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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04734002
Other study ID # GO-SURGERY
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date November 30, 2020

Study information

Verified date January 2021
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Background: Surgical treatment in the neonatal period mostly consists of congenital anomalies. Due to the different characteristics of newborns, the practice of monitoring this group of patients by neonatal specialists in neonatal intensive care units is increasingly common in the world and in our country. In our hospital, neonatal surgery intensive care unit model has been applied for about six years. Objectives: This study was aimed at examining the data gathered from the neonatal surgery intensive care unit we created at Ihsan Dogramaci Children's Hospital and the contribution of this model toward improving the health of newborns with surgical problems. Methods: The file records of newborns admitted to the neonatal and neonatal surgery intensive care units which operate on two separate floors at Ihsan Dogramaci Children's Hospital were retrospectively analyzed for the period January 2014 to December 2019. The information of the patients was recorded retrospectively for the study period with the information obtained from the hospital database. The investigators believe that the neonatal surgery intensive care unit model should become widespread in Turkey. As there is a paucity of information concerning this subject in the literature worldwide and in our country, through this study the investigators wanted to draw attention to the subject by sharing our own experience working at İhsan Dogramaci Children's Hospital.


Description:

Background: Surgical treatment in the neonatal period mostly consists of congenital anomalies. Due to the different characteristics of newborns, the practice of monitoring this group of patients by neonatal specialists in neonatal intensive care units is increasingly common in the world and in our country. In our hospital, neonatal surgery intensive care unit model has been applied for about six years. Objectives: This study was aimed at examining the data gathered from the neonatal surgery intensive care unit we created at Ihsan Dogramaci Children's Hospital and the contribution of this model toward improving the health of newborns with surgical problems. Methods: In this study, the file records of newborns admitted to the neonatal and neonatal surgery intensive care units which operate on two separate floors at Ihsan Dogramaci Children's Hospital were retrospectively analyzed for the period January 2014 to December 2019. The demographic, neonatal, and clinical information of the patients-including medical and surgical diseases and mortality rates-was recorded retrospectively for the study period with the information obtained from the hospital database. In addition, the gestational week, birth weight, gender, and length of hospital stay of the patients who were operated on in our unit in the last 2 years were examined. The data obtained from the hospital database were recorded in Microsoft Excel and SPSS 22.0 Base, and statistical analysis was performed. Aİm: This study was aimed at examining the data gathered from the neonatal surgery intensive care unit we created at Ihsan Dogramaci Children's Hospital and the contribution of this model toward improving the health of newborns with surgical problems.


Recruitment information / eligibility

Status Completed
Enrollment 5442
Est. completion date November 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 28 Days
Eligibility Inclusion Criteria: - Newborns hospitalized in the Hacettepe University neonatal intensive care unit. - All newborns who had surgery. Exclusion Criteria: - Babies older than 28 days. - babies not recorded in the hospital database.

Study Design


Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Siddharth V, Gupta SK, Agarwala S, Satpathy S, Goel P. Outcome of Care Provided in Neonatal Surgery Intensive Care Unit of a Public Sector Tertiary Care Teaching Hospital of India. J Indian Assoc Pediatr Surg. 2019 Oct-Dec;24(4):257-263. doi: 10.4103/jiaps.JIAPS_177_18. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Neonatal Surgery Intensive Care Unit working principle This study was aimed at examining the data gathered from the neonatal surgery intensive care unit the investigators created at Ihsan Dogramaci Children's Hospital and the contribution of this model toward improving the health of newborns with surgical problems. five years
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