Target Fortification of Breast Milk: How Often Breast Milk Needs to be Measured? — TFO2  

Postnatal Growth Disorder Clinical Trial

Official title: Target Fortification of Breast Milk: The Effect of Different Schedules for Milk Analysis on the Growth and Development of Preterm Infants.

Status Not yet recruiting

Clinical Trial 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.

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
• Postnatal Growth Disorder

• NCT number: NCT02865941
• Study type: Interventional
• Source: McMaster Children's Hospital
• Contact: Christoph Fusch, MD, PhD
• Phone: +1 521 2100
• Email: fusch@mcmaster.ca
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2016
• Completion date: June 2019