Ultrasonographical of Suprarenal Gland in High Risk Neonates (USSGneonates)

August 26, 2024 updated by: safaa ELMeneza, Al-Azhar University

Ultrasonographical Study of Suprarenal Gland in High Risk Neonates

Observation study The aim is to study the suprarenal blood flow among high-risk neonates and its relation to the risk factors

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ultrasonographical study of the suprarenal gland in high risk newborn infants Al-Zhrraa University hospital Sample size 105 Inclusion criteria: 1- High-risk newborn 2- Need NICU admission Exclusion criteria: Cases with Major congenital anomalies and NEC Primary outcome: Abnormal suprarenal blood flow Informed consent will be obtained from all parents and mothers of the newborns enrolled in the study.

All cases will be subjected to - Full history taking: (prenatal -natal - postnatal). According to the routine admission sheet of NICU of Alzahraa University Hospital, Faculty of Medicine for girls, AL-Azhar University, Cairo, Egypt.

Through clinical examination (APGAR score -estimation of gestational age using modified Ballard score "Ballard, 1991" - body weight - severity of respiratory illness using Downs score and Silverman's score).

Laboratory investigations:

  • Blood gases.
  • Serum electrolytes and blood glucose.
  • CBC. CRP.
  • Liver and kidney functions. Radiological evaluation: in the form of Abdominal and chest x-ray. Ultrasonographical studies were done for suprarenal gland blood flow. - Statistical Analysis, Data were collected, revised, coded, and entered into the statistical package for social science (SPSS)

Study Type

Observational

Enrollment (Actual)

105

Contacts and Locations

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

Study Locations

  • Egypt
    • Pediatrics/neonatology
      • Cairo, Pediatrics/neonatology, Egypt, 11351
        • Faculty of medicine for girls

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

Non-Probability Sample

Study Population

neonates with high risk illness

Description

Inclusion Criteria:

  • High risk neonates

Exclusion Criteria:

  • congenital anomalies

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
Neonates
High risk newborn infants admitted to NICU
Diagnostic test: Ultrasonographical examination
Study size and Doppler / blood flow / of the suprarenal gland

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adrenocortical insufficiency
Time Frame: 12 months
Blood flow velocity RI ED TMAX
12 months

Collaborators and Investigators

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

Sponsor

Al-Azhar University

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 (Actual)

November 15, 2023

Primary Completion (Actual)

July 15, 2024

Study Completion (Actual)

August 15, 2024

Study Registration Dates

First Submitted

August 26, 2024

First Submitted That Met QC Criteria

August 26, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 26, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AlAzharU
  • 2462 (Other Identifier: AlAzharU)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Used for results publications

IPD Sharing Time Frame

2 years

IPD Sharing Access Criteria

Journal authority

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Study Data/Documents

  1. Study Protocol

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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