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

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ClinicalTrials.gov Identifier: NCT02830503
Recruitment Status : Recruiting
First Posted : July 13, 2016
Last Update Posted : April 11, 2018
Sponsor:
Collaborator:
Statens Serum Institut
Information provided by (Responsible Party):
Gorm Greisen, Rigshospitalet, Denmark

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.


Condition or disease Intervention/treatment Phase
Preterm Birth Procedure: Feeding tube daily replacement Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Feeding Tube Practices and Colonization of the Preterm Stomach in the First Week of Life: A Randomized Controlled Trial
Study Start Date : June 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Experimental: Intervention
Feeding tube daily replacement
Procedure: Feeding tube daily replacement
Feeding tubes replaced once a day in the first week of life.

No Intervention: Control
Feeding tubes replaced as normal practice in the department (normally once a week).



Primary Outcome Measures :
  1. Concentration (CFU/ml) of bacteria in gastric aspirates [ Time Frame: on day seven of life ]

Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830503


Contacts
Contact: Gorm Greisen, Professor 35455023 ggreisen@regionh.dk
Contact: Sandra M Petersen, MD +4526703936 sandrameinich@gmail.com

Locations
Denmark
Department of Neonatology, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Principal Investigator: Gorm Greisen, MD, DrMedSci         
Sponsors and Collaborators
Gorm Greisen
Statens Serum Institut
Investigators
Principal Investigator: Gorm Greisen, Professor Rigshospitalet, Denmark

Responsible Party: Gorm Greisen, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02830503     History of Changes
Other Study ID Numbers: H-15021673
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications