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

Premature Infant Clinical Trial

Official title:

Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs): A Post-Market Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06212427
• Other study ID #: 2211INF
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2023
• Est. completion date: February 28, 2026

Study information

• Verified date: June 2024
• Source: Société des Produits Nestlé (SPN)
• Contact: Inez Sroda
• Phone: +41217858259
• Email: Inez.Sroda[@]rd.nestle.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 14 Days

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Premature Infant

Intervention

Dietary Supplement:
• HMO supplement
Liquid supplement containing 2 specific HMOs. Supplement will be given 3-4 times a day, not mixed with any feeding.

Locations

Country	Name	City	State
Austria	Kepler Universitätsklinikum Linz	Linz
Germany	Evangelisches Waldkrankenhaus Spandau	Berlin-Spandau
Germany	Kinderklinik Darmstadt	Darmstadt
Germany	Wilhelmstift Hamburg	Hamburg
Germany	Uniklinik Heidelberg	Heidelberg
Germany	Klinikum Nürnberg	Nürnberg

Sponsors (1)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feeding tolerance	Time to reach full enteral feeding rate of 150 mL/kg/day	From birth until achievement of full enteral feeding (1 to 3 weeks)
Primary	Feeding tolerance	Time to reach cessation of parenteral feeding	From birth until achievement of full enteral feeding (1 to 3 weeks)
Secondary	Gastrointestinal tolerance	Through data collected from neonatal unit records	From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks
Secondary	Weight gain	Measured in kilograms per day	From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks
Secondary	Length gain	Measured in centimeters per week	From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks
Secondary	Head circumference gain	Measured in centimeters per week	From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks
Secondary	Safety via reporting of adverse events (AEs) and serious adverse events (SAEs)	Type, incidence, severity, seriousness, and relation to HMO supplement consumption as well as concomitant medications and non-pharmacological treatments.; The incidence of specific illnesses of interest; a. Necrotizing enterocolitis b Confirmed or suspected late-onset sepsis c. Bronchopulmonary dysplasia d. Retinopathy of prematurity	From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks