Gastric Tube PlacementNCT04127773
Correct Gastric Tube Placement in Very Low Birth Weight Neonates
An observational study of Gastric Tube Placement, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
Gastric tube (GT) placement is a recurrent procedure in VLBW infants due to feeding impairment correlated with low birth weight. Correct GT depth is mandatory to ensure an appropriate and safe enteral feeding: X-ray is the gold standard in order to check GT position, but this cannot be routinely performed due to x-ray… Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Gastric Tube Placement
- What is being tested?
- oro gastric tube
- Type of treatment
- Medical device
- How many people
- 220 participants
- Where
- 1 siteItaly
- Study dates
- 6 Mar 2015to Apr 2020
- Phase
- Observational
- 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 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: VLBW infants
Who may be able to join
- Birth Weight ≤1500 grams (Very Low Birth Weight Infants)
- Need for both umbilical catheter and gastric tube positioning at birth
Who cannot join
- Birth Weight >1500 grams
- Congenital respiratory or gastrointestinal tract malformations (from oral cavity to stomach included)
- Critically unstable preterm infants will be excluded according to nurse or physician evaluation
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Mangiagalli Regina Elena
Milan, 20100
About this study
Official title: Correct Gastric Tube Placement in Very Low Birth Weight Neonates: Comparison of NEX and NEMU Methods
Gastric tube (GT) placement is a recurrent procedure in VLBW infants due to feeding impairment correlated with low birth weight.
Correct GT depth is mandatory to ensure an appropriate and safe enteral feeding: X-ray is the gold standard in order to check GT position, but this cannot be routinely performed due to x-ray exposure risk. Feeding a neonate through a misplaced GT is potentially harmful and may increase morbidity, mortality and hospitalization length.
Nurses estimate GT depth through external measurements. This study aims to identify the most appropriate insertion length predictor for orogastric tube placement in VLBW infants by comparing two different methods.
Read the detailed description
Several methods have been suggested to estimate orogastric tube insertion length, but none of them has been validated in VLBW infants. The most commonly used methods are NEX (Nose-Ear-Xyphoid) and NEMU (Nose-Ear-Mid-Umbilicus) as predictors of nasogastric tube insertion. For the purpose of the present study NEX and NEMU methods were adjusted for orogastric tube placement.
Hence, primary aim of this study is:
To identify the most appropriate insertion length predictor for orogastric tube placement in VLBW infants by comparing NEX and NEMU methods.
Secondary aim is:
- To develop a new mathematical formula, based on the neonate's weight or length, to predict the insertion length of orogastric tube in VLBW infants
- Conditions
- Gastric Tube Placement
- Being tested
- oro gastric tube
- Keywords
- VLBW - Very Low Birth Weight Infant, Gastric tube, Enteral nutrition, Prematurity, Nursing
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oro gastric tubeDevice
According to clinical need, an orogastric tube will be inserted at birth using the group method in VLBW infants in whom an umbilical catheter has been placed. An X-ray chest will be performed according to routine clinical practice to assess the position of the umbilical catheter. On the same X-ray the position of the gastric tube will be assessed by a radiologist blinded to the method used for orogastric tube placement.
| Study group | Role | What they receive |
|---|---|---|
| NEX group | oro gastric tube placement using NEX insertion length predictor Receives: Device: oro gastric tube | |
| NEMU group | oro gastric tube placement using NEMU insertion length predictor Receives: Device: oro gastric tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric tube position
Control on X-ray chest of the gastric tube placement by NEX and NEMU methods
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start6 Mar 2015
- Primary completionApr 2020
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Tube PlacementStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiara Baracetti, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Investigators
- Chiara Baracetti, RN, Principal investigator, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Mangiagalli Regina Elena, Milano (ITALY)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127773
- Sponsor's protocol ID
- GT PLACEMENT IN VLBW
- Status last verified
- Feb 2021
- First submitted
- 14 Jul 2019
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correct Gastric Tube Placement in Very Low Birth Weight Neonates: Comparison of NEX and NEMU Methods
- ClinicalTrials.gov ID
- NCT04127773
- Acronym / sponsor ID
- GT PLACEMENT IN VLBW
- Conditions
- Gastric Tube Placement
- Keywords
- VLBW - Very Low Birth Weight Infant, Gastric tube, Enteral nutrition, Prematurity, Nursing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 6 Mar 2015 (actual)
- Primary completion
- Apr 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 16 Oct 2019 (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.
Gastric tube (GT) placement is a recurrent procedure in VLBW infants due to feeding impairment correlated with low birth weight.
Correct GT depth is mandatory to ensure an appropriate and safe enteral feeding: X-ray is the gold standard in order to check GT position, but this cannot be routinely performed due to x-ray exposure risk. Feeding a neonate through a misplaced GT is potentially harmful and may increase morbidity, mortality and hospitalization length.
Nurses estimate GT depth through external measurements. This study aims to identify the most appropriate insertion length predictor for orogastric tube placement in VLBW infants by comparing two different methods.
Detailed description
Several methods have been suggested to estimate orogastric tube insertion length, but none of them has been validated in VLBW infants. The most commonly used methods are NEX (Nose-Ear-Xyphoid) and NEMU (Nose-Ear-Mid-Umbilicus) as predictors of nasogastric tube insertion. For the purpose of the present study NEX and NEMU methods were adjusted for orogastric tube placement.
Hence, primary aim of this study is:
To identify the most appropriate insertion length predictor for orogastric tube placement in VLBW infants by comparing NEX and NEMU methods.
Secondary aim is:
- To develop a new mathematical formula, based on the neonate's weight or length, to predict the insertion length of orogastric tube in VLBW infants
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NEX group | – | Device: oro gastric tubeoro gastric tube placement using NEX insertion length predictor |
| NEMU group | – | Device: oro gastric tubeoro gastric tube placement using NEMU insertion length predictor |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- VLBW infants
Key inclusion criteria (2 listed)
- Birth Weight ≤1500 grams (Very Low Birth Weight Infants)
- Need for both umbilical catheter and gastric tube positioning at birth
Key exclusion criteria (3 listed)
- Birth Weight >1500 grams
- Congenital respiratory or gastrointestinal tract malformations (from oral cavity to stomach included)
- Critically unstable preterm infants will be excluded according to nurse or physician evaluation
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 |
|---|---|---|
| oro gastric tubeAccording to clinical need, an orogastric tube will be inserted at birth using the group method in VLBW infants in whom an umbilical catheter has been placed. An X-ray chest will be performed according to routine clinical practice to assess the position of the umbilical catheter. On the same X-ray the position of the gastric tube will be assessed by a radiologist blinded to the method used for orogastric tube placement. | Device | NEMU group, NEX group |
Primary outcome
Gastric tube position
Time frame: within 24 hours
Control on X-ray chest of the gastric tube placement by NEX and NEMU methods
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 15 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Chiara Baracetti, RN principal investigator
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Mangiagalli Regina Elena, Milano (ITALY)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Tube Placement, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 2 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 15 Feb 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 Italy. 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?
Gastric tube position (time frame: within 24 hours). 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 15 Feb 2021.