The Influence of Infant Feeding Type on Preterm Infant's Intestinal Microbiome

NCT ID: NCT04972214

Last Updated: 2021-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-17

Study Completion Date

2023-02-28

Brief Summary

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This study aims to examine the factors associated with preterm infant's intestinal microbiota depending on feeding type (breast milk or preterm formula)

Detailed Description

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The gut microbiome has been increasingly found to affect human health. Feeding plays an important role in determining the composition and diversity of the neonatal gut microbiome. Preterm infants are at a high risk of gut microbiota disruption and dysbiosis because of physiological immaturity and environmental factors. In preterm infants, breast milk has been associated with improved growth and cognitive development and a reduced risk of necrotizing enterocolitis and late onset sepsis.

The objective of study is to determine the impact of feeding type on gut microbiome of very preterm infants admitted in a neonatal intensive care unit (NICU). Meconium and the additional 2 fecal samples will be collected from preterm infants. Fecal samples will be collected every 14 days, during 28 days, from diapers into sterile tubes. DNA will be extracted from fecal samples and different bacterial genus and species will be analyzed.

The type of infant feeding (breast milk or preterm formula) is recorded daily to classify the type of infant feeding received during the 14 days prior to each fecal sample collection.

Conditions

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Microbial Colonization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Very Preterm Infants

preterm infants were born at gestational age of less than 32 weeks

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

\- Very preterm infants (\< 32 weeks gestational age) admitted in the NICU of CHA Bundang Medical Center within the first 24 hours after birth

Exclusion Criteria

* Parents refuse to participate/sign informed consent
* Major congenital anomalies
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHA University

OTHER

Sponsor Role lead

Responsible Party

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Hye-Rim Kim

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hye-Rim Kim, MD

Role: PRINCIPAL_INVESTIGATOR

CHA Bundang Medical Center

Locations

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CHA Bundang Medical center

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hye-Rim Kim, MD

Role: CONTACT

82-10-3676-7097

Facility Contacts

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Hye-Rim Kim

Role: primary

82-10-3676-7097

Other Identifiers

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2021-03-062-004

Identifier Type: -

Identifier Source: org_study_id

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