AzTrials
AzTrials

Necrotizing EnterocolitisWHEATNCT05213806

WithHolding Enteral Feeds Around Blood Transfusion (International)

A study testing Withholding feeds around transfusion and Continued feeds around transfusion in people with Necrotizing Enterocolitis, run by IWK Health Centre at 40 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The WHEAT International trial is a comparative effectiveness trial exploring whether withholding enteral feeds around the time of blood transfusion in very premature infants (<30 weeks) will reduce the occurrence of Necrotizing Enterocolitis (NEC). Read more about this study

Who is it for?
Ages Up to 30 weeks
Conditions the study is for
Necrotizing Enterocolitis
What is being tested?
Withholding feeds around transfusion and Continued feeds around transfusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,333 participants
Where
40 sitesin 2 countries
Study dates
28 Jan 2022to 31 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 Up to 30 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 1. Preterm birth at <30+0 gestational weeks + days

Who cannot join

  • Parent(s) opt-out of trial participation.
  • Packed red cell transfusion with concurrent enteral feeds prior to enrolment. (Infants who have received a packed red cell transfusion while nil-by-mouth are eligible; or minimal enteral nutrition (<15 ml/kg/day feeds) at the time of transfusion; defined as before, during and for at least 4 hours after transfusion, are eligible.
  • Infants who are not being fed at the time of randomization (<15ml/kg) or where enteral feeding is contraindicated [e.g. Major congenital abnormality of the gastrointestinal tract (GIT)].
  • Previous episode of NEC Bell stage 2 or higher or SIP prior to first study packed cell transfusion.

Trial locations and contacts

40 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Cari-Lee Carnell contact

9024706630

cari-lee.carnell@iwk.nshealth.ca

Tara Hatfield contact

9024706630

tara.hatfield@iwk.nshealth.ca

40 sites in 2 countries

United Kingdom39 sites, 39 recruiting

  • East Kent University Hospitals NHS Foundation Trust (William Harvey Hospital)

    Ashford

    Sean Mun, MD, kwokseanmun@nhs.net

    Recruiting

  • Buckinghamshire Healthcare NHS Trust (Stoke Mandeville Hospital)

    Aylesbury

    Gopa Sarkar, gopa.sarkar@nhs.net

    Recruiting

  • Barnsley Hospital NHS Foundation Trust

    Barnsley

    Ezzedin Gouta, MD, egouta@nhs.net

    Recruiting

  • Birmingham Women's and Children's NHS Foundation Trust (Birmingham Women's Hospital NICU)

    Birmingham

    Gemma Holder, MD, gemma.holder@nhs.net

    Recruiting

  • University Hospitals Birmingham NHS Trust (2 Hospitals: Heartland's Hospital & Good Hope Hospital)

    Birmingham

    Imogen Storey, MD, imogen.storey@uhb.nhs.uk

    Recruiting

  • Bradford Teaching Hospitals NHS Foundation Trust (Bradford Royal Infirmary)

    Bradford

    Sam Oddie, MD, sam.oddie@bthft.nhs.uk

    Recruiting

  • North Bristol NHS Trust (Southmead Hospital)

    Bristol

    Daniela Vieten-Kay, MD, daniela.vieten-kay@nbt.nhs.uk

    Recruiting

  • East and North Essex NHS Foundation Trust - Colchester Hospital

    Colchester

    Jonathan Campbell, MD, jonathan.campbell@esneft.nhs.uk

    Recruiting

  • University Hospital Coventry & Warwickshire NHS Trust (University Hospital Coventry)

    Coventry

    Arthi Lakshmanan, MD, arthi.lakshmanan@uhcw.nhs.uk

    Recruiting

  • University Hospitals of Derby and Burton NHS Trust (Royal Derby Hospital)

    Derby

    Shalini Ojha, PhD, Shalini.Ojha@nottingham.ac.uk

    Recruiting

  • NHS Tayside (Ninewells Hospital)

    Dundee

    Jennifer Scotland, MD, jennifer.scotland3@nhs.scot

    Recruiting

  • Medway Hospital NHS Foundation Trust (Oliver Fisher Neonatal Unit, Medway Maritime Hospital)

    Gillingham

    Ghada Ramadan, MD, gramadan@nhs.net

    Recruiting

  • Gloucestershire Hospitals NHS Foundation Trust (Gloucestershire Royal Hospital)

    Gloucester

    Joanne Colliver, RN, joanne.colliver@nhs.net

    Recruiting

  • Calderdale & Huddersfield NHS Foundation Trust (Calderdale Royal Hospital)

    Halifax

    James Houston, MD, james.houston2@cht.nhs.uk

    Recruiting

  • The Hillingdon Hospitals NHS Foundation Trust (Hillingdon Hospital)

    Hillingdon, UK

    Elizabeth Lek, MD, elizabeth.lek@nhs.net

    Recruiting

  • East and North Essex NHS Foundation Trust - Ipswich Hospital

    Ipswich

    Prathiba Pai, MD, prathiba.pai@esneft.nhs.uk

    Recruiting

  • Leeds Teaching Hospitals NHS Trust (Leeds General Infirmary & St James' University Hospital)

    Leeds

    Amelia Shaw, MD, amelia.shaw2@nhs.net

    Recruiting

  • University Hospitals of Leicester NHS Trust (Leicester Royal Infirmary)

    Leicester

    Joe Fawke, MD, joe.fawke@uhl-tr.nhs.uk

    Recruiting

  • Liverpool Women's Hospital NHS Foundation Trust (Liverpool Women's Hospital)

    Liverpool

    Srinivasarao Babarao, MD, srinivasarao.babarao@lwh.nhs.uk

    Recruiting

  • Barts Health NHS Trust (3 Hospitals: Royal London Hospital, Whipps Cross Hospital, Newham General Hospital)

    London, UK

    Ajay Sinja, MD, ajay.sinha@nhs.net

    Recruiting

  • Chelsea and Westminster Hospital NHS Foundation Trust (Chelsea and Westminster Hospital)

    London, UK

    Prof Christopher Gale, MD, Christopher.gale2@nhs.net

    Recruiting

  • Imperial College Healthcare NHS Trust (2 Hospitals: St Mary's Hospital & Queen Charlotte's and Chelsea Hospital)

    London, UK

    Jayanta Banerjee, MD, jayanta.banerjee@nhs.net

    Recruiting

  • North West London NHS Trust (Northwick Park Hospital)

    London

    Richard Nicholl, MD, rnicholl@nhs.net

    Recruiting

  • Bedfordshire Hospitals NHS Foundation Trust (Luton & Dunstable University Hospital)

    Luton, UK

    Doris Iyambo, MD, doris.iyambo@ldh.nhs.uk

    Recruiting

  • Manchester University NHS Foundation Trust (2 Hospitals: St Mary's Hospital - Oxford Road, North Manchester General)

    Manchester

    Ruth Gottstein, MD, ruth.gottstein@mft.nhs.uk

    Recruiting

  • Manchester University NHS Foundation Trust (Wythenshawe)

    Manchester

    Kuldip Bakaya, MD, kuldip.bakaya@mft.nhs.uk

    Recruiting

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust (Royal Victoria Infirmary)

    Newcastle upon Tyne

    Elda Dermyshi, MD, elda.dermyshi@nhs.net

    Recruiting

  • Norfolk & Norwich University Hospitals NHS Foundation Trust (Norfolk & Norwich University Hospital)

    Norwich, England

    Jasmine Myhill, rdoffice@nnuh.nhs.uk

    Recruiting

  • Nottingham University Hospitals NHS Trust (2 Hospitals: City Hospital, Queen's Medical Centre)

    Nottingham

    Dulip Jayasinghe, MD, dulip.jayasinghe1@nhs.net

    Recruiting

  • Oxford University Hospitals NHS FT (John Radcliffe Hospital)

    Oxford

    Eleri Adams, MD, eleri.adams@ouh.nhs.uk

    Recruiting

  • North West Anglia NHS Trust (Peterborough City Hospital)

    Peterborough

    Katherine McDevitt, MD, katherine.mcdevitt@nhs.net

    Recruiting

  • Portsmouth University Hospitals NHS Trust (Queen Alexandra Hospital)

    Portsmouth

    Tim Scorrer, MD, tim.scorrer@porthosp.nhs.uk

    Recruiting

  • Lancashire Teaching Hospitals NHS Foundation Trust (Royal Preston Hospital)

    Preston

    Richa Gupta, MD, richa.gupta@lthtr.nhs.uk

    Recruiting

  • The Shrewsbury & Telford Hospitals NHS Trust (Royal Shrewsbury Hospital)

    Shrewsbury

    Sanjeev Deshpandar, MD

    Recruiting

  • University Hospital Southampton NHS Foundation Trust (Southampton General Hospital)

    Southampton

    Mark Johnson, MD, mark.johnson@uhs.nhs.uk

    Recruiting

  • Betsi Cadwaladr University Health Board (Glan Cwyd Hospital)

    Wales

    Ian Barnard, MD, ian.barnard@wales.nhs.uk

    Recruiting

  • Walsall Healthcare NHS Trust (Walsall Manor Hospital)

    Walsall

    Pooja Siddhi, MD, p.siddhi@nhs.net

    Recruiting

  • West Hertfordshire Hospitals NHS Trust (Watford General Hospital)

    Watford

    Nazakat Merchant, MD, nazakat.merchant@nhs.net

    Recruiting

  • Royal Wolverhampton NHS Trust (New Cross Hospital)

    Wolverhampton

    Richard Heaver, MD, r.heaver@nhs.net

    Recruiting

Other trials in United Kingdom

Canada1 site, 1 recruiting

  • IWK Health

    Halifax, Nova Scotia, B3K 6R8

    Cari-Lee Carnell, 9024706630, cari-lee.carnell@iwk.nshealth.ca

    Balpreet Singh, MD

    Recruiting

Other trials in Canada

About this study

Official title: The WHEAT International Trial: WithHolding Enteral Feeds Around Red Cell Transfusion to Prevent Necrotizing Enterocolitis in Preterm Neonates: an International, Multi-centre, Randomized Controlled Trial

The WHEAT International trial is a comparative effectiveness trial exploring whether withholding enteral feeds around the time of blood transfusion in very premature infants (<30 weeks) will reduce the occurrence of Necrotizing Enterocolitis (NEC). Currently both continued feeding and withholding feeding are approved care practices. The current study will randomize infants from Neonatal Intensive Care Units (NICUs) across Canada and the United Kingdom (UK) into one of the two care approaches (withholding or continued feeds) to determine if any significant outcomes are found.

Read the detailed description

BACKGROUND: Necrotizing enterocolitis (NEC) is a devastating disease that affects mostly the intestine of premature infants. The wall of the intestine is invaded by bacteria, which cause local infection and inflammation that can ultimately destroy the wall of the bowel (intestine). NEC is among the most potentially devastating neonatal diseases and has a mortality of up to 33%, the most severe form (requiring surgery or resulting in death) affects about 5% of infants born at less than 30 gestational weeks; survivors are at high risk of long-term health and developmental problems. Prevention of NEC has been identified as one of the most important research uncertainties in the field of preterm birth. A temporal association between red cell transfusion and the subsequent development of the disease is well described. This 'transfusion-associated NEC' may also be more severe with higher mortality. Very preterm or extremely low birth weight infants are among the most frequently transfused patients: between 56% and 90-95% have at least one transfusion, and those transfused received an average of 5 transfusions in their neonatal stay. Withholding milk feeds during red cell transfusion may reduce the risk of NEC by decreasing postprandial mesenteric ischemia but there may be harmful effects of pausing enteral feeds. However, due to a lack of good quality evidence, there is no consensus regarding the optimal feeding strategy during a blood transfusion.

Both comparator pathways of care are standard practice in Canada and the UK; the WHEAT trial is a comparative effectiveness trial. The two care pathways that will be compared are:

  1. Withholding Feeds Around Transfusion: All enteral feeds will be discontinued (the infant will be placed nil by mouth) for 4 hours prior to packed red cell transfusion, during the packed red cell transfusion and until 4 hours post packed red cell transfusion.
  2. Continuing Feeds Around Transfusion: Enteral feeds will continue to be given prior, during and after the packed red cell transfusion, in the manner in which they were being given prior to the decision to transfuse.

Infants will remain allocated to the same care pathway until 34(+6) weeks(+days) gestational age.

Being tested
Withholding feeds around transfusion, Continued feeds around transfusion
Keywords
Comparative Effectiveness Trial, Necrotizing Enterocolitis, Premature Infants, Blood Transfusion, Withholding enteral feeds
Medical subject headings
Enterocolitis, Necrotizing, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Withholding feeds around transfusionOther

    Withholding enteral feeds for preterm infants (<30 weeks) around the time of blood transfusions to determine if any impact on the development and/or severity of Necrotizing Enterocolitis.

  • Continued feeds around transfusionOther

    Continued enteral feeds

Study groups in NCT05213806
Study groupRoleWhat they receive
Withholding feeds around transfusionActive comparatorAll enteral feeds will be discontinued (the infant will be placed nil by mouth) for 4 hours prior to packed red cell transfusion, during the transfusion and until 4 hours post transfusion. During this period, hydration and blood glucose will be maintained according to local practice, commonly by providing parenteral nutrition or intravenous dextrose. Four hours after the red cell transfusion has finished, feeds will be recommenced to how they were being received prior to the decision to transfuse. This duration of withholding feeds will follow the approach used in other trials and observational studies, and identified as the most acceptable in a survey of UK neonatal units. It gives time for milk in the small bowel to transit into the large bowel before the transfusion and for the circulation to stabilize after the transfusion before milk feeds given into the stomach pass through into the small intestine.
Receives: Other: Withholding feeds around transfusion
Continuing feeds around transfusionActive comparatorEnteral feeds will continue to be given prior, during and after the packed red cell transfusion, in the manner in which they were being given prior to the decision to transfuse. Infants will remain allocated to the same care pathway until 34(+6) weeks(+days) gestational age.
Receives: Other: Continued feeds around transfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. NEC Stage II

    Stage II or greater NEC recorded after the first trial blood transfusion; defined according to the modified Bell staging criteria: based on clinical features and abdominal imaging findings, or on surgical or histological findings of NEC.

    Measured: From randomization to 40 weeks postmenstrual age

Secondary outcomes (12)

  1. Severe NEC

    Histologically or surgically confirmed or recorded on the death certificate. These infants will be identified as described in Battersby et al. which will include infants recorded as being transferred for surgery.

    Measured: From randomization to 40 weeks postmenstrual age

  2. Death

    All-cause mortality

    Measured: From randomization to 40 weeks postmenstrual age

  3. Late onset sepsis

    Culture positive sepsis, onset after 72 hours of life

    Measured: From randomization to 40 weeks postmenstrual age

  4. Number of days with a central venous line in situ

    Number of days with a central venous line in situ

    Measured: From birth to date of discharge home

  5. Number of central line associated bloodstream infections

    Number of central line associated bloodstream infections: Positive blood culture confirmed bloodstream infection

    Measured: From randomization to 40 weeks postmenstrual age

  6. Duration of any parenteral nutrition in days

    Duration of any parenteral nutrition in days

    Measured: From birth to 40 weeks postmenstrual age

  7. Growth

    Weight and head circumference z score.

    Measured: At date of discharge home

  8. Spontaneous Intestinal Perforation

    Histologically or surgically confirmed or recorded in the death certificate.

    Measured: From randomization to 40 weeks postmenstrual age

  9. Duration of hospital stay

    Total duration of neonatal care in days including all levels of care (intensive care, high dependency care, special care and ordinary care)

    Measured: From birth to date of discharge home

  10. Bronchopulmonary Dysplasia (BPD)/Chronic Lung Disease

    Requiring respiratory support at 36 weeks gestation

    Measured: At 36 weeks postmenstrual age

  11. Retinopathy of prematurity (ROP)

    ROP requiring treatment

    Measured: From randomization to 40 weeks postmenstrual age

  12. Severe Brain Injury

    Intraventricular haemorrhage (IVH) grade 3 or 4 or cystic periventricular leukomalacia (PVL)

    Measured: At 40 weeks postmenstrual age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2022
  2. Study start28 Jan 2022
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
The WHEAT trial is a randomised controlled, unblinded, international, multicentre, parallel-group superiority trial comparing two clinical pathways. Participants will be randomised to either pathway. In the United Kingdom, the trial is running across 77 neonatal units. In Canada, the trial is running at 15 neonatal sites, all of which participate in recruitment, intervention delivery, and follow-up procedures in line with the study protocol. Across both countries, participant recruitment will continue until 31 December 2026. The last participant randomised is expected to complete the trial participation period by 31 March 2027, following completion of the follow-up period defined as neonatal unit discharge or 40+0 weeks postmenstrual age, whichever occurs first. Analysis of trial data will take place after completion of follow-up, with results anticipated to be communicated by September 2027.
Masking
None (open label)
Enrolment
4,333 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05213806
Sponsor's protocol ID
1027137
Other IDs
PJT-175289
Acronym
WHEAT
Status last verified
Nov 2025
First submitted
8 Dec 2021
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified participant data, the data dictionary, statistical code and other study materials.

Publications

  • Battersby C, Longford N, Mandalia S, Costeloe K, Modi N; UK Neonatal Collaborative Necrotising Enterocolitis (UKNC-NEC) study group. Incidence and enteral feed antecedents of severe neonatal necrotising enterocolitis across neonatal networks in England, 2012-13: a whole-population surveillance study. Lancet Gastroenterol Hepatol. 2017 Jan;2(1):43-51. doi: 10.1016/S2468-1253(16)30117-0. Epub 2016 Nov 8.

    PubMed 28404014

  • Duro D, Kalish LA, Johnston P, Jaksic T, McCarthy M, Martin C, Dunn JC, Brandt M, Nobuhara KK, Sylvester KG, Moss RL, Duggan C. Risk factors for intestinal failure in infants with necrotizing enterocolitis: a Glaser Pediatric Research Network study. J Pediatr. 2010 Aug;157(2):203-208.e1. doi: 10.1016/j.jpeds.2010.02.023. Epub 2010 May 6.

    PubMed 20447649

  • Hintz SR, Kendrick DE, Stoll BJ, Vohr BR, Fanaroff AA, Donovan EF, Poole WK, Blakely ML, Wright L, Higgins R; NICHD Neonatal Research Network. Neurodevelopmental and growth outcomes of extremely low birth weight infants after necrotizing enterocolitis. Pediatrics. 2005 Mar;115(3):696-703. doi: 10.1542/peds.2004-0569.

    PubMed 15741374

  • Rees CM, Pierro A, Eaton S. Neurodevelopmental outcomes of neonates with medically and surgically treated necrotizing enterocolitis. Arch Dis Child Fetal Neonatal Ed. 2007 May;92(3):F193-8. doi: 10.1136/adc.2006.099929. Epub 2006 Sep 19.

    PubMed 16984980

  • Duley L, Uhm S, Oliver S; Preterm Birth Priority Setting Partnership Steering Group. Top 15 UK research priorities for preterm birth. Lancet. 2014 Jun 14;383(9934):2041-2042. doi: 10.1016/S0140-6736(14)60989-2. No abstract available.

    PubMed 24931684

  • Seges RA, Kenny A, Bird GW, Wingham J, Baals H, Stauffer UG. Pediatric surgical patients with severe anaerobic infection: report of 16 T-antigen positive cases and possible hazards of blood transfusion. J Pediatr Surg. 1981 Dec;16(6):905-10. doi: 10.1016/s0022-3468(81)80844-5.

    PubMed 6279816

  • Stritzke AI, Smyth J, Synnes A, Lee SK, Shah PS. Transfusion-associated necrotising enterocolitis in neonates. Arch Dis Child Fetal Neonatal Ed. 2013 Jan;98(1):F10-4. doi: 10.1136/fetalneonatal-2011-301282. Epub 2012 Mar 23.

    PubMed 22447991

  • Blau J, Calo JM, Dozor D, Sutton M, Alpan G, La Gamma EF. Transfusion-related acute gut injury: necrotizing enterocolitis in very low birth weight neonates after packed red blood cell transfusion. J Pediatr. 2011 Mar;158(3):403-9. doi: 10.1016/j.jpeds.2010.09.015. Epub 2010 Nov 10.

    PubMed 21067771

  • Mally P, Golombek SG, Mishra R, Nigam S, Mohandas K, Depalhma H, LaGamma EF. Association of necrotizing enterocolitis with elective packed red blood cell transfusions in stable, growing, premature neonates. Am J Perinatol. 2006 Nov;23(8):451-8. doi: 10.1055/s-2006-951300. Epub 2006 Sep 28.

    PubMed 17009195

  • Cunningham KE, Okolo FC, Baker R, Mollen KP, Good M. Red blood cell transfusion in premature infants leads to worse necrotizing enterocolitis outcomes. J Surg Res. 2017 Jun 1;213:158-165. doi: 10.1016/j.jss.2017.02.029. Epub 2017 Feb 28.

    PubMed 28601308

  • Keir AK, Yang J, Harrison A, Pelausa E, Shah PS; Canadian Neonatal Network. Temporal changes in blood product usage in preterm neonates born at less than 30 weeks' gestation in Canada. Transfusion. 2015 Jun;55(6):1340-6. doi: 10.1111/trf.12998. Epub 2015 Feb 5.

    PubMed 25652740

  • Kirpalani H, Whyte RK, Andersen C, Asztalos EV, Heddle N, Blajchman MA, Peliowski A, Rios A, LaCorte M, Connelly R, Barrington K, Roberts RS. The Premature Infants in Need of Transfusion (PINT) study: a randomized, controlled trial of a restrictive (low) versus liberal (high) transfusion threshold for extremely low birth weight infants. J Pediatr. 2006 Sep;149(3):301-307. doi: 10.1016/j.jpeds.2006.05.011.

    PubMed 16939737

  • Jasani B, Rao S, Patole S. Withholding Feeds and Transfusion-Associated Necrotizing Enterocolitis in Preterm Infants: A Systematic Review. Adv Nutr. 2017 Sep 15;8(5):764-769. doi: 10.3945/an.117.015818. Print 2017 Sep.

    PubMed 28916576

  • Sahin S, Gozde Kanmaz Kutman H, Bozkurt O, Yavanoglu Atay F, Emre Canpolat F, Uras N, Suna Oguz S, Underwood MA. Effect of withholding feeds on transfusion-related acute gut injury in preterm infants: a pilot randomized controlled trial. J Matern Fetal Neonatal Med. 2020 Dec;33(24):4139-4144. doi: 10.1080/14767058.2019.1597844. Epub 2019 Mar 28.

    PubMed 30890001

  • Neu J. Necrotizing enterocolitis: the search for a unifying pathogenic theory leading to prevention. Pediatr Clin North Am. 1996 Apr;43(2):409-32. doi: 10.1016/s0031-3955(05)70413-2.

    PubMed 8614608

Questions about this trial

What is this clinical trial studying?

A study testing Withholding feeds around transfusion and Continued feeds around transfusion in people with Necrotizing Enterocolitis, run by IWK Health Centre at 40 sites in 2 countries.

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 4 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: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United Kingdom, Canada. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cari-Lee Carnell (9024706630, cari-lee.carnell@iwk.nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NEC Stage II (time frame: From randomization to 40 weeks postmenstrual age). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05213806, which also lists 16 linked publications.

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 29 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in