Blood Group Antigen AbnormalityNCT03734978
Association Between Different Blood Groups and Sepsis in Preterm Infants
An observational study of Blood Group Antigen Abnormality and Prematurity, run by Ufuk Cakir at 1 site in Turkey (Türkiye).
Trial summary
To investigate whether there is a relationship between sepsis and blood groups in preterm infants.This retrospective cohort study included preterm neonates born at <32 weeks of gestation with a birth weight <1500 g. Neonates were grouped by blood type (O, A, B, AB) and sepsis were compared among these groups. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Blood Group Antigen Abnormality, Prematurity, Sepsis
- What is being tested?
- Diagnosis
- How many people
- 2,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2018to 31 Oct 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Neonates born at gestational age <32 weeks with birth weight <1500
Who may be able to join
- Preterm neonates born at <32 weeks of gestation with a birth weight <1500 g.
Who cannot join
- Neonates born with severe congenital defects, birth weight ≥1500 g and gestational age ≥32 weeks were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zekai Tahir Burak Hospital
Ankara, 06130
ufuk cakir, M.D., 5058581781, drufukcakir@hotmail.com
cuneyt tayman, prof, drufukcakir@hotmail.com
About this study
Official title: Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Clinical Professor
To investigate whether there is a relationship between sepsis and blood groups in preterm infants.This retrospective cohort study included preterm neonates born at <32 weeks of gestation with a birth weight <1500 g. Neonates were grouped by blood type (O, A, B, AB) and sepsis were compared among these groups.
Read the detailed description
This retrospective study was conducted on data collected between 1 January 2011 and 31 August 2018 in the neonatal intensive care unit (NICU) of the Health Sciences University Zekai Tahir Burak Women's Health Education and Research Hospital.
Neonates born at GA <32 weeks with birth weight (BW) <1500 g were included in the study.
Data pertaining to the neonates were recorded from medical records for each patient, and their ABO blood type was recorded.
The neonates were grouped by blood type (O, A, B, AB) and also separated into non-O (A, B, AB) and O groups and non-A (O, B, AB) and A groups for comparison of early and late onset sepsis.
- Conditions
- Blood Group Antigen Abnormality, Prematurity, Sepsis
- Being tested
- Diagnosis
- Keywords
- Blood group, sepsis, preterms
- Medical subject headings
- Premature Birth, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiagnosisDiagnostic test
biochemistry
| Study group | Role | What they receive |
|---|---|---|
| A blood group | prematurity with sepsis Receives: Diagnostic Test: Diagnosis | |
| O blood group | prematurity with sepsis Receives: Diagnostic Test: Diagnosis | |
| B blood group | prematurity with sepsis Receives: Diagnostic Test: Diagnosis | |
| AB blood group | prematurity with sepsis Receives: Diagnostic Test: Diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association Between Different Blood Groups and Sepsis in Preterm Infants
The neonates were grouped by blood type (O, A, B, AB) and also separated into non-O (A, B, AB) and O groups and non-A (O, B, AB) and A groups for comparison of demographic characteristics, clinical features, and sepsis.
Measured: Through study completion, an average of 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start15 Dec 2018 (estimated)
- Primary completion1 Feb 2019 (estimated)
- Study completion31 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Group Antigen AbnormalityStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ufuk Cakir
- Sponsor type
- University, hospital or other
- Collaborators
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Responsible party
- Sponsor-investigator, Ufuk Cakir, Ankara University
- Investigators
- ufuk cakir, Principal investigator, Zekai Tahir Burak Women's Health Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734978
- Sponsor's protocol ID
- BGaPS
- Status last verified
- Nov 2018
- First submitted
- 2 Nov 2018
- Last updated
- 8 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Clinical Professor
- ClinicalTrials.gov ID
- NCT03734978
- Acronym / sponsor ID
- BGaPS
- Conditions
- Blood Group Antigen Abnormality, Prematurity, Sepsis
- Keywords
- Blood group, sepsis, preterms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Ufuk CakirUniversity, hospital or other
- Collaborators
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Study start
- 15 Dec 2018 (estimated)
- Primary completion
- 1 Feb 2019 (estimated)
- Study completion
- 31 Oct 2019 (estimated)
- First posted
- 8 Nov 2018 (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 investigate whether there is a relationship between sepsis and blood groups in preterm infants.This retrospective cohort study included preterm neonates born at <32 weeks of gestation with a birth weight <1500 g. Neonates were grouped by blood type (O, A, B, AB) and sepsis were compared among these groups.
Detailed description
This retrospective study was conducted on data collected between 1 January 2011 and 31 August 2018 in the neonatal intensive care unit (NICU) of the Health Sciences University Zekai Tahir Burak Women's Health Education and Research Hospital.
Neonates born at GA <32 weeks with birth weight (BW) <1500 g were included in the study.
Data pertaining to the neonates were recorded from medical records for each patient, and their ABO blood type was recorded.
The neonates were grouped by blood type (O, A, B, AB) and also separated into non-O (A, B, AB) and O groups and non-A (O, B, AB) and A groups for comparison of early and late onset sepsis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A blood group | – | Diagnostic Test: Diagnosisprematurity with sepsis |
| O blood group | – | Diagnostic Test: Diagnosisprematurity with sepsis |
| B blood group | – | Diagnostic Test: Diagnosisprematurity with sepsis |
| AB blood group | – | Diagnostic Test: Diagnosisprematurity with sepsis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Neonates born at gestational age <32 weeks with birth weight <1500
Key inclusion criteria (1 listed)
- Preterm neonates born at <32 weeks of gestation with a birth weight <1500 g.
Key exclusion criteria (1 listed)
- Neonates born with severe congenital defects, birth weight ≥1500 g and gestational age ≥32 weeks were excluded.
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 |
|---|---|---|
| Diagnosisbiochemistry | Diagnostic test | A blood group, AB blood group, B blood group, O blood group |
Primary outcome
Association Between Different Blood Groups and Sepsis in Preterm Infants
Time frame: Through study completion, an average of 3 month
The neonates were grouped by blood type (O, A, B, AB) and also separated into non-O (A, B, AB) and O groups and non-A (O, B, AB) and A groups for comparison of demographic characteristics, clinical features, and sepsis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Individual participant dataSharing planned: No
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.
ufuk cakir principal investigator
Zekai Tahir Burak Women's Health Research and Education 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 Blood Group Antigen Abnormality and Prematurity, run by Ufuk Cakir 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 8 Nov 2018. 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 ufuk cakir (05058581781, drufukcakir@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between Different Blood Groups and Sepsis in Preterm Infants (time frame: Through study completion, an average of 3 month). 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 8 Nov 2018.