How blood transfusions and feeding affect the gut of very preterm babies
Mechanisms Affecting the Gut of Preterm Infants Receiving Blood Transfusion With Different Enteral Feed Interventions
Imperial College Healthcare NHS Trust · NCT07191678
We will test if continuing versus stopping milk feeds during blood transfusions changes gut and brain oxygen levels in very preterm babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 270 (estimated) |
| Ages | 23 Weeks to 30 Weeks |
| Sex | All |
| Sponsor | Imperial College Healthcare NHS Trust (other) |
| Locations | 1 site (London) |
| Trial ID | NCT07191678 on ClinicalTrials.gov |
What this trial studies
MAGPIE-2 is a mechanistic observational study nested within the WHEAT randomized trial, which randomizes very preterm infants to either withhold or continue enteral feeds during red blood cell transfusion. The study will recruit about 270 infants already enrolled in WHEAT and perform weekly and peri-transfusion monitoring using near-infrared spectroscopy (NIRS) and Doppler ultrasound. NIRS will measure cerebral and splanchnic tissue oxygenation to calculate the splanchnic-cerebral oxygenation ratio (SCOR), while Doppler will assess superior mesenteric artery blood flow. The goal is to identify physiological changes in gut perfusion and oxygenation that might explain links between transfusion, feeding practice, and NEC risk.
Who should consider this trial
Good fit: Very preterm infants born between 23 and less than 30 weeks gestation who are enrolled in the WHEAT trial and whose parents provide written consent are eligible, provided they are stable enough for non-invasive monitoring.
Not a fit: Infants who already have Bell stage 2 or higher NEC, have had bowel surgery or major congenital abdominal anomalies, or are too clinically unstable for monitoring are unlikely to benefit from this mechanistic monitoring.
Why it matters
Potential benefit: If successful, findings could guide feeding practices around transfusion to reduce NEC risk and improve outcomes for very preterm infants.
How similar studies have performed: Previous observational studies have reported a temporal link between transfusion and NEC and smaller NIRS/Doppler studies have shown peri-transfusion changes in gut oxygenation, but results are mixed and mechanisms remain unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Very preterm babies (born between 23 to \<30 weeks of gestational age ) in the WHEAT International trial * Written informed consent from parents Exclusion Criteria: * 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
Where this trial is running
London
- Queen Charlotte's & Chelsea Hospital, Neontal Unit — London, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Jayanta Banerjee, MD (RES), FRCPCH, MBBS
- Email: jayanta.banerjee@nhs.net
- Phone: 07771826045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: NEC - Necrotizing Enterocolitis, NEC, Preterm Babies, Preterm Infant Health, Necrotizing Enterocolitis, Necrotising Enterocolitis, Preterm