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

• ClinicalTrials.gov Identifier: NCT06039618
• Recruitment Status: Completed
• First Posted: September 15, 2023
• Last Update Posted: September 18, 2023
• Sponsor: Evangelisches Krankenhaus Bethesda zu Duisburg
• Information provided by (Responsible Party): Antoine Naem, Evangelisches Krankenhaus Bethesda zu Duisburg

Tracking Information

• First Submitted Date: September 6, 2023
• First Posted Date: September 15, 2023
• Last Update Posted Date: September 18, 2023
• Actual Study Start Date: January 1, 2013
• Actual Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 9, 2023)

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Capabilities of Perinatal Healthcare Institutions in the Federation of Bosnia and Herzegovina
• 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.
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Newborns that were born in the maternity wards of the Federation of Bosnia and Herzegovina
• Condition: Prenatal Care

Intervention

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.

Study Groups/Cohorts

• 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.
  Intervention: 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 9, 2023): 22897
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 31, 2017
• Actual Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 22 Weeks to 42 Weeks (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Bosnia and Herzegovina

Administrative Information

• NCT Number: NCT06039618
• Other Study ID Numbers: 02-09/2-77/20
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Antoine Naem, Evangelisches Krankenhaus Bethesda zu Duisburg
• Original Responsible Party: Same as current
• Current Study Sponsor: Evangelisches Krankenhaus Bethesda zu Duisburg
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Anis Cerovac, M.D.; General Hospital Tešanj

• PRS Account: Evangelisches Krankenhaus Bethesda zu Duisburg
• Verification Date: September 2023