NCT06039618

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22,897

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

5 years

First QC Date

September 6, 2023

Last Update Submit

September 15, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

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

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.

Interventions

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.

Referred to a Centre of Higher Level

Eligibility Criteria

Age22 Weeks - 42 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital Tešanj

Tešanj, Bosnia and Herzegovina

Location

Study Officials

  • Anis Cerovac, M.D.

    General Hospital Tešanj

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

September 6, 2023

First Posted

September 15, 2023

Study Start

January 1, 2013

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

September 18, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations