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Individualized Fortification of Breast Milk

NCT01609894 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2016-08-11

No results posted yet for this study

Summary

The proposed research will investigate individualized fortification of breast milk based on daily milk analysis of carbohydrate, protein, and fat content in a randomized double blind controlled trial. The combination of additional fat, carbohydrate and protein and commercial fortifier will be added to ensure that the milk contains the target amounts of nutrient. Growth and development of these infants will be compared with that of infants fed mother's milk that has been supplemented with the current standard amounts. The postnatal growth of the infants will be assessed by measuring weight, length and head circumference and fat and lean mass using highly accurate, non-invasive methods throughout the intervention period and at the first follow-up visit after discharge at 3 months. Neurological development will be analyzed at the age of 18 months.

The investigators hypothesize that individualized fortification of breast milk improves the nutritional intake of preterm infants, optimizing growth, and thus this will positively impact neurodevelopment and health.

Conditions

  • Postnatal Growth Disorder
  • Neurodevelopment

Interventions

DIETARY_SUPPLEMENT

Individualized fortification of breast milk

Lactose, fat and protein content will be measured prior to breast milk fortification. Subsequently, breast milk for preterm infants will individually fortified adjusted by using data from milk analysis.

DIETARY_SUPPLEMENT

Routine fortification of breast milk

Infants will be fed routine fortified breast milk.

Sponsors & Collaborators

  • McMaster Children's Hospital

    lead OTHER

Principal Investigators

  • Christph Fusch, MD, PhD, FRCPC · McMaster Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2018-06-30

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 NCT01609894 on ClinicalTrials.gov