Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs)

Nestlé

Status: Enrolling

Conditions: Premature Infant; Low Birthweight Infant

Treatments: Dietary Supplement: HMO supplement

Study type: Interventional

Funder types: Industry

Identifiers

NCT06212427

2211INF

Details and patient eligibility

About

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.

Enrollment: 188 estimated patients

Sex: All

Ages: Under 14 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Written informed consent has been obtained from at least one parent (or other legally acceptable representative [LAR], if applicable)
2. 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
3. Infant gestational age is ≤ 34 weeks as determined by the first day of the mother's last menstrual period or by fetal ultrasound
4. Infant birth weight ≤ 2500g
5. Infant postnatal age ≤ 14 days
6. 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

1. Infant is clinically unstable, for example:

   1. 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
   2. Infant has received an exchange transfusion within the past 48 hours
   3. Infant has had an episode of severe asphyxia at birth (PH less than 7.0)
   4. Infant has signs of necrotizing enterocolitis according to modified Bell staging criteria (stage IIA or higher)

2. Major congenital (e.g., heart disease, skeletal dysplasia, chondrodystrophy, gastrointestinal obstruction or atresia) or chromosomal abnormality (e.g., trisomy 21, Turner syndrome)

3. Infant has other medical condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study

4. Participation in another interventional clinical study that may interfere with the results of this study

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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188 participants in 1 patient group

HMO supplement

Other group

Treatment:

Dietary Supplement: HMO supplement