Capabilities of Perinatal Healthcare Institutions in the Federation of Bosnia and Herzegovina

Capabilities of Perinatal Healthcare Institutions in Primary and Tertiary Care of Low Birth Weight Infants in the Federation of Bosnia and Herzegovina: A Cross-sectional Multicentric Study.

The aim of this study is to assess the level of the perinatal healthcare institution (PHI) where the newborns were delivered. We included newborns of both genders that were born in the maternity wards in 10 cantons of the Federation of Bosnia and Herzegovina (FBiH). From the PHI of the first and second level, 159 newborns were referred to the third level. Out of a total of 159 LBWI referred from other PHI, only 19.5% LBWI were transported in less than 4 hours. In second level PHI, most LBWI died in the first 12 hours after birth.

Study Overview

• Status: Completed
• Conditions: Prenatal Care
• Intervention / Treatment: Other: Referral to Centre of Higher Organizational Level

• Study Type: Observational
• Enrollment (Actual): 22897

Contacts and Locations

Study Locations

• Bosnia and Herzegovina
  • Tešanj, Bosnia and Herzegovina
    • General Hospital Tesanj

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Newborns that were born in the maternity wards of the Federation of Bosnia and Herzegovina

Description

Inclusion Criteria:

• Newborns of both genders that were born in the maternity wards in 10 cantons of the FBiH
• A gestational age between 22 and 42 weeks, and a birth weight less than 2500g.

Exclusion Criteria:

• Infants younger than 22 weeks or older than 42 weeks.
• Infants whose mothers refused to give consent for participation in the study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Referred to a Centre of Higher Level; Those are the newborns that were referred at the time of delivery or within one week after birth to centers of higher organizational level.	Other: Referral to Centre of Higher Organizational Level; Referral to Centre of Higher Organizational Level. This means referral from a primary neonatal care center to a secondary one, or from the secondary to the tertiary center.
Treated at the Centre of Admission; Those are the newborns that were not referred to other centers and were treated in the health facility were the birth took place, and hospitalized in the same center until discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Referral to a centre of higher organizational level.	Referring the neonate with low birth weight to a more specialized centre.	Before birth and up to 4 hours or more after delivery.

Collaborators and Investigators

• Sponsor: Evangelisches Krankenhaus Bethesda zu Duisburg
• Investigators: Principal Investigator: Anis Cerovac, M.D., General Hospital Tesanj

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: September 6, 2023
• First Submitted That Met QC Criteria: September 9, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 02-09/2-77/20

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