ArticlePilot and feasibility studies2018
Prophylaxis of acute respiratory infections via improving the immune system in late preterm newborns with
Article in Pilot and feasibility studies, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01540162 (Open-labelled, Controlled, Parallel Group Study to Assess the Efficacy and Safety of MUTAFLOR in 3 Weeks Treatment for Immunity Improvement in Preterm Infants With 1 Year Follow-up Period), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.
What it found
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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.
Open-labelled, Controlled, Parallel Group Study to Assess the Efficacy and Safety of MUTAFLOR in 3 Weeks Treatment for Immunity Improvement in Preterm Infants With 1 Year Follow-up Period
Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.
- Probiotics for preventing acute upper respiratory tract infections.The Cochrane database of systematic reviews · 2022Pooled it
- The Effectiveness of Heat-KilledNutrients · 2024Trial
- Potential Benefit of Probiotic E. Coli Nissle in Term Neonates.Klinische Padiatrie · 2023Trial
- Oral Immunization withBiomolecules · 2023Article
- Next-Generation Probiotics for Inflammatory Bowel Disease.International journal of molecular sciences · 2022Review
- Probiotics, Their Extracellular Vesicles and Infectious Diseases.Frontiers in microbiology · 2022Review
- Effects of neonatal nutrition interventions on neonatal mortality and child health and development outcomes: A systematic review.Campbell systematic reviews · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAcute respiratory infections (ARIs), caused by the high level of immaturity of the immune system, are a major cause of morbidity in preterm newborns. The probiotic
methodsRight after birth, 62 late preterm newborns were included into an open-labeled, controlled 4-week trial with two parallel groups and a follow-up phase until the age of 1 year. All children of the treatment group received an EcN suspension orally for 3 weeks, whereas the control group was only observed. Primary efficacy variable was the number of participants with at least one ARI during the first 28 days of life. Secondary efficacy variables were the number of ARIs and the number and duration of hospitalizations caused by ARIs during the first year of life.
resultsThe number of participants with at least one ARI during the first 28 days of life was significantly lower in the group treated with EcN compared to that in the control group. Although only of exploratory nature, analyses of secondary efficacy variables suggest that EcN treatment may also reduce the average number of ARIs, the average number of hospitalizations caused by ARIs, and the mean duration of such hospitalizations. There is also some evidence that early EcN treatment may have long-term benefits on newborns' health status.
conclusionThe present pilot trial provides first evidence that EcN is able to reduce the incidence of ARIs in the neonatal period of late preterm newborns. Additionally, EcN is characterized by an excellent individual biocompatibility in the absence of adverse drug reactions. Limitations of the current trial are discussed and recommendations for future confirmatory studies are made.
trial registrationClinicalTrials.gov identifier: NCT01540162; retrospectively registered on 16 February 2012.
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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.