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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized fortification of breast milk | Experimental |
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| Routine fortification of breast milk | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized fortification of breast milk | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| growth during first three weeks of intervention | change in body weight gain will be accessed daily. | first three weeks during intervention before 36 weeks of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| enteral energy intake | fat, carbohydrate, protein, and caloric intake by enteral feeding will be assesed daily | from inclusion at postmentrual age <32 weeks until 36 weeks |
| neurodevelopment | Bayley Scales of Infant Development III |
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Inclusion criteria:
Exclusion criteria:
Post-randomisation exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christoph Fusch, MD, PhD, FRCPC | Contact | +1 905 521 2100 | 75721 | fusch@mcmaster.ca |
| Niels Rochow, MD | Contact | +1 905 521 2100 | 23106 | rochow@mcmaster.ca |
| Name | Affiliation | Role |
|---|---|---|
| Christph Fusch, MD, PhD, FRCPC | McMaster Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Health Science, McMaster Children's Hospital | Recruiting | Hamilton | Ontario | L8S 4K1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33226632 | Derived | Fabrizio V, Trzaski JM, Brownell EA, Esposito P, Lainwala S, Lussier MM, Hagadorn JI. Individualized versus standard diet fortification for growth and development in preterm infants receiving human milk. Cochrane Database Syst Rev. 2020 Nov 23;11(11):CD013465. doi: 10.1002/14651858.CD013465.pub2. | |
| 32446787 | Derived |
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| Routine fortification of breast milk | Dietary Supplement | Infants will be fed routine fortified breast milk. |
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| at 18 month corrected age |
| weight gain | change in body weight [g] | from inclusion at postmentrual age <32 weeks until 18 month corrected age |
| body length | change in body length [cm] | from inclusion at postmentrual age <32 weeks until 18 month corrected age |
| head circumference | change in head circumference [cm] | from inclusion at postmentrual age <32 weeks until 18 month corrected age |
| body composition | change in body composition measured with air displacement plethysmography (body weight, body volume, calculated fat and lean mass) | from inclusion at postmentrual age <32 weeks until 3 month corrected age |
| body composition (bio-electrical impedance analysis) | 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) | from inclusion at postmentrual age <32 weeks until 18 month corrected age |
| skin fold thickness | change in skin fold thickness [cm] | from inclusion at postmentrual age <32 weeks until 18 month corrected age |
| feeding intolerance | occurence of feeding intolerance defined by vomitting, bloody gastric residuals, or abnormal abdomen (tender, discolored, absent bowel sounds) | during intervention (postmentrual age <32 weeks until 36 weeks) |
| morbidity | during intervention (postmentrual age <32 weeks until 36 weeks) |
| nutrient's blood parameter | triglycerides, glucose, blood urea nitrogen, blood gases, electrolytes, pH | during intervention (postmentrual age <32 weeks until 36 weeks) |
| breast milk analysis | using near-infrared analysis breast milk's macronutrients (fat, lactose and protein) will be measured daily | during intervention (postmentrual age <32 weeks until 36 weeks) |
| Rochow N, Fusch G, Ali A, Bhatia A, So HY, Iskander R, Chessell L, El Helou S, Fusch C. Individualized target fortification of breast milk with protein, carbohydrates, and fat for preterm infants: A double-blind randomized controlled trial. Clin Nutr. 2021 Jan;40(1):54-63. doi: 10.1016/j.clnu.2020.04.031. Epub 2020 May 6. |