Necrotizing Enterocolitis of NewbornNCT04083638
The Relationship Between Erythrocyte Transfusion and Nutrition and Necrotizing Enterocolitis in Preterm Infants
An observational study of Necrotizing Enterocolitis of Newborn, run by Dr. Behcet Uz Children's Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study; The aim of this study was to investigate the changes in fasting and dietary and mesenteric blood flow in the acute period during and after transfusion and to evaluate the necrotizing enterocolitis. Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Necrotizing Enterocolitis of Newborn
- What is being tested?
- IFAB
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 1 month
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants
Who may be able to join
- <32 gestational week and/or <1500 g birth weight
Who cannot join
- Major congenital anomalies, hemodynamic instability
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Behçet Uz Children's Hospital
İzmirli, İzmir, 35210
Senem A Özdemir, MD, 5327614670, drsenemalkan@yahoo.com
Senem Alkan Ozdemir, MD, 05327614670, drsenemalkan@yahoo.com
About this study
Official title: Investigation of the Relationship Between Erythrocyte Transfusion and Nutrition and Necrotizing Enterocolitis in Preterm Infants: a Randomized Controlled Clinical Trial
In this study; The aim of this study was to investigate the changes in fasting and dietary and mesenteric blood flow in the acute period during and after transfusion and to evaluate the necrotizing enterocolitis.
- Conditions
- Necrotizing Enterocolitis of Newborn
- Being tested
- IFAB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IFABDiagnostic test
Intestinal Fatty Acid Binding Protein will be taken from all participants before the tx and after the tx
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Control group Receives: Diagnostic Test: IFAB | |
| Group 2 | Feeding will not stop during the transfusion Receives: Diagnostic Test: IFAB |
What is being measured
The primary outcome is the main question the study is designed to answer.
necrotizing enterocolitis
Measured: 0-48 hours after tx
Mortality
If all babies die after tx study will be finished
Measured: 0-24 hour after tx
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start1 Jan 2020 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing Enterocolitis of NewbornStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Behcet Uz Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Senem Alkan Özdemir, Dr. Behcet Uz Children's Hospital
- Investigators
- Rüya Çolak, MD, Study chair, Behcet Uz Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083638
- Sponsor's protocol ID
- 2019/279
- Status last verified
- Sep 2019
- First submitted
- 6 Sep 2019
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Erythrocyte Transfusion and Nutrition and Necrotizing Enterocolitis in Preterm Infants: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04083638
- Acronym / sponsor ID
- 2019/279
- Conditions
- Necrotizing Enterocolitis of Newborn
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Dr. Behcet Uz Children's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 10 Sep 2019 (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.
In this study; The aim of this study was to investigate the changes in fasting and dietary and mesenteric blood flow in the acute period during and after transfusion and to evaluate the necrotizing enterocolitis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: IFABControl group |
| Group 2 | – | Diagnostic Test: IFABFeeding will not stop during the transfusion |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants
Key inclusion criteria (1 listed)
- <32 gestational week and/or <1500 g birth weight
Key exclusion criteria (1 listed)
- Major congenital anomalies, hemodynamic instability
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 |
|---|---|---|
| IFABIntestinal Fatty Acid Binding Protein will be taken from all participants before the tx and after the tx | Diagnostic test | Group 1, Group 2 |
Primary outcome
necrotizing enterocolitis
Time frame: 0-48 hours after tx
Mortality
Time frame: 0-24 hour after tx
If all babies die after tx study will be finished
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
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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. This study is not recruiting at the moment.
Rüya Çolak, MD study chair
Behcet Uz Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Necrotizing Enterocolitis of Newborn, run by Dr. Behcet Uz Children's Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Sep 2019. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Senem A Özdemir, MD (05327614670, drsenemalkan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
necrotizing enterocolitis (time frame: 0-48 hours after tx). The study lists 2 primary outcomes in all. 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 10 Sep 2019.