A prospective, randomised, double-blind crossover study comparing 0.15 g/L rhBSSL added to pasteurized breast milk versus placebo during one week of treatment in preterm infants born before week 32 of gestational age - BVT. BSSL - 021

Phase 1

• Conditions: Enzyme replacement therapy in pre-term infants. Reduced fat uptake capabilities due to prematurity of pre-term infants

• Registration Number: EUCTR2007-002434-10-FR
• Lead Sponsor: Biovitrum AB (publ.)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-07-25
• Study Completion: 2010-02-17
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

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

Inclusion Criteria

1.Preterm infants born before week 32 of gestation and who are less or equal than 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 pasteurized breast milk
4.Preterm infants, enterally fed via nasal tube or bottle
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 other than Eoprotin® (eg, Enfamil, Nutriprem)
a.Otherwise eligible infants who are receiving milk fortifiers other than Eoprotin® 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 =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 pasteurized breast milk.;Secondary Objective: •Compare the length and body weight in preterm infants following treatment with rhBSSL to that in placebo when administered in pasteurized breast milk.<br>•Study the safety of rhBSSL when administered in pasteurized breast milk. <br>;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