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

Complication of Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02632266
• Other study ID #: STUDY00002292
• Status: Completed
• Phase: Phase 4
• Start date: July 2015
• Est. completion date: May 2019

Study information

• Verified date: September 2020
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a prospective, randomize, double-blinded study in preterm infants born between 28-34 weeks gestation admitted to the NICU at the University of Kansas Hospital. After obtaining informed consent, babies will be randomized to either liquid or powdered HMF using opaque, sealed envelopes with preassigned randomization. The feeding protocol as established in the KU NICU will be followed, beginning with initiation of trophic feeds, and advancement of enteral feeds depending on the gestational age and preceding illnesses. Once infants reach 80ml/kg/day of enteral feeds, human milk will be fortified to 22 kilocalories by adding either liquid or powdered fortifier. The beginning of the study(Study day 1) will be defined as reaching and tolerating 100ml/kg/day of 24 kilocalorie human milk fortified with either liquid or powdered fortifier. Enteral feeds will be advanced per unit protocol until they reach 150-160ml/kg/day and 110-120 kcal/kg/day. the volume of feeds will be adjusted based on the documented weight to provide energy and protein requirements as recommended by the ESPGHAN guidelines. Babies will be followed up until the time of NICU discharge.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Weeks to 34 Weeks

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Complication of Prematurity
• Premature Birth

Intervention

Dietary Supplement:
• Powder HMF
powder human milk fortifier
• Liquid HMF
Liquid human milk fortifier

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (6)

Agostoni C, Buonocore G, Carnielli VP, De Curtis M, Darmaun D, Decsi T, Domellöf 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, — View Citation

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. — View Citation

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. Erratum in: J Pediatr 1988 Dec;113(6):1118. — View Citation

Hylander MA, Strobino DM, Dhanireddy R. Human milk feedings and infection among very low birth weight infants. Pediatrics. 1998 Sep;102(3):E38. — View Citation

Lucas A, Cole TJ. Breast milk and neonatal necrotising enterocolitis. Lancet. 1990 Dec 22-29;336(8730):1519-23. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Nutrition biomarkers	Measurements of a baby's Ca, P, Mg, Alkaline Phosphatase and Prealbumin will be taken	Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier
Secondary	Tolerance to enteral feeds	number of significant residuals, number of times feeds were held, NEC	Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier