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

Not Applicable

Completed

• Conditions: Preterm Birth
• Interventions: Procedure: Feeding tube daily replacement

• Registration Number: NCT02830503
• Lead Sponsor: Gorm Greisen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-10
• Study Start: 2016-06
• Study First Submitted QC: 2016-07-08
• Study First Posted: 2016-07-13
• Primary Completion: 2019-06
• Study Completion: 2020-07
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-15
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Feeding tube daily replacement	Feeding tube daily replacement

Primary Outcome Measures

Name	Time	Method
Concentration (CFU/ml) of bacteria in gastric aspirates	on day seven of life

Secondary Outcome Measures

Name	Time	Method
Number of patients with potentially pathogenic bacteria at any concentration in gastric aspirates	day seven of life.	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	First week of life
Concentration (CFU/ml) of bacteria in maternal milk	First week of life	Investigate any correlation between maternal milk flora and gastric flora.
Number of patients with probiotics cultured from gastric aspirates aspirates	First week of life	Determination of whether probiotic bacteria are detectable in the gastric aspirates, and in which concentration.

Trial Locations

Locations (1)

Department of Neonatology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark