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

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05809063
Collaborator
(none)
300
1
12
24.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: observational

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Characterization, Risk Factors and Outcome of Neonates Admitted to Neonatal Intensive Care Units (NICU) at Sohag University Hospitals
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. document the number, & outcome in neonates with respiratory diseases admitted to neonatal intensive care units [12 months]

    all neonates admitted with respiratory diseases in neonatal intensive care units

  2. document the number, & outcome in neonates with cardiovascular diseases admitted to neonatal intensive care units [12 months]

    all neonates admitted with cardiovascular diseases in neonatal intensive care units

  3. document the number, & outcome in neonates with gastrointestinal diseases admitted to neonatal intensive care units [12 months]

    all neonates admitted with gastrointestinal diseases in neonatal intensive care units

  4. document the number, & outcome in neonates with renal diseases admitted to neonatal intensive care units [12 months]

    all neonates admitted with renal diseases in neonatal intensive care units

  5. document the number, & outcome in neonates with central nervous system diseases admitted to neonatal intensive care units [12 months]

    all neonates admitted with central nervous system diseases in neonatal intensive care units

  6. document the number, & outcome in neonates with metabolic diseases admitted to neonatal intensive care units [12 months]

    all neonates admitted with metabolic diseases in neonatal intensive care units

  7. document the number, & outcome in neonates with endocrinal diseases admitted to neonatal intensive care units [12 months]

    all neonates admitted with endocrinal diseases in neonatal intensive care units

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Day to 28 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag University hospitals Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Rofida Abdelsabor Abdelbasset, Resident of pediatric and neonatology department, Sohag University Hospitals, Sohag University
ClinicalTrials.gov Identifier:
NCT05809063
Other Study ID Numbers:
  • Soh-Med-23-03-15MS
First Posted:
Apr 12, 2023
Last Update Posted:
Apr 12, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 12, 2023