A prospective, randomised, double-blind crossover study comparing 0.15 g/L rhBSSL added to infant formula versus placebo during one week of treatment in preterm infants born before week 32 of gestational age - BVT.BSSL-020

• Conditions: Enzyme replacement therapy in pre-term infants. Reduced fad uptake capabilities due to prematurity of pre-term infants; MedDRA version: 9.1Level: HLGTClassification code 10013317Term: Lipid metabolism disorders

• Registration Number: EUCTR2007-002423-33-IT
• Lead Sponsor: BIOVITRUM AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Preterm infants born before week 32 of gestation and who are < o = 32 weeks of gestation (extrapolated age) at the time of enrollment 2. Preterm infants appropriate for gestational age (each site should use its own growth curves or procedures and keep a copy of those used in the investigator?s file. The same growth curve should be used for all patients at one site) 3. Preterm infants receiving infant formula whose mothers are not intending to provide breast milk 4. Preterm infants receiving enteral nutrition (bottle or nasal tube)
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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