Clinical trial NCT06212427: Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs)
Official title: Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs): A Post-Market Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature Infant
Low Birthweight Infant
Keywords: Human Milk Oligosaccharides
Feeding tolerance
Growth
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2024-01-18
Enrollment: 188
Sex: ALL
Minimum age (years): 0
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


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

Primary outcomes:
measure: Feeding tolerance
timeFrame: From birth until achievement of full enteral feeding (1 to 3 weeks)
measure: Feeding tolerance
timeFrame: From birth until achievement of full enteral feeding (1 to 3 weeks)
Secondary outcomes:
measure: Gastrointestinal tolerance
timeFrame: From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks
measure: Weight gain
timeFrame: From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks
measure: Length gain
timeFrame: From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks
measure: Head circumference gain
timeFrame: From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks
measure: Safety via reporting of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler Universitätsklinikum Linz
city: Berlin-Spandau
country: Germany
facility: Evangelisches Waldkrankenhaus Spandau
city: Darmstadt
country: Germany
facility: Kinderklinik Darmstadt
city: Hamburg
country: Germany
facility: Wilhelmstift Hamburg
city: Heidelberg
country: Germany
facility: Uniklinik Heidelberg
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg
Study officials:
References: