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NSICUHE: Neonatal Surgery Intensive Care Unit: Hacettepe Experience

Sponsor
Hacettepe University (Other)
Overall Status
Completed
CT.gov ID
NCT04734002
Collaborator
(none)
5,442
Enrollment
1
Location
11
Actual Duration (Months)
495.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    5442 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Neonatal Surgery Intensive Care Unit: Hacettepe Experience
    Actual Study Start Date :
    Jan 1, 2020
    Actual Primary Completion Date :
    Jun 30, 2020
    Actual Study Completion Date :
    Nov 30, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Neonatal Surgery Intensive Care Unit working principle [five years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 28 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hacettepe University Ankara Turkey

    Sponsors and Collaborators

    • Hacettepe University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    H. Tolga Çelik, associate professor, Hacettepe University
    ClinicalTrials.gov Identifier:
    NCT04734002
    Other Study ID Numbers:
    • GO-SURGERY
    First Posted:
    Feb 2, 2021
    Last Update Posted:
    Feb 2, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Feb 2, 2021