human milk (mother's own or donor) falls below 20 kcal/oz, then an appropriate amount of human milk cream will be added to the milk to bring the content as close as possible to 20 kcal/oz. For example, if the human milk is 19 kcal/oz, 2 mL of human milk cream will be added to 100mL of human milk.

Human Milk Cream Group

Eligibility Criteria

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

You may qualify if:

• Birth weight 750 - 1250g
• Able to adhere to expected feeding protocol of mother's own milk/donor milk with fortification of Prolacta® fortifier
• Reasonable expectation of survival
• Enteral feeding must begin before the 21st day of life

You may not qualify if:

• Decision to not start minimum enteral feed before day 21 of life
• Unable to obtain informed consent from parent/guardian prior to the initiation of fortification of enteral feeding
• Enrolled in any other clinical study affecting nutritional management during the study period
• Presence of clinically significant congenital heart disease or major congenital malformations
• Reasonable potential for early transfer to a non-study institution

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Prolacta Bioscience: collaborator

Study Sites (2)

Baylor College of Medicine / Texas Children's Hospital

Houston, Texas, 77030, United States

Location

UT Health Science Center, San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (6)

• Sullivan S, Schanler RJ, Kim JH, Patel AL, Trawoger R, Kiechl-Kohlendorfer U, Chan GM, Blanco CL, Abrams S, Cotten CM, Laroia N, Ehrenkranz RA, Dudell G, Cristofalo EA, Meier P, Lee ML, Rechtman DJ, Lucas A. An exclusively human milk-based diet is associated with a lower rate of necrotizing enterocolitis than a diet of human milk and bovine milk-based products. J Pediatr. 2010 Apr;156(4):562-7.e1. doi: 10.1016/j.jpeds.2009.10.040. Epub 2009 Dec 29.

  PMID: 20036378 BACKGROUND

• Wojcik KY, Rechtman DJ, Lee ML, Montoya A, Medo ET. Macronutrient analysis of a nationwide sample of donor breast milk. J Am Diet Assoc. 2009 Jan;109(1):137-40. doi: 10.1016/j.jada.2008.10.008.

  PMID: 19103335 BACKGROUND

• Hawthorne KM, Griffin IJ, Abrams SA. Current issues in nutritional management of very low birth weight infants. Minerva Pediatr. 2004 Aug;56(4):359-72.

  PMID: 15457134 BACKGROUND

• Fabrizio V, Trzaski JM, Brownell EA, Esposito P, Lainwala S, Lussier MM, Hagadorn JI. Individualized versus standard diet fortification for growth and development in preterm infants receiving human milk. Cochrane Database Syst Rev. 2020 Nov 23;11(11):CD013465. doi: 10.1002/14651858.CD013465.pub2.

  PMID: 33226632 DERIVED

• Amissah EA, Brown J, Harding JE. Protein supplementation of human milk for promoting growth in preterm infants. Cochrane Database Syst Rev. 2020 Sep 23;9(9):CD000433. doi: 10.1002/14651858.CD000433.pub3.

  PMID: 32964431 DERIVED

• Hair AB, Blanco CL, Moreira AG, Hawthorne KM, Lee ML, Rechtman DJ, Abrams SA. Randomized trial of human milk cream as a supplement to standard fortification of an exclusive human milk-based diet in infants 750-1250 g birth weight. J Pediatr. 2014 Nov;165(5):915-20. doi: 10.1016/j.jpeds.2014.07.005. Epub 2014 Aug 15.

  PMID: 25130571 DERIVED

MeSH Terms

Conditions

Premature Birth; Breast Feeding

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Feeding Behavior; Behavior

Study Officials

• Amy B Hair, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 8, 2011
• Study Start: December 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

US (2)