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Feeding Tube Practices and Colonization of the Preterm Stomach in the First Week of Life

Primary Purpose

Preterm Birth

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Feeding tube daily replacement
Sponsored by
Gorm Greisen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth

Eligibility Criteria

1 Hour - 48 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Under 32 weeks GA at birth
  • Admission time considered to be more than seven days
  • Signed informed consent within 48 hours after birth

Exclusion Criteria:

  • Transfer to another hospital within seven days
  • Major gastrointestinal malformations
  • No tube feeding within first 48 h of birth

Sites / Locations

  • Department of Neonatology, Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Feeding tube daily replacement

Feeding tubes replaced as normal practice in the department (normally once a week).

Outcomes

Primary Outcome Measures

Concentration (CFU/ml) of bacteria in gastric aspirates

Secondary Outcome Measures

Number of patients with potentially pathogenic bacteria at any concentration in gastric aspirates
Qualitative differences between bacteria found in the gastric aspirates of intervention and control group. Potentially pathogenic bacteria= Enterobacteriaceae and S. aureus.
pH (acidity) of gastric aspirates
Number of patients with probiotics cultured from gastric aspirates aspirates
Determination of whether probiotic bacteria are detectable in the gastric aspirates, and in which concentration.
Concentration (CFU/ml) of bacteria in maternal milk
Investigate any correlation between maternal milk flora and gastric flora.

Full Information

First Posted
May 10, 2016
Last Updated
September 15, 2020
Sponsor
Gorm Greisen
Collaborators
Statens Serum Institut
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1. Study Identification

Unique Protocol Identification Number
NCT02830503
Brief Title
Feeding Tube Practices and Colonization of the Preterm Stomach in the First Week of Life
Official Title
Feeding Tube Practices and Colonization of the Preterm Stomach in the First Week of Life: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
July 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gorm Greisen
Collaborators
Statens Serum Institut

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Project summary 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Feeding tube daily replacement
Arm Title
Control
Arm Type
No Intervention
Arm Description
Feeding tubes replaced as normal practice in the department (normally once a week).
Intervention Type
Procedure
Intervention Name(s)
Feeding tube daily replacement
Intervention Description
Feeding tubes replaced once a day in the first week of life.
Primary Outcome Measure Information:
Title
Concentration (CFU/ml) of bacteria in gastric aspirates
Time Frame
on day seven of life
Secondary Outcome Measure Information:
Title
Number of patients with potentially pathogenic bacteria at any concentration in gastric aspirates
Description
Qualitative differences between bacteria found in the gastric aspirates of intervention and control group. Potentially pathogenic bacteria= Enterobacteriaceae and S. aureus.
Time Frame
day seven of life.
Title
pH (acidity) of gastric aspirates
Time Frame
First week of life
Title
Number of patients with probiotics cultured from gastric aspirates aspirates
Description
Determination of whether probiotic bacteria are detectable in the gastric aspirates, and in which concentration.
Time Frame
First week of life
Title
Concentration (CFU/ml) of bacteria in maternal milk
Description
Investigate any correlation between maternal milk flora and gastric flora.
Time Frame
First week of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
48 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Under 32 weeks GA at birth Admission time considered to be more than seven days Signed informed consent within 48 hours after birth Exclusion Criteria: Transfer to another hospital within seven days Major gastrointestinal malformations No tube feeding within first 48 h of birth
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gorm Greisen, Professor
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neonatology, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35959833
Citation
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.
Results Reference
derived

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Feeding Tube Practices and Colonization of the Preterm Stomach in the First Week of Life

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