Phase III Study of rhBSSL vs Placebo in preterm infants V1

• Research type

  Research Study

• Full title

  A Prospective, Randomised, Double-Blind, Phase 3 Study Comparing rhBSSL and Placebo Added to Infant Formula or Pasteurised Breast Milk During 4 Weeks of Treatment in Preterm Infants Born Before Week 32 of Gestational Age.

• IRAS ID

  78177

• Contact name

  Nicholas Embleton

• Sponsor organisation

  Swedish Orphan Biovitrum AB 9publ)

• Eudract number

  2010-023909-35

• Research summary

  Preterm infants are at risk of poor growth. Good nutrition aims to meet their growth and nutrient retention, and optimise outcome. Despite this, growth is often inadequate despite use of parenteral nutrition (intravenous feeding) and enteral feeding (via gastric tube). Poor early growth is associated with worse neuro-developmental outcome. Preterm infants who show catch up growth in their first year are more likely to have better health, growth, & development in childhood.The secretion of digestive enzymes from the pancreas is not fully developed in preterm infants. Many different lipases (digestive enzymes) are secreted by the pancreas and act together to breakdown fats and make them easier to absorb. One of the lipases is known as bile-salt-stimulated lipase (BSSL). In preterm infants, pancreatic lipases are low compared to term babies. BSSL is secreted in breast milk. BSSL is inactivated in pasteurized breast milk and not present in infant milk formulas. It improves fat absorption of substances needed for the developing brain and eye, and growth.A recombinant human BSSL (rhBSSL) is being developed for addition to preterm infant formula or pasteurized breast milk. Two studies of rhBSSL have been conducted in 63 preterm infants and have shown rhBSSL to be safe and well-tolerated.This is a phase 3 randomised, double-blind study to determine the efficacy (improved growth) of rhBSSL and to compare the safety and tolerability of rhBSSL compared to placebo treatment.Approximately 432 patients will be enrolled into the study.There will be a 4 week treatment period followed by a 12-month follow up. Study procedures include physical examination, blood & fecal (stool) testing, body weight, measurement of length and head circumference, blood pressure, heart rate & temperature. Swedish Orphan Biovitrum AB is the sponsor of this clinical trial.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  11/AL/0223

• Date of REC Opinion

  24 Jun 2011

• REC opinion

  Further Information Favourable Opinion