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Stopping versus Continuing Enteral Feeding during Packed Red Blood Cell Transfusion in Preterm Infants: A Pilot Randomized Controlled Trial

Stopping versus Continuing Enteral Feeding during Packed Red Blood Cell Transfusion in Preterm Infants: A Pilot Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260317005
Enrollment
20
Registered
2026-03-17
Start date
2025-01-26
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal epithelial injury Transfusion associated necrotizing enterocolitis (TANEC) Transfusion associated circulatory overload (TACO) Prematurity Anemia Transfusion associated necrotizing enterocolitis (TANEC) Transfusion associated circulatory overload (TACO) Intestinal fatty acid-binding protein

Interventions

Enteral feeding was stopped immediately after randomization and withheld for a total of 12 hours (4 hours before transfusion, during transfusion, and 4 hours after transfusion). For infants receiving
Experimental Procedure/Surgery,No Intervention Procedure/Surgery
Stopping enteral feeding during pRBC transfusion,Continuing feeding during pRBC transfusion

Sponsors

Faculty of Medicine, Chiang Mai University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Neonates born at 34-week gestation or less requiring packed RBC transfusion prior to a postmenstrual age (PMA) of 44 weeks

Exclusion criteria

Exclusion criteria: 1. Genetic syndrome 2. Congenital anomalies 3. Prior pRBC transfusion 4. NEC stage II or more 5. spontaneous intestinal perforation (SIP)

Design outcomes

Primary

MeasureTime frame
Recruitment rate 12 months persons per month,Protocol adherence 12 hours percentage,Retention 48 hours after transfusion percentage,Hypoglycemia 4 hours during transfusion Percentage,Hyperglycemia 4 hours during transfusion percentage

Secondary

MeasureTime frame
Intestinal fatty acid-binding protein pre- and post-transfusion Enzyme-linked immunosorbent assay,Transfusion-associated necrotizing enterocolitis 48 hours after transfusion clinical determination,Transfusion-associated circulatory overload 24 hours after transfusion clinical determination

Countries

Thailand

Contacts

Public ContactSatit Manopunya

Chiang Mai University

satit.manopunya@cmu.ac.th0982391956

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026