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

NCT ID: NCT06663085

Last Updated: 2024-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-30

Study Completion Date

2025-01-15

Brief Summary

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

Detailed Description

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using NIRS to evaluate splanchnic oxygenation

Conditions

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Splanchnic Oxygenation NIRS PreTerm Neonate Enteral Feeds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

control group: not received enteral feeding during transfusion intervention group: received enteral feeding
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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control group not received enteral feeding

control group not received enteral feeding during blood transfusion

Group Type NO_INTERVENTION

No interventions assigned to this group

intervention group received enteral feeding

intervention group still received enteral feeding during blood transfusion

Group Type ACTIVE_COMPARATOR

Enteral feeding

Intervention Type DIETARY_SUPPLEMENT

intervention group received enteral feeding breastmilk during transfusion

Interventions

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Enteral feeding

intervention group received enteral feeding breastmilk during transfusion

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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breastmilk

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gadjah Mada University

OTHER

Sponsor Role lead

Responsible Party

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Leksmana Hidayatullah

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dr Sardjito General Hospital

Yogyakarta, Special Region of Yogyakarta, Indonesia

Site Status

Countries

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Indonesia

Central Contacts

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leksmana hidayatullah, medical doctor

Role: CONTACT

+6281284298440

Facility Contacts

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leksmana hidayatullah, medical doctor

Role: primary

+6281284298440

leksmana hidayatullah, medical doctor

Role: backup

Other Identifiers

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KE/FK/1583/EC/2024

Identifier Type: -

Identifier Source: org_study_id

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