Using NIRS to Evaluate Splanchnic Oxygenation During Blood Transfusion in Preterm Infant
The Effect of Enteral Feeding on Splanchnic Oxygenation During Blood Transfusion in Preterm Infants
1 other identifier
interventional
42
1 country
1
Brief Summary
To evaluate the differences splanchnic oxygen saturation in preterm infants receiving red blood cell transfusion with and without enteral feeding, and their outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2024
CompletedFirst Posted
Study publicly available on registry
October 29, 2024
CompletedStudy Start
First participant enrolled
October 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2025
CompletedOctober 29, 2024
October 1, 2024
2 months
October 24, 2024
October 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cerebral splanchnic oxygenation ratio using nirs
percentage of splanchnic oxygenaation divided with cerebral oxygenation
from enrollment to 48 hours after transfusion
Study Arms (2)
control group not received enteral feeding
NO INTERVENTIONcontrol group not received enteral feeding during blood transfusion
intervention group received enteral feeding
ACTIVE COMPARATORintervention group still received enteral feeding during blood transfusion
Interventions
intervention group received enteral feeding breastmilk during transfusion
Eligibility Criteria
You may qualify if:
- Infant with gestational age \< 37 weeks
- Planned to receive blood transfusion
- Had received minimum 25 ml/kg/day enteral feeding
- in stable condition
You may not qualify if:
- Infant with multiple congenital anomalies
- Infant with suspected/confirmed genetic anomalies
- Parents or family did not sign the informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr Sardjito General Hospital
Yogyakarta, Special Region of Yogyakarta, 62, Indonesia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
October 24, 2024
First Posted
October 29, 2024
Study Start
October 30, 2024
Primary Completion
December 30, 2024
Study Completion
January 15, 2025
Last Updated
October 29, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share
the data will not be planned to share until publication, if any person want to see the data can contact the investigator by email