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.
Who can participate
Age range
0 Days – 14 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 postnatal age ≤ 14 days
. Infant has tolerated trophic feeds (e.g., 10-15 mL/kg/day) for at least 24 hours but has not yet reached full enteral feeding
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feeding tolerance
Timeframe: From birth until achievement of full enteral feeding (1 to 3 weeks)
2
Feeding tolerance
Timeframe: From birth until achievement of full enteral feeding (1 to 3 weeks)
. 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)
. Major congenital (e.g., heart disease, skeletal dysplasia, chondrodystrophy, gastrointestinal obstruction or atresia) or chromosomal abnormality (e.g., trisomy 21, Turner syndrome)
. Infant has other medical condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study
. Participation in another interventional clinical study that may interfere with the results of this study