Microbiome Establishment in Preterm Infants
PIMENTO
Preterm Infants: Microbiome Establishment, Neuro Cross-talk, and Origins
PIMENTO
Preterm Infants: Microbiome Establishment, Neuro Cross-talk, and Origins
Sponsor study identifier
observational
91
1 country
1
Study Start
April 7, 2021
Actual (reported)Primary Completion
December 31, 2022
Actual (reported)Study Completion
January 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Our bodies are home to millions and millions of microbes (bacteria, fungi and viruses), that live in harmony with us without producing any negative (disease producing) effects. Research is beginning to show that these microbes interact with us to help with our immune system, digestive tract and brain development among many other effects. This community of microbes, known collectively as our microbiome, may commence colonisation while we are developing in the womb and becomes quickly established after we are born. Much remains unknown about how preterm birth affects the development of our microbiome. The goal of this longitudinal observational study is to gather more information of how and from where we get those first few microbes, the pattern in which our microbiome develops, and how intensive care for a preterm baby affects this. The main questions it aims to answer are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 7, 2021
Actual (reported)December 31, 2022
Actual (reported)March 13, 2023
Actual (reported)April 7, 2023
Actual (reported)January 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Longitudinal microbiome development
Changes in community structure of gut microbiome in preterm infants during stay in the neonatal unit
Birth to discharge from neonatal unit (up to 20 weeks of age)
The effect of respiratory support on microbiome development in preterm infants
Comparison of microbiome successional colonisation in infants requiring varying degrees of initial respiratory support.
Birth to discharge from neonatal unit (up to 20 weeks of age)
Probiotic colonisation and persistence
Evaluation of probiotic strains in the gut microbiome using next generation sequencing during probiotic commencement, colonisation and persistence after
Birth to discharge from neonatal unit (up to 20 weeks of age)
Breastmilk Microbiome
Birth to discharge from neonatal unit (up to 20 weeks of age)
Infants admitted to the neonatal intensive care unit at Cork University Maternity Hospital, Ireland .
Cork University Maternity Hospital
Cork, T12 DC4A, Ireland
Hill CJ, Lynch DB, Murphy K, Ulaszewska M, Jeffery IB, O'Shea CA, Watkins C, Dempsey E, Mattivi F, Tuohy K, Ross RP, Ryan CA, O' Toole PW, Stanton C. Evolution of gut microbiota composition from birth to 24 weeks in the INFANTMET Cohort. Microbiome. 2017 Jan 17;5(1):4. doi: 10.1186/s40168-016-0213-y.
Shao Y, Forster SC, Tsaliki E, Vervier K, Strang A, Simpson N, Kumar N, Stares MD, Rodger A, Brocklehurst P, Field N, Lawley TD. Stunted microbiota and opportunistic pathogen colonization in caesarean-section birth. Nature. 2019 Oct;574(7776):117-121. doi: 10.1038/s41586-019-1560-1. Epub 2019 Sep 18.
Stool, Urine, Blood, breastmilk, oral swabs, skins swabs, vaginal swabs
Eugene Dempsey
University College Cork
91 participants (actual enrollment reported by the registry).
First Submitted
March 13, 2023
First Posted
April 7, 2023
Study Start
April 7, 2021
Actual (reported)Probiotics and Intestinal Microbiome in Preterm Infants
Contact the study team to confirm eligibility.
Fouhy F, Guinane CM, Hussey S, Wall R, Ryan CA, Dempsey EM, Murphy B, Ross RP, Fitzgerald GF, Stanton C, Cotter PD. High-throughput sequencing reveals the incomplete, short-term recovery of infant gut microbiota following parenteral antibiotic treatment with ampicillin and gentamicin. Antimicrob Agents Chemother. 2012 Nov;56(11):5811-20. doi: 10.1128/AAC.00789-12. Epub 2012 Sep 4.
Lyons KE, Ryan CA, Dempsey EM, Ross RP, Stanton C. Breast Milk, a Source of Beneficial Microbes and Associated Benefits for Infant Health. Nutrients. 2020 Apr 9;12(4):1039. doi: 10.3390/nu12041039.
Herrmann K, Carroll K. An exclusively human milk diet reduces necrotizing enterocolitis. Breastfeed Med. 2014 May;9(4):184-90. doi: 10.1089/bfm.2013.0121. Epub 2014 Mar 3.
Healy D, Wang S, Grimaud G, Warda AK, Ross P, Stanton C, Dempsey EM. Longitudinal observational study protocol - Preterm Infants: Microbiome Establishment, Neuro-CrossTalk and Origins (PIMENTO). BMJ Open. 2023 Sep 25;13(9):e075060. doi: 10.1136/bmjopen-2023-075060.
Primary Completion
December 31, 2022
Actual (reported)Study Completion
January 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 7, 2023
Record last verified: 2023-03
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