Target Fortification of Breast Milk: How Often Breast Milk Needs to be Measured? (TFO2)

August 10, 2016 updated by: Christoph Fusch, McMaster Children's Hospital

Target Fortification of Breast Milk: The Effect of Different Schedules for Milk Analysis on the Growth and Development of Preterm Infants.

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 Overview

Status

Unknown

Conditions

Postnatal Growth Disorder

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Christoph Fusch, MD, PhD
Phone Number: 75721 +1 521 2100
Email: fusch@mcmaster.ca

Study Contact Backup

Name: Niels Rochow, MD
Phone Number: 23106 +1 521 2100
Email: rochow@mcmaster.ca

Study Locations

Canada
- Ontario
  - Hamilton, Ontario, Canada, L8S 4K1
    - Faculty of Health Science, McMaster Children's Hospital
    - Contact:
      
      Christoph Fusch, MD, PhD, FRCPC
      
      Phone Number: 75721 +1 905 521 2100
      
      Email: fusch@mcmaster.ca
    - Principal Investigator:
      
      Christoph Fusch, MD, PhD, FRCPC
    - Sub-Investigator:
      
      Niels Rochow, MD
    - Sub-Investigator:
      
      Gerhard Fusch, PhD
    - Sub-Investigator:
      
      Salhab el Helou, MD, FRCPC
    - Sub-Investigator:
      
      Sabiha Ahmad
    - Sub-Investigator:
      
      Akshdeep Singh Bhatia
    - Sub-Investigator:
      
      Klaus Wutzke, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (Child)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5 milk analysis Macronutrient content (for protein, carbohydrate and fat content) will be analyzed five times per week, of native breast milk batches which had been prepared for 24 hours feeding. Routine fortifier will be added to breast milk batches. Modular products for individual adjustment of protein and/or carbohydrate and/or fat will be given in order to achieve target macronutrient level.	Dietary supplement: Fortification with modular protein Modular product supplementation is based on most recent breast analysis done for the participant. Dietary supplement: Fortification with modular carbohydrate Modular product supplementation is based on most recent breast analysis done for the participant. Dietary supplement: Fortification with modular fat Modular product supplementation is based on most recent breast analysis done for the participant.
Experimental: 1 milk analysis Macronutrient content (for protein, carbohydrate and fat content) will be analyzed once per week of native breast milk batches which had been prepared for 24 hours feeding. Routine fortifier will be added to breast milk batches. Modular products for individual adjustment of protein and/or carbohydrate and/or fat will be given in order to achieve target macronutrient level.	Dietary supplement: Fortification with modular protein Modular product supplementation is based on most recent breast analysis done for the participant. Dietary supplement: Fortification with modular carbohydrate Modular product supplementation is based on most recent breast analysis done for the participant. Dietary supplement: Fortification with modular fat Modular product supplementation is based on most recent breast analysis done for the participant.

Participant Group / Arm