The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in infant formula.
In this double-blind crossover study, patients will be randomized to receive infant formula including BSSL or infant formula without BSSL for the first 7 days. After a wash-out period of 2 days the patients will "crossover" to the other treatment regimen and receive an additional 7 days treatment. The primary efficacy measurements will be made by collecting stool during the last three days of each treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
33
Presidio Ospedaliero di Alta Specializzazione G.Salesi Azienda Ospedaliero Universitaria Ospedali Riuniti "Umberto I-G.M.Lancisi -G.Salesi
Ancona, Italy
Azienda Ospedaliera "Ospedale Policlinico Consorziale",U.O Neonatologia e Terapia Intensiva Neonatale
Bari, Italy
3) U.O. di Neonatologia e Terapia Intensiva Neonatale Università degli Studi di Milano, Ospedale Maggiore Policlinico,Mangiagalli e Regina Elena-Fondazione IRCCS
Milan, Italy
Coefficient of Fat Absorption in stool
Time frame: Stool collected for a 72-hour period during the final 3 days of each treatment period
Change in length and body weight between the start and end of each treatment period
Time frame: Baseline and after one week of treatment
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4) Policlinico Universitario-Azienda Ospedaliera di Padova, Dipartimento di Pediatria
Padova, Italy
Clinical Pediatrica-Neonatologia, Policlinico Gemelli, Universita Cattolica
Rome, Italy
U.O. Neonatologia, Patologia Neonatale e Terapia Intensiva
Rome, Italy