Novel Human Milk Based Human Milk Fortifier

NCT04478487 | Enrolling By Invitation DMC

• 1 other identifier: MC-2018-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to assess weight gain of VLBW infants fed human milk supplemented with a novel human milk-based fortifier, in comparison to use of other fortifiers (historic controls).

Conditions

Infant, Premature, Diseases

Outcome Measures

Primary Outcomes (1)

• weight gain (gm/kg/day)

  Weights.

  Daily from first day of enrollment until 36 weeks post menstrual age or discharge

Secondary Outcomes (4)

• length increment (cm/kg/day)

  Weekly until 36 weeks post menstrual age or discharge

• Head Circumference increment (cm/kg/day)

  Weekly until 36 weeks post menstrual age or discharge

• Volume of Fortifier

  Daily until 36 weeks post menstrual age or discharge

• Morbidity

  weekly until 36 weeks post menstrual age or discharge

Study Arms (1)

Study Participants

EXPERIMENTAL

all preterm infants ≤ 32 weeks and 0 days gestational age (GA) with a birth weight 700 g to 1500 g at the hospital, who are enterally fed human milk in the neonatal intensive care unit (NICU) for at least 7 days. Various blending ratios of the fortifier with either the mother's expressed milk or donor milk will be used to deliver macro and micronutrients based on established guidelines to be adjusted according to the infant's tolerance for volume and calories. The estimated time for each subject's participation is approximately from 1 week through 8 weeks, depending on the weight and age at enrollment. Historic control cases treated by another human milk based human milk fortifier will be obtained from medical records, matched on birth weight and gender, with sample size twice (n=80) that of the study population.

Dietary Supplement: Medolac human milk based human milk fortifier (MHMHMF)

Interventions

Medolac human milk based human milk fortifier (MHMHMF) DIETARY_SUPPLEMENT

MHMHMF is admixed with expressed or donor human milk in graded doses according to tolerated feed volume according to established guidelines and maintain adequate micronutrient levels.

Also known as: exclusive human milk diet for VLBW infants

Study Participants

Eligibility Criteria

• Age: 23 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Birth weight between 750 g-1500 g.
• ≤ 32 weeks gestational age at birth. GA will be determined by an ultrasound scan or the neonatologist's estimate, with consideration to maternal date.
• Subject has been classified as appropriate for GA (AGA).
• Enteral feeding of human milk must be initiated by 21 days of life for infants with a birthweight of 750-1000 g (birth date is day of life 0) and initiated by 14 days of life for infants with a birthweight of 1.0 - 1.5 kg birthweight.
• Mother agrees to feed the infant human milk as the exclusive feeding during the study period. Human milk may be mothers own or donor milk, plus MHMHMF.
• Singleton or twin births only.

You may not qualify if:

• Serious congenital abnormalities or underlying disease that may affect growth and development.
• minute APGAR: 5 4.
• Steroids used within the past 5 days
• Grade Ill or IV periventricular/ intraventricular hemorrhage (PVH/IVH).
• Maternal cocaine, alcohol or opioid abuse during pregnancy or currently or if the mother or infant is currently receiving treatment for HIV infection.
• Infant major surgery (intra-thoracic or intra-abdominal procedures or other surgery requiring general anesthesia).
• Asphyxia defined as progressive hypoxemia and hypercapnia with significant metabolic acidemia characterized by APGAR score \<3 at 10 minutes, seizures within the first 12 hours of life, or a cord blood gas \< 7.0 and seizures and/or severe tonic abnormalities in the first 12 hours of life.
• Infant has any other condition that, in the opinion of the investigator, compromises the ability to draw inference about the ability of the MHMHMF to support growth.

Sponsors & Collaborators

• Northwest Health: lead
• Neolac Inc dba Medolac Laboratories: collaborator

Study Sites (1)

Willow Creek Women's Hospital

Johnson, Arkansas, 72741, United States

Location

Related Publications (29)

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  BACKGROUND

• Thoene M, Lyden E, Weishaar K, Elliott E, Wu R, White K, Timm H, Anderson-Berry A. Comparison of a Powdered, Acidified Liquid, and Non-Acidified Liquid Human Milk Fortifier on Clinical Outcomes in Premature Infants. Nutrients. 2016 Jul 26;8(8):451. doi: 10.3390/nu8080451.

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Related Links

• Medolac Laboratories

MeSH Terms

Conditions

Infant, Premature, Diseases

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Sean Fels

  Medolac Laboratories

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, NICU

Model Details: This is a non-controlled observational trial using objective measures (body weight) to assess the support of growth and tolerance of a new fortifier based on human milk, thereby enabling an exclusive human milk diet for VLBW infants in the NICU.

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: July 20, 2020
• Study Start: September 1, 2019
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)