Department of Neonatology, Rigshospitalet
Copenhagen, 2100, Denmark
NCT Number: NCT02830503
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.
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Notify Me1 hour–48 hour
All sexes
Interventional
Not applicable
Copenhagen, 2100, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Feeding tubes replaced once a day in the first week of life.
Time frame: on day seven of life
Time frame: 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.
Time frame: First week of life
Time frame: First week of life
Determination of whether probiotic bacteria are detectable in the gastric aspirates, and in which concentration.
Time frame: First week of life
Investigate any correlation between maternal milk flora and gastric flora.
Gorm Greisen
Other
Feeding Tube Practices and Colonization of the Preterm Stomach in the First Week of Life: A Randomized Controlled Trial
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