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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03734978
Other study ID # BGaPS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 15, 2018
Est. completion date October 31, 2019

Study information

Verified date November 2018
Source Ankara University
Contact ufuk cakir
Phone 05058581781
Email drufukcakir@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date October 31, 2019
Est. primary completion date February 1, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Diagnosis
biochemistry

Locations

Country Name City State
Turkey Zekai Tahir Burak Hospital Ankara

Sponsors (2)

Lead Sponsor Collaborator
Ufuk Cakir Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Through study completion, an average of 3 month
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