Actively Recruiting
Mechanisms Affecting the Gut of Preterm Infants Receiving Blood Transfusion With Different Enteral Feed Interventions
Led by Imperial College Healthcare NHS Trust · Updated on 2026-04-01
270
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
I
Imperial College Healthcare NHS Trust
Lead Sponsor
U
University of Leeds
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how blood transfusions and feeding practices affect gut blood flow and oxygen levels in very preterm infants. This study is part of the larger WHEAT trial, which compares stopping versus continuing milk feeds during red blood cell transfusions. The focus is on understanding the physiological changes that might lead to necrotising enterocolitis (NEC), a serious gut condition that affects about 10% of extremely preterm babies and can have severe consequences. The study involves 270 very preterm infants already enrolled in the WHEAT trial, divided evenly between those who have feeds withheld during transfusion and those who continue feeding. Researchers use non-invasive tools like near-infrared spectroscopy (NIRS) and Doppler ultrasound to monitor oxygen levels in the brain and gut, and blood flow in the gut's main artery. Measurements occur weekly until babies reach 34 weeks corrected age or are discharged, with detailed monitoring around transfusions including continuous oxygen monitoring before, during, and after transfusion. Participants will have several assessments including 2-hour weekly NIRS and ultrasound scans, plus continuous oxygen monitoring during transfusions and follow-ups at 24 and 48 hours post-transfusion. The main measure is the change in the ratio of gut to brain oxygenation after transfusion between feeding strategies. Secondary measures include blood flow speeds and relationships with blood hemoglobin levels. The study also examines measurement consistency between operators. This comprehensive monitoring aims to improve understanding that could lead to safer feeding and transfusion practices for these vulnerable infants.
CONDITIONS
Brief Title
Mechanisms Affecting the Gut of Preterm Infants Receiving Blood Transfusion With Different Enteral Feed Interventions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Very preterm babies born between 23 to less than 30 weeks of gestational age enrolled in the WHEAT International trial
- Written informed consent from parents
You will not qualify if you...
- Babies considered too unstable for non-invasive monitoring and ultrasound scans by the clinical team
- Babies with Bells stage 2 NEC, previous bowel surgery, or congenital abdominal conditions such as diaphragmatic hernia, gastroschisis, or exomphalos
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until 34 weeks corrected gestational age or neonatal discharge
Participants are monitored using weekly 2-hour near-infrared spectroscopy (NIRS) and Doppler ultrasound assessments to measure cerebral and gut oxygenation and blood flow until 34 weeks corrected gestational age or neonatal discharge.
Weekly visits with 2-hour NIRS and Doppler ultrasound assessments
Duration - Around each transfusion event
Participants undergo continuous oxygenation monitoring from 4 hours before to 4 hours after each blood transfusion, plus additional 2-hour monitoring sessions at approximately 24 and 48 hours post-transfusion to assess changes related to transfusion events.
Continuous monitoring during a 12-hour window for each transfusion plus 2 additional 2-hour monitoring sessions post-transfusion
Trial Site Locations
Total: 1 location
1
Queen Charlotte's & Chelsea Hospital, Neontal Unit
London, United Kingdom, W12 0HS
Actively Recruiting
Research Team
J
Jayanta Banerjee, MD (RES), FRCPCH, MBBS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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