Evaluation of Prolact-Plus Human Milk Fortifier

NCT00486590 | Completed

• 1 other identifier: MPPF 001-2006
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 4

Brief Summary

Prolacta Bioscience has developed the first purely human fortifier, Prolact-Plus, that can provide a source of many of the required nutrients for premature, newborn infants, particularly protein and calories. This product is made from donor human milk from which the skim (non-lipid portion) has been separated and then concentrated. A certain amount of the lipid content has been added back to achieve higher caloric content within a small delivery volume. The product is then pasteurized and filled in small quantities in order to allow for the addition of mother's own milk (or, possibly, milk from another donor). The goal of the preparation is to achieve an increase of approximately 4 cal/oz of mother's milk and to provide a protein level (when mixed with average pre-term milk) of about 3.5-3.8 g/100 Kcal of feed. The data on Prolact-Plus will be obtained prospectively from infants who will receive human milk fortified in this fashion. The data on standard,bovine (cow)-fortified milk will be obtained retrospectively from medical records at the participating institutions. While this design is not necessarily optimal in this setting, it is an efficient and quick approach to evaluating the acute clinical effect of Prolact-Plus. It is anticipated that further studies will be conducted that will examine longer-term accounts and possibly do this in a controlled, randomized environment. The goal of this study is to evaluate the short-term effect of Prolact-Plus fortified human milk when compared with bovine-based fortification of human milk on parameters such as growth and short-term development, infectious complications and incidence of feeding intolerance in a cohort design. Statistically, the study will attempt to evaluate a null hypothesis of equivalent results with respect to these parameters between the two types of fortifiers as compared with a two-sided alternative (difference between the groups). In addition, data will be collected on overall survival and length of stay in the NICU. These data will be collected for descriptive purposes, although an attempt will be made to compare the findings with those obtained from the bovine-based fortifier.

Conditions

Infant, Very Low Birth Weight

Keywords

Human milk fortification; Premature neonate; Very low birth weight

Outcome Measures

Primary Outcomes (2)

• Feeding intolerance

  30 days

• Necrotizing enterocolitis

  30 days

Secondary Outcomes (2)

• Length of stay in NICU and hospital

  Indeterminate

• Growth parameters, e.g. weight, head circumference, and length

  30 days

Interventions

Prolact-Plus Human Milk Fortifier PROCEDURE

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Between 23 and 32 weeks gestational age
• Weigh between 500 and 1600g
• In the retrospective group, an infant must have been able to adhere to a feeding protocol that included only mother's own milk fortified by either bovine or human product from the time that enteral feeding began (or whenever fortified human milk feeding began) through the next 30 days of life or hospital discharge, whichever came first.
• In the prospective group, the infant must be expected to be able to adhere to a feeding protocol that includes only mother's own milk fortified by the human product from the time that enteral feeding began (or whenever fortified human milk feeding began) through the next 30 days of life or hospital discharge, whichever comes first.
• Informed consent obtained from parent or legal guardian.
• Mother must be willing to adhere to a feeding protocol that includes 30 days of mother's own milk for the prospective arm of the study.

You may not qualify if:

• Less than a 50% probability of survival through the study period (first 30 days of enteral feeding or hospital discharge).
• On any other clinical study during the study period
• Receipt of any bovine-based formula or fortifier prior to the infant's enrollment in the study.

Sponsors & Collaborators

• Prolacta Bioscience: lead

Study Sites (4)

Shands Children's Hospital

Gainesville, Florida, 32610-0296, United States

Location

Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021, United States

Location

Miami Children's Hospital

Miami, Florida, 33155, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

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

• Martin L Lee, PhD

  Prolacta Bioscience

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 12, 2007
• First Posted: June 14, 2007
• Study Start: August 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: September 17, 2021

Record last verified: 2008-02

Locations

US (4)