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

Not Applicable

Recruiting

• Conditions: Premature Infant; Low Birthweight Infant
• Interventions: Dietary Supplement: HMO supplement

• Registration Number: NCT06212427
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-20
• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2024-01-08
• Study First Posted: 2024-01-18
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-13
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 188

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HMO supplement	HMO supplement	-

Primary Outcome Measures

Name	Time	Method
Feeding tolerance	From birth until achievement of full enteral feeding (1 to 3 weeks)	Time to reach cessation of parenteral feeding

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal tolerance	From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks	Through data collected from neonatal unit records
Weight gain	From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks	Measured in kilograms per day
Head circumference gain	From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks	Measured in centimeters per week
Safety via reporting of adverse events (AEs) and serious adverse events (SAEs)	From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks	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
Length gain	From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks	Measured in centimeters per week

Trial Locations

Locations (6)

Kinderklinik Darmstadt; 🇩🇪 Darmstadt, Germany

Evangelisches Waldkrankenhaus Spandau; 🇩🇪 Berlin-Spandau, Germany

Wilhelmstift Hamburg; 🇩🇪 Hamburg, Germany

Uniklinik Heidelberg; 🇩🇪 Heidelberg, Germany

Klinikum Nürnberg; 🇩🇪 Nürnberg, Germany

Kepler Universitätsklinikum Linz; 🇦🇹 Linz, Austria