Individualized Fortification of Breast Milk
- Conditions
- Postnatal Growth DisorderNeurodevelopment
- Interventions
- Dietary Supplement: Individualized fortification of breast milkDietary Supplement: Routine fortification of breast milk
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 112
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Individualized fortification of breast milk Individualized fortification of breast milk 1. Macronutrient content (for protein, carbohydrate and fat content) will be analyzed of native breast milk batches which had been prepared for 24 hr feeding. 2. Routine fortifier will be added to breast milk batches. 3. Modular products for individual adjustment of protein and/or carbohydrate and/or fat will be given in order to achieve target macronutrient level. Routine fortification of breast milk Routine fortification of breast milk 1. Macronutrient content (for protein, carbohydrate and fat content) will be analyzed of native breast milk batches which had been prepared for 24 hr feeding. 2. Routine fortifier will be added to breast milk batches.
- 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