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

Phase 3TerminatedNCT01413581

Swedish Orphan Biovitrum415 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

415

Conditions

Prevention of Growth Restriction

Interventions

rhBSSL (recombinant human bile-salt-stimulated lipase)DRUG

rhBSSL added to infant formula/pasteurized breast milk during a 4 week treatment period.

PlaceboDRUG

Placebo added to infant formula/pasteurized breast milk during a 4 week treatment period.

Eligibility

Sex: ALLMax age: 10 Weeks

Medical Language ↔ Plain English

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.

Locations (49)

Outcomes

Primary Outcomes

Growth velocity in grams per kilogram per day during 4 weeks of treatment.

Time frame: Baseline and Day 29

Secondary Outcomes

Change from baseline in body weight (g) at 3 months

Time frame: Baseline and Month 3

Body weight (g) at 12 months' corrected age

Time frame: 12 months´ corrected age

Body weight (g) at 24 months' corrected age

Time frame: 24 months´ corrected age

Change from baseline in total body length (mm) at 4 weeks

Time frame: Baseline and Day 29

Change from baseline in total body length (mm) at 3 months

Time frame: Baseline and Month 3

Total body length (mm) at 12 months' corrected age

Time frame: 12 months' corrected age

Total body height (cm) at 24 months' corrected age

Time frame: 24 months' corrected age

Growth restriction

Defined as growth velocity \<15 gram per kilogram bodyweight per day during 4 weeks of treatment

Time frame: Day 29

Time to readiness for discharge

Time until each of the following are fulfilled * sustained weight gain (weight of 1800 g sustained for three days) * ability to maintain normal body temperature * ability to suckle feed * ability to maintain stable cardiorespiratory function

Data from ClinicalTrials.gov

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