Targeted vs Standard Fortification of Breast Milk

Summary

BACKGROUND:

Human milk (HM) is recommended for all very low birth infants (VLBW)). Breast-milk is highly variable in nutrient content, failing to meet the nutritional demands of VLBW. Fortification of HM is recommended to prevent extra-uterine growth retardation and associated poor neurodevelopmental outcome. However, standard fortification with fixed dose multicomponent fortifier does not account for the variability in milk composition. Targeted fortification is a promising alternative and needs further investigation.

The aim of the study is to evaluate if targeted fortification of human milk may optimize growth and development in preterm infants.

STUDY DESIGN:

Randomized single blind controlled trial.

METHODS \& ANALYSIS:

We will recruit preterm infants (≤ 32 weeks of gestation) within the first 7 days of life. After reaching 80 ml/kg/day of enteral feeding, patients will be randomised to receive standard fortification (HMF, Nutricia) or targeted fortification (modular components: Bebilon Bialko, Nutricia - protein, Fantomalt, Nutricia - carbohydrates, Calogen, Nutricia - lipids). The intervention will continue until 37 weeks of post-conception age, or hospital discharge. Parents and outcome assessors will be blinded to the intervention.

The primary outcome - weight gain velocity will be measured starting from the day infants regain their birth weight up to 4 weeks, then weekly until discharge.

Secondary outcomes such as neurodevelopment at 12 months of corrected age (CA) will be assessed with Bayley Scale of Development III, repeated at 36 months of CA. Additionally a Wescheler Preschool and Primary Scale of Intelligence IV test will be applied at 3,5 years of CA. Secondary outcomes such as length and head growth, body composition will be assesed at discharge and at 4 months. Incidence of necrotizing enterocolitis (NEC), sepsis, retinopathy of prematurity (ROP) and bronchopulmonary dysplasia (BPD) will also be followed.

Conditions

• BPD - Bronchopulmonary Dysplasia
• NEC - Necrotizing Enterocolitis
• Weight Gain
• VLBW - Very Low Birth Weight Infant
• ROP - Retinopathy of Prematurity

Interventions

DIETARY_SUPPLEMENT

Tailored enteral nutrition

The mean of three measurements per batch (3 x 2-3ml) will be used to calculate the required amount of extra fat, protein, and carbohydrate for the following 3 days of fortification using a predefined Excel spread sheet (Microsoft Inc, Redmond, Washington). The intervention will consist of adding fat, protein, and/or carbohydrate to achieve target levels of macronutrients. The defined macronutrient concentration in breast milk is 4.4 g/100 mL of fat, 3 g/100 mL of protein, and 8.8 g/ 100 mL of carbohydrate to meet the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) guidelines (6.6 g/kg/d of fat, 4.5 g/kg/d of protein, and 13.2 g/kg/d of carbohydrate) assuming an intake of 150 mL/kg/d.

Sponsors & Collaborators

• Medical University of Warsaw

  collaborator OTHER

• Institute of Mother and Child

  collaborator UNKNOWN

• Princess Anna Mazowiecka Hospital, Warsaw, Poland

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Max Age

32 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-01

Primary Completion

2024-12-31

Completion

2024-12-31

Countries

• Poland

Study Locations