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

Launched by SOCIÉTÉ DES PRODUITS NESTLÉ (SPN) · Jan 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a special liquid supplement, which includes two types of human milk oligosaccharides (HMOs), affects the feeding tolerance and growth of premature infants. The HMOs being tested are called 2'-fucosyllactose (2'FL) and lacto-N-neotetraose (LNnT). The researchers want to see if giving this supplement helps these infants, who are born early and might weigh less than normal, to feed better and grow healthier while observing any side effects.

To participate in this study, infants need to be born at or before 34 weeks of pregnancy and weigh 2500 grams or less at birth. They should be under 14 days old and have started some feeding, although not at full amounts yet. Parents or guardians will need to provide consent and be able to follow the study's guidelines. If an infant has certain serious health issues or is part of another clinical trial, they may not be eligible. Families can expect to closely monitor their child's feeding and growth during the study, contributing to valuable information that could help many other premature infants in the future.

Gender

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Eligibility criteria

• 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