Feeding Tube Practices and Colonization of the Preterm Stomach in the First Week of Life
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02830503|
Recruitment Status : Recruiting
First Posted : July 13, 2016
Last Update Posted : April 11, 2018
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.
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.
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.
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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).
- Concentration (CFU/ml) of bacteria in gastric aspirates [ Time Frame: on day seven of life ]
- 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.
- pH (acidity) of gastric aspirates [ Time Frame: First week of life ]
- 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.
- Concentration (CFU/ml) of bacteria in maternal milk [ Time Frame: First week of life ]Investigate any correlation between maternal milk flora and gastric flora.
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
|Contact: Gorm Greisen, Professoremail@example.com|
|Contact: Sandra M Petersen, MDfirstname.lastname@example.org|
|Department of Neonatology, Rigshospitalet||Recruiting|
|Copenhagen, Denmark, 2100|
|Principal Investigator: Gorm Greisen, MD, DrMedSci|
|Principal Investigator:||Gorm Greisen, Professor||Rigshospitalet, Denmark|