Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04271995 |
| Other study ID # |
19QC5444 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 2, 2020 |
| Est. completion date |
December 30, 2021 |
Study information
| Verified date |
February 2023 |
| Source |
Imperial College London |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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
Read more »
