Growth and Safety of Two Partially-hydrolyzed Feeding Systems for Preterm Infants: a Multi-centered, Open-label Clinical Trial
Status: Active_not_recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This is an open-label trial consisting of two sub-studies to be conducted sequentially with the purpose of evaluating the safety and suitability of a two feeding systems in pre-term infants (one containing HMOs and one without HMOs).
Eligibility
Participation Requirements
Sex: All
Maximum Age: 10 days
Healthy Volunteers: t
View:
• Written informed consent has been obtained from one or both parent(s) /legally acceptable representative (LAR) in accordance with local regulation.
• Infants' birth weight ≤1500 g and AGA.
• Infant's gestational age \< 37 weeks.
• Infant is clinically stable and does not have deteriorating respiratory function after birth.
• Infant is eligible to start experimental formula after 24 hours of trophic feeding, but still within the first 10 days (≤240 hours) of life.
Locations
Other Locations
Germany
Klinikum Nuernberg
Nuremberg
Poland
Klinika Neonatologii, Szpital Uniwersyteck
Bydgoszcz
Slovakia
Univerzitna nemocnica Martin
Martin
Fakultna nemocnica s poliklinikou Nove Zamky
Nové Zámky
Time Frame
Start Date: 2020-09-10
Completion Date: 2026-12
Participants
Target number of participants: 70
Treatments
Experimental: Sub-study 1
Pre-term formulas with HMO
Experimental: Sub-study 2
Pre-term formulas without HMO
Related Therapeutic Areas
Sponsors
Leads: Société des Produits Nestlé (SPN)