Feeding Tube Practices and Colonization of the Preterm Stomach in the First Week of Life
NCT ID: NCT02830503
Last Updated: 2020-09-16
Study Results
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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COMPLETED
NA
23 participants
INTERVENTIONAL
2016-06-30
2020-07-31
Brief Summary
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Rationale
Many NICU's replace their feeding tubes once a week or more rarely in order to avoid disturbing the infants. The researchers discovered that there are high concentrations of potentially pathogenic bacteria in the yield of resident nasogastric feeding tubes, even within one day of use (own data, manuscript submitted). Preterm infants are vulnerable to the colonization of the gut, and development of dysbiosis might lead to necrotizing enterocolitis. The researchers speculate if replacing the resident feeding tube every day and thereby decreasing the amount of potentially pathogenic bacteria given to the infants via the feeding tube will lead to fewer bacteria present in the upper part of the gastrointestinal tract of the infant and hence a reduced competition with probiotic colonization.
Objectives
The investigators plan to conduct an intervention study in premature infants receiving probiotics (\< 32 weeks of gestation) where the feeding tube will be replaced every day in the intervention group and once a week (standard practice) in the control group. The main outcome will be bacterial concentration in the stomach after one week of life.
Methods
The study is a prospective, randomized controlled trial in preterm infants. Infants will be randomized to the intervention group in which the tube is replaced every day or the control group which will follow normal practice in the department. The intervention will last one week. The infants will be followed until discharge. The investigators plan to include 11 infants in each group.
Primary outcome
Concentration of bacteria in gastric aspirates on day seven.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention
Feeding tube daily replacement
Feeding tube daily replacement
Feeding tubes replaced once a day in the first week of life.
Control
Feeding tubes replaced as normal practice in the department (normally once a week).
No interventions assigned to this group
Interventions
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Feeding tube daily replacement
Feeding tubes replaced once a day in the first week of life.
Eligibility Criteria
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Inclusion Criteria
* Admission time considered to be more than seven days
* Signed informed consent within 48 hours after birth
Exclusion Criteria
* Major gastrointestinal malformations
* No tube feeding within first 48 h of birth
1 Hour
48 Hours
ALL
No
Sponsors
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Statens Serum Institut
OTHER
Gorm Greisen
OTHER
Responsible Party
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Gorm Greisen
Professor
Principal Investigators
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Gorm Greisen, Professor
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Department of Neonatology, Rigshospitalet
Copenhagen, , Denmark
Countries
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References
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Munkstrup C, Krogfelt KA, Greisen G, Juhl SM. Feeding tube practices and the colonisation of the preterm stomach in the first week of life. Dan Med J. 2022 Jul 13;69(8):A06210494.
Other Identifiers
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H-15021673
Identifier Type: -
Identifier Source: org_study_id
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