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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01609894
Other study ID # 201205IFO
Secondary ID
Status Recruiting
Phase N/A
First received May 30, 2012
Last updated August 10, 2016
Start date August 2013

Study information

Verified date August 2016
Source McMaster Children's Hospital
Contact Christoph Fusch, MD, PhD, FRCPC
Phone +1 905 521 2100
Email fusch@mcmaster.ca
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 112
Est. completion date
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender Both
Age group N/A to 32 Weeks
Eligibility 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 exclusion criteria:

1. Infants fed more than 25% of mean caloric intake for a consecutive week with formula milk;

2. Fluid restriction < 140mL/kg/d for = 3 consecutive days;

3. Sepsis - all infants with gram-negative sepsis will be removed from the study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

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.
Routine fortification of breast milk
Infants will be fed routine fortified breast milk.

Locations

Country Name City State
Canada Faculty of Health Science, McMaster Children's Hospital Hamilton Ontario

Sponsors (1)

Lead Sponsor Collaborator
McMaster Children's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary neurodevelopment Bayley Scales of Infant Development III at 18 month corrected age No
Secondary weight gain change in body weight [g] from inclusion at postmentrual age <32 weeks until 18 month corrected age No
Secondary body length change in body length [cm] from inclusion at postmentrual age <32 weeks until 18 month corrected age No
Secondary head circumference change in head circumference [cm] from inclusion at postmentrual age <32 weeks until 18 month corrected age No
Secondary 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 No
Secondary 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 No
Secondary skin fold thickness change in skin fold thickness [cm] from inclusion at postmentrual age <32 weeks until 18 month corrected age No
Secondary 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) No
Secondary morbidity during intervention (postmentrual age <32 weeks until 36 weeks) No
Secondary nutrient's blood parameter triglycerides, glucose, blood urea nitrogen, blood gases, electrolytes, pH during intervention (postmentrual age <32 weeks until 36 weeks) No
Secondary 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) No
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