Individualized Fortification of Breast Milk — IFO  

Neurodevelopment Clinical Trial

Official title: Individualized Fortification of Breast Milk With Fat, Carbohydrate and Protein for Preterm Infants

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Growth Disorders
• Neurodevelopment
• Postnatal Growth Disorder

• NCT number: NCT01609894
• Study type: Interventional
• Source: McMaster Children's Hospital
• Contact: Christoph Fusch, MD, PhD, FRCPC
• Phone: +1 905 521 2100
• Email: fusch@mcmaster.ca
• Status: Recruiting
• Phase: N/A
• Start date: August 2013