Use of Human Milk Cream to Decrease Length of Stay in Extremely Premature Infants

NCT02475434 | Completed

• 1 other identifier: H-37231
• Study Type: interventional
• Target: 210
• Locations: 2 countries
• Sites: 8

Brief Summary

At present, widespread use of the human milk-based caloric supplement (cream) has not occurred, particularly in infants with bronchopulmonary dysplasia (BPD), and further data are needed to support its adoption as a standard care practice. The investigators hypothesize that infants who receive an exclusive human milk (HM)-based diet with the addition of a HM-derived cream caloric supplement (Cream group) will have a shorter length of initial hospital stay compared to infants receiving the standard regimen of an exclusive HM-based diet (Control group). The investigators hypothesize that the effects of the cream caloric supplement will be greater in the subgroup of infants who develop BPD so the relationship will be evaluated between Cream Supplement study group and postmenstrual age (PMA) at discharge and the incidence of BPD. Investigators will also evaluate the post-hospital discharge growth, body composition, and neurodevelopmental outcomes at 18 to 24 months CGA of the infants 500-1250 grams BW who received an exclusive human milk diet including cream supplement or control in the NICU.

Conditions

Bronchopulmonary Dysplasia

Keywords

Human Milk; Prematurity; Nutrition; Human Milk Cream

Outcome Measures

Primary Outcomes (1)

• Length of Stay

  The primary endpoint for the study is the difference in length of hospital stay (days) between the two groups from birth until discharge or removal from the study (due to transfer to non-study institution or death), whichever comes first.

  From birth to death or discharge from the Neonatal ICU, assessed up to 5 months

Secondary Outcomes (1)

• Incidence of Bronchopulmonary dysplasia and relationship to postmenstrual age at discharge in infants who received cream supplement

  From birth to death or discharge from the Neonatal ICU, assessed up to 5 months

Study Arms (2)

Cream Supplement group

EXPERIMENTAL

Infants randomized to the cream supplement group will receive an exclusive HM-based diet with the addition of a HM-derived cream caloric supplement.

Dietary Supplement: Cream Supplement group

Control Group

NO INTERVENTION

Infants randomized to the Control group will receive the standard regimen of an exclusive HM-based diet (no cream supplement).

Interventions

Cream Supplement group DIETARY_SUPPLEMENT

Infants in the intervention arm will receive the cream supplement in addition to the standard regimen.

Also known as: ProlactCR

Cream Supplement group

Eligibility Criteria

• Age: Up to 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Birth weight 500-1250g.
• Must be likely to be able to adhere to a feeding protocol involving mother's own milk/donor milk that will include fortification using HM-based product (Prolact+H2MF®) and, potentially, human milk-based cream supplement.
• Enteral feeding must begin before day 14 of life and parenteral nutrition must be started by day 2 of life.
• Informed consent obtained from parent or legal guardian prior to reaching 100 ml/kg/day of fortified feeds. Consent should be obtained as soon as possible for eligible infants to collect tracheal aspirates (if intubated) and meconium stool. However, consent must be obtained prior to reaching 100 ml/kg/day of fortified feeds because this is when randomization will occur.

You may not qualify if:

• Unlikely to survive the study period.
• Enrolled in another clinical study affecting nutritional management during the study period.
• Decision to not start minimum enteral feed before day 14 of life or parenteral nutrition before day 2 of life.
• Presence of clinically significant congenital heart disease or other major congenital malformation.
• Presence prior to enrollment of intestinal perforation or Stage 2 Necrotizing enterocolitis prior to tolerating fortified feeds.
• Reasonable likelihood of early transfer to a non-study institution.
• Unable to participate for any reason based on the decision of the study investigator.

Sponsors & Collaborators

• St. John Hospital & Medical Center: collaborator
• Timpanogos Regional Hospital: collaborator
• Orlando Health, Inc.: collaborator
• St. Louis Children's Hospital: collaborator
• Baylor Scott and White Health: collaborator
• Westchester Medical Center: collaborator
• Unity Health Toronto: collaborator
• Texas Tech University Health Sciences Center, El Paso: collaborator
• Cook Children's Medical Center: collaborator
• University of Oklahoma: collaborator
• Baylor College of Medicine: lead
• Prolacta Bioscience: collaborator
• Medical University Innsbruck: collaborator
• The University of Texas Health Science Center, Houston: collaborator
• Michigan State University: collaborator
• Akron Children's Hospital: collaborator

Study Sites (8)

Orlando Health, Inc. - Winnie Palmer Hospital for Women and Babies

Orlando, Florida, 32806, United States

Location

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Children's Hospital Medical Center of Akron

Boardman, Ohio, 44512, United States

Location

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

Location

Baylor College of Medicine / Texas Children's Hospital

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

Wasatch Neonatal

Orem, Utah, 84057, United States

Location

University Hospital

Innsbruck, 6020, Austria

Location

Related Publications (13)

• Schanler RJ. Outcomes of human milk-fed premature infants. Semin Perinatol. 2011 Feb;35(1):29-33. doi: 10.1053/j.semperi.2010.10.005.

  PMID: 21255704 BACKGROUND

• 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

• Cristofalo EA, Schanler RJ, Blanco CL, Sullivan S, Trawoeger R, Kiechl-Kohlendorfer U, Dudell G, Rechtman DJ, Lee ML, Lucas A, Abrams S. Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants. J Pediatr. 2013 Dec;163(6):1592-1595.e1. doi: 10.1016/j.jpeds.2013.07.011. Epub 2013 Aug 20.

  PMID: 23968744 BACKGROUND

• Abrams SA, Schanler RJ, Lee ML, Rechtman DJ. Greater mortality and morbidity in extremely preterm infants fed a diet containing cow milk protein products. Breastfeed Med. 2014 Jul-Aug;9(6):281-5. doi: 10.1089/bfm.2014.0024. Epub 2014 May 27.

  PMID: 24867268 BACKGROUND

• Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics. 2012 Mar;129(3):e827-41. doi: 10.1542/peds.2011-3552. Epub 2012 Feb 27.

  PMID: 22371471 BACKGROUND

• Biniwale MA, Ehrenkranz RA. The role of nutrition in the prevention and management of bronchopulmonary dysplasia. Semin Perinatol. 2006 Aug;30(4):200-8. doi: 10.1053/j.semperi.2006.05.007.

  PMID: 16860160 BACKGROUND

• Theile AR, Radmacher PG, Anschutz TW, Davis DW, Adamkin DH. Nutritional strategies and growth in extremely low birth weight infants with bronchopulmonary dysplasia over the past 10 years. J Perinatol. 2012 Feb;32(2):117-22. doi: 10.1038/jp.2011.67. Epub 2011 May 26.

  PMID: 21617642 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

• Vieira AA, Soares FV, Pimenta HP, Abranches AD, Moreira ME. Analysis of the influence of pasteurization, freezing/thawing, and offer processes on human milk's macronutrient concentrations. Early Hum Dev. 2011 Aug;87(8):577-80. doi: 10.1016/j.earlhumdev.2011.04.016. Epub 2011 May 17.

  PMID: 21592688 BACKGROUND

• 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 BACKGROUND

• Walsh MC, Kliegman RM. Necrotizing enterocolitis: treatment based on staging criteria. Pediatr Clin North Am. 1986 Feb;33(1):179-201. doi: 10.1016/s0031-3955(16)34975-6.

  PMID: 3081865 BACKGROUND

• Lohmann P, Luna RA, Hollister EB, Devaraj S, Mistretta TA, Welty SE, Versalovic J. The airway microbiome of intubated premature infants: characteristics and changes that predict the development of bronchopulmonary dysplasia. Pediatr Res. 2014 Sep;76(3):294-301. doi: 10.1038/pr.2014.85. Epub 2014 Jun 18.

  PMID: 24941215 BACKGROUND

• Olsen IE, Groveman SA, Lawson ML, Clark RH, Zemel BS. New intrauterine growth curves based on United States data. Pediatrics. 2010 Feb;125(2):e214-24. doi: 10.1542/peds.2009-0913. Epub 2010 Jan 25.

  PMID: 20100760 BACKGROUND

Related Links

• Product Description

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Amy B Hair, MD

  Texas Children's Hospital, Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Pediatrics-Neonatology, Director of Neonatal Nutrition

Study Record Dates

• First Submitted: June 5, 2015
• First Posted: June 18, 2015
• Study Start: June 10, 2015
• Primary Completion: June 25, 2019
• Study Completion: December 30, 2025
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

AU (1); US (7)