Neonatal DisorderNCT04271995
Gastric Lipase Enhanced Nasogastric Tube Study in Neonates
An observational study of Neonatal Disorder, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The newborn infants who are sick and those who are born prior to due date (preterm) are admitted to the neonatal unit. These babies are unable to feed through their mouth, so a special tube is passed through their nose to the stomach, nasogastric (NG) tube) to provide milk feeds. Read more about this study
- Who is it for?
- Ages 1 day to 3 months
- Conditions the study is for
- Neonatal Disorder
- How many people
- 233 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Mar 2020to 30 Dec 2021
- 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 1 day to 3 months
- All sexes
- No healthy volunteers
- Child
Study population: All infants admitted to the neonatal unit requiring insertion of nasogastric tube
Who may be able to join
- All infants (preterm and term) who require the insertion of nasogastric tubes for supplementary enteral feeding as part of their routine clinical management
Who cannot join
- Clinically unstable, critically ill infants
- Infants undergoing palliative care
- Infants with bowel conditions such as necrotising enterocolitis, bowel obstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Diagnostic Accuracy Study Evaluating Point of Care Gastric Lipase Enhanced pH Test Strip to Confirm Correct Nasogastric Tube Position in Newborn Infant
The newborn infants who are sick and those who are born prior to due date (preterm) are admitted to the neonatal unit. These babies are unable to feed through their mouth, so a special tube is passed through their nose to the stomach, nasogastric (NG) tube) to provide milk feeds. The bedside nurse inserts the tube and then aspirate some of the fluid from the stomach. As the stomach normally produce acid, these aspirate is then tested on a colour coded paper strip to check if the fluid is acidic. However, on many occasions this test is not very clear. This could be due to misplacement of the tube or the stomach in a newborn not being able to produce enough acid. This then leads to re-siting of another tube and following the same procedure. Sometimes the clinical team may like to do an X Ray to check the position of the tube resulting in unnecessary exposure to radiation. The study will use a special chemical added to the currently existing paper test strip which the investigators believe will enhance the capability of detecting the correct position of the NG tube. This idea has been tested in adults and found to have increased the sensitivity of the test strip significantly. Based on the adult study the study will require to test 233 babies to see if this increases the sensitivity of correct NG tube placement. Parents of all babies who requires an NG tube for milk feeds will be approached and after appropriate consent could be recruited to the study. Babies who are clinically very unstable, moribund and those with diagnosis of bowel obstruction will be excluded from the study.
Read the detailed description
STUDY OBJECTIVES
Primary Objective:
- To determine the sensitivity of the chemical (tributyrin) impregnated pH test strip in comparison to the routine pH test strip to increase the sensitivity of detection of correct positioning of the nasogastric tube
Secondary objectives:
- To measure the number of nasogastric tube re-insertion attempts that could be avoided if the tributyrin impregnated pH test strip was used instead of the standard pH test strip
- To determine the number of chest radiographs which could be avoided if the tributyrin impregnated pH test strip was used instead of the standard pH test strip
- To carry out human factors assessment of perceived usability, trust and acceptance of the lipase-based pH test strip
STUDY DESIGN Prospective point of care diagnostic accuracy study
Primary outcome
- Sensitivity of proposed test in determining correct nasogastric (NG) tube position
Secondary outcomes
- Number of chest x rays performed
- Time to confirm tube placement
- Number of nasogastric tube attempts to get the correct pH
- Assessment of human factors - Perceived usability, trust and acceptance from professionals' perspective
Subject selection and setting
Participants will be recruited from Imperial College Healthcare NHS Trust from the neonatal units at both the Queen Charlotte's and Chelsea and St. Mary's hospital sites. Eligible participants will be identified by the clinical team and recruited by a member of the research team.
The vast majority of admitted infants will require nasogastric tube insertion as part of their clinical management such as preterm infants, sick term infants with hypoxic- ischaemic encephalopathy and meconium aspiration syndrome as well as admitted infants for hypoglycaemia and jaundice management.
Study method
The clinical trial will be a diagnostic accuracy study of two diagnostic tests and will be reported in accordance with the Standards for reporting diagnostic accuracy studies (STARD) guidelines. The index tests will be (i) the novel tributyrin impregnated pH test strip and (ii) standard pH test strip. The reference test used for comparison will be chest x-ray performed earlier or later but with the same nasogastric tube in situ; or where this is not required 'trial by use' (any chest x-rays undertaken would be decided and authorised by the participant's clinical team who are clearly separated from the research team. Undergoing a chest x-ray does not from part of screening for the study and is not a requirement of the study protocol).
Ingenza novel lipase/pH test strip
The test detects the organic acid released from tributyrin, a chemical ester impregnated onto pH paper by the action of human gastric lipase that is stable in gastric juice and resistant towards antacid medications, as well as unlikely to migrate. Ingenza have impregnated enteral pH indicator strips that are in current clinical use with emulsion formulations of tributyrin, protected by intellectual property as human gastric lipase substrates. Therefore, the novel test strips will provide a positive result in the presence of an acidic environment (pH less than or equal to 5.5) or gastric lipase.
Index testing
After the tube insertion, the carer will aspirate the tube to obtain a sample of gastric fluid. This will be done immediately following insertion or as part of daily position confirmation that is routinely performed prior to initiation of nasogastric feeding. The aspirate will be used by the healthcare professional, as part of routine care and the remaining sample passed to a member of the research team. The healthcare professional will test the aspirate routinely and make their decision based on the current standard pH strip test. The remaining sample will be used by the research nurse blinded to the standard test, to wet the gastric lipase enhanced pH test strip. The research nurse will then independently assess the results of the study test paper at two minutes. Digital photographs of both the routine and the study test papers will be assessed independently by member of the study team to verify the findings. The healthcare professional will be blinded to the results of the proposed test strip. The research nurse will record the results of the standard test strip only after documenting the result of the proposed test.
For standard pH strips a pH of ≤5.5 will indicate correct tube placement and >5.5 indicates incorrect nasogastric tube position. For the gastric lipase enhanced pH strip test a positive result will be determined according to the manufacturer's recommendations.
INCLUSION CRITERIA
All infants (preterm and term) who require the insertion of nasogastric tubes for supplementary enteral feeding as part of their routine clinical management
EXCLUSION CRITERIA
Clinically unstable, critically ill infants Infants undergoing palliative care Infants with bowel conditions such as necrotising enterocolitis, bowel obstruction
- Conditions
- Neonatal Disorder
- Keywords
- nasogastric tube, gastric lipase
- Medical subject headings
- Infant, Newborn, Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of standard and ingenza pH strips
Where test sensitivity is defined as the proportion of pH readings that are equal to or below (<=) a certain cut-off when aspirates are obtained from tubes placed inside the stomach. Stomach placements are confirmed either by chest x-rays, or in its absence, by clinical observations).
Measured: 6 months
Secondary outcomes (5)
Number of chest x rays performed
Number of chest X Rays performed to confirm nasogastric tube position after insertion and failure of detection of position using currently available pH measurement strips
Measured: 6 months
Time to confirm tube placement
Total time in minutes to confirm nasogastric tube position
Measured: 6 months
Number of nasogastric tube attempts to get the correct pH
Number of nasogastric tube attempts to get the correct pH
Measured: 6 months
Specificity of standard and ingenza pH strips
Where test specificity is defined as the proportion of pH readings that are greater than (>) a certain cut-off when aspirates are obtained from tubes placed outside the stomach. Non-stomach placements are confirmed by chest x-rays or through reported adverse events.
Measured: 6 months
pH readings obtained by standard and ingenza strips under all cut-offs
pH readings obtained by standard and ingenza strips under all cut-offs
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start2 Mar 2020
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal DisorderStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271995
- Sponsor's protocol ID
- 19QC5444
- Status last verified
- Feb 2023
- First submitted
- 13 Feb 2020
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Diagnostic Accuracy Study Evaluating Point of Care Gastric Lipase Enhanced pH Test Strip to Confirm Correct Nasogastric Tube Position in Newborn Infant
- ClinicalTrials.gov ID
- NCT04271995
- Acronym / sponsor ID
- 19QC5444
- Conditions
- Neonatal Disorder
- Keywords
- nasogastric tube, gastric lipase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 17 Feb 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.
The newborn infants who are sick and those who are born prior to due date (preterm) are admitted to the neonatal unit. These babies are unable to feed through their mouth, so a special tube is passed through their nose to the stomach, nasogastric (NG) tube) to provide milk feeds. The bedside nurse inserts the tube and then aspirate some of the fluid from the stomach. As the stomach normally produce acid, these aspirate is then tested on a colour coded paper strip to check if the fluid is acidic. However, on many occasions this test is not very clear. This could be due to misplacement of the tube or the stomach in a newborn not being able to produce enough acid. This then leads to re-siting of another tube and following the same procedure. Sometimes the clinical team may like to do an X Ray to check the position of the tube resulting in unnecessary exposure to radiation. The study will use a special chemical added to the currently existing paper test strip which the investigators believe will enhance the capability of detecting the correct position of the NG tube. This idea has been tested in adults and found to have increased the sensitivity of the test strip significantly. Based on the adult study the study will require to test 233 babies to see if this increases the sensitivity of correct NG tube placement. Parents of all babies who requires an NG tube for milk feeds will be approached and after appropriate consent could be recruited to the study. Babies who are clinically very unstable, moribund and those with diagnosis of bowel obstruction will be excluded from the study.
Detailed description
STUDY OBJECTIVES
Primary Objective:
- To determine the sensitivity of the chemical (tributyrin) impregnated pH test strip in comparison to the routine pH test strip to increase the sensitivity of detection of correct positioning of the nasogastric tube
Secondary objectives:
- To measure the number of nasogastric tube re-insertion attempts that could be avoided if the tributyrin impregnated pH test strip was used instead of the standard pH test strip
- To determine the number of chest radiographs which could be avoided if the tributyrin impregnated pH test strip was used instead of the standard pH test strip
- To carry out human factors assessment of perceived usability, trust and acceptance of the lipase-based pH test strip
STUDY DESIGN Prospective point of care diagnostic accuracy study
Primary outcome
- Sensitivity of proposed test in determining correct nasogastric (NG) tube position
Secondary outcomes
- Number of chest x rays performed
- Time to confirm tube placement
- Number of nasogastric tube attempts to get the correct pH
- Assessment of human factors - Perceived usability, trust and acceptance from professionals' perspective
Subject selection and setting
Participants will be recruited from Imperial College Healthcare NHS Trust from the neonatal units at both the Queen Charlotte's and Chelsea and St. Mary's hospital sites. Eligible participants will be identified by the clinical team and recruited by a member of the research team.
The vast majority of admitted infants will require nasogastric tube insertion as part of their clinical management such as preterm infants, sick term infants with hypoxic- ischaemic encephalopathy and meconium aspiration syndrome as well as admitted infants for hypoglycaemia and jaundice management.
Study method
The clinical trial will be a diagnostic accuracy study of two diagnostic tests and will be reported in accordance with the Standards for reporting diagnostic accuracy studies (STARD) guidelines. The index tests will be (i) the novel tributyrin impregnated pH test strip and (ii) standard pH test strip. The reference test used for comparison will be chest x-ray performed earlier or later but with the same nasogastric tube in situ; or where this is not required 'trial by use' (any chest x-rays undertaken would be decided and authorised by the participant's clinical team who are clearly separated from the research team. Undergoing a chest x-ray does not from part of screening for the study and is not a requirement of the study protocol).
Ingenza novel lipase/pH test strip
The test detects the organic acid released from tributyrin, a chemical ester impregnated onto pH paper by the action of human gastric lipase that is stable in gastric juice and resistant towards antacid medications, as well as unlikely to migrate. Ingenza have impregnated enteral pH indicator strips that are in current clinical use with emulsion formulations of tributyrin, protected by intellectual property as human gastric lipase substrates. Therefore, the novel test strips will provide a positive result in the presence of an acidic environment (pH less than or equal to 5.5) or gastric lipase.
Index testing
After the tube insertion, the carer will aspirate the tube to obtain a sample of gastric fluid. This will be done immediately following insertion or as part of daily position confirmation that is routinely performed prior to initiation of nasogastric feeding. The aspirate will be used by the healthcare professional, as part of routine care and the remaining sample passed to a member of the research team. The healthcare professional will test the aspirate routinely and make their decision based on the current standard pH strip test. The remaining sample will be used by the research nurse blinded to the standard test, to wet the gastric lipase enhanced pH test strip. The research nurse will then independently assess the results of the study test paper at two minutes. Digital photographs of both the routine and the study test papers will be assessed independently by member of the study team to verify the findings. The healthcare professional will be blinded to the results of the proposed test strip. The research nurse will record the results of the standard test strip only after documenting the result of the proposed test.
For standard pH strips a pH of ≤5.5 will indicate correct tube placement and >5.5 indicates incorrect nasogastric tube position. For the gastric lipase enhanced pH strip test a positive result will be determined according to the manufacturer's recommendations.
INCLUSION CRITERIA
All infants (preterm and term) who require the insertion of nasogastric tubes for supplementary enteral feeding as part of their routine clinical management
EXCLUSION CRITERIA
Clinically unstable, critically ill infants Infants undergoing palliative care Infants with bowel conditions such as necrotising enterocolitis, bowel obstruction
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All infants admitted to the neonatal unit requiring insertion of nasogastric tube
Key inclusion criteria (1 listed)
- All infants (preterm and term) who require the insertion of nasogastric tubes for supplementary enteral feeding as part of their routine clinical management
Key exclusion criteria (3 listed)
- Clinically unstable, critically ill infants
- Infants undergoing palliative care
- Infants with bowel conditions such as necrotising enterocolitis, bowel obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of standard and ingenza pH strips
Time frame: 6 months
Where test sensitivity is defined as the proportion of pH readings that are equal to or below (<=) a certain cut-off when aspirates are obtained from tubes placed inside the stomach. Stomach placements are confirmed either by chest x-rays, or in its absence, by clinical observations).
5 secondary outcomes
Number of chest x rays performed
Time frame: 6 months
Time to confirm tube placement
Time frame: 6 months
Number of nasogastric tube attempts to get the correct pH
Time frame: 6 months
Specificity of standard and ingenza pH strips
Time frame: 6 months
pH readings obtained by standard and ingenza strips under all cut-offs
Time frame: 6 months
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 1 Mar 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Neonatal Disorder, run by Imperial College London at 1 site in United Kingdom.
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 1 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 1 Mar 2023. 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 United Kingdom. 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?
Sensitivity of standard and ingenza pH strips (time frame: 6 months). 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 1 Mar 2023.