Target Fortification of Breast Milk: The Effect of Different Schedules for Milk Analysis on the Growth and Development of Preterm Infants.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- McMaster Children's Hospital
- Enrollment
- 56
- Locations
- 2
- Primary Endpoint
- Growth during first three weeks of intervention
Study Overview
Brief Summary
It has been observed that target fortification on different schedules leads to meal to meal variation. It changes the ratio of protein to energy and the percentage of carbohydrate to non-protein energy which may, affect growth. In the past, the investigators have analyzed the outcomes of breast milk composition when target fortification is done with different analysis schedules. The investigators were able to measure the macronutrient intake for different milk analysis schedules via a theoretical model and show that the more frequent schedules reduce the variation of fortified-breast milk, whereas a reduced schedule leads to a high variation of macronutrients. It was observed that, in all the breast milk samples measured twice per week, infants achieved on average the recommended macronutrients in line with current recommendations. Nonetheless, the model only looks at the macronutrient intake and does not investigates the relationship between macronutrient variation and its effect on growth.
The aim of the current study is to compare a frequent schedule of measurement of macronutrient analysis with a reduced schedule of measurement and to study its affect on growth, protein accretion and metabolic parameter.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 29 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Gestational age < 30 weeks (maternal dates or early fetal ultrasound);
- •Tolerating an enteral intake of ≥100 mL/kg/d for ≥ 24h;
- •Subject is anticipated to receive the intervention for ≥ 3 consecutive weeks after full enteral feeding (≥150 mL/kg/d) has been achieved;
- •Written informed consent has been obtained from the infant's legal representative.
- •Multiple births: Each infant will be included in the study if he/she meets the study criteria, and siblings will be individually randomized to one or other of the treatment arms.
- •Discussion with Most Responsible Physician (MRP) and the staff in order to discuss any potential transfer during the next 7 days.
Exclusion Criteria
- •Gastrointestinal malformation, major congenital anomalies and chromosomal abnormalities;
- •Babies with enterostoma or short gut syndrome;
- •Infants fed more than 25% of mean caloric intake for a consecutive week with formula milk;
- •Fluid restriction <140 mL/kg/d for ≥ 3 consecutive days;
- •Sepsis - all infants with gram-negative sepsis will be removed from the study;
- •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);
- •Renal disease, defined by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased blood urea nitrogen >10 mmol/L and creatinine of 130mmol/L
- •Participation in another clinical trial that may provide an alternative nutritional intervention, which might affect the outcomes of this study. outcomes of this study;
- •Probability of transfer to another neonatal intensive care unit or level II nursery outside the McMaster Children's Hospital, as discussed with the most responsible physician (MRP)
Outcomes
Primary Outcomes
Growth during first three weeks of intervention
Time Frame: first three weeks during intervention before 36 weeks of gestation
Secondary Outcomes
- Daily Nutrient intake (kcal, lactose, protein, fat) measured with conventional milk analysis(from inclusion at postmenstrual age <30 weeks until 36 weeks of gestation)
- Oxidative stress by 8-Oxo-2'-deoxyguanosine metabolites in urine(from inclusion at postmenstrual age <30 weeks until discharge)
- Head circumference [cm](from inclusion at postmenstrual age <30 weeks until discharge)
- Weight Gain(from inclusion at postmenstrual age <30 weeks until 36 weeks of gestation or discharge)
- Body length [cm](from inclusion at postmenstrual age <30 weeks until discharge)
- Protein synthesis analyzed by nitrogen excretion in urine [µmol/mL](first three weeks during intervention before 36 weeks of gestation)
- Lean mass [g](from inclusion at postmenstrual age <30 weeks until discharge)
- Feeding intolerance questionaire(from inclusion at postmenstrual age <30 weeks until discharge)
- Fat mass [g](from inclusion at postmenstrual age <30 weeks until discharge)
Investigators
Christoph Fusch
Professor
McMaster Children's Hospital