Insuffeciency of the Suprarenal GlandUSSGneonatesNCT06575504
Ultrasonographical of Suprarenal Gland in High Risk Neonates
An observational study of Insuffeciency of the Suprarenal Gland, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Observation study The aim is to study the suprarenal blood flow among high-risk neonates and its relation to the risk factors Read more about this study
- Who is it for?
- Ages 1 day to 10 days
- Conditions the study is for
- Insuffeciency of the Suprarenal Gland
- What is being tested?
- Ultrasonographical examination
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2023to 15 Aug 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 10 days
- All sexes
- No healthy volunteers
- Child
Study population: neonates with high risk illness
Who may be able to join
- High risk neonates
Who cannot join
- congenital anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Being tested
- Ultrasonographical examination
- Keywords
- Doppler Ultrasound, Suprarenal gland, high risk neonates, NICU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographical examinationDiagnostic test
Study size and Doppler / blood flow / of the suprarenal gland
| Study group | Role | What they receive |
|---|---|---|
| Neonates | High risk newborn infants admitted to NICU Receives: Diagnostic Test: Ultrasonographical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adrenocortical insufficiency
Blood flow velocity RI ED TMAX
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start15 Nov 2023
- Primary completion15 Jul 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insuffeciency of the Suprarenal GlandStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, safaa ELMeneza, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575504
- Sponsor's protocol ID
- AlAzharU
- Other IDs
- 2462
- Acronym
- USSGneonates
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Used for results publications
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographical Study of Suprarenal Gland in High Risk Neonates
- ClinicalTrials.gov ID
- NCT06575504
- Acronym / sponsor ID
- USSGneonates / AlAzharU
- Conditions
- Insuffeciency of the Suprarenal Gland
- Keywords
- Doppler Ultrasound, Suprarenal gland, high risk neonates, NICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates | – | Diagnostic Test: Ultrasonographical examinationHigh risk newborn infants admitted to NICU |
Who may qualify
- Ages
- 1 day to 10 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- neonates with high risk illness
Key inclusion criteria (1 listed)
- High risk neonates
Key exclusion criteria (1 listed)
- congenital anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonographical examinationStudy size and Doppler / blood flow / of the suprarenal gland | Diagnostic test | Neonates |
Primary outcome
Adrenocortical insufficiency
Time frame: 12 months
Blood flow velocity RI ED TMAX
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: Yes. Used for results publications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insuffeciency of the Suprarenal Gland, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adrenocortical insufficiency (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.