NCT02830503

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Gorm Greisen · Academic / Other
• Sex: All
• Age: 1 Hour – 48 Hours
• Healthy volunteers: Not accepted

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.

Conditions

• Preterm Birth

Interventions

Type	Name	Description
PROCEDURE	Feeding tube daily replacement	Feeding tubes replaced once a day in the first week of life.

Timeline

• Start date: 2016-06-01
• Primary completion: 2019-06-01
• Completion: 2020-07-01
• First posted: 2016-07-13
• Last updated: 2020-09-16

Locations

1 site across 1 country: Denmark