Characterization, Risk Factors and Outcome of Neonates Admitted to Neonatal Intensive Care Units (NICU) at Sohag University Hospitals

March 30, 2023 updated by: Rofida Abdelsabor Abdelbasset, Sohag University

The neonatal period considered the time from birth up to the first 28 days of life & further classified into:

  • Very early birth (birth to < 24 hours).
  • Early birth (24 hours to < 7 days).
  • Late or last neonatal period (7 days to 28 days).

It is characterized by the transition from extra uterine life and rapid growth and development. It is the common vulnerable time or period of human life as it accounts for more high mortalities and morbidities, however, most of them are preventable.

The pattern of neonatal disease is a useful indicator of the availability, utilization and effectiveness of maternal and child health care services.

It varies from place to place and from time to time even in the same locality. Information on admission and mortality patterns of hospitalized neonates should reflect the major causes of illnesses and standard of care provided to neonates in a particular locality.

To improve neonatal services with better overall outcomes and less sever morbidities early identification of the risk factors is paramount so that appropriate interventions can be directed towards the most prevalent and treatable neonatal illnesses. To achieve this goal, it is important to study the pattern of neonatal admissions

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: Mohammed A Bakhet, Professor

Study Locations

  • Egypt
      • Sohag, Egypt
        • Sohag University hospitals

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

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

- All neonates that will be admitted in Neonatal Intensive Care Units (NICU) including preterm, term and post term neonates.

Description

Inclusion Criteria:

  • All neonates that will be admitted in Neonatal Intensive Care Units (NICU) including preterm, term and post term neonates.

Exclusion Criteria:

  • Failure to obtain consent.
  • Neonates need preparation for advanced interventions not available in our unit like cardiac operations.
  • Neonates require peritoneal dialysis.
  • Traumatic injury.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cardiovascular patients
neonates that have cardiovascular diseases
Other: observational
document the number , disease pattern& outcome of neonates admitted to the neonatal intensive care units
respiratory patients
neonates that have respiratory diseases
Other: observational
document the number , disease pattern& outcome of neonates admitted to the neonatal intensive care units
gastrointestinal diseases
neonates that havegastrointestinal diseases
Other: observational
document the number , disease pattern& outcome of neonates admitted to the neonatal intensive care units
renal patients
neonates that have renal diseases
Other: observational
document the number , disease pattern& outcome of neonates admitted to the neonatal intensive care units
central nervous system diseases
neonates that have central nervous system diseases
Other: observational
document the number , disease pattern& outcome of neonates admitted to the neonatal intensive care units
metabolic patients
neonates that have metabolic diseases
Other: observational
document the number , disease pattern& outcome of neonates admitted to the neonatal intensive care units
endocrinal patients
neonates that have endocrinal diseases
Other: observational
document the number , disease pattern& outcome of neonates admitted to the neonatal intensive care units

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
document the number, & outcome in neonates with respiratory diseases admitted to neonatal intensive care units
Time Frame: 12 months
all neonates admitted with respiratory diseases in neonatal intensive care units
12 months
document the number, & outcome in neonates with cardiovascular diseases admitted to neonatal intensive care units
Time Frame: 12 months
all neonates admitted with cardiovascular diseases in neonatal intensive care units
12 months
document the number, & outcome in neonates with gastrointestinal diseases admitted to neonatal intensive care units
Time Frame: 12 months
all neonates admitted with gastrointestinal diseases in neonatal intensive care units
12 months
document the number, & outcome in neonates with renal diseases admitted to neonatal intensive care units
Time Frame: 12 months
all neonates admitted with renal diseases in neonatal intensive care units
12 months
document the number, & outcome in neonates with central nervous system diseases admitted to neonatal intensive care units
Time Frame: 12 months
all neonates admitted with central nervous system diseases in neonatal intensive care units
12 months
document the number, & outcome in neonates with metabolic diseases admitted to neonatal intensive care units
Time Frame: 12 months
all neonates admitted with metabolic diseases in neonatal intensive care units
12 months
document the number, & outcome in neonates with endocrinal diseases admitted to neonatal intensive care units
Time Frame: 12 months
all neonates admitted with endocrinal diseases in neonatal intensive care units
12 months

Collaborators and Investigators

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

Sponsor

Sohag University

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.

General Publications

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 (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

March 30, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-03-15MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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