Neurodevelopment, Postnatal Growth Disorder
Conditions
Keywords
Postnatal development, Breast milk fortification, Composition of breast milk
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.
Interventions
DIETARY_SUPPLEMENTIndividualized 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_SUPPLEMENTRoutine fortification of breast milk
Infants will be fed routine fortified breast milk.
Sponsors
McMaster Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 32 Weeks
Healthy volunteers
No
Inclusion criteria
1. Gestational age \< 32weeks (maternal dates or early fetal ultrasound); 2. Tolerating an enteral intake of ≥ 100 ml/kg/d for ≥ 24h; 3. Subject is anticipated to receive the intervention for ≥ 3 consecutive weeks after full enteral feeding (≥ 150 mL/kg/d) has been achieved; and 4. Written informed consent has been obtained from the infant's legal representative.
Exclusion criteria
1. Infants with intrauterine growth restriction, small for gestational age defined by a weight less than 3rd percentile using sex specific reference data for birth weight 2. Gastrointestinal malformation, major congenital anomalies and chromosomal abnormalities; 3. Babies with enterostoma or short gut syndrome; 4. Necrotizing enterocolitis, defined by feeding intolerance associated with positive x-ray findings (pneumatosis intestinalis - Bell Stage 2; air in the biliary tract or free air in the peritoneum - Bell Stage 3); 5. Renal disease, defined by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased blood urea nitrogen 10 mmol/L79 and creatinine of 130 mmol/L80; 6. Hepatic dysfunction, defined by jaundice (direct bilirubin \>1.0 mg/dl) that is associated with one or more abnormal liver function tests (AST, ALT or GGT); 7. Participation in another clinical trial that may affect outcomes of this study; or 8. Probability of transfer to another NICU or level II nursery outside the McMaster Children's Hospital before the minimum period of three weeks is completed. Post-randomisation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| neurodevelopment | at 18 month corrected age | Bayley Scales of Infant Development III |
| weight gain | from inclusion at postmentrual age <32 weeks until 18 month corrected age | change in body weight \[g\] |
| body length | from inclusion at postmentrual age <32 weeks until 18 month corrected age | change in body length \[cm\] |
| head circumference | from inclusion at postmentrual age <32 weeks until 18 month corrected age | change in head circumference \[cm\] |
| 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) |
| 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 \[cm\] |
| 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) |
| morbidity | during intervention (postmentrual age <32 weeks until 36 weeks) | — |
| 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 |
| 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) |
Countries
Canada
Contacts
Primary ContactChristoph Fusch, MD, PhD, FRCPC
Backup ContactNiels Rochow, MD
Outcome results
None listed