Ultrasonographical of Suprarenal Gland in High Risk Neonates

NCT ID: NCT06575504

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 105 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-15
• Study Completion Date: 2024-08-15

Brief Summary

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

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)

Conditions

Insuffeciency of the Suprarenal Gland

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Neonates

High risk newborn infants admitted to NICU

Ultrasonographical examination

Intervention Type: DIAGNOSTIC_TEST

Study size and Doppler / blood flow / of the suprarenal gland

Interventions

Ultrasonographical examination

Study size and Doppler / blood flow / of the suprarenal gland

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• High risk neonates

Exclusion Criteria

• congenital anomalies

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 10 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

safaa ELMeneza

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of medicine for girls

Cairo, Pediatrics/neonatology, Egypt

Countries

Egypt

Study Documents

Document Type: Study Protocol

View Document

Other Identifiers

2462

Identifier Type: OTHER

Identifier Source: secondary_id

AlAzharU

Identifier Type: -

Identifier Source: org_study_id