Mechanisms Affecting the Gut of Preterm Infants Receiving Blood Transfusion With Different Enteral Feed Interventions

NCT07191678 | Recruiting DMC

• 1 other identifier: 23HH8296
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

NEC - Necrotizing Enterocolitis; NEC; Preterm Babies; Preterm Infant Health

Keywords

NEC; Necrotizing Enterocolitis; Necrotising Enterocolitis; Preterm

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  Weekly Doppler ultrasound assessments until 34 weeks corrected age or neonatal discharge.

• Change in SMA Diastolic Velocity Post-Transfusion

  Weekly Doppler ultrasound assessments until 34 weeks corrected age or neonatal discharge.

• Relationship Between Pre-Transfusion Haemoglobin and SCOR, crSO2, srSO2

  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.

Study Arms (2)

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.

Eligibility Criteria

• Age: 23 Weeks - 30 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Very preterm babies (born between 23 to \<30 weeks of gestational age ) in the WHEAT International trial
• Written informed consent from parents

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead
• University of Leeds: collaborator
• Imperial College London: collaborator
• Nottingham University Hospitals NHS Trust: collaborator

Study Sites (1)

Queen Charlotte's & Chelsea Hospital, Neontal Unit

London, W12 0HS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Premature Birth

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Jayanta Banerjee, MD (RES), FRCPCH, MBBS

CONTACT

07771826045; jayanta.banerjee@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 25, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)