Splanchnic OxygenationNCT06663085
Using NIRS to Evaluate Splanchnic Oxygenation During Blood Transfusion in Preterm Infant
A study testing Enteral feeding in people with Splanchnic Oxygenation and NIRS, run by Gadjah Mada University at 1 site in Indonesia.
Trial summary
To evaluate the differences splanchnic oxygen saturation in preterm infants receiving red blood cell transfusion with and without enteral feeding, and their outcomes. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Splanchnic Oxygenation, NIRS, PreTerm Neonate
- What is being tested?
- Enteral feeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteIndonesia
- Study dates
- 30 Oct 2024to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Infant with gestational age < 37 weeks
- Planned to receive blood transfusion
- Had received minimum 25 ml/kg/day enteral feeding
- in stable condition
Who cannot join
- Infant with multiple congenital anomalies
- Infant with suspected/confirmed genetic anomalies
- Parents or family did not sign the informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Dr Sardjito General Hospital
Yogyakarta, Special Region of Yogyakarta, 62
leksmana hidayatullah, medical doctor, +6281284298440, leksmanahidayatullah@gmail.com
leksmana hidayatullah, medical doctor
About this study
Official title: 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.
Read the detailed description
using NIRS to evaluate splanchnic oxygenation
- Conditions
- Splanchnic Oxygenation, NIRS, PreTerm Neonate, Enteral Feeds
- Being tested
- Enteral feeding
- Keywords
- transfusion, nirs, splanchnic oxygenation, preterm neonate, enteral feeds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral feedingDietary supplement
Also called breastmilk
intervention group received enteral feeding breastmilk during transfusion
| Study group | Role | What they receive |
|---|---|---|
| control group not received enteral feeding | No intervention | control group not received enteral feeding during blood transfusion |
| intervention group received enteral feeding | Active comparator | intervention group still received enteral feeding during blood transfusion Receives: Dietary Supplement: Enteral feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral splanchnic oxygenation ratio using nirs
percentage of splanchnic oxygenaation divided with cerebral oxygenation
Measured: from enrollment to 48 hours after transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start30 Oct 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Splanchnic OxygenationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- control group: not received enteral feeding during transfusion intervention group: received enteral feeding
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leksmana Hidayatullah, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663085
- Sponsor's protocol ID
- KE/FK/1583/EC/2024
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the data will not be planned to share until publication, if any person want to see the data can contact the investigator by email
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Enteral Feeding on Splanchnic Oxygenation During Blood Transfusion in Preterm Infants
- ClinicalTrials.gov ID
- NCT06663085
- Acronym / sponsor ID
- KE/FK/1583/EC/2024
- Conditions
- Splanchnic Oxygenation, NIRS, PreTerm Neonate, Enteral Feeds
- Keywords
- transfusion, nirs, splanchnic oxygenation, preterm neonate, enteral feeds
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 30 Oct 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
using NIRS to evaluate splanchnic oxygenation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- control group: not received enteral feeding during transfusion intervention group: received enteral feeding
| Arm | Type | Receives |
|---|---|---|
| control group not received enteral feeding | No intervention | –control group not received enteral feeding during blood transfusion |
| intervention group received enteral feeding | Active comparator | Dietary Supplement: Enteral feedingintervention group still received enteral feeding during blood transfusion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Infant with gestational age < 37 weeks
- Planned to receive blood transfusion
- Had received minimum 25 ml/kg/day enteral feeding
- in stable condition
Key exclusion criteria (3 listed)
- Infant with multiple congenital anomalies
- Infant with suspected/confirmed genetic anomalies
- Parents or family did not sign the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enteral feedingAlso: breastmilkintervention group received enteral feeding breastmilk during transfusion | Dietary supplement | intervention group received enteral feeding |
Primary outcome
cerebral splanchnic oxygenation ratio using nirs
Time frame: from enrollment to 48 hours after transfusion
percentage of splanchnic oxygenaation divided with cerebral oxygenation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Individual participant dataSharing planned: No. the data will not be planned to share until publication, if any person want to see the data can contact the investigator by email
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enteral feeding in people with Splanchnic Oxygenation and NIRS, run by Gadjah Mada University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact leksmana hidayatullah, medical doctor (+6281284298440, leksmanahidayatullah@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cerebral splanchnic oxygenation ratio using nirs (time frame: from enrollment to 48 hours after transfusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024; AzTrials last refreshed its copy on 2 Nov 2026.