Replacement Therapy in Preterm Infants
Conditions
Keywords
Replacement therapy, Pasteurized breast milk, Preterm infants, BSSL
Brief summary
The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in pasteurized breast milk.
Detailed description
In this double-blind crossover study, patients will be randomized to receive pasteurized breast milk including BSSL or pasteurized breast milk 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 pasteurized breast milk; 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 pasteurized breast milk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Coefficient of Fat Absorption measured 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 | Baseline and after one week of treatment |
Countries
France, Italy
Outcome results
None listed