NCT01609894

Individualized Fortification of Breast Milk

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: McMaster Children's Hospital · Academic / Other
• Sex: All
• Age: 32 Weeks
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2013-08-01
• Primary completion: 2018-06-01
• First posted: 2012-06-01
• Last updated: 2016-08-11

Locations

1 site across 1 country: Canada