Trial reportJournal of pediatric gastroenterology and nutrition2014
rhBSSL improves growth and LCPUFA absorption in preterm infants fed formula or pasteurized breast milk.
Trial report in Journal of pediatric gastroenterology and nutrition, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.
- Pooled it
- Recombinant Bile Salt-Stimulated Lipase in Preterm Infant Feeding: A Randomized Phase 3 Study.PloS one · 2016Trial
- Roles of Milk Fat Globule Membrane on Fat Digestion and Infant Nutrition.Food science of animal resources · 2022Review
- Pre-digestion of the lipids in infant formula affects gut maturation of the preterm pig.PloS one · 2022Article
- The Role of Dietary Fats in the Development and Prevention of Necrotizing Enterocolitis.Nutrients · 2021Review
- Breast Milk: A Source of Functional Compounds with Potential Application in Nutrition and Therapy.Nutrients · 2021Review
- Review
- [Research advances in the effect of bioactive substances in breast milk on the growth and development of infants].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2020Article
- The level of bile salt-stimulated lipase in the milk of Chinese women and its association with maternal BMI.Journal of biomedical research · 2019Article
- Fat composition in infant formula contributes to the severity of necrotising enterocolitis.The British journal of nutrition · 2018Article
- Review concludes that specific recommendations are needed to harmonise the provision of fresh mother's milk to their preterm infants.Acta paediatrica (Oslo, Norway : 1992) · 2018Review
- Bile salt dependent lipase promotes intestinal adaptation in rats with massive small bowel resection.Bioscience reports · 2018Article
- Review
- Purification and characterization of recombinant human bile salt-stimulated lipase expressed in milk of transgenic cloned cows.PloS one · 2017Article
- The Fate of Fat: Pre-Exposure Fat Losses during Nasogastric Tube Feeding in Preterm Newborns.Nutrients · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 7 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesPreterm 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.
methodsTwo 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.
resultsSixty-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.
conclusionsIn 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.