Enteral FeedingBABAFIXNCT04233333
Fixation of the Orogastric Tube: Which Method for the Newborn ?
A study testing method of fixation of the orogastric tube in people with Enteral Feeding and Gastric Emptying, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
Trial summary
It is recommended to respect the perioral zone by fixing the feeding tube only on the newborn's cheek, in order to promote oral acquisition and avoid repeated dislodgment of probes (HAS). This rule is easily applicable for nasogastric tubes. The difficulty is found for orogastric tubes. Read more about this study
- Who is it for?
- Ages Up to 2 months
- Conditions the study is for
- Enteral Feeding, Gastric Emptying
- What is being tested?
- method of fixation of the orogastric tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 12 Feb 2020to Mar 2022
- 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 Up to 2 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns admitted to neonatal intensive care unit
- Express consent of the holders of parental authority
- Orogastric tube indication (enteral feeding, digestive aspiration)
Who cannot join
- Newborns over 2 months of age corrected
- Indication of nasogastric tube
- Port of gastrostomy
- Pathology resulting in hypersalivation or hyper sweating
- Swallowing disorder
- Genetic disease
Show all 12Show fewer
- Severe neurological impairment
- Cleft lip and / or palate
- Other malformation in the oral sphere or perioral area
- Sedation with morphine analgesics
- Anticonvulsant treatment
- Palliative care
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de la Réunion
Saint-Pierre, 97448
Lucie AUZANNEAU
Sylvie PAYET
About this study
It is recommended to respect the perioral zone by fixing the feeding tube only on the newborn's cheek, in order to promote oral acquisition and avoid repeated dislodgment of probes (HAS). This rule is easily applicable for nasogastric tubes. The difficulty is found for orogastric tubes. The "mustache" is usually used to fix it, but this interferes with the perioral zone and must be changed more often than necessary.
To achieve a more sustainable orogastric tube's fixation to the cheek, a German team directed by W. Krämer developed and tested an orogastric tube's fixing technique that was subsequently approved and used.
Read more
Using this German method, a randomized, monocentric superiority study, including 30 newborns and premature babies requiring an orogastric tube, will compared german probe's fixation method to the mustache.
The aim of the study is to ensure a more effective orogastric tube's fixation to reduce the number of fixation changes, probe placements and negative oral stimulations in newborns.
- Conditions
- Enteral Feeding, Gastric Emptying
- Being tested
- method of fixation of the orogastric tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
method of fixation of the orogastric tubeDevice
Methods of fixation of the orogastric tube will be randomized
| Study group | Role | What they receive |
|---|---|---|
| mustache fixation | Active comparator | Not described Receives: Device: method of fixation of the orogastric tube |
| W.K fixation | Experimental | Not described Receives: Device: method of fixation of the orogastric tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average duration of holding the fixation
Measured: 7 days
Secondary outcomes (1)
Number of tube's dislodgements
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start12 Feb 2020
- Primary completion11 Feb 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral FeedingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233333
- Sponsor's protocol ID
- 2017/CHU/08
- Acronym
- BABAFIX
- Status last verified
- Apr 2021
- First submitted
- 15 Jan 2020
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fixation of the Orogastric Tube: Which Method for the Newborn ?
- ClinicalTrials.gov ID
- NCT04233333
- Acronym / sponsor ID
- BABAFIX / 2017/CHU/08
- Conditions
- Enteral Feeding, Gastric Emptying
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 11 Feb 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 18 Jan 2020 (actual)
- 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.
It is recommended to respect the perioral zone by fixing the feeding tube only on the newborn's cheek, in order to promote oral acquisition and avoid repeated dislodgment of probes (HAS). This rule is easily applicable for nasogastric tubes. The difficulty is found for orogastric tubes. The "mustache" is usually used to fix it, but this interferes with the perioral zone and must be changed more often than necessary.
To achieve a more sustainable orogastric tube's fixation to the cheek, a German team directed by W. Krämer developed and tested an orogastric tube's fixing technique that was subsequently approved and used.
Using this German method, a randomized, monocentric superiority study, including 30 newborns and premature babies requiring an orogastric tube, will compared german probe's fixation method to the mustache.
The aim of the study is to ensure a more effective orogastric tube's fixation to reduce the number of fixation changes, probe placements and negative oral stimulations in newborns.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mustache fixation | Active comparator | Device: method of fixation of the orogastric tube |
| W.K fixation | Experimental | Device: method of fixation of the orogastric tube |
Who may qualify
- Ages
- Up to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Newborns admitted to neonatal intensive care unit
- Express consent of the holders of parental authority
- Orogastric tube indication (enteral feeding, digestive aspiration)
Key exclusion criteria (12 listed)
- Newborns over 2 months of age corrected
- Indication of nasogastric tube
- Port of gastrostomy
- Pathology resulting in hypersalivation or hyper sweating
- Swallowing disorder
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 |
|---|---|---|
| method of fixation of the orogastric tubeMethods of fixation of the orogastric tube will be randomized | Device | W.K fixation, mustache fixation |
Primary outcome
Average duration of holding the fixation
Time frame: 7 days
1 secondary outcome
Number of tube's dislodgements
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing method of fixation of the orogastric tube in people with Enteral Feeding and Gastric Emptying, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
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 12 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: status not confirmed, as of the sponsor's last update on 5 Apr 2021. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucie AUZANNEAU ((0)262 35 99 49 ext. +262, lucie.auzanneau@chu-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average duration of holding the fixation (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.