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rhBSSL improves growth and LCPUFA absorption in preterm infants fed formula or pasteurized breast milk
Charlotte Casper1, Virgilio P Carnielli, Jean-Michel Hascoet
1*Unit of Neonatology, Children's Hospital, Paul Sabatier University Toulouse, Toulouse, France †Division of Neonatology, Polytechnic University of Marche and Salesi's Children Hospital, Ancona, Italy ‡Department of Neonatology, Maternite Regionale, Université de Lorraine, Nancy §Department of Neonatology, Assistance Publique Hôpitaux de Paris Necker Hospital, Paris Descartes University, Paris, France ||Division of Neonatology, Department of Pediatrics, Catholic University Sacred Heart, Rome, Italy ¶Swedish Orphan Biovitrum (Sobi), Stockholm #Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.
Insights
Treatment with bile salt-stimulated lipase (BSSL) in preterm infants significantly improved growth velocity and absorption of essential fatty acids. This 7-day intervention was well-tolerated, offering a promising approach for enhancing infant development.
Area of Science:
- Neonatal Nutrition
- Gastroenterology
- Pediatric Development
Background:
- Preterm infants frequently exhibit suboptimal growth, impacting organ development.
- Bile salt-stimulated lipase (BSSL), crucial for fat digestion, is lost during milk pasteurization and absent in infant formulas.
- Restoring BSSL activity may enhance nutrient absorption and growth in vulnerable preterm populations.
Purpose of the Study:
- To evaluate the efficacy of recombinant human BSSL (rhBSSL) in improving growth velocity and fat absorption in preterm infants.
- To assess the safety and tolerability of rhBSSL treatment in this population.
- To investigate the impact of rhBSSL on the absorption of specific fatty acids.
Main Methods:
- Two randomized, double-blind, crossover clinical trials were conducted.
- rhBSSL or placebo was administered for 7 days in pasteurized breast milk or formula.
- Combined data analysis assessed growth velocity and fat absorption in preterm infants.
Main Results:
- rhBSSL treatment significantly increased mean growth velocity by 2.93 g·kg·day (P<0.001).
- The risk of suboptimal growth (<15 g·kg·day) was reduced from 52% to 30% (P=0.004).
- Absorption of docosahexaenoic acid and arachidonic acid increased significantly (P=0.013 and P=0.001, respectively), with no effect on total fat absorption.
Conclusions:
- One week of rhBSSL treatment in preterm infants was well-tolerated and safe.
- rhBSSL significantly improved growth and absorption of key long-chain polyunsaturated fatty acids.
- These findings support rhBSSL as a potential therapeutic agent for improving preterm infant nutrition and development.
Objectives:
Preterm infants often experience suboptimal growth, which can affect organ development. The aim of this study was to improve growth by treatment with bile salt-stimulated lipase (BSSL), naturally present in breast milk, but lost after pasteurization, and absent in formula.
Methods:
Two clinical trials were performed with a predefined analysis of combined data to investigate the effects of recombinant human BSSL (rhBSSL) treatment on growth velocity and fat absorption in preterm infants. The studies were randomized and double-blinded comparing 7-day treatment with rhBSSL and placebo, administered in pasteurized breast milk or formula, using a crossover design.
Results:
Sixty-three infants were evaluated for safety. At randomization, the mean (standard deviation) weight was 1467 (193) g and mean postmenstrual age was 32.6 (0.5) weeks. Sixty and 46 infants were evaluated for growth velocity and fat absorption, respectively. rhBSSL treatment significantly improved mean growth velocity by 2.93 g · kg · day (P<0.001) compared with placebo (mean 16.86 vs 13.93 g · kg · day) and significantly decreased the risk of suboptimal growth (<15 g · kg · day) (30% vs 52%, P=0.004). rhBSSL significantly increased absorption of the long-chain polyunsaturated fatty acids, docosahexaenoic acid, and arachidonic acid by 5.76% (P=0.013) and 8.55% (P=0.001), respectively, but had no significant effect on total fat absorption. The adverse-event profile was similar to placebo.
Conclusions:
In preterm infants fed pasteurized breast milk or formula, 1 week of treatment with rhBSSL was well tolerated and significantly improved growth and long-chain polyunsaturated fatty acid absorption compared to placebo. This publication presents the first data regarding the use of rhBSSL in preterms and the results have led to further clinical studies.
