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Targeted Breast Milk Fortification for Very Low Birth Weight Infants in the NICU

NCT04025021 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-02-23

Study results available
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Summary

This study evaluates the effectiveness of individualized human milk fortification for very low birth weight (\<1500 g) babies in the NICU (Neonatal Intensive Care Unit) to optimize their growth. Breast milk analysis will occur on a weekly basis using the Miris Human Milk Analyzer. In the Control group, participants will receive standard TPN (total parenteral nutrition) and lipids and breast milk fortification according to MetroHealth's NICU guidelines. The Intervention group will receive TPN and lipids optimized depending on the results of breast milk analysis, followed by additional individualized fortification using additional microlipids and/or liquid protein to achieve the goal of 4g protein/kg/day and 100-130 kcal/kg/day.

Conditions

  • Human Milk
  • Neonate
  • Breast Milk

Interventions

DIETARY_SUPPLEMENT

Targeted Fortification

The TPN and SMOF lipids will be optimized to provide a goal of 4 g/kg/day of protein, and 100-130kcal/kg/day. At 100 ml/kg/day of enteral feeds additional liquid protein and/or microlipids will be added to the breast milk to provide goal of 4 g/kg/day of protein and 100-130 kcal/kg/day. This will be determined by analysis of the milk and reported composition. They will continue targeted fortification for 4 weeks after achieving full feeds of 150 ml/kg/day.

DEVICE

The Miris Human Milk Analyzer

The Miris human milk analyzer is a mid infrared that reports the amount of energy absorbed at each wavelength. The amount of fat (grams), lactose (grams), total protein (grams), true protein (grams), and energy (kcal) per 100 ml will be reported.

Sponsors & Collaborators

  • MetroHealth Medical Center

    lead OTHER

Principal Investigators

  • Sharon Groh-Wargo, PhD, RDN · MetroHealth Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2021-03-31
Completion
2021-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04025021 on ClinicalTrials.gov