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

Study Overview
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Brief Summary
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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.

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

Conditions
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Preterm Birth

Intervention / Treatment
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* Procedure: Feeding tube daily replacement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 48 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |