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

Feeding Tube Practices and Colonization of the Preterm Stomach in the First Week of Life: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Preterm Birth
• Intervention / Treatment: Procedure: Feeding tube daily replacement

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Department of Neonatology, Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 2 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Feeding tube daily replacement	Procedure: Feeding tube daily replacement; Feeding tubes replaced once a day in the first week of life.
No Intervention: Control; Feeding tubes replaced as normal practice in the department (normally once a week).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Concentration (CFU/ml) of bacteria in gastric aspirates	on day seven of life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	day seven of life.
pH (acidity) of gastric aspirates		First week of life
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.	First week of life
Concentration (CFU/ml) of bacteria in maternal milk	Investigate any correlation between maternal milk flora and gastric flora.	First week of life

Collaborators and Investigators

• Sponsor: Gorm Greisen
• Collaborators: Statens Serum Institut
• Investigators: Principal Investigator: Gorm Greisen, Professor, Rigshospitalet, Denmark

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: May 10, 2016
• First Submitted That Met QC Criteria: July 8, 2016
• First Posted (Estimate): July 13, 2016

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: H-15021673

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED