The frequently asked questions document for GASTRIC can be downloaded here.
Screening and Eligibility
Who can screen and randomise patients?
Doctors, nurses and other healthcare professionals (including research nurses/practitioners) who are appropriately trained and delegated by the PI. These staff will be listed on the Training Logs and do not have to be GCP trained or be on the Delegation Log.
Who can confirm eligibility?
Eligibility can be confirmed by a qualified healthcare professional caring for the patient in the paediatric critical care unit, so long as they have undergone trial training documented on the GASTRIC-PICU Training Log. They do not need to be medically trained and they do not need to be on the GASTRIC-PICU Delegation Log or GCP trained.
How long is a patient screened for?
All patients should be screened at admission to the PICU and then for the duration of their critical care admission until recruitment, refusal, or critical care discharge. A patient can be recruited at any time during PICU admission provided they are within 24hrs of meeting all inclusion criteria and none of the exclusion criteria.
Can eligible patients be randomised in the Emergency Department if they have been accepted for admission to the paediatric critical care unit?
No, the emergency department cannot randomise patients as the decision to start feeding (one of the eligibility criteria) is up to the clinical team who looks after the patient in PICU.
Can retrieval teams randomise patients for GASTRIC?
No, retrieval teams will not be randomising patients as the decision to start feeding (one of the eligibility criteria) is up to the clinical team who looks after the patient in PICU.
If a patient is admitted to PICU but is not invasively ventilated at the time of screening, can they be re-screened if they are intubated at a later time?
Yes. Patients who are not invasively ventilated on admission to PICU can become eligible for the study if invasive mechanical ventilation occurs at any time of being admitted to PICU and the site’s screening procedures should include these patients.
Should all patients invasively ventilated be screened?
Yes. Any patients admitted to PICU and who are receiving invasive mechanical ventilation or become invasively ventilated should be entered on the screening log.
Are tracheostomy ventilated patients eligible?
Yes, patients ventilated via tracheostomy can be included as long as they are not on any form of long-term invasive ventilation and providing they meet all other eligibility criteria.
Are preterm babies eligible?
Yes, preterm babies are eligible but only when they reach 37 weeks corrected gestational age. Preterm babies that reach 37 weeks, although eligible, may have been on PICU for a while (invasively mechanically ventilated and fed for > 24 hours). We advise careful consideration in these cases as the parents may be used to regular GRV measurements being taken.
Are patients who are established on home enteral feeds (via PEG or NG) eligible?
Yes, as long as they meet all the eligibility criteria and are randomised within 24 hours after first meeting these criteria. Feeding would be interrupted for intubation, and as they are now critically ill, they would start feeds according the PICU’s guidelines (not what they are usually on).
If a patient who has already started receiving gastric tube feeds, is switched from non-invasive to invasive ventilation, but the feed type/amount stays the same, are they eligible?
Yes, a patient is eligible even if the feed type and amount stay the same after intubation.
Are patients in refractory septic shock with high inotropic requirement and raised lactate where we don't know about the gut perfusion prior to starting feeds eligible and is it safe for them to take part in the trial or should this cohort of patients be excluded?
Yes, these patients can be included (within 24 hours of first meeting eligibility).
Are patients who are proned safe to take part?
Yes, as patients are still fed when proned, follow your usual proning guidance.
Is there a specific amount of feed required in order for the patient to be eligible for the trial (e.g. patients receiving trophic feeds only)?
No. Any amount of feed is fine. Patients receiving trophic feeds only are eligible.
Are patients who are receiving Dioralyte (or equivalent) eligible for the study?
Patients who are only receiving Dioralyte are not eligible for the trial, unless there is an intention to start gastric feeding and provided they meet all eligibility criteria. For GASTRIC participants, Dioralyte administration does not need to be recorded on the CRFs (the same applies to equivalent rehydration treatments).
What does the exclusion criterion ‘recent gut pathology’ cover? What patients shouldn’t be included in the study?
Patients with necrotising enterocolitis (NEC), active GI bleeding, or any intestinal surgery where you are not able to assess feed intolerance by checking the abdomen should be excluded. Examples include congenital diaphragmatic hernia (CDH) or exomphalos.
Are patients currently enrolled on a different study eligible for recruitment?
The Trial Management Group will consider co-enrolment of GASTRIC participants onto other interventional studies on a case-by-case basis, and we ask that you contact the GASTIC team if you have any queries, and co-enrolment agreements will be put in place, as requested. Co enrolment(s) will be documented on the GASTRIC Trial Case Report Form. Participants are permitted to co-enrol in studies that do not involve an intervention (e.g., observational studies).
For the list of current agreed co-enrolments to GASTRIC-PICU trial, please see the bottom of this page.
There is a special population on my unit in whom there is no clinical equipoise – can I exclude them from the study?
We do not encourage excluding patients outside the pre-defined exclusion criteria. If you feel there is a specific population in your unit in whom there is no clinical equipoise, please contact the study team to discuss.
Randomisation
When should the patient be randomised?
Ideally, patients are randomised as soon as they become eligible (i.e they first meet all inclusion criteria and none of the exclusion criteria). Patients must be randomised within 24 hours of becoming eligible or they cannot be included in the study. If in any doubt as to whether the child will remain ventilated for 48 hours, then randomise them.
What happens if a patient has been randomised in error, i.e. they don’t meet eligibility criteria?
Please, contact the ICNARC study team as soon as you are aware that this has occurred, however as a general rule the patient should stay in the study and the team should follow the usual process, i.e. data collection must take place and the family should be approached for consent. ICNARC team will advise if the patient can be removed from the study but this will be in exceptional circumstances.
What happens if a patient has been re-randomised in error?
Should any errors occur, the expectation is to not re-randomise and let the GASTRIC trial team know as soon as possible so a member of the team can edit the randomisation form for you. If a patient is re-randomised by mistake, you should always follow the first allocation. The second randomisation will be marked by the GASTRIC trial team as an error. You must also document the error in a file note and submit this to gastric@icnarc.org as soon as possible.
What is the definition of ‘cardiac’ as a reason for admission?
Cardiac means or includes structural heart disease which is congenital heart disease or any structural defects in the heart. This does not mean or does not include heart rhythm or myocardial function abnormalities which occur within a structurally normal heart.
Intervention
How long should the intervention be applied?
Trial treatment will continue until tube feeds have been discontinued during the PICU admission or until discharge from PICU, whichever is sooner. Therefore, if the patient is transferred to the ward, the trial will stop, even if they are still being fed by the gastric route.
Can we follow our own department incremental feeding guidelines?
Yes, departments should use their own feeding guidelines for the usual care arm so long as GRV is measured at least 6 hourly, and for the no GRV arm so long as they do not use GRV to guide the incremental advancement of feeds.
In the ‘Routine GRV’ arm, should we follow our own department guidelines?
Yes, this is the usual care arm of the trial and therefore units should follow their own PICU guidance, but GRV must be measured at least every 6 hours.
In the No GRV arm – is it ok to still test the pH/confirm the NG tube position?
Yes, you must still test the pH (to confirm NGT position) without aspirating the whole stomach contents – a 0.3-0.5ml aspirate of gastric acid is enough to test the pH.
How should feed intolerance be assessed in patients allocated to the No GRV arm of the trial?
Feed intolerance should be assessed by clinical signs only, including vomiting, abdominal distention, or pain. However, it is important to note that there are other causes of these non-specific symptoms, and these should be considered. If in doubt, then this should be discussed with a more experienced ICU nurse or doctor before stopping the feeds.
Should the intervention be continued if the patient is readmitted to PICU?
The intervention should be continued if the patient is readmitted to PICU within 30 days of first randomisation. They should then go back to the same arm they were allocated to.
Are we allowed to aspirate to remove air only?
Yes, if the patient is in the ‘Routine GRV arm’.
If the patient is in the ‘No GRV’ arm, this would be classified as a GRV. Therefore, it must be documented on the eCRF as a GRV and all relevant information, i.e. GRV fluid volume, will have to be recorded. This will be flagged up as protocol deviation and reason will have to be documented on eCRF.
Does the intervention continue if a patient is extubated and put on CPAP?
If the patient is still being fed enterally, then the intervention should continue until the patient is no longer fed via gastric route.
What if parents are trained to feed their child? Does the intervention need to be followed?
Yes, if it is your usual practice to train parents to deliver gastric feeding then parents who consent to their child being in the study should receive appropriate training and follow the study arm the child has been assigned to (i.e routine GRV or No GRV).
Consent
Who can take informed consent?
Consent must be sought by a GCP-trained staff member who has been delegated this duty on the trial delegation log. They also have to be listed on the trial training log.
A patient was transferred to another site shortly after randomisation. Who should consent the parents/legal guardians?
GASTRIC-PICU participating site: If the staff at the randomising site were not able to approach for consent due to timeframes, the new hospital can take over this process and follow the necessary consent procedures providing that site are participating in the GASTRIC-PICU trial. Please ensure communication between sites to determine the progress of this. The new site will continue all treatment data collection according to the protocol from the timepoint of the handover.
Non-participating site: If the new site are not participating in GASTRIC-PICU, then the randomising site are responsible for following through the consent process.
Please inform the ICNARC CTU of any patient transfers.
What should I discuss with the parent if they are considering declining consent?
If a parent considers declining consent for continued participation in the trial, please ask them whether they would be happy with:
(i) ongoing data collection
(ii) follow-up questionnaires
These can still be continued even if the treatment aspects of the trial have not. If so, they will need to complete & sign the relevant parts of the consent form and this should also be documented in the patient’s medical notes. See the Consent Guide for more detail.
What data needs to be collected when the parent declines consent?
If a parent declines consent, all data up to the point of refusal should be collected. The following information should be recorded on the CRF (MACRO), listed in order of CRF pages:
- · Screening / Randomisation: all details
- · Treatment: enter all data up to date/time of refusal (this is likely to mean a partial day for the date of refusal)
- Feeding Record
- Daily Intake
- GRV Measurements Log
- · Ventilation: all Invasive mechanical ventilation requirement up to 30 days post-randomisation
- · Consent details: complete all details (inc. date approached, and date consent refused), selecting Yes/No for each section as appropriate.
- · Outcomes – Survival Status:
- 30 Days: Survival status up to 30 days post-randomisation
- · Safety: SAEs (if applicable).
The collection of this minimised anonymised dataset is stated in the PIS. This does not apply if the parent explicitly refuses all data collection/usage – if the parent request this, please contact the GASTRIC team at ICNARC.
What do we do if a patient dies but the parents were not approached for consent prior to this?
Consent will not be sought from these parents; however, they should be informed about their child’s participation in the study (when appropriate) as per study protocol. More information can be found in the study protocol and the consent guide.
Data collection
What are the data entry requirements?
Data will be entered into MACRO - an electronic CRF. A CRF guidance document is provided. Optional paper worksheets may also be used, but all data will need to be transferred to MACRO.
What happens if a patient is transferred to another hospital site?
If a patient is due to be transferred, we ask you to contact the GASTRIC-PICU trial team at ICNARC to let them know. If the patient is transferred to another GASTRIC-PICU site, this new site will continue all treatment data collection according to the protocol from the timepoint of the handover. It is the responsibility of the randomising hospital to complete all data, and consenting processes, up to this timepoint. Once this is complete the patient will be transferred on MACRO and the new site will take over.
If a patient is transferred to a site not participating in GASTRIC-PICU, it is the responsibility of the randomising hospital to complete all data up to this timepoint and consenting processes. We ask for you to contact the non-participating GASTRIC-PICU hospital to obtain at least the feeding data up to the end of Day 7 after randomisation, respiratory support up to the end of Day 30 after randomisation and the ultimate hospital discharge information following transfer.
When do we start data collection if consent is yet to happen?
Participant data collection can begin immediately and should be recorded on MACRO. If consent is refused or later withdrawn, all data occurring up to the point of this decision will be retained and a minimised anonymised dataset will be collected and retained for monitoring safety and important outcomes in the trial, unless explicitly requested otherwise.
What happens if a parent/guardian withdraws their consent?
The Withdrawal of Consent eCRF should be completed when the parent/guardian has explicitly withdrawn their consent from aspects they previously consented to. The change to each of these, and a reason for the withdrawal, should be recorded on the eCRF. All data collected up to the point of withdrawal will be retained in the trial.
How should drugs be recorded on MACRO?
All drugs that a patient receives should be recorded on the CRF, whether they are given orally or intravenously. These should be recorded under ‘Other IV fluids received today (ml): include maintenance fluid, drugs (do not include fluid boluses/blood products)’.
Should feeding stoppage for extubation be recorded on the Feeding Record on MACRO?
Yes, any unplanned feeding stoppage should be recorded on the Feeding Record. If the feeding stoppage is not planned as part of the feeding regime, it should be recorded.
If a patient starts receiving invasive ventilation before being admitted to PICU, what date/time should be recorded as a start of invasive ventilation, i.e. can date/time of admission to PICU be recorded here?
You should record the actual start date/time if this is known.
Should failed attempts to aspirate be recorded on the GRV log?
Yes, you should always record any GRV that you perform, including failed GRV attempts and if the amount you aspirate is very low, it’s ok to leave the volume field blank. Please add a comment to explain low volume, i.e. ‘full aspiration attempted but not possible’.
How should participation in GASTRIC be recorded on PICANet?
Please, use GASTRIC-PICU followed by the trial ID, ‘GASTRIC-PICU-GNNN-NNN’. No spaces.
Serious Adverse Events
Which adverse events and serious adverse events should be reported?
Serious adverse events only need to be reported if they are considered to be possibly, probably or definitely causally related to the study (i.e., either as a consequence of measuring GRV, or not measuring GRV). However, the key safety outcomes in the GASTRIC-PICU trial are ventilator-associated pneumonia (VAP) and necrotising enterocolitis (NEC). Incidence of these events will be captured via the Case Report Forms and does not need to be reported additionally as SAEs.
Non serious adverse events do not need reporting for trial purposes.
Serious Adverse Events that are considered not or unlikely to be related to trial treatment do not have to be reported.
Agreed Co-enrolment with GASTRIC-PICU
- ASCEND
- BACHb
- CRESCENT
- DESTINY
- DOLFIN
- PRESSURE
- PROSPECT
- REMAP-CAP