Preterm BirthNCT02830503
Feeding Tube Practices and Colonization of the Preterm Stomach in the First Week of Life
A study testing Feeding tube daily replacement in people with Preterm Birth, run by Gorm Greisen at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 1 hour to 48 hours
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Feeding tube daily replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2016to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Under 32 weeks GA at birth
- Admission time considered to be more than seven days
- Signed informed consent within 48 hours after birth
Who cannot join
- Transfer to another hospital within seven days
- Major gastrointestinal malformations
- No tube feeding within first 48 h of birth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feeding Tube Practices and Colonization of the Preterm Stomach in the First Week of Life: A Randomized Controlled Trial
Project summary
Rationale
Read more
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
- Being tested
- Feeding tube daily replacement
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feeding tube daily replacementProcedure or surgery
Feeding tubes replaced once a day in the first week of life.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Feeding tube daily replacement Receives: Procedure: Feeding tube daily replacement |
| Control | No intervention | Feeding tubes replaced as normal practice in the department (normally once a week). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration (CFU/ml) of bacteria in gastric aspirates
Measured: on day seven of life
Secondary outcomes (4)
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.
Measured: day seven of life.
pH (acidity) of gastric aspirates
Measured: First week of life
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.
Measured: First week of life
Concentration (CFU/ml) of bacteria in maternal milk
Investigate any correlation between maternal milk flora and gastric flora.
Measured: First week of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2019
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gorm Greisen
- Sponsor type
- University, hospital or other
- Collaborators
- Statens Serum Institut
- Responsible party
- Sponsor-investigator, Gorm Greisen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Gorm Greisen, Professor, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830503
- Sponsor's protocol ID
- H-15021673
- Status last verified
- Sep 2020
- First submitted
- 10 May 2016
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35959833
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feeding Tube Practices and Colonization of the Preterm Stomach in the First Week of Life: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02830503
- Acronym / sponsor ID
- H-15021673
- Conditions
- Preterm Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Gorm GreisenUniversity, hospital or other
- Collaborators
- Statens Serum Institut
- Study start
- Jun 2016
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 13 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Feeding tube daily replacementFeeding tube daily replacement |
| Control | No intervention | –Feeding tubes replaced as normal practice in the department (normally once a week). |
Who may qualify
- Ages
- 1 hour to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Under 32 weeks GA at birth
- Admission time considered to be more than seven days
- Signed informed consent within 48 hours after birth
Key exclusion criteria (3 listed)
- Transfer to another hospital within seven days
- Major gastrointestinal malformations
- No tube feeding within first 48 h of birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feeding tube daily replacementFeeding tubes replaced once a day in the first week of life. | Procedure or surgery | Intervention |
Primary outcome
Concentration (CFU/ml) of bacteria in gastric aspirates
Time frame: on day seven of life
4 secondary outcomes
Number of patients with potentially pathogenic bacteria at any concentration in gastric aspirates
Time frame: day seven of life.
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
Concentration (CFU/ml) of bacteria in maternal milk
Time frame: First week of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Derived from this study: PubMed 35959833Munkstrup 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gorm Greisen, Professor principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feeding tube daily replacement in people with Preterm Birth, run by Gorm Greisen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration (CFU/ml) of bacteria in gastric aspirates (time frame: on day seven of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02830503, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.