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Target Fortification of Breast Milk: How Often Breast Milk Needs to be Measured?

NCT02865941 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2016-08-15

No results posted yet for this study

Summary

It has been observed that target fortification on different schedules leads to meal to meal variation. It changes the ratio of protein to energy and the percentage of carbohydrate to non-protein energy which may, affect growth. In the past, the investigators have analyzed the outcomes of breast milk composition when target fortification is done with different analysis schedules. The investigators were able to measure the macronutrient intake for different milk analysis schedules via a theoretical model and show that the more frequent schedules reduce the variation of fortified-breast milk, whereas a reduced schedule leads to a high variation of macronutrients. It was observed that, in all the breast milk samples measured twice per week, infants achieved on average the recommended macronutrients in line with current recommendations. Nonetheless, the model only looks at the macronutrient intake and does not investigates the relationship between macronutrient variation and its effect on growth.

The aim of the current study is to compare a frequent schedule of measurement of macronutrient analysis with a reduced schedule of measurement and to study its affect on growth, protein accretion and metabolic parameter.

Conditions

  • Postnatal Growth Disorder

Interventions

DIETARY_SUPPLEMENT

Fortification with modular protein

Modular product supplementation is based on most recent breast analysis done for the participant.

DIETARY_SUPPLEMENT

Fortification with modular carbohydrate

Modular product supplementation is based on most recent breast analysis done for the participant.

DIETARY_SUPPLEMENT

Fortification with modular fat

Modular product supplementation is based on most recent breast analysis done for the participant.

Sponsors & Collaborators

  • McMaster Children's Hospital

    lead OTHER

Principal Investigators

  • Christoph Fusch, MD, PhD · McMaster Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
29 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-06-30
Completion
2019-06-30

Countries

  • Canada

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 NCT02865941 on ClinicalTrials.gov