Screening of Coexistence Between Sickle Cell Anaemia and G6PD Deficiency

September 24, 2024 updated by: Fatma Hussein Mahmoud

Newborn Screening of Coexistence Between Sickle Cell Anaemia and G6PD Deficiency in NEW VALLEY GOVERNORATE

G6PD deficiency may have a subtle effect on the severity of hemolysis and also worsen the degree of anaemia in SCD when the two disorders coexist. Therefore, selective decision should be taken in patients in whom the two conditions coexist in the choice of drug and in the treatment of infections.The prevalence of the G-6-PD deficiency is high in SCD patients, but does not differ from that observed among non-SCD subjects .However, the G-6-PD deficiency appears to worsen the clinical features of SCD, there were more hospitalizations, major vaso-occlusive crises among G-6-PD deficient sickle cell patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Sickle cell disease (SCD) is not frequent in Egypt except in the Oases where the carrier rate varies from 9 to 22%. It is a hereditary blood disorder characterized by the production of abnormal hemoglobin molecules that cause red blood cells to take on a crescent or sickle shape. This haemoglobin called haemoglobin S, which causes red blood cells to become stiff and sticky, leading to various health complications as recurrent pain, fatigue, anaemia, and increased infection susceptibility.prevalence of G6PD deficiency is 4.3% with a male:female ratio of 3.2:1. Enzyme activity was significantly higher in males than females. It is located on X chromosome which leads to a lower level of reduced glutathione, an antioxidant, in red blood cells (RBCs). Most of the time, those who are affected have no symptoms. However, they should avoid specific triggers that may promote oxidative stress such as fava beans, that may fragilize RBCs and cause hemolysis. G6PD deficiency may have a subtle effect on the severity of hemolysis and also worsen the degree of anaemia in SCD when the two disorders coexist. Therefore, selective decision should be taken in patients in whom the two conditions coexist in the choice of drug and in the treatment of infections. The prevalence of the G-6-PD deficiency is high in SCD patients, but does not differ from that observed among non-SCD subjects .However, the G-6-PD deficiency appears to worsen the clinical features of SCD, there were more hospitalizations, major vaso-occlusive crises among G-6-PD deficient sickle cell patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Fatma Hussein Mahmoud, Assistant lecturer
  • Phone Number: +2 01062172982
  • Email: fh449615@gmail.com

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study will be conducted on all newborn delivered in pediatric department in NEW VALLEY UNIVERSITY from jan2025 to Jan 2026

Description

Inclusion Criteria:

- All new born with good general health

Exclusion Criteria:

  • 1-new born with high reticulocytic count 2-new born with bad general health

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Newborns who are delivered in NEW VALLEY GOVERNORATE
Screening of coexistence between sickle cell anaemia and G6PD deficiency
Diagnostic test: G6pd enzyme sickling test
Measuring the enzyme level of G6PD and presence of Hbs
Diagnostic test: G6PD enzyme and sickling test
Measuring enzyme level of G6PD and level of HbS
Diagnostic test: G6PD enzyme and HPLC
Measuring G6PD enzyme level in neonates and measuring level of HbS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
prevelance of coexistence between sickle cell anaemia and G6PD deficiency in NEW VALLEY GOVERNORATE
Time Frame: One year
Evaluate the prevalence of coexistence between sickle cell anaemia and G6PD deficiency in NEW VALLEY GOVERNORATE to create data base for endemic hereditary disease
One year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Early diagnosis to decrease incidanc of complications
Time Frame: One year
Early diagnosis of coexistence between sickle cell anaemia and G6PD deficiency to tell specific treatment and maintain haemoglobin level high to prevent more complications
One year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fatma Hussein Mahmoud

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Coexistence of SCD and G6PD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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