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Targeted vs Standard Fortification of Breast Milk

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ClinicalTrials.gov Identifier: NCT03775785
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : August 8, 2019
Sponsor:
Collaborators:
Medical University of Warsaw
Institute of Mother and Child
Information provided by (Responsible Party):
Joanna Seliga-Siwecka, Princess Anna Mazowiecka Hospital, Warsaw, Poland

Brief 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, Polycal, 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.


Condition or disease Intervention/treatment Phase
BPD - Bronchopulmonary Dysplasia NEC - Necrotizing Enterocolitis Weight Gain VLBW - Very Low Birth Weight Infant ROP - Retinopathy of Prematurity Dietary Supplement: Tailored enteral nutrition Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This is a multi-centre superiority randomised parallel group, 1:1 allocation study.

After reaching 80 ml/kg/day of enteral feeding, patients will be randomised to receive standard fortification-SF (Bebilon HMF, Nutricia) or targeted fortification -TF (proteins, lipids,carbohydrates). Allocation will be performed electronically.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The decision to start fortification will be made by the attending physician blinded to the intervention allocated. An employee outside the research team will feed data into the computer in separate datasheets so that the researchers can analyse data without having access to information about the allocation.
Primary Purpose: Treatment
Official Title: Effect of Targeted vs Standard Fortification of Breast Milk on Growth and Development of Preterm Infants (≤ 32 Weeks): a Randomised Controlled Trial
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
Experimental: tailored enteral nutrition
Tailored Human milk fortification procedure Tailored milk fortification will be done twice a day (8 am and 8 pm) for each following 12 hour nursing shift. Standard fortification will be added first. The remainder amount of protein, lipids and carbohydrates required to meet the recommended by ESPGHAN doses will be acheived by adding single ingrediant nutrients.
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.


No Intervention: standard enteral nutrition
Standard fortification will be added according to the unit protocol.



Primary Outcome Measures :
  1. Growth [ Time Frame: from birth at postmentrual age <32 to up to 37 weeks of post-conceptional age ]
    weight will be assessed every day.

  2. Velocity of weight gain in grams [ Time Frame: from birth at postmentrual age <32 to up to 37 weeks of post-conceptional age ]
    weight will be assessed every day.


Secondary Outcome Measures :
  1. Neurodevelopmental outcome [ Time Frame: at 12 and 36 weeks of corrected age. ]
    the number of infants with mental development index (MDI) Bayley Scale of Development III

  2. Necrotizing enterocolitis (NEC) [ Time Frame: from birth at postmentrual age <32 to up to 37 weeks of post-gestational age ]
    The number of patients NEC >1 stage as defined by Bell's criteria

  3. Bronchopulmonary dysplasia (BPD) [ Time Frame: from 28 days at postmentrual age <32 to up to 37 weeks of post gestational age ]
    The number of patients with (BPD) defined as oxygen requirement of > 21% at 28 days of life

  4. Late onset sepsis (LOS) [ Time Frame: from 72 hours of life at postmentrual age <32 up to 37 weeks of post gestational age ]
    The number of patients with LOS defined as a positive blood culture or a positive cerebral spinal fluid culture

  5. Retinopathy of prematurity (ROP) [ Time Frame: from 3 weeks of life at postmentrual age <32 to 37 weeks of post gestational age ]
    The number of patients with ROP > grade I as defined as the World Health Organisation criteria



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients eligible for the trial must comply with all of the following at randomization:

  1. Gestational age at birth ≤ 32 weeks
  2. Enteral feeding of at least 80ml/kg/day
  3. Donor or maternal milk based enteral feeding (at least 50%)
  4. Parenteral/legal guardian consent

Exclusion Criteria:

  1. >50% formula based enteral feeding
  2. Small for gestational age (birth weight < 3rd percentile)
  3. Congenital abnormalities which increase the risk of NEC
  4. NEC
  5. Withdrawal of feeding > 7 days
  6. Sepsis
  7. Death

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775785


Locations
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Poland
Department of Neonatology and Neonatal Intensive Care Warsaw Medical University Recruiting
Warsaw, Poland, 00-315
Contact: Joanna Seliga-Siwecka, MD PhD    +48225966155    seliga.joanna@gmail.com   
Contact: Joanna Seliga-Siwecka         
Division of Neonatology and Neonatal Intensive Care, 1st Department of Obstetrics and Gynaecology, The Medical University of Warsaw Not yet recruiting
Warszawa, Poland, 02-015
Contact: Justyna Romańska, MD    +48225830340    justyna_romanska@gazeta.pl   
Sponsors and Collaborators
Princess Anna Mazowiecka Hospital, Warsaw, Poland
Medical University of Warsaw
Institute of Mother and Child
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Responsible Party: Joanna Seliga-Siwecka, Principal Investigator, Princess Anna Mazowiecka Hospital, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT03775785    
Other Study ID Numbers: 1/2018
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified participation data will be available on request from the corresponding author. Data reuse will be permitted for meta-analysis.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data will be available for 24 months after data analysis completion.
Access Criteria: researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joanna Seliga-Siwecka, Princess Anna Mazowiecka Hospital, Warsaw, Poland:
enteral nutrition
fortification
tailored enteral nutrition
Additional relevant MeSH terms:
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Enterocolitis
Enterocolitis, Necrotizing
Bronchopulmonary Dysplasia
Retinopathy of Prematurity
Body Weight
Birth Weight
Weight Gain
Retinal Diseases
Eye Diseases
Body Weight Changes
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases