Neonatal Surgery Intensive Care Unit: Hacettepe Experience (NSICUHE)

January 27, 2021 updated by: H. Tolga Çelik, Hacettepe University

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.

Study Overview

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 Type

Observational

Enrollment (Actual)

5442

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Newborns hospitalized in the Hacettepe University neonatal intensive care unit. 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal Surgery Intensive Care Unit working principle
Time Frame: 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.
five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

January 20, 2021

First Submitted That Met QC Criteria

January 27, 2021

First Posted (Actual)

February 2, 2021

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

January 27, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • GO-SURGERY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Surgery--Complications

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