Association Between Different Blood Groups and Sepsis in Preterm Infants

November 6, 2018 updated by: Ufuk Cakir

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

2000

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

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

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Neonates born at gestational age <32 weeks with birth weight <1500

Description

Inclusion Criteria:

  • Preterm neonates born at <32 weeks of gestation with a birth weight <1500 g.

Exclusion Criteria:

  • Neonates born with severe congenital defects, birth weight ≥1500 g and gestational age ≥32 weeks were excluded.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A blood group
prematurity with sepsis
Diagnostic test: Diagnosis
biochemistry
O blood group
prematurity with sepsis
Diagnostic test: Diagnosis
biochemistry
B blood group
prematurity with sepsis
Diagnostic test: Diagnosis
biochemistry
AB blood group
prematurity with sepsis
Diagnostic test: Diagnosis
biochemistry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 3 month

Collaborators and Investigators

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

Sponsor

Ufuk Cakir

Collaborators

Zekai Tahir Burak Women's Health Research and Education Hospital

Investigators

  • Principal Investigator: ufuk cakir, Zekai Tahir Burak Women's Health Research and Education Hospital

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 (Anticipated)

December 15, 2018

Primary Completion (Anticipated)

February 1, 2019

Study Completion (Anticipated)

October 31, 2019

Study Registration Dates

First Submitted

November 2, 2018

First Submitted That Met QC Criteria

November 6, 2018

First Posted (Actual)

November 8, 2018

Study Record Updates

Last Update Posted (Actual)

November 8, 2018

Last Update Submitted That Met QC Criteria

November 6, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BGaPS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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