FAQs

NeoGASTRIC is an international trial with sites from across the United Kingdom and Australia.

In the UK all nations are taking part – England, Scotland, Wales and Northern Ireland.

In Australia, sites from 3 states are taking part – New South Wales, South Australia and Victoria.

The overall trial will recruit 7,040 infants, with a goal of 5,840 infants from the UK and 1,200 from Australia.

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Please email neoGASTRIC@npeu.ox.ac.uk if you would like to find out more about the study or would like to participate as a recruiting site or continuing care site.

The recruitment period will last for around 36 months - from 31^st of March 2023 until 2026.

A Local Information Pack (LIP) will first be provided to the recruiting site and their Research & Development team. This will include all of the necessary information and documentation about the neoGASTRIC trial. To complete the site set-up process, the following mandatory documentation is needed:

• mNCA contract signed by all parties
• All CVs and GCP documentation for key site staff (i.e. PI, lead RN, Associate PI or Co-PI)
• A signed Site Initiation Visit (SIV) attendance log and report
• A Delegation log completed and signed
• [EN1] Completion of evidence of the necessary IT training for key site staff, including the Randomisation website and OpenClinica database
• Local PI Protocol sign off
• Research & Development confirmation of local Capacity & Capability (C&C)

Once the site set up process is complete, a Sponsor Green Light for neoGASTRIC-related activities for the site will be provided to officially open the site for recruitment.

For neoGASTRIC, a PI should be a senior neonatal health professional who can take overall responsibility for managing the study at their site and ensuring it is conducted according to the study protocol. This can be a doctor, nurse, ANNP (Associate Neonatal Nurse Practitioner) or Allied Health Professional.

A Co-PI is someone who would jointly lead the trial at a recruiting site and who can act as a back-up when the Principal Investigator (PI) is away. Where possible, they would be the Co-PI for the whole of the trial period.

The NIHR Associate PI Scheme is an in-work training opportunity, providing practical experience for healthcare professionals starting their research career. This scheme is a great way for someone to get experience in research as well as being someone who can help on the trial.

Staff can register their interest to act as an Associate PI with the support of the PI. The duration for the NIHR Associate PI scheme is 6 months and should include the recruitment period (2023-2026).

More information about this scheme and how to sign up can be found here: Associate PIs | neoGASTRIC | NPEU (ox.ac.uk)

Yes. Please do let the neoGASTRIC Coordinating Centre know the names of the staff fulfilling these roles either via email or via the Delegation Log, which is completed as part of the site setup process. Please also do not hesitate to get in touch with the neoGASTRIC Coordinating Centre with any further questions around this.

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We request that recruiting sites complete the localised details on the mNCA and review the document for agreement.

Once reviewed, the site can either sign in their preferred way or you can provide the name and direct email address for the authorised signatory and this will be sent directly to then using Adobe Sign. Please note that we cannot send signature requests to generic inboxes in order to comply with audit requirements.

All parties involved with the trial are required to formally sign this document; this includes the sponsor, a recruiting site representative and the recruiting site Principal Investigator.

Under the model Non-Commercial Agreement (mNCA) signed for neoGASTRIC, a recruitment target is set. Payments will be made to sites at the suggested time-point of every 3 months as per the number of babies recruited during this period.

The trial is adopted onto the NIHR portfolio, so recruits will count as accruals for the portfolio. Every baby randomised will be an accrual and this will be uploaded monthly to the NIHR CPMS platform by the neoGASTRIC Coordinating Centre.

Before a recruiting site can open for recruitment, key site staff will be required to attend the following training:

1) A Site Initiation Visit (SIV), which is conducted over zoom or face-to-face and takes around 1-2 hours. The purpose of the SIV is to go through all of the key clinical and administrative requirements of the study. It is also a good opportunity for sites to speak directly with the Chief Investigator and/or key staff from the neoGASTRIC Coordinating Centre.

For staff not able to attend an SIV or who join the trial after the SIV, there is an Education Package available. The Education Package is a PowerPoint presentation that can be given by site staff who attended the SIV. This is available on the website here. This training needs to be documented on a training log.

2) The IT Training requirements will be for site staff who will be assessing participant eligibility, completing the randomisation process and/or entering trial data into the OpenClinica database. These short training videos are available online.

SIVs will usually take place virtually and all staff involved in the trial at your hospital are encouraged to attend. If a key staff member is unable to attend the SIV your site has been invited to, there will be an opportunity to join a subsequent SIV.

Please note that before recruitment can begin, key site staff (PI and Lead nurse) must attend an SIV as part of their required training.

As well as the key staff at site, all site staff with delegated responsibilities that include data entry, maintaining the Investigator Site File (ISF) or signing off the CRF forms (i.e. responsibilities E-H on the delegation log), will need to provide a signed CV and valid GCP certificate.

This is normally required three years after GCP training was last completed. The neoGASTRIC study coordinating team will send reminders to staff two months before the expiry of the GCP certificate that is held on file.

Some hospitals may have their own GCP training, or staff can complete this directly via the NIHR at: https://www.nihr.ac.uk/health-and-care-professionals/learning-and-support/good-clinical-practice.htm

All site staff who are involved with the neoGASTRIC study will need to be listed on the Delegation Log document. This is provided to the recruiting site after the SIV has taken place. Staff will need to have their name and contact details listed against their role and allocated responsibilities for the duration of the trial.

Staff who are only responsible for either screening, eligibility or randomising tasks, do need to be on the delegation log (Responsibilities A-C) but do not need to provide a GCP certificate or their CV (However if a site has a local policy that these documents are required, these can be stored within your eISF).

Staff who have data entry responsibilities do need to provide a GCP certificate and their CV before they are permitted to undertake these tasks (Responsibilities D-F)

At a minimum the roles and responsibilities of the PI and Lead research nurse will need to be provided to the neoGASTRIC Coordinating Team in order to satisfactorily meet this criteria as part of fulfilling the site setup process.

Please note that the delegation log can be updated throughout the course of the study and that any changes in staff and/or responsibilities should be noted and sent to the neoGASTRIC Coordinating Team.

Each Recruiting site will be provided with the following training logs to complete:

• Site Initiation Visit training Log – A list of site staff who attended the virtual SIV Staff signatures also required.
• Randomisation Training log Log – A list of site staff who have watched the short randomisation training video. This staff will be able to then complete the randomisation process. Staff signatures also required.
• Generic Training Log – to record trial-specific training for those who are not able to attend SIV, or join the team after SIV

These training logs are to be completed, signed and returned via email to the neoGASTRIC Coordinating Centre before a site can be opened to begin recruitment.

All recruiting sites will receive a neoGASTRIC Site Document Box before they can open for recruitment. This box will contain paper copies of key trial documentation (e.g. the protocol, Parent Information Sheets, guidance sheets), promotional materials (e.g. posters, cot cards, feeding tube stickers) and stationary.

The Document Box will be sent to recruiting sites around the time of the scheduled Site Initiation Visit (SIV). This is provided along with a neoGASTRIC banner, if the site is able to display this.

Sites can also ask for any document to be resent to them at any time by getting in touch with the neoGASTRIC study team.

Please note that these documents will also be available via the electronic investigators site file (eISF).

Yes, an electronic investigators site file (eISF) will be provided to recruiting sites after the Site Initiation Visit (SIV) and close to when the site is ready to open for recruitment. Sites are responsible to maintain the eISF and to save it securely.

A range of study posters and stationary is provided to all recruiting sites via the Document Box. Please display the neoGASTRIC study posters and banners in visible areas e.g. breastfeeding rooms, parent kitchen/break-out rooms, parental boards and corridors and reception areas. Additionally, you can use promotional and stationery items which could help with raising study awareness, while also acting as visible reminders for screening and recruitment.

Screening and eligibility can be assessed by appropriately trained and delegated clinicians, research nurses and healthcare professionals. These members of staff should be listed on the delegation log – Refer to section Site Training Requirements Q: “What is a delegation log?”

An infant can be enrolled into the neoGASTRIC study if they have a congenital anomaly that would not affect the way that the infant can be fed, compared to another infant without the congenital anomaly but of a similar gestational age.

Please note that the exclusion criteria lists major congenital anomaly, which is left open for a local clinician's discretion.

It unlikely for a baby to have NEC before randomisation as randomisation is likely to occur in the first few days after birth. However, any suspected NEC at the time of randomisation would be an exclusion criterion.

If the parent/carer(s) is determined to be competent to understand the trial then the infant can be enrolled in the trial.

This is a decision for the Principle Investigator at the recruiting site (PI) to make, but please do contact the neoGASTRIC Coordinating Centre if you are not sure. If you think the parent/carer is not able to make an informed decision, please do not enrol them and mark this in the infant's notes.

Yes. Infants enrolled in other interventional studies are eligible for participation in the neoGASTRIC trial, including BASE, DOLFIN, SurfON and WHEAT trials. However, please get in touch with the neoGASTRIC Coordinating Centre if you have any further queries or concerns around this.

Parents often want to be in more than one trial if they feel like it is helpful and a low risk to their child. The neoGASTRIC study is exploring a practice that is variable throughout UK hospitals, and there is no new treatment introduced. Instead of giving infants the current arbitrary care, this trial is formally randomising the different care pathways. Please follow the links below for further information around the topic.

Please find the link to the qualitative feasibility study paper for this trial, which highlights what parents prioritise when considering the trial and views on trial acceptability: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-021-00784-5

Here is the full HTA report which includes views on approach to consent and outcomes: https://www.imperial.ac.uk/media/imperial-college/medicine/dept-medicine/infectious-diseases/neonatology/GASTRIC-Study-protocol-for-upload-HTA-V-2-9-March-2018.pdf

To help make the opt-out consent process for neoGASTRIC consistent please:

1. Ensure neoGASTRIC posters and/or banners are displayed in prominent places and particularly in places parents regularly use like the parents' room or expressing room.
2. Give the neoGASTRIC information leaflet to parents/legal representatives before babies are randomised. We want to make sure parents know about and have seen the information leaflet, and have had an opportunity to opt out before the baby is enrolled in neoGASTRIC.
3. If the parents have seen banners/posters about neoGASTRIC or have read the information sheet antenatally they may need less information, but all parents should receive the neoGASTRIC information again when their baby is admitted to the neonatal unit.
4. Ideally the neoGASTRIC information leaflet should be given to parents when appropriate after the baby has been admitted to the neonatal unit. This might be different time for different families.

• This could be part of an 'admission pack' that contains other information about the neonatal unit and other research.
• We would like you to explain to parents that neoGASTRIC is an opt-out study and more information is in the Parent Information Leaflet

4. • For example, when giving out leaflet/pack you might say: 'We are a research active unit and one research study we are taking part in is called neoGASTRIC. There is more information about neoGASTRIC in this pack. Your baby will be included in the neoGASTRIC study unless you tell us you don't want your baby to take part – you can do this at any time'.
5. For some families it may not be right to give them information about the trial soon after their baby is admitted – for example if their baby is very sick.

• In this situation, parents should be given information about neoGASTRIC later when it is more appropriate. All babies can be enrolled into neoGASTRIC up to 24 hours after birth, and sicker babies may be eligible for longer (until the start feeding see item below) – so there is time to give parents information later.

6. If baby is not likely to be on >15 mg/kg/day of milk feeds soon, it's OK to pause randomisation to give parents more time to read about the neoGASTRIC trial. Babies are eligible to be randomised up until the point where they have been receiving more than 15ml/kg/day for milk for more than 24 hours.

7. It is important that parents are able to understand the information about neoGASTRIC and the opt-out consent process. We have translated parent information into the 10 most common languages in the UK for this reason.

8. If a baby's parents cannot receive or understand information about the neoGASTRIC trial and the opt-out consent process (language barrier, mental capacity etc.) then the baby should not be recruited and this should be noted in the baby's notes and on the screening log.

9. Where a baby has been enrolled in neoGASTRIC: parents should know that their baby is in the neoGASTRIC trial, and they should know that they could have asked for their baby not to be in neoGASTRIC at the beginning or at any time.

Please refer to Guidance Sheet 3 and contact the neoGASTRIC coordinating centre if you have any further questions.

No. There is no requirement to record that the PIS has been given to parents and there will not be any monitoring around this. However, we feel its good practice to mark in the patient notes/EPR that the parent/carer has received the PIS, to help with internal monitoring.

Yes. Parents can absolutely be given information about the trial antenatally however the infant cannot be randomised until it is born.

Yes. We have the PIS translated into 10 languages – Arabic, Bengali, Bulgarian, Hindi, Polish, Punjabi, Romanian, Slovak, Urdu and Welsh. If a language is not available, please use your usual translation systems in your hospital.

Please also contact the neoGASTRIC Coordinating Centre with any translation requests as it may be possible to provide additional languages later in the trial.

Site staff that are listed on the delegation log with randomisation responsibilities and who have completed the randomisation training are able to complete the randomisation process. Please note that staff who have randomisation responsibilities do not need a valid GCP certificate.

A site-wide single log-in will be provided for each recruiting site. These log-in details will be found on the lid inside the provided Document Box.

An infant can be randomised until they still meet the eligibility criteria; there is no maximum age criteria.

Infants can be randomised until they have been receiving more than 15ml/kg/day for more than 24 hours. So in practice this means that all infants can be randomised in the first 24 hours of life regardless of their feed volume (as they will have received feed for less than 24 hours).

Infants that have a period of 'trophic' feeds up to 15ml/kg/day can be randomised until they have had 24 hours on more than trophic feeds.

Therefore, if a baby is not feeding straight away, it is OK to wait until they are starting feeds. Once a baby is randomised, the feed log needs to be completed and the arm of the trial followed.

No. NeoGASTRIC is an individually randomised trial where each infant will be randomly allocated to a trial arm (routine measurement of GRV vs no routine measurement of GRV) irrespective of their local practice.

If you know a baby is going to be transferred to another unit in the first few days of life, please hold off randomisation. If the unit baby is moving to is listed as a continuing care sites (see Sites section of the website), then it's OK to go ahead and randomise as the baby will be able to continue in the trial. If baby is going to transfer to a non CCS unit, then please do not randomise.

Yes. If an error is made on the randomisation form. This cannot be updated via the Randomisation System itself, but the gestational age can be edited within OpenClinica. Please note that this will raise a Query within OpenClinica to highlight that the gestational age is different to what was at randomisation. Do then comment against the query to confirm which gestational age is correct.

Overall there is only a small amount of data that will need to be captured on a daily basis and entered into the corresponding Case Reporting Forms (CRFs). The primary CRF is the Feed Log, which is completed each day for at least 14 days. Subsequent forms will require completion only when needed e.g. the transfer/discharge form, the infections & gut signs form, incidents form etc.

The Screening Log is accessed via the Randomisation system at the top of the neoGASTRIC Website

The screening log should be completed at least once a month. This data is important for the SWAT analysis.

Sites will be provided with cot cards and labels to stick on feeding tubes to help prevent this from happening. We also have stickers that can be added to patient paper notes where relevant and magnets that can be added to patient boards

We are always keen to hear feedback from sites around this topic, so please do get in touch if you have any suggestions.

The feed log can be completed either of two ways: electronically and/or manually onto a printed copy. Please note that all data captured will still need to be entered directly into the OpenClinica online portal. The paper form will not be collected by the neoGASTRIC coordinating centre.

The feed log can be accessed via the OpenClinica platform. Paper copies of the feed log are provided to recruiting sites via the Document Box. These can be kept cot side or stored however best suits the staff who will be completing the log.

Staff at both recruiting sites and continuing care sites that have been trained in completion of the feed log for the neoGASTRIC trial can complete the daily feed log. These staff do not need to be on the delegation log.

However only staff who have been delegated data entry responsibilities on the Delegation Log will have an individual log-in to the OpenClinica portal. All data captured from the feed log and other data forms must be formally entered into the OpenClinica portal and submitted once complete.

On day 0 please complete the daily feed log for the whole 24 hour period, irrespective of the time of day the baby was randomised. The feeding log should then be completed for each calendar day (24 hours from 00:00) onwards.

If an infant reaches full feeds during the first 14 days post randomisation, the whole feed log should still be completed for the 14 days.

If an infant has not reached full feeds for 3 consecutive days, move onto the 15 days onwards daily feed log and continue to complete until baby has reached full feeds over 3 consecutive days.

Daily Feed logs:

Feed logs are to be completed for all babies up to 14 days.

Once past day 14, if the infant has completed 3 consecutive days of full feeds, the feed logs are stopped at day 14.

If at Day 15 the baby has not reached full feeds for 3 consecutive days, please continue to complete daily feed log up until baby reaches full feeds, until discharge home or until the infant reaches 44+0 gestational age.

All other data:

Please do continue to complete the Infection & Gut Signs forms and/or and SAEs until the infant has been discharged home, withdrawn or reached 44+0 weeks gestational age.

At this time there is a form to be completed about the baby's time on the unit.

The term 'serious clinical concerns' has been updated to 'clinical indication or concern'. If there is a clinical reason for not remaining on the allocated arm, this can be indicated and baby is still compliant to the protocol.

If the feeding tube has been removed within the first 14 days of participating on the trial, record on the feed log when the tube was removed. If the infant is on the measuring gastric residual volume arm, this obviously cannot continue; however do still continue to record other applicable data e.g. any instances of vomiting up until 14 days and feed volume where relevant.

Decimal measurements are not accepted on OpenClinica. Please round up/down accordingly to the nearest whole ml.

Yes. However do record this reason as to why the gastric residual volumes have stopped being recorded on the feed log. However, please do continue to populate the feed log as much as possible up until day 14.

When a baby is NBM, there is no need to aspirate as per study arm whilst baby is NBM, BUT continue to complete the feeding log throughout this time period.

On each day of the feed log, there is a question that will ask 'were any feeds withheld for any length of time on this day?'. This question only applies if the feeds were intentionally withheld within the first 14 days only.

There is space on the feed log to document how long feeds were withheld and for what reasons (including for aspirates). Specifically we want to know about feeds that were withheld for vomiting as this is a secondary outcome (in the first 14 days only).

No. If the baby has not yet started milk feeds then this does not count as a withheld feed. A baby has to start milk feeds for them to be withheld.

If the infant is nil by mouth (NBM) because there is no milk available then this would be marked as a no. It is only if there was intention that the baby was purposely made NBM because of gut related issues or potentially for a blood transfusion that we would log the period the baby was NBM for.

Full feeds are defined as ≥145ml/kg/day

Ideally, we would like infants to stay on the allocated arm of the trial even after full feeds have been established at both recruiting and any continuing care sites, unless local protocol indicates this is not allowed.

We are aware that some sites may not have equipoise to continue one arm after a baby is established on feeds and we do still want them to take part in the trial.

In summary, we would prefer sites (recruiting and continuing care) to continue with the allocated arm, but understand and allow them to revert back to local practice if absolutely necessary.

No, in this case, you would not mark 'yes'. We aim for the baby to have received full feeds over the course of a full day. If the increase to full feeds occurs later in the day, such as at 4pm, the baby should be on full feeds for 3 additional days after the initial day to ensure they receive the full enteral feed over a full 24-hour period.

No. As the primary outcome has been previously reached, a new feed log does not need to be started.

No. The amount of IV fluids being given to an infant is not being measured as part of the neoGASTRIC trial. Only the total volume of milk feeds should be captured on the feed logs.

Yes. For the neoGASTRIC trial full feeds is defined as reaching at least 145ml/kg/day. Most infants will go beyond this and full feeds should not be limited to the neoGASTRIC minimum.

The Infection & Gut Signs form should be started only when an infant has been on 5 continuous days of antibiotics that is not for prophylaxis. Please remember to check the criteria listed on the front page of the Infection & Gut Signs form.

Please refer to Guidance Sheet 8 Safety & Incident Reporting. Guidance Sheets are provided in the Document Box and are accessible via the eISF.

Please also contact the neoGASTRIC Coordinating Centre with any queries around the Incident or Serious Adverse Event and submit the applicable forms as soon as possible.

Please contact the neoGASTRIC coordinating centre if this happens as we may need to take action and complete an incident form

When an infant dies, the appropriate procedure is to complete the transfer/discharge form. This form is used to ensure that we properly capture and document the situation.

Please refer to Guidance Sheet 6 (a) and (b) Transfer of Infants and the Continuing Care sites Guidance sheet for further details. Please also notify the neoGASTRIC coordinating centre of any planned or completed infant transfers as soon as possible.

When an infant is transferred to another unit, the recruiting site should:

1. Include one of the Transfer Packs (found in the Document Box) with the infant;
2. Include a copy of the current feed log to the Transfer Pack (if before 14 days, or before full feeds after day 14)
3. Contact the neoGASTRIC Coordinating Centre if the site is not a confirmed continuing care site;
4. Complete the Transfer/Discharge form via OpenClinica.

A continuing care site (CCS) is a site that an infant is being transferred to from one of the neoGASTRIC named recruiting sites. A CCS will receive a Transfer Pack with information about the neoGASTRIC trial including any instructions on the data collection that is required in order to continue the infant's participation in the trial.

To continue this participation, the CCS's Research and Development team will be contacted by the neoGASTRIC Coordinating Centre (NPEU). Data cannot be collected at CCS until regulatory approvals are in place for this site.

If a baby is transferred to a neoGASTRIC recruitment site, then this is OK to collect data.

All registered Continuing Care Sites are listed on the neoGASTRIC website in the "Sites" section. This is continually updated as more CCS open throughout the course of the trial.

CCS are set up routinely by the neoGASTRIC Coordinating Centre however it can take some time to complete the set up process so please do inform the neoGASTRIC Coordinating Centre of any units that you commonly transfer infants to so that we can start this process early.

A CCS main responsibility is to continue with the infant's allocated trial arm (to measure or not to measure gastric residual volumes) and to continue completing the daily feed log until the infant transferred or discharged or reaches 44+0 gestational weeks.

A CCS will also be responsible to completing all other reporting forms when they become applicable, including:

• Infections and Gut Signs Form
• Incident Reporting Form
• Serious Adverse Event (SAE) Report
• Transfer/Discharge Form
• Withdrawal and Discontinuation Form

Yes, please reach out to the neoGASTRIC coordinating centre to be connected with the appropriate individual, or you can contact the relevant person at the CCS directly.

CCS are asked to securely return all completed data collection forms to the recruiting site via secure email. The recruiting site's contact details are available via the Parent Information Sheet that is included in the Transfer Pack.

If an infant is transferred to a non-continuing care site, please inform the neoGASTRIC Coordinating Team of the transfer via either phone or email. Data collection will not be possible for infants transferred to non-continuing care sites. Therefore, when completing OpenClinica forms, please add annotations indicating that the infant has been transferred to a non-continuing care site. This will generate queries that the trial coordinating team will address and resolve.

Once an infant has been randomised into the trial, a parent/carer can request that their infant's level involvement of the trial be changed, reduced, or end entirely, at any point and for any reason. This is a change of consent.

The Withdrawal form should be used when baby's parent(s) express a wish to opt-out of any or all data collection for neoGASTRIC after their baby has been randomised.

The Discontinuation form should be used when baby is being permanently withdrawn from their trial-allocated pathway of care before they have reached full feeds for three consecutive days; but their involvement in neoGASTRIC is otherwise not changing (that is, all data collection is continuing).

Refer to guidance sheet 7 for more information.

Absolutely. It is an MHRA and safety requirement to check the NG or OG tube position before commencing with any feed. This is done by aspirating <0.5ml or so of aspirate from the stomach, and checking the pH level. Taking an aspirate is not affected by the trial and this must continue as normal regardless of which arm of the trial the infant is on.

Please note that the neoGASTRIC trial is only looking at the practice of routinely aspirating the whole stomach contents.

Yes, for infants participating in the 'routine GRV measurement arm', at measurements should be taken at least four times a day. Sites can measure gastric residuals more regularly than this, if that is the local policy. E.g. before every feed. If sites measure less than 4 GRVs per day, without a clinical indication, this may result in an adherence. Please see the Adherence FAQs here.

Yes. Please do follow your usual local procedure and return the gastric residual ae per your usual practice.

No, this is OK. However please detail this in the neoGASTRIC Daily Feed Log.

Yes. When there are clinical indications, gastric residual measurements should continue to follow clinical care practices. There is space on the Daily Feed Log where these types of situations can be captured.

When regular gastric residual measurement is no longer clinically indicated, the infant should be allocated back to their randomised care pathway, if this is considered clinically appropriate.

Please measure gastric residual volumes (GRV) as clinically indicated. This situation is captured on the Daily Feed Log.

Abdominal distension due to air that is not accompanied by any other abdominal issues would not constitute a serious concern.

It is perfectly OK for infants in either arm of the study to have air aspirated from the gastric tube, or for the tube to be left open to vent. We would regard it as routine care and very common, especially for infants on CPAP. As long as aspiration is ceased when you stop getting air and start getting liquid, it fits within the protocol for the no aspirate arm.