Growth and Nutritional Status of Very Low Birth Weight Infants Fed a High Protein Exclusive Human Milk Diet

NCT03839173 | Unknown

• 1 other identifier: 1147989-3
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this two-arm investigation is to determine if growth patterns of very low birth weight infants (VLBW) (birth weight 750-1500 grams) fed human milk (maternal or donor) supplemented with a human milk-based fortifier grow according to established guidelines and maintain adequate micronutrient levels.

Conditions

Premature Infant; Breast Milk Expression

Keywords

premature infant; breast milk; breastmilk; human milk; human milk fortifier

Outcome Measures

Primary Outcomes (4)

• Return to birth weight day

  Day of life infant returns to birth weight

  birth to 30 days

• Growth Velocity

  rate of weight gain measured as g/kg/day

  Weekly until 36 weeks post menstrual age or discharge

• Mean Serum Magnesium

  Serum and urine Magnesium

  Every 14 days until 36 weeks post menstrual age or discharge

• Mean Serum CO2

  Serum CO2

  Every 14 days until 36 weeks post menstrual age or discharge

Secondary Outcomes (11)

• Mean z-scores

  Weekly until 36 weeks post menstrual age or discharge

• Mean serum Vitamin D, 1 25 (OH) 2D

  Every 14 days until 36 weeks post menstrual age or discharge

• Mean serum parathyroid Hormone (PTH)

  Every 14 days until 36 weeks post menstrual age or discharge

• Mean serum Sodium

  Every 14 days until 36 weeks post menstrual age or discharge

• Mean serum Blood Urea Nitrogen (BUN)

  Every 14 days until 36 weeks post menstrual age or discharge

Study Arms (2)

Retrospective Chart Review

NO INTERVENTION

Retrospective Chart Review for historical controls. Historic controls fed cow's milk fortifier

Prospective

EXPERIMENTAL

All neonates with birth weights ranging from 750-1500 grams and gestational ages 23-33 weeks admitted to the NICU at Augusta University within 24 hours of life will be eligible for screening within 72 hours of admission and upon parent's or legal guardian's consent. Infants will be fed a human milk fortifier made with donor human milk. Data will be compared with historic control data.

Other: Human milk based human milk fortifier

Interventions

Human milk based human milk fortifier OTHER

A human milk fortifier with added minerals made from donor human milk

Prospective

Eligibility Criteria

• Age: 23 Weeks - 33 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Birth weight 750-1800 grams
• Admitted to AU NICU within 24 hours of life
• Estimated gestational age (EGA) 23 to 33 weeks as confirmed by the Ballard score
• Birth weight appropriate for gestational age (AGA) defined as \>3rd% on a gender-specific Fenton growth curve (Fenton 2013, Calgary, Canada)
• Enteral feedings initiated within 7 days of life
• Breastmilk diet, maternal or donor milk

You may not qualify if:

• Renal conditions affecting electrolyte metabolism and/or excretion
• Gastro-intestinal conditions that preclude feeding or affect nutrient absorption (gastroschisis, omphalocele)
• EGA \>33 weeks or birth weight \>1800 grams or EGA \<23 weeks or birth weight \<750 grams
• Apgar \<3 at 5 minutes
• Grade 3 or higher intraventricular hemorrhage (IVH)
• Intrauterine growth restriction (IUGR), as defined as \<3rd% on a gender-specific Fenton growth curve
• Congenital anomalies including congenital heart disease or other major defect requiring surgical intervention
• Intake of cow's milk formula or fortifier before or after the initiation of the study protocol

Sponsors & Collaborators

• Augusta University: lead
• Neolac Inc dba Medolac Laboratories: collaborator

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

Location

Related Publications (17)

• Ehrenkranz RA, Dusick AM, Vohr BR, Wright LL, Wrage LA, Poole WK. Growth in the neonatal intensive care unit influences neurodevelopmental and growth outcomes of extremely low birth weight infants. Pediatrics. 2006 Apr;117(4):1253-61. doi: 10.1542/peds.2005-1368.

  PMID: 16585322 BACKGROUND

• Fenton TR, Kim JH. A systematic review and meta-analysis to revise the Fenton growth chart for preterm infants. BMC Pediatr. 2013 Apr 20;13:59. doi: 10.1186/1471-2431-13-59.

  PMID: 23601190 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

• Koletsko B PB, Uauy R. Nutritional Care of Preterm Infants. Basel, Switzerland: Karger, 2014.

  BACKGROUND

• Kim JH, Chan G, Schanler R, Groh-Wargo S, Bloom B, Dimmit R, Williams L, Baggs G, Barrett-Reis B. Growth and Tolerance of Preterm Infants Fed a New Extensively Hydrolyzed Liquid Human Milk Fortifier. J Pediatr Gastroenterol Nutr. 2015 Dec;61(6):665-71. doi: 10.1097/MPG.0000000000001010.

  PMID: 26488118 BACKGROUND

• Moya F, Sisk PM, Walsh KR, Berseth CL. A new liquid human milk fortifier and linear growth in preterm infants. Pediatrics. 2012 Oct;130(4):e928-35. doi: 10.1542/peds.2011-3120. Epub 2012 Sep 17.

  PMID: 22987877 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

• Gates A BJ. [Neonatal Outcomes Augusta Univeristy NICU] Unpublished raw data. Augusta 2017.

  BACKGROUND

• Stoll BJ, Hansen NI, Bell EF, Shankaran S, Laptook AR, Walsh MC, Hale EC, Newman NS, Schibler K, Carlo WA, Kennedy KA, Poindexter BB, Finer NN, Ehrenkranz RA, Duara S, Sanchez PJ, O'Shea TM, Goldberg RN, Van Meurs KP, Faix RG, Phelps DL, Frantz ID 3rd, Watterberg KL, Saha S, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Neonatal outcomes of extremely preterm infants from the NICHD Neonatal Research Network. Pediatrics. 2010 Sep;126(3):443-56. doi: 10.1542/peds.2009-2959. Epub 2010 Aug 23.

  PMID: 20732945 BACKGROUND

• Thoene M, Hanson C, Lyden E, Dugick L, Ruybal L, Anderson-Berry A. Comparison of the effect of two human milk fortifiers on clinical outcomes in premature infants. Nutrients. 2014 Jan 3;6(1):261-75. doi: 10.3390/nu6010261.

  PMID: 24394538 BACKGROUND

• Kumar N, Monga R, Sampath V, Ehrhart B. Prospective Comparison of Enfamil and Similac Liquid Human Milk Fortifier on Clinical Outcomes in Premature Infants. Am J Perinatol. 2017 Dec;34(14):1411-1416. doi: 10.1055/s-0037-1603940. Epub 2017 Jun 21. No abstract available.

  PMID: 28637062 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

• Gross SJ. Growth and biochemical response of preterm infants fed human milk or modified infant formula. N Engl J Med. 1983 Feb 3;308(5):237-41. doi: 10.1056/NEJM198302033080501.

  PMID: 6848932 BACKGROUND

• Agostoni C, Buonocore G, Carnielli VP, De Curtis M, Darmaun D, Decsi T, Domellof M, Embleton ND, Fusch C, Genzel-Boroviczeny O, Goulet O, Kalhan SC, Kolacek S, Koletzko B, Lapillonne A, Mihatsch W, Moreno L, Neu J, Poindexter B, Puntis J, Putet G, Rigo J, Riskin A, Salle B, Sauer P, Shamir R, Szajewska H, Thureen P, Turck D, van Goudoever JB, Ziegler EE; ESPGHAN Committee on Nutrition. Enteral nutrient supply for preterm infants: commentary from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2010 Jan;50(1):85-91. doi: 10.1097/MPG.0b013e3181adaee0.

  PMID: 19881390 BACKGROUND

• Ong KK, Kennedy K, Castaneda-Gutierrez E, Forsyth S, Godfrey KM, Koletzko B, Latulippe ME, Ozanne SE, Rueda R, Schoemaker MH, van der Beek EM, van Buuren S, Fewtrell M. Postnatal growth in preterm infants and later health outcomes: a systematic review. Acta Paediatr. 2015 Oct;104(10):974-86. doi: 10.1111/apa.13128.

  PMID: 26179961 BACKGROUND

• Ghandehari H, Lee ML, Rechtman DJ; H2MF Study Group. An exclusive human milk-based diet in extremely premature infants reduces the probability of remaining on total parenteral nutrition: a reanalysis of the data. BMC Res Notes. 2012 Apr 25;5:188. doi: 10.1186/1756-0500-5-188.

  PMID: 22534258 BACKGROUND

• Food and Drug Administration, HHS. Current good manufacturing practices, quality control procedures, quality factors, notification requirements, and records and reports, for infant formula. Final rule. Fed Regist. 2014 Jun 10;79(111):33057-72.

  PMID: 24922980 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Breast Milk Expression

Condition Hierarchy (Ancestors)

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

Study Officials

• Amy Gates, RD

  Augusta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Dietitian and Pediatric Nutrition Specialist

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: July 25, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: July 29, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)