Effect of Extensively Hydrolyzed Liquid Human Milk Fortifier on Growth and Tolerance in Moderately Premature Infants

NCT02632266 | Completed Phase 4

• 1 other identifier: STUDY00002292
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is for the researchers to examine the safety and efficacy of liquid human milk fortifier (HMF) in moderately preterm infants compared to powdered human milk fortifier.

Conditions

Complication of Prematurity

Keywords

prematurity; growth; nutrition; human milk fortifier

Outcome Measures

Primary Outcomes (4)

• Cumulative weight gain

  Weight gain of baby during the course of the study

  Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier

• Change in weight

  Weight gain of baby week-to-week, during the course of the study

  Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier

• Linear length

  change in length week-to-week during the course of the study

  Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier

• Head growth

  Change in head measurements week-to-week during the course of the study

  Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier

Secondary Outcomes (2)

• Nutrition biomarkers

  Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier

• Tolerance to enteral feeds

  Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier

Study Arms (2)

Powder HMF

ACTIVE COMPARATOR

Once patient has reached 80ml/kg/day of enteral feedings, 1 pack of powder HMF will be added to 50 ml of human or donor breast milk, then increased to a maximum of 2 packs for 50 ml following the unit feeding advancement protocol and this will be continued up until 48 hours prior to discharge.

Dietary Supplement: Powder HMF

Liquid HMF

ACTIVE COMPARATOR

Once patient has reached 80ml/kg/day of enteral feedings, researchers will add 1 packet (5 ml) of liquid HMF to 50 ml of human or donor breast milk, then increase to 2 packs to 50 ml following the unit feeding protocol and this will be continued up until 48 hours prior to discharge.

Dietary Supplement: Liquid HMF

Interventions

Powder HMF DIETARY_SUPPLEMENT

powder human milk fortifier

Powder HMF

Liquid HMF DIETARY_SUPPLEMENT

Liquid human milk fortifier

Liquid HMF

Eligibility Criteria

• Age: 28 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Inborn preterm infants born between 28 0/7 and 34 0/7 weeks gestation and fed either mother's own milk or donor human milk

You may not qualify if:

• Newborn infants \<28 weeks and \>34 weeks gestation, those with life threatening illness, congenital and chromosomal anomalies, gastrointestinal anomalies or necrotizing enterocolitis and fed premature formula

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (6)

• Hylander MA, Strobino DM, Dhanireddy R. Human milk feedings and infection among very low birth weight infants. Pediatrics. 1998 Sep;102(3):E38. doi: 10.1542/peds.102.3.e38.

  PMID: 9724686 RESULT

• Lucas A, Cole TJ. Breast milk and neonatal necrotising enterocolitis. Lancet. 1990 Dec 22-29;336(8730):1519-23. doi: 10.1016/0140-6736(90)93304-8.

  PMID: 1979363 RESULT

• Greer FR, McCormick A. Improved bone mineralization and growth in premature infants fed fortified own mother's milk. J Pediatr. 1988 Jun;112(6):961-9. doi: 10.1016/s0022-3476(88)80227-0.

  PMID: 3373407 RESULT

• Cibulskis CC, Armbrecht ES. Association of metabolic acidosis with bovine milk-based human milk fortifiers. J Perinatol. 2015 Feb;35(2):115-9. doi: 10.1038/jp.2014.143. Epub 2014 Aug 7.

  PMID: 25102321 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

• Vishal Pandey, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 16, 2015
• Study Start: July 1, 2015
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: September 3, 2020

Record last verified: 2020-09

Locations

US (1)