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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06039618
Recruitment Status : Completed
First Posted : September 15, 2023
Last Update Posted : September 18, 2023
Sponsor:
Information provided by (Responsible Party):
Antoine Naem, Evangelisches Krankenhaus Bethesda zu Duisburg

Study Description
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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.

Condition or disease Intervention/treatment
Prenatal Care Other: Referral to Centre of Higher Organizational Level

Study Design
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Study Type : Observational
Actual Enrollment : 22897 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: 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.
Actual Study Start Date : January 1, 2013
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

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Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Referral to a centre of higher organizational level. [ Time Frame: Before birth and up to 4 hours or more after delivery. ]
    Referring the neonate with low birth weight to a more specialized centre.


Eligibility Criteria
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Ages Eligible for Study:   22 Weeks to 42 Weeks   (Child)
Sexes Eligible for Study:   All
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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06039618


Locations
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Bosnia and Herzegovina
General Hospital Tešanj
Tešanj, Bosnia and Herzegovina
Sponsors and Collaborators
Evangelisches Krankenhaus Bethesda zu Duisburg
Investigators
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Principal Investigator: Anis Cerovac, M.D. General Hospital Tešanj
More Information
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Responsible Party: Antoine Naem, Research Assistant, Evangelisches Krankenhaus Bethesda zu Duisburg
ClinicalTrials.gov Identifier: NCT06039618    
Other Study ID Numbers: 02-09/2-77/20
First Posted: September 15, 2023    Key Record Dates
Last Update Posted: September 18, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No