Using NIRS to Evaluate Splanchnic Oxygenation During Blood Transfusion in Preterm Infant

October 28, 2024 updated by: Leksmana Hidayatullah, Gadjah Mada University

The Effect of Enteral Feeding on Splanchnic Oxygenation During Blood Transfusion in Preterm Infants

To evaluate the differences splanchnic oxygen saturation in preterm infants receiving red blood cell transfusion with and without enteral feeding, and their outcomes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

using NIRS to evaluate splanchnic oxygenation

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Indonesia
      • Yogyakarta, Indonesia, 62
        • Dr Sardjito General Hospital
        • Contact:
        • Contact:
          • leksmana hidayatullah, medical doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Infant with gestational age < 37 weeks
  • Planned to receive blood transfusion
  • Had received minimum 25 ml/kg/day enteral feeding
  • in stable condition

Exclusion Criteria:

  • Infant with multiple congenital anomalies
  • Infant with suspected/confirmed genetic anomalies
  • Parents or family did not sign the informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group not received enteral feeding
control group not received enteral feeding during blood transfusion
Active Comparator: intervention group received enteral feeding
intervention group still received enteral feeding during blood transfusion
Dietary supplement: Enteral feeding
intervention group received enteral feeding breastmilk during transfusion
Other Names:
  • breastmilk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cerebral splanchnic oxygenation ratio using nirs
Time Frame: from enrollment to 48 hours after transfusion
percentage of splanchnic oxygenaation divided with cerebral oxygenation
from enrollment to 48 hours after transfusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gadjah Mada University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 30, 2024

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

January 15, 2025

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

October 28, 2024

First Posted (Actual)

October 29, 2024

Study Record Updates

Last Update Posted (Actual)

October 29, 2024

Last Update Submitted That Met QC Criteria

October 28, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KE/FK/1583/EC/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

the data will not be planned to share until publication, if any person want to see the data can contact the investigator by email

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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