The goal of this post-market study is to describe the effect of a liquid supplement containing 2 specific human milk oligosaccharides (HMOs), 2'-fucosyllactose \[2'FL\] and lacto-N-neotetraose \[LNnT\], on feeding tolerance, growth, and adverse events of special interest in preterm infants in a real-world setting.
A comparison with data collected retrospectively from a historical group at each site will be made for time to reach full enteral feeding, growth and adverse events. Infants in the historical group were not exposed to an HMO supplement but followed the same local nutrition protocol to avoid confounding by differences in clinical or feeding practice.
Written informed consent has been obtained from at least one parent (or other legally acceptable representative [LAR], if applicable)
Infant's parent(s)/LAR is of legal age of majority, has parental authority, must understand the consent form and other relevant study documents, and is willing and able to fulfil the requirements of the study protocol
Infant gestational age is ≤ 34 weeks as determined by the first day of the mother's last menstrual period or by fetal ultrasound
Infant birth weight ≤ 2500g
Infant has hemodynamic instability as evidenced by clinical signs of sepsis, hypotension (MAP < 5th percentile for age for at least three hours), or is receiving vasopressor drugs
Infant has received an exchange transfusion within the past 48 hours
Infant has had an episode of severe asphyxia at birth (PH less than 7.0)
Infant has signs of necrotizing enterocolitis according to modified Bell staging criteria (stage IIA or higher)
Single group
HMO supplement
Dietary supplementLiquid supplement containing 2 specific HMOs. Supplement will be given 3-4 times a day, not mixed with any feeding.
Feeding tolerance
Time to reach full enteral feeding rate of 150 mL/kg/day
Feeding tolerance
Time to reach cessation of parenteral feeding
Gastrointestinal tolerance
Through data collected from neonatal unit records
Weight gain
Measured in kilograms per day
Length gain
Measured in centimeters per week
Head circumference gain
Measured in centimeters per week
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