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

NCT ID: NCT05809063

Last Updated: 2023-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neonatal Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

cardiovascular patients

neonates that have cardiovascular diseases

observational

Intervention Type OTHER

document the number , disease pattern\& outcome of neonates admitted to the neonatal intensive care units

respiratory patients

neonates that have respiratory diseases

observational

Intervention Type OTHER

document the number , disease pattern\& outcome of neonates admitted to the neonatal intensive care units

gastrointestinal diseases

neonates that havegastrointestinal diseases

observational

Intervention Type OTHER

document the number , disease pattern\& outcome of neonates admitted to the neonatal intensive care units

renal patients

neonates that have renal diseases

observational

Intervention Type OTHER

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

observational

Intervention Type OTHER

document the number , disease pattern\& outcome of neonates admitted to the neonatal intensive care units

metabolic patients

neonates that have metabolic diseases

observational

Intervention Type OTHER

document the number , disease pattern\& outcome of neonates admitted to the neonatal intensive care units

endocrinal patients

neonates that have endocrinal diseases

observational

Intervention Type OTHER

document the number , disease pattern\& outcome of neonates admitted to the neonatal intensive care units

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

observational

document the number , disease pattern\& outcome of neonates admitted to the neonatal intensive care units

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sohag University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rofida Abdelsabor Abdelbasset

Resident of pediatric and neonatology department, Sohag University Hospitals

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sohag University hospitals

Sohag, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

rofida A Mohamed, Resident

Role: CONTACT

01032853330

Mohammed A Bakhet, Professor

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Magdy M Amin, Professor

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Persson M, Shah PS, Rusconi F, Reichman B, Modi N, Kusuda S, Lehtonen L, Hakansson S, Yang J, Isayama T, Beltempo M, Lee S, Norman M; International Network for Evaluating Outcomes of Neonates. Association of Maternal Diabetes With Neonatal Outcomes of Very Preterm and Very Low-Birth-Weight Infants: An International Cohort Study. JAMA Pediatr. 2018 Sep 1;172(9):867-875. doi: 10.1001/jamapediatrics.2018.1811.

Reference Type BACKGROUND
PMID: 29971428 (View on PubMed)

Mansoor KP, Ravikiran SR, Kulkarni V, Baliga K, Rao S, Bhat KG, Baliga BS, Kamath N. Modified Sick Neonatal Score (MSNS): A Novel Neonatal Disease Severity Scoring System for Resource-Limited Settings. Crit Care Res Pract. 2019 May 9;2019:9059073. doi: 10.1155/2019/9059073. eCollection 2019.

Reference Type BACKGROUND
PMID: 31210987 (View on PubMed)

Dorling JS, Field DJ, Manktelow B. Neonatal disease severity scoring systems. Arch Dis Child Fetal Neonatal Ed. 2005 Jan;90(1):F11-6. doi: 10.1136/adc.2003.048488.

Reference Type BACKGROUND
PMID: 15613564 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Soh-Med-23-03-15MS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of L-arginine and Glutamine on Preterm
NCT01263041 COMPLETED PHASE2/PHASE3