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.

Standard fortification will be added according to the unit protocol.

BPD - Bronchopulmonary Dysplasia

NEC - Necrotizing Enterocolitis

Weight Gain

VLBW - Very Low Birth Weight Infant

ROP - Retinopathy of Prematurity

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.

Tailored enteral nutrition

Department of Neonatology and Neonatal Intensive Care Warsaw Medical University

Division of Neonatology and Neonatal Intensive Care, 1st Department of Obstetrics and Gynaecology, The Medical University of Warsaw

Targeted vs Standard Fortification of Breast Milk

Effect of Targeted vs Standard Fortification of Breast Milk on Growth and Development of Preterm Infants (≤ 32 Weeks): a Randomised Controlled Trial

the number of infants with mental development index (MDI) Bayley Scale of Development III

The number of patients NEC >1 stage as defined by Bell's criteria

The number of patients with (BPD) defined as oxygen requirement of > 21% at 28 days of life

The number of patients with LOS defined as a positive blood culture or a positive cerebral spinal fluid culture

The number of patients with ROP > grade I as defined as the World Health Organisation criteria

Deidentified participation data will be available on request from the corresponding author. Data reuse will be permitted for meta-analysis.

Joanna Seliga-Siwecka

Principal Investigator

Princess Anna Mazowiecka Hospital, Warsaw, Poland

Medical University of Warsaw

Institute of Mother and Child

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.

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.

50 mg/kg given two times a day (100 mg/kg/day) for total 7 days.

100 mg/kg given two times a day (200 mg/kg/day) for total 7 days

150 mg/kg given two times a day (300 mg/kg/day) for total 7 days.

Bronchopulmonary Dysplasia

Bronchopulmonary Dysplasia Associated Pulmonary Hypertension

Pulmonary Hypertension

Premature Birth

Chronic Lung Disease of Prematurity

L-Citrulline as 10 % solution (100 mg/ml) will be provided to the bedside nurse by the Investigational Pediatric Pharmacy. The drug will be given via gavage feeding by bolus infusions followed by a 0.5 ml water flush twice daily (0900 and 2100). Bolus dosing will be needed due to the small volumes (0.5-1.5 ml per dose in most infants). The volume of nasogastric tubing used in preterm infants (Ameritus 4.0 Fr 50 cm) is 0.48 ml, therefore we will follow the administration with 0.5 ml of saline/water flush to ensure all the study drug is delivered to the patient.
Administration of study drug - Will be given via gavage feeding tube twice daily (0900 +/- 30 mins, 2100 +/- 30 mins). L-citrulline will be given by the bedside nurse as a bolus followed by 0.5 ml water flush. L-citrulline will be given separate from feeds to avoid any confusion.
Study drug will be started when infant has been off of TPN for at least 3 days so that IV arginine in TPN does not interfere.

Enteral L-citrulline

University of Texas Medical Branch

Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing

L-arginine and citrulline levels in the plasma will be measured via liquid chromatography-mass spectroscopy (LCMS) and a change (increase) in plasma levels of 20% on day 7 from baseline on day 0 will be considered significant.

Measured by at least one adverse event that are determined to be related to the study drug.

Previous studies have shown that a plasma level of > 37 micromol/L was effective in preventing pulmonary hypertension.

Amna Qasim

The University of Texas Medical Branch, Galveston

Previous studies in patients undergoing cardiac surgery have shown that post-operative pulmonary hypertension did not develop in patients with citrulline level > 37 micromol/L. A cross-sectional study reported that citrulline levels < 29 micromol/L was associated with BPD_PH (100% sensitivity and 75% specificity) hence this may be used as a screening tool for BPD_PH2. The investigators will use the higher levels of citrulline of the reported levels as our goal (>37µmol/L). The investigators will supplement infants with 3 different dosages and check serum levels to see what dose is required to achieve the optimal plasma level of citrulline (>37µmol/L).

In the intervention group, mothers will be asked to provide at least 1 feed of fresh milk (i.e. within 4 hours of milk expression) per day.Other time, feed frozen milk.

Necrotizing Enterocolitis

Mothers will be asked to provide at least 1 feed of fresh milk (i.e. within 4 hours of milk expression) per day, other time, feed frozen milk

Fresh Milk

Zhengzhou Children's Hospital

Pilot Study of the Feasibility of Feeding Preterm Infants With Fresh Versus Frozen Mother's Own Breast Milk in the NICU

Feasibility as defined by the percentage of mothers who can provide at least 1 feed of fresh milk a day from study enrollment until the infants are 32 weeks CGA

bronchopulmonary dysplasia/carbohydrate

Targeted vs Standard Fortification of Breast Milk

Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing

Pilot Study of the Feasibility of Feeding Preterm Infants With Fresh Versus Frozen Mother's Own Breast Milk in the NICU

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