Individualized Fortification of Breast Milk

Not Applicable

• Conditions: Postnatal Growth Disorder; Neurodevelopment

• Registration Number: NCT01609894
• Lead Sponsor: McMaster Children's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-30
• Study First Submitted QC: 2012-05-30
• Study First Posted: 2012-06-01
• Study Start: 2013-08
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-10
• Last Update Posted: 2016-08-11
• Primary Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
growth during first three weeks of intervention	first three weeks during intervention before 36 weeks of gestation	change in body weight gain will be accessed daily.

Secondary Outcome Measures

Name	Time	Method
weight gain	from inclusion at postmentrual age <32 weeks until 18 month corrected age	change in body weight \[g\]
head circumference	from inclusion at postmentrual age <32 weeks until 18 month corrected age	change in head circumference \[cm\]
neurodevelopment	at 18 month corrected age	Bayley Scales of Infant Development III
body length	from inclusion at postmentrual age <32 weeks until 18 month corrected age	change in body length \[cm\]
body composition	from inclusion at postmentrual age <32 weeks until 3 month corrected age	change in body composition measured with air displacement plethysmography (body weight, body volume, calculated fat and lean mass)
feeding intolerance	during intervention (postmentrual age <32 weeks until 36 weeks)	occurence of feeding intolerance defined by vomitting, bloody gastric residuals, or abnormal abdomen (tender, discolored, absent bowel sounds)
nutrient's blood parameter	during intervention (postmentrual age <32 weeks until 36 weeks)	triglycerides, glucose, blood urea nitrogen, blood gases, electrolytes, pH
breast milk analysis	during intervention (postmentrual age <32 weeks until 36 weeks)	using near-infrared analysis breast milk's macronutrients (fat, lactose and protein) will be measured daily
enteral energy intake	from inclusion at postmentrual age <32 weeks until 36 weeks	fat, carbohydrate, protein, and caloric intake by enteral feeding will be assesed daily
skin fold thickness	from inclusion at postmentrual age <32 weeks until 18 month corrected age	change in skin fold thickness \[cm\]
body composition (bio-electrical impedance analysis)	from inclusion at postmentrual age <32 weeks until 18 month corrected age	change in body composition measured with bio-electrical impedance analysis (impedance at 5, 50, 100 and 200 kHz, resistance at 50 kHz, reactance at 50 kHz, phase angle at 50 kHz)
morbidity	during intervention (postmentrual age <32 weeks until 36 weeks)

Trial Locations

Locations (1)

Faculty of Health Science, McMaster Children's Hospital; 🇨🇦 Hamilton, Ontario, Canada