Comparison of rhBSSL With Placebo When Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants (LAIF)

Sobi

Status and phase

Terminated

Phase 3

Conditions

Prevention of Growth Restriction

Treatments

Drug: rhBSSL (recombinant human bile-salt-stimulated lipase)

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01413581

BVT.BSSL-030

Details and patient eligibility

About

The purpose of this study is to demonstrate that rhBSSL improves growth in preterm infants as compared with placebo.

Full description

The purpose of this study is to demonstrate that rhBSSL improves growth in preterm infants as compared with placebo. The infants should be born before week 32 of gestational age.

The study drug, rhBSSL or placebo, will be administered during a 4 week treatment period by adding it to either infant formula or pasteurized breast milk.

The study will also evaluate the safety and tolerability of rhBSSL.

Eligible patients will be randomized in a ratio of 1:1 (rhBSSL:placebo). The study consists of maximum 1 week screening period, a 4-week treatment period and a 2 year follow-up period.

Enrollment

415 patients

Sex

All

Ages

Under 10 weeks old

Volunteers

No Healthy Volunteers

Inclusion criteria

Preterm infants born before week 32 of gestation.
Preterm infant who is less than 33 weeks postmenstrual age at the time of randomization.
Preterm infant who is appropriate for gestational age (AGA) or small for gestational age (SGA) at birth.
Preterm infant who is receiving food enterally (bottle or gavage tube) at a level of at least 100 ml/kg/day at randomization.
Preterm infant whose enteral feeding consists of only infant formula or only pasteurized breast milk at the time of inclusion, and who are expected to remain on only infant formula for 4 weeks, or only pasteurized breast milk for at least 2 weeks following treatment initiation.
Preterm infant who is expected not to receive any fresh breast milk for 4 weeks following treatment initiation.
Informed consent is obtained.

Exclusion criteria

Expected stay in the hospital is less than 4 weeks from the first dose of study drug.
Criteria to ensure no disease or treatment affecting growth or development, e.g. brain disease, necrotizing enterocolitis.
Enrolled in another concurrent clinical intervention study.