Neonatal SepsisNCT04800445
Salivary C- Reactive Protein, Mean Platelet Volume and Neutrophil Lymphocyte Ratio as Diagnostic Markers for Neonatal Sepsis
An observational study of Neonatal Sepsis, run by Cairo University at 1 site in Egypt.
Trial summary
To evaluate reliability of salivary C-reactive protein ,mean platelet volume , neutrophil -lymphocyte ratio , and platelet lymphocyte ratio in diagnosis of neonatal sepsis Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Sepsis
- What is being tested?
- Salivary CRP
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Apr 2020to 10 Jan 2022
- 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 28 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Full term neonates of both genders from birth to the 28th day of life who were admitted to Cairo University NICU with clinical features of either early- or late-onset neonatal sepsis diagnosed by culture, CRP more than 10 ,and has three or more the clinical findings of sepsis were enrolled in this study. Neonates with no symptoms or signs suggestive 0f sepsis who had been hospitalized In Cairo University Nicu . Serum CRP level for neonates in this group was negative (CRP < 10 mg/L) as control group.
Who may be able to join
- - Full term neonates of both genders from birth to the 28th day of life diagnosed with sepsis by history, clinical findings, laboratory findings, and blood culture. The clinical findings included the presence of three or more of the following:
- (1) temperature instability (hypothermia, hyperthermia) .
- (2) respiratory alterations (grunting, intercostal retractions, apnea, tachypnea, cyanosis) .
- (3) cardiovascular alterations (bradycardia, tachycardia, poor perfusion, hypotension) .
- (4) neurologic alterations (hypotonia, lethargy, seizures)
- (5) gastrointestinal alterations (feeding intolerance, abdominal distension). CRP values >10 mg/L were considered to be positive.
Who cannot join
- - Preterm neonates .
- Neonates with CNS malformations, metabolic disorders, chromosomal abnormalities, intrauterine growth restriction, or birth asphyxia were excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Salivary C-reactive Protein,Mean Platelet Volume and Neutrophil Lymphocyte Ratio as Diagnostic Markers for Neonatal Sepsis
To evaluate reliability of salivary C-reactive protein ,mean platelet volume , neutrophil -lymphocyte ratio , and platelet lymphocyte ratio in diagnosis of neonatal sepsis
- Conditions
- Neonatal Sepsis
- Being tested
- Salivary CRP
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary CRPDiagnostic test
Salivary C reactive protein in neonatal sepsis
| Study group | Role | What they receive |
|---|---|---|
| Case group of fullterm neonates with neonatal sepsis | Not described Receives: Diagnostic Test: Salivary CRP | |
| Healthy fullterm neonates | Not described Receives: Diagnostic Test: Salivary CRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary c reactive protein in neonatal sepsis
Salivary C reactive protein of value as non invasive procedure in diagnosis of neonatal sepsis
Measured: 28 days
Secondary outcomes (1)
Mean platelet volume
Asses the validity of Mean Platlet Volume as marker of neonatal sepsis which is equal about ( 9 - 11.4 ) in septic group and about ( 7.5 - 8.5 ) in control group
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start4 Apr 2020
- Primary completion4 Dec 2020
- Study completion10 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal SepsisStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eslam Mohamed Naeim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800445
- Sponsor's protocol ID
- MS-53-2020
- Status last verified
- Aug 2021
- First submitted
- 26 Feb 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary C-reactive Protein,Mean Platelet Volume and Neutrophil Lymphocyte Ratio as Diagnostic Markers for Neonatal Sepsis
- ClinicalTrials.gov ID
- NCT04800445
- Acronym / sponsor ID
- MS-53-2020
- Conditions
- Neonatal Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 4 Apr 2020 (actual)
- Primary completion
- 4 Dec 2020 (actual)
- Study completion
- 10 Jan 2022 (estimated)
- First posted
- 16 Mar 2021 (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.
To evaluate reliability of salivary C-reactive protein ,mean platelet volume , neutrophil -lymphocyte ratio , and platelet lymphocyte ratio in diagnosis of neonatal sepsis
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group of fullterm neonates with neonatal sepsis | – | Diagnostic Test: Salivary CRP |
| Healthy fullterm neonates | – | Diagnostic Test: Salivary CRP |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Full term neonates of both genders from birth to the 28th day of life who were admitted to Cairo University NICU with clinical features of either early- or late-onset neonatal sepsis diagnosed by culture, CRP more than 10 ,and has three or more the clinical findings of sepsis were enrolled in this study. Neonates with no symptoms or signs suggestive 0f sepsis who had been hospitalized In Cairo University Nicu . Serum CRP level for neonates in this group was negative (CRP < 10 mg/L) as control group.
Key inclusion criteria (6 listed)
- - Full term neonates of both genders from birth to the 28th day of life diagnosed with sepsis by history, clinical findings, laboratory findings, and blood culture. The clinical findings included the presence of three or more of the following:
- (1) temperature instability (hypothermia, hyperthermia) .
- (2) respiratory alterations (grunting, intercostal retractions, apnea, tachypnea, cyanosis) .
- (3) cardiovascular alterations (bradycardia, tachycardia, poor perfusion, hypotension) .
- (4) neurologic alterations (hypotonia, lethargy, seizures)
Key exclusion criteria (2 listed)
- - Preterm neonates .
- Neonates with CNS malformations, metabolic disorders, chromosomal abnormalities, intrauterine growth restriction, or birth asphyxia were excluded from the study
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 |
|---|---|---|
| Salivary CRPSalivary C reactive protein in neonatal sepsis | Diagnostic test | Case group of fullterm neonates with neonatal sepsis, Healthy fullterm neonates |
Primary outcome
Salivary c reactive protein in neonatal sepsis
Time frame: 28 days
Salivary C reactive protein of value as non invasive procedure in diagnosis of neonatal sepsis
1 secondary outcome
Mean platelet volume
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
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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 Neonatal Sepsis, run by Cairo 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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 9 Aug 2021. 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?
Results are not available in the source record.
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?
Salivary c reactive protein in neonatal sepsis (time frame: 28 days). 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 9 Aug 2021.