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

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02830503
• Other study ID #: H-15021673
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: July 2020

Study information

• Verified date: September 2020
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 2020
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 48 Hours

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Procedure:
• Feeding tube daily replacement
Feeding tubes replaced once a day in the first week of life.

Locations

Country	Name	City	State
Denmark	Department of Neonatology, Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Gorm Greisen	Statens Serum Institut

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration (CFU/ml) of bacteria in gastric aspirates		on day seven of life
Secondary	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.
Secondary	pH (acidity) of gastric aspirates		First week of life
Secondary	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
Secondary	Concentration (CFU/ml) of bacteria in maternal milk	Investigate any correlation between maternal milk flora and gastric flora.	First week of life