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

NCT02830503 | Completed

• 1 other identifier: H-15021673
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Concentration (CFU/ml) of bacteria in gastric aspirates

  on day seven of life

Secondary Outcomes (4)

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

  day seven of life.

• pH (acidity) of gastric aspirates

  First week of life

• Number of patients with probiotics cultured from gastric aspirates aspirates

  First week of life

• Concentration (CFU/ml) of bacteria in maternal milk

  First week of life

Study Arms (2)

Intervention

EXPERIMENTAL

Feeding tube daily replacement

Procedure: Feeding tube daily replacement

Control

NO INTERVENTION

Feeding tubes replaced as normal practice in the department (normally once a week).

Interventions

Feeding tube daily replacement PROCEDURE

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

Intervention

Eligibility Criteria

• Age: 1 Hour - 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Under 32 weeks GA at birth
• Admission time considered to be more than seven days
• Signed informed consent within 48 hours after birth

You may not qualify if:

• Transfer to another hospital within seven days
• Major gastrointestinal malformations
• No tube feeding within first 48 h of birth

Sponsors & Collaborators

• Gorm Greisen: lead
• Statens Serum Institut: collaborator

Study Sites (1)

Department of Neonatology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Munkstrup C, Krogfelt KA, Greisen G, Juhl SM. Feeding tube practices and the colonisation of the preterm stomach in the first week of life. Dan Med J. 2022 Jul 13;69(8):A06210494.

  PMID: 35959833 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Gorm Greisen, Professor

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: July 13, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: July 1, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

DK (1)