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Completed

NCT Number: NCT02830503

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

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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Key information

Age range

1 hour–48 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neonatology, Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Feeding tube daily replacement

Procedure

Feeding tubes replaced once a day in the first week of life.

Primary outcomes

  1. Concentration (CFU/ml) of bacteria in gastric aspirates

    Time frame: on day seven of life

Secondary outcomes

  1. Number of patients with potentially pathogenic bacteria at any concentration in gastric aspirates

    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.

  2. pH (acidity) of gastric aspirates

    Time frame: First week of life

  3. Number of patients with probiotics cultured from gastric aspirates aspirates

    Time frame: First week of life

    Determination of whether probiotic bacteria are detectable in the gastric aspirates, and in which concentration.

  4. Concentration (CFU/ml) of bacteria in maternal milk

    Time frame: First week of life

    Investigate any correlation between maternal milk flora and gastric flora.

Sponsors and collaborators

Lead sponsor

Gorm Greisen

Other

Collaborators

  • Statens Serum Institut

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Jul 13, 2016
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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