An observational study in NEC - Necrotizing Enterocolitis, NEC and Preterm Babies, sponsored by Imperial College Healthcare NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 23 Weeks to 30 Weeks. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by Imperial College Healthcare NHS Trust · Observational
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.
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.
228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.
This study's planned enrollment of 270 is above the median of 144 across 95 observational studies indexed under Enterocolitis, Necrotizing.
Browse Enterocolitis, Necrotizing studies →Imperial College Healthcare NHS Trust is the lead sponsor of 80 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Infants who have been randomised in the WHEAT Trial to have their enteral feeds withheld 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.
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.
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 Cerebral Oxygenation (crSO2) Post-Transfusion
Measures cerebral tissue oxygenation using NIRS to assess impact of transfusion and feeding strategy.
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
Measures gut tissue oxygenation using NIRS to evaluate perfusion changes 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
Assesses SMA blood flow velocity using Doppler ultrasound to evaluate gut perfusion.
Time frame: 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.
Time frame: 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.
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
Assesses correlation between haemoglobin levels and SMA blood flow velocities and indices.
Time frame: 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.
Time frame: One-time assessment during weekly Doppler ultrasound in a subset of 35 infants across 7 centres.
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Imperial College Healthcare NHS Trust