NCT03734978

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

December 15, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

November 8, 2018

Status Verified

November 1, 2018

Enrollment Period

2 months

First QC Date

November 2, 2018

Last Update Submit

November 6, 2018

Conditions

Keywords

Blood groupsepsispreterms

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

A blood group

prematurity with sepsis

Diagnostic Test: Diagnosis

O blood group

prematurity with sepsis

Diagnostic Test: Diagnosis

B blood group

prematurity with sepsis

Diagnostic Test: Diagnosis

AB blood group

prematurity with sepsis

Diagnostic Test: Diagnosis

Interventions

DiagnosisDIAGNOSTIC_TEST

biochemistry

A blood groupAB blood groupB blood groupO blood group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zekai Tahir Burak Hospital

Ankara, 06130, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Premature BirthSepsis

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • ufuk cakir

    Zekai Tahir Burak Women's Health Research and Education Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 2, 2018

First Posted

November 8, 2018

Study Start

December 15, 2018

Primary Completion

February 1, 2019

Study Completion

October 31, 2019

Last Updated

November 8, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations