NEC - Necrotizing EnterocolitisMAGPIE-2NCT07191678
Mechanisms Affecting the Gut of Preterm Infants Receiving Blood Transfusion With Different Enteral Feed Interventions
An observational study of NEC - Necrotizing Enterocolitis and NEC, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
MAGPIE-2 is a prospective observational study designed to investigate the physiological mechanisms linking blood transfusion and enteral feeding practices to gut perfusion and oxygenation in very preterm infants. Read more about this study
- Who is it for?
- Ages 23 to 30 weeks
- Conditions the study is for
- NEC - Necrotizing Enterocolitis, NEC, Preterm Babies
- How many people
- 270 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Nov 2025to 30 Apr 2027
- Phase
- Observational
- 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 23 to 30 weeks
- All sexes
- No healthy volunteers
- Child
Study population: This study will recruit 270 very preterm infants born between 23 and 30 weeks gestational age who are already enrolled in the WHEAT International trial. These infants are receiving care in neonatal units across the UK participating in WHEAT. MAGPIE-2 will include 135 infants in each arm of the WHEAT trial (feeds withheld vs continued during transfusion). All participants must have informed parental consent for additional non-invasive monitoring. The study population represents a high-risk group for necrotising enterocolitis (NEC), and the inclusion criteria align with the WHEAT trial to ensure consistency in clinical context and intervention exposure. Exclusion criteria include infants with pre-existing NEC, congenital abdominal anomalies, or those deemed clinically unstable for monitoring.
Who may be able to join
- Very preterm babies (born between 23 to <30 weeks of gestational age ) in the WHEAT International trial
- Written informed consent from parents
Who cannot join
- Babies who are deemed too unstable to perform the non-invasive monitoring and the ultrasound scan measurements by the attending clinical team
- Babies who have already developed Bells stage 2 NEC, had bowel surgery or congenital abdominal conditions such as congenital diaphragmatic hernia, gastroschisis and exomphalos
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Charlotte's & Chelsea Hospital, Neontal Unit
London, W12 0HS
Jayanta Banerjee, MD (Res), FRCPCH, MBBS, 07771826045, jayanta.banerjee@nhs.net
Jayanta Banerjee, MD (Res), FRCPCH, MBBS
About this study
MAGPIE-2 is a prospective observational study designed to investigate the physiological mechanisms linking blood transfusion and enteral feeding practices to gut perfusion and oxygenation in very preterm infants. The study is nested within the WHEAT International randomised controlled trial, which compares two standard care approaches: withholding versus continuing milk feeds during red blood cell transfusion. While WHEAT evaluates clinical outcomes such as necrotising enterocolitis (NEC), MAGPIE-2 focuses on the underlying physiological changes that may contribute to NEC development.
NEC is a serious gastrointestinal condition affecting approximately 10% of extremely preterm infants and is associated with high mortality and long-term neurodevelopmental impairment. Previous observational studies have suggested a temporal link between blood transfusion and NEC onset, particularly when feeds are continued during transfusion. However, the mechanisms remain poorly understood.
Read more
MAGPIE-2 will use non-invasive monitoring tools-near-infrared spectroscopy (NIRS) and Doppler ultrasound-to measure cerebral and splanchnic (gut) tissue oxygenation and superior mesenteric artery (SMA) blood flow. These measurements will be used to calculate the Splanchnic-Cerebral Oxygenation Ratio (SCOR), a validated marker of gut tissue perfusion and ischaemia. A reduction in SCOR may indicate compromised gut oxygenation, potentially contributing to NEC.
The study will recruit 270 infants (135 per arm) already enrolled in the WHEAT trial. Weekly measurements will be taken until 34 weeks corrected gestational age or discharge. Peri-transfusion monitoring includes continuous NIRS from 4 hours before to 4 hours after transfusion, and additional 2-hour recordings at approximately 24 and 48 hours post-transfusion. SMA Doppler assessments will be performed weekly.
Primary outcomes include changes in SCOR post-transfusion between the two feeding strategies. Secondary outcomes include changes in cerebral and splanchnic oxygenation, SMA blood flow velocities, and the impact of severe anaemia (pre-transfusion haemoglobin ≤80 g/L) on these parameters. The study also includes an assessment of inter-operator variability in Doppler measurements.
MAGPIE-2 aims to provide mechanistic insights that could inform safer transfusion and feeding practices in neonatal care, potentially reducing the incidence of NEC in this vulnerable population.
Read the detailed description
MAGPIE-2 is a mechanistic observational study nested within the WHEAT International randomised controlled trial, which compares two standard neonatal care practices: withholding versus continuing enteral feeds during red blood cell transfusion in very preterm infants. While WHEAT evaluates clinical outcomes such as necrotising enterocolitis (NEC), MAGPIE-2 is designed to explore the physiological mechanisms that may underlie the development of NEC in this context.
NEC is a leading cause of morbidity and mortality in extremely preterm infants, with onset often temporally associated with blood transfusion. The pathophysiology is thought to involve gut ischaemia, inflammation, and impaired perfusion, but the precise mechanisms remain unclear. MAGPIE-2 addresses this gap by applying non-invasive monitoring techniques to assess gut and brain oxygenation and perfusion in infants undergoing transfusion.
The study will recruit 270 infants (135 per arm) already enrolled in the WHEAT trial. These infants will undergo weekly and peri-transfusion assessments using near-infrared spectroscopy (NIRS) and Doppler ultrasound. NIRS will measure cerebral and splanchnic (gut) tissue oxygenation, allowing calculation of the Splanchnic-Cerebral Oxygenation Ratio (SCOR), a validated marker of gut perfusion. Doppler ultrasound will assess blood flow in the superior mesenteric artery (SMA), which supplies the gut regions most vulnerable to NEC.
Measurements will be taken:
Weekly (2-hour NIRS and SMA Doppler) until 34 weeks corrected gestational age or discharge Peri-transfusion: continuous NIRS from 4 hours before to 4 hours after transfusion (12-hour window), and 2-hour recordings at approximately 24 and 48 hours post-transfusion The primary outcome is the relative change in SCOR post-transfusion between the two feeding strategies. Secondary outcomes include changes in cerebral and splanchnic oxygenation, SMA peak systolic and diastolic velocities, and the relationship between pre-transfusion haemoglobin levels and perfusion metrics. The study also includes an assessment of inter-operator variability in Doppler measurements and a mediation analysis to explore causal pathways.
MAGPIE-2 will use mixed-effects regression models to account for within-subject and within-centre variability, and propensity score weighting to adjust for selection bias. The study is powered to detect a 20% absolute difference in SCOR, which is considered clinically significant for identifying gut ischaemia.
By integrating physiological data with clinical trial design, MAGPIE-2 aims to provide mechanistic evidence to support safer transfusion and feeding practices in neonatal care. The findings may inform future guidelines and reduce the incidence of NEC in this high-risk population.
- Keywords
- NEC, Necrotizing Enterocolitis, Necrotising Enterocolitis, Preterm
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Withhold feeds during routine packed red cell transfusion | Infants who have been randomised in the WHEAT Trial to have their enteral feeds withheld during routine packed red cell transfusion. | |
| Continue feeds during routine packed red cell transfusion | Infants who have been randomised in the WHEAT Trial to have their enteral feeds continued during routine packed red cell transfusion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Splanchnic-Cerebral Oxygenation Ratio (SCOR) post-transfusion
SCOR is calculated as the ratio of splanchnic (gut) to cerebral tissue oxygenation, measured using near-infrared spectroscopy (NIRS). A reduction in SCOR may indicate gut hypoperfusion or ischaemia. This outcome assesses the relative change in SCOR following blood transfusion in infants whose feeds were withheld versus continued.
Measured: Continuous from 4 hours pre-transfusion to 4 hours post-transfusion (12-hour window) for each transfusion received with WHEAT Trial intervention; plus additional weekly 2-hour recordings until 34 weeks corrected age or neonatal discharge.
Secondary outcomes (7)
Change in Cerebral Oxygenation (crSO2) Post-Transfusion
Measures cerebral tissue oxygenation using NIRS to assess impact of transfusion and feeding strategy.
Measured: Continuous from 4 hours pre-transfusion to 4 hours post-transfusion (12-hour window) for each transfusion received with WHEAT Trial intervention; plus additional weekly 2-hour recordings until 34 weeks corrected age or neonatal discharge.
Change in Splanchnic Oxygenation (srSO2) Post-Transfusion
Measures gut tissue oxygenation using NIRS to evaluate perfusion changes post-transfusion.
Measured: Continuous from 4 hours pre-transfusion to 4 hours post-transfusion (12-hour window) for each transfusion received with WHEAT Trial intervention; plus additional weekly 2-hour recordings until 34 weeks corrected age or neonatal discharge.
Change in SMA Peak Systolic Velocity Post-Transfusion
Assesses SMA blood flow velocity using Doppler ultrasound to evaluate gut perfusion.
Measured: Weekly Doppler ultrasound assessments until 34 weeks corrected age or neonatal discharge.
Change in SMA Diastolic Velocity Post-Transfusion
Measures SMA end-diastolic velocity to assess vascular resistance and perfusion.
Measured: Weekly Doppler ultrasound assessments until 34 weeks corrected age or neonatal discharge.
Relationship Between Pre-Transfusion Haemoglobin and SCOR, crSO2, srSO2
Evaluates association between haemoglobin levels and tissue oxygenation in gut and brain.
Measured: Continuous from 4 hours pre-transfusion to 4 hours post-transfusion (12-hour window) for each transfusion received with WHEAT Trial intervention; plus additional NIRS weekly 2-hour recordings until 34 weeks corrected age or neonatal discharge.
Relationship Between Haemoglobin and SMA Doppler Parameters
Assesses correlation between haemoglobin levels and SMA blood flow velocities and indices.
Measured: Weekly Doppler ultrasound assessments until 34 weeks corrected age or neonatal discharge.
Inter-Operator Variability in SMA Doppler Measurements
Assesses consistency between operators in measuring SMA velocities and indices using ICC.
Measured: One-time assessment during weekly Doppler ultrasound in a subset of 35 infants across 7 centres.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start3 Nov 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NEC - Necrotizing EnterocolitisStudies of the same condition, open and under way.
- 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
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds, Imperial College London, Nottingham University Hospitals NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191678
- Sponsor's protocol ID
- 23HH8296
- Acronym
- MAGPIE-2
- Status last verified
- Mar 2026
- First submitted
- 17 Sep 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms Affecting the Gut of Preterm Infants Receiving Blood Transfusion With Different Enteral Feed Interventions
- ClinicalTrials.gov ID
- NCT07191678
- Acronym / sponsor ID
- MAGPIE-2 / 23HH8296
- Keywords
- NEC, Necrotizing Enterocolitis, Necrotising Enterocolitis, Preterm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- University of Leeds, Imperial College London, Nottingham University Hospitals NHS Trust
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 25 Sep 2025 (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.
MAGPIE-2 is a prospective observational study designed to investigate the physiological mechanisms linking blood transfusion and enteral feeding practices to gut perfusion and oxygenation in very preterm infants. The study is nested within the WHEAT International randomised controlled trial, which compares two standard care approaches: withholding versus continuing milk feeds during red blood cell transfusion. While WHEAT evaluates clinical outcomes such as necrotising enterocolitis (NEC), MAGPIE-2 focuses on the underlying physiological changes that may contribute to NEC development.
NEC is a serious gastrointestinal condition affecting approximately 10% of extremely preterm infants and is associated with high mortality and long-term neurodevelopmental impairment. Previous observational studies have suggested a temporal link between blood transfusion and NEC onset, particularly when feeds are continued during transfusion. However, the mechanisms remain poorly understood.
MAGPIE-2 will use non-invasive monitoring tools-near-infrared spectroscopy (NIRS) and Doppler ultrasound-to measure cerebral and splanchnic (gut) tissue oxygenation and superior mesenteric artery (SMA) blood flow. These measurements will be used to calculate the Splanchnic-Cerebral Oxygenation Ratio (SCOR), a validated marker of gut tissue perfusion and ischaemia. A reduction in SCOR may indicate compromised gut oxygenation, potentially contributing to NEC.
The study will recruit 270 infants (135 per arm) already enrolled in the WHEAT trial. Weekly measurements will be taken until 34 weeks corrected gestational age or discharge. Peri-transfusion monitoring includes continuous NIRS from 4 hours before to 4 hours after transfusion, and additional 2-hour recordings at approximately 24 and 48 hours post-transfusion. SMA Doppler assessments will be performed weekly.
Primary outcomes include changes in SCOR post-transfusion between the two feeding strategies. Secondary outcomes include changes in cerebral and splanchnic oxygenation, SMA blood flow velocities, and the impact of severe anaemia (pre-transfusion haemoglobin ≤80 g/L) on these parameters. The study also includes an assessment of inter-operator variability in Doppler measurements.
MAGPIE-2 aims to provide mechanistic insights that could inform safer transfusion and feeding practices in neonatal care, potentially reducing the incidence of NEC in this vulnerable population.
Detailed description
MAGPIE-2 is a mechanistic observational study nested within the WHEAT International randomised controlled trial, which compares two standard neonatal care practices: withholding versus continuing enteral feeds during red blood cell transfusion in very preterm infants. While WHEAT evaluates clinical outcomes such as necrotising enterocolitis (NEC), MAGPIE-2 is designed to explore the physiological mechanisms that may underlie the development of NEC in this context.
NEC is a leading cause of morbidity and mortality in extremely preterm infants, with onset often temporally associated with blood transfusion. The pathophysiology is thought to involve gut ischaemia, inflammation, and impaired perfusion, but the precise mechanisms remain unclear. MAGPIE-2 addresses this gap by applying non-invasive monitoring techniques to assess gut and brain oxygenation and perfusion in infants undergoing transfusion.
The study will recruit 270 infants (135 per arm) already enrolled in the WHEAT trial. These infants will undergo weekly and peri-transfusion assessments using near-infrared spectroscopy (NIRS) and Doppler ultrasound. NIRS will measure cerebral and splanchnic (gut) tissue oxygenation, allowing calculation of the Splanchnic-Cerebral Oxygenation Ratio (SCOR), a validated marker of gut perfusion. Doppler ultrasound will assess blood flow in the superior mesenteric artery (SMA), which supplies the gut regions most vulnerable to NEC.
Measurements will be taken:
Weekly (2-hour NIRS and SMA Doppler) until 34 weeks corrected gestational age or discharge Peri-transfusion: continuous NIRS from 4 hours before to 4 hours after transfusion (12-hour window), and 2-hour recordings at approximately 24 and 48 hours post-transfusion The primary outcome is the relative change in SCOR post-transfusion between the two feeding strategies. Secondary outcomes include changes in cerebral and splanchnic oxygenation, SMA peak systolic and diastolic velocities, and the relationship between pre-transfusion haemoglobin levels and perfusion metrics. The study also includes an assessment of inter-operator variability in Doppler measurements and a mediation analysis to explore causal pathways.
MAGPIE-2 will use mixed-effects regression models to account for within-subject and within-centre variability, and propensity score weighting to adjust for selection bias. The study is powered to detect a 20% absolute difference in SCOR, which is considered clinically significant for identifying gut ischaemia.
By integrating physiological data with clinical trial design, MAGPIE-2 aims to provide mechanistic evidence to support safer transfusion and feeding practices in neonatal care. The findings may inform future guidelines and reduce the incidence of NEC in this high-risk population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Withhold feeds during routine packed red cell transfusion | – | –Infants who have been randomised in the WHEAT Trial to have their enteral feeds withheld during routine packed red cell transfusion. |
| Continue feeds during routine packed red cell transfusion | – | –Infants who have been randomised in the WHEAT Trial to have their enteral feeds continued during routine packed red cell transfusion. |
Who may qualify
- Ages
- 23 to 30 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study will recruit 270 very preterm infants born between 23 and 30 weeks gestational age who are already enrolled in the WHEAT International trial. These infants are receiving care in neonatal units across the UK participating in WHEAT. MAGPIE-2 will include 135 infants in each arm of the WHEAT trial (feeds withheld vs continued during transfusion). All participants must have informed parental consent for additional non-invasive monitoring. The study population represents a high-risk group for necrotising enterocolitis (NEC), and the inclusion criteria align with the WHEAT trial to ensure consistency in clinical context and intervention exposure. Exclusion criteria include infants with pre-existing NEC, congenital abdominal anomalies, or those deemed clinically unstable for monitoring.
Key inclusion criteria (2 listed)
- Very preterm babies (born between 23 to <30 weeks of gestational age ) in the WHEAT International trial
- Written informed consent from parents
Key exclusion criteria (2 listed)
- Babies who are deemed too unstable to perform the non-invasive monitoring and the ultrasound scan measurements by the attending clinical team
- Babies who have already developed Bells stage 2 NEC, had bowel surgery or congenital abdominal conditions such as congenital diaphragmatic hernia, gastroschisis and exomphalos
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
Change in Splanchnic-Cerebral Oxygenation Ratio (SCOR) post-transfusion
Time frame: Continuous from 4 hours pre-transfusion to 4 hours post-transfusion (12-hour window) for each transfusion received with WHEAT Trial intervention; plus additional weekly 2-hour recordings until 34 weeks corrected age or neonatal discharge.
SCOR is calculated as the ratio of splanchnic (gut) to cerebral tissue oxygenation, measured using near-infrared spectroscopy (NIRS). A reduction in SCOR may indicate gut hypoperfusion or ischaemia. This outcome assesses the relative change in SCOR following blood transfusion in infants whose feeds were withheld versus continued.
7 secondary outcomes
Change in Cerebral Oxygenation (crSO2) Post-Transfusion
Time frame: Continuous from 4 hours pre-transfusion to 4 hours post-transfusion (12-hour window) for each transfusion received with WHEAT Trial intervention; plus additional weekly 2-hour recordings until 34 weeks corrected age or neonatal discharge.
Change in Splanchnic Oxygenation (srSO2) Post-Transfusion
Time frame: Continuous from 4 hours pre-transfusion to 4 hours post-transfusion (12-hour window) for each transfusion received with WHEAT Trial intervention; plus additional weekly 2-hour recordings until 34 weeks corrected age or neonatal discharge.
Change in SMA Peak Systolic Velocity Post-Transfusion
Time frame: Weekly Doppler ultrasound assessments until 34 weeks corrected age or neonatal discharge.
Change in SMA Diastolic Velocity Post-Transfusion
Time frame: Weekly Doppler ultrasound assessments until 34 weeks corrected age or neonatal discharge.
Relationship Between Pre-Transfusion Haemoglobin and SCOR, crSO2, srSO2
Time frame: Continuous from 4 hours pre-transfusion to 4 hours post-transfusion (12-hour window) for each transfusion received with WHEAT Trial intervention; plus additional NIRS weekly 2-hour recordings until 34 weeks corrected age or neonatal discharge.
Relationship Between Haemoglobin and SMA Doppler Parameters
Time frame: Weekly Doppler ultrasound assessments until 34 weeks corrected age or neonatal discharge.
Inter-Operator Variability in SMA Doppler Measurements
Time frame: One-time assessment during weekly Doppler ultrasound in a subset of 35 infants across 7 centres.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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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.
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 NEC - Necrotizing Enterocolitis and NEC, run by Imperial College Healthcare NHS Trust 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 2 inclusion and 2 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 1 Apr 2026. 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?
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 Jayanta Banerjee, MD (RES), FRCPCH, MBBS (07771826045, jayanta.banerjee@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Splanchnic-Cerebral Oxygenation Ratio (SCOR) post-transfusion (time frame: Continuous from 4 hours pre-transfusion to 4 hours post-transfusion (12-hour window) for each transfusion received with WHEAT Trial intervention; plus additional weekly 2-hour recordings until 34 weeks corrected age or neonatal discharge.). 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 Apr 2026.