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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.
A comparison with data collected retrospectively from a historical group at each site will be made for time to reach full enteral feeding, growth and adverse events. Infants in the historical group were not exposed to an HMO supplement but followed the same local nutrition protocol to avoid confounding by differences in clinical or feeding practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HMO supplement | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HMO supplement | Dietary Supplement | Liquid supplement containing 2 specific HMOs. Supplement will be given 3-4 times a day, not mixed with any feeding. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Feeding tolerance | Time to reach cessation of parenteral feeding | From birth until achievement of full enteral feeding (1 to 3 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal tolerance | Through data collected from neonatal unit records | From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks |
| Weight gain | Measured in kilograms per day |
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Inclusion Criteria:
Exclusion Criteria:
Infant is clinically unstable, for example:
Major congenital (e.g., heart disease, skeletal dysplasia, chondrodystrophy, gastrointestinal obstruction or atresia) or chromosomal abnormality (e.g., trisomy 21, Turner syndrome)
Infant has other medical condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study
Participation in another interventional clinical study that may interfere with the results of this study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Inez Sroda | Contact | +41217858259 | Inez.Sroda@rd.nestle.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kepler Universitätsklinikum Linz | Recruiting | Linz | 4020 | Austria |
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| From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks |
| Length gain | Measured in centimeters per week | From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks |
| Head circumference gain | Measured in centimeters per week | From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks |
| 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 |
| Evangelisches Waldkrankenhaus Spandau | Recruiting | Berlin-Spandau | Germany |
|
| Kinderklinik Darmstadt | Recruiting | Darmstadt | Germany |
|
| Wilhelmstift Hamburg | Withdrawn | Hamburg | Germany |
| Uniklinik Heidelberg | Recruiting | Heidelberg | Germany |
|
| Klinikum Nürnberg | Recruiting | Nuremberg | 90419 | Germany |
|
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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