Replacement Therapy in Preterm Infants
Conditions
Keywords
Preterm infants, Replacement therapy, Infant formula, BSSL, BSSL is present in fresh mother's milk but not in infant formula.
Brief summary
The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in infant formula.
Detailed description
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.
Interventions
DRUGrhBSSL
0.15 g/L rhBSSL added to infant formula; one week treatment
DRUGPlacebo
One week treatment
Sponsors
Swedish Orphan Biovitrum
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 32 Weeks
Healthy volunteers
No
Inclusion criteria
* Preterm infants * less than or equal to 32 weeks of gestational age * appropriate for gestational age * enterally fed with infant formula
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Coefficient of Fat Absorption in stool | Stool collected for a 72-hour period during the final 3 days of each treatment period |
Secondary
| Measure | Time frame |
|---|---|
| Change in length and body weight between the start and end of each treatment period | Baseline and after one week of treatment |
Countries
Italy
Outcome results
None listed