NCT05809063

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

April 12, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

March 30, 2023

Last Update Submit

March 30, 2023

Conditions

Neonatal Diseases

Outcome Measures

Primary Outcomes (7)

  • document the number, & outcome in neonates with respiratory diseases admitted to neonatal intensive care units

    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

    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

    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

    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

    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

    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

    all neonates admitted with endocrinal diseases in neonatal intensive care units

    12 months

Study Arms (7)

cardiovascular patients

neonates that have cardiovascular diseases

Other: observational

respiratory patients

neonates that have respiratory diseases

Other: observational

gastrointestinal diseases

neonates that havegastrointestinal diseases

Other: observational

renal patients

neonates that have renal diseases

Other: observational

central nervous system diseases

neonates that have central nervous system diseases

Other: observational

metabolic patients

neonates that have metabolic diseases

Other: observational

endocrinal patients

neonates that have endocrinal diseases

Other: observational

Interventions

observationalOTHER

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

cardiovascular patientscentral nervous system diseasesendocrinal patientsgastrointestinal diseasesmetabolic patientsrenal patientsrespiratory patients

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University hospitals

Sohag, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 29971428BACKGROUND

  • 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.

    PMID: 31210987BACKGROUND

  • 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.

    PMID: 15613564BACKGROUND

MeSH Terms

Conditions

Infant, Newborn, Diseases

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Central Study Contacts

rofida A Mohamed, Resident

CONTACT

01032853330rofidaabdelsabour@med.sohag.edu.eg

Mohammed A Bakhet, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of pediatric and neonatology department, Sohag University Hospitals

Study Record Dates

First Submitted

March 30, 2023

First Posted

April 12, 2023

Study Start

April 1, 2023

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

April 12, 2023

Record last verified: 2023-03

Locations

EG(1)