Enzyme replacement therapy in pre-term infants. Reduced fad uptake capabilities due to prematurity of pre-term infants MedDRA version: 9.1 Level: HLGT Classification code 10013317 Term: Lipid metabolism disorders
Conditions
Interventions
Product Name: Recombinant Human bile salt-stimulated lipase
Product Code: rhBSSL
Pharmaceutical Form: Oral solution
INN or Proposed INN: Multienzymes (lipase, protease etc.)
Current Sponsor code: rhBS
Sponsors
BIOVITRUM AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Preterm infants born before week 32 of gestation and who are =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Infants receiving parenteral nutrition (except glucose) 2. Infants receiving milk fortifiers (eg, Enfamil, Nutriprem, Milupa Eoprotin) a. Otherwise eligible infants who are receiving milk fortifiers may be enrolled if the use of fortifiers is discontinued 2 days before the first dose 3. Infants requiring mechanical ventilation 4. Infants small for their gestational age (SGA) 5. Infants requiring > o = 30% O2 6. Infants receiving phototherapy (babies who have completed phototherapy and otherwise qualify for the study may be admitted) 7. Infants with severe brain disease including grade III or IV periventricular or intra ventricular hemorrhage, meningitis or hydrocephalus, intracranial hemorrhage of grade III or IV, periventricular leukomalacia 8. Major dysmorphology or congenital abnormalities that can affect growth and development 9. Infants with hemodynamically significant persistent ductus arteriosus (PDA) 10. Clinical evidence of sepsis (including low or high white cell count and/or low platelet count, and bacteriologically proven evidence of systemic infection) 11. Documented congenital infection (eg CMV) 12. Presence of necrotizing enterocolitis 13. Haemorrhagic pulmonary events 14. Prior or concomitant treatment with corticosteroids, except hydrocortisone 15. Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion 16. Enrollment in another concurrent clinical study within 2 days of the screening visit through the completion of the follow-up visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the fat absorption (coefficient of fat absorption) in preterm infants following treatment with rhBSSL to that with placebo when administered in infant formula.;Secondary Objective: Compare the length and body weight in preterm infants following treatment with rhBSSL to that in placebo when administered in infant formula. Study the safety of rhBSSL when administered in infant formula.;Primary end point(s): Coefficient of fat absorption (CFA) measured in stool collected for a 72-hour period during the final 3 days of each treatment period | — |
Countries
Italy
Outcome results
None listed