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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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