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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
188
Liquid supplement containing 2 specific HMOs. Supplement will be given 3-4 times a day, not mixed with any feeding.
Kepler Universitätsklinikum Linz
Linz, Austria
RECRUITINGEvangelisches Waldkrankenhaus Spandau
Berlin-Spandau, Germany
RECRUITINGKinderklinik Darmstadt
Darmstadt, Germany
RECRUITINGWilhelmstift Hamburg
Hamburg, Germany
WITHDRAWNUniklinik Heidelberg
Heidelberg, Germany
RECRUITINGKlinikum Nürnberg
Nuremberg, Germany
RECRUITINGFeeding tolerance
Time to reach full enteral feeding rate of 150 mL/kg/day
Time frame: From birth until achievement of full enteral feeding (1 to 3 weeks)
Feeding tolerance
Time to reach cessation of parenteral feeding
Time frame: From birth until achievement of full enteral feeding (1 to 3 weeks)
Gastrointestinal tolerance
Through data collected from neonatal unit records
Time frame: From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks
Weight gain
Measured in kilograms per day
Time frame: From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks
Length gain
Measured in centimeters per week
Time frame: From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks
Head circumference gain
Measured in centimeters per week
Time frame: 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
Time frame: From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks
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