Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000935134p
Ethics application status
Submitted, not yet approved
Date submitted
4/06/2019
Date registered
4/07/2019
Date last updated
4/07/2019
Date data sharing statement initially provided
4/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Mean platelet volume in asymptomatic chorioamnionitis exposed term infants
Scientific title
Mean platelet volume (MPV) in chorioamnionitis-exposed asymptomatic neonates. A retrospective case control study
Secondary ID [1] 298407 0
none
Universal Trial Number (UTN)
U1111-1234-6198
Trial acronym
Linked study record
nil

Health condition
Health condition(s) or problem(s) studied:
chorioamnionitis 313111 0
Condition category
Condition code
Infection 311590 311590 0 0
Other infectious diseases
Reproductive Health and Childbirth 311591 311591 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All asymptomatic full term chorioamnionitis (CA) exposed infants admitted to Neonatal intensive care unit (NICU) from May 2016 until may 2019 will be enrolled. Blood samples from CA exposed infants to examine for Full blood count indices and C-reactive protein (CRP) data will be collected. These data will be compared to the information retrieved from control group who are healthy infants delivered to healthy mothers with uneventful pregnancies. The aim is to examine the significance of mean platelet volume as a significant marker for early onset sepsis in CA exposed infants. Blood samples from CA exposed infants group are collected on admission (day 1) and again on day 3 after receiving 48 hours course of antibiotic treatment.
Intervention code [1] 314651 0
Diagnosis / Prognosis
Intervention code [2] 314652 0
Early Detection / Screening
Comparator / control treatment
Control arm of 65 healthy term infants delivered to healthy mothers with uneventful pregnancies and no chorioamnionitis during the same period of data collection (May 2016-May 2019). The demographic data of mothers and infants are comparable to chorioamnionitis exposed infants group. Neither mothers nor infants of the control group received antibiotics.
Control group
Active

Outcomes
Primary outcome [1] 320295 0
The proportion of infants with increased mean platelet volume in chorioamnionitis exposed arm. Measurement of full blood count indices is done by using an automated haematology analyser (DxH800; Beckman Coulter, USA) with ethylenediaminetetraacetic acid (EDTA) anticoagulated whole blood samples.
Timepoint [1] 320295 0
on admission (day1) and on (day 3) after receiving antibiotics
Secondary outcome [1] 371087 0
Incidence of blood culture positive cases among Chorio-amnionitis exposed infants who are asymptomatic at birth and remained asymptomatic throughout the hospital stay. . Blood culture was performed by a sample of 1 ml of venous blood transferred into BACTEC culture vial (BACTEC FX/VIRTUE BacT/ALERT).
Timepoint [1] 371087 0
On day 2 of admission ( after 48 hours antibiotics administration in NICU)
Secondary outcome [2] 371088 0
Incidence of thrombocytopenia among Chorio-amnionitis exposed infants who are asymptomatic at birth and remained asymptomatic throughout the hospital stay. Measurement of full blood count indices is done by using an automated haematology analyser (DxH800; Beckman Coulter, USA) with ethylenediaminetetraacetic acid (EDTA) anticoagulated whole blood samples.
Timepoint [2] 371088 0
On admission and after 2 days of antibiotic adminstration

Eligibility
Key inclusion criteria
1- Term infants 37 weeks gestation or more who are borne to chorioamnionitis mothers.
2- All infants were healthy asymptomatic at birth and after admission.
Minimum age
0 Hours
Maximum age
6 Hours
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1- Preterm infants <37 weeks gestation
2- Symptomatic term infants (Apnea, respiratory distress, cyanosis, poor feeding, temperature instability, hypoglycemia, or seizures)
3-Birth asphyxia
4-Infants with hematologic disorders or chromosomal anomalies.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Case control
Timing
Retrospective
Statistical methods / analysis
All asymptomatic term CA exposed infants (65 patient) admitted to NICU during the study period will be enrolled. A matched number of healthy controls will be selected with the same demographic data of CA infants group.
Statistical analysis of data will be done using IBM SPSS program version 23. The quantitative data will be presented as mean and standard deviations (SD). Qualitative data will be presented as count and percentages. Student t test will be used to compare quantitative data between the two groups while Chi-square test to compare qualitative data. Paired samples T-test will be used to compare quantitative data at two different time points for the same group and McNemar test for qualitative data. Receiver- operating characteristics (ROC) curve will be used to measure validity of MPV for prediction of neonatal sepsis .

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/07/2019
Actual
Date of last participant enrolment
Anticipated
10/09/2019
Actual
Date of last data collection
Anticipated
20/09/2019
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment outside Australia
Country [1] 21561 0
United Arab Emirates
State/province [1] 21561 0
Dubai

Funding & Sponsors
Funding source category [1] 302957 0
Hospital
Name [1] 302957 0
Dubai hospital
Country [1] 302957 0
United Arab Emirates
Primary sponsor type
Hospital
Name
Dubai Hospital
Address
NICU, DUBAI HOSPITAL. THIRD FLOOR. ALBARAHA, Alkornisch street No.1. DUBAI 7272 UAE.
Country
United Arab Emirates
Secondary sponsor category [1] 302909 0
None
Name [1] 302909 0
Address [1] 302909 0
Country [1] 302909 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303509 0
Dubai scientific research ethics committee DSREC
Ethics committee address [1] 303509 0
Dubai Scientific Research Ethics Committee DSREC.
DSREC CONTINUOUS MEDICAL EDUCATION DEPARTMENT RASHID MEDICAL LIBRARY PO BOX 4545 DUBAI. UAE.
Ethics committee country [1] 303509 0
United Arab Emirates
Date submitted for ethics approval [1] 303509 0
19/03/2019
Approval date [1] 303509 0
Ethics approval number [1] 303509 0

Summary
Brief summary
Maternal chorioamnionitis (CA) is serious problem causing significant neonatal morbidities and long term neurodevelopmental sequalae in exposed infants. Current guidelines still recommend admission, laboratory evaluation, and antibiotic administration to all chorioamnionitis exposed infants. The incidence of early onset sepsis is currently low with the routine intrapartum antibiotics administration to mothers at risk. New diagnostic tools are needed for early diagnosis of sepsis in apparently healthy infants exposed to chorioamnionitis. Mean platelet volume (MPV) measurement was evolving as a potential inflammatory marker in neonatal sepsis in different studies. We aim to study whether MPV in asymptomatic chorioamnionitis-exposed infants can be used as an adjuvant diagnostic tool of early onset sepsis in these infants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93910 0
Dr Atef Alshafei
Address 93910 0
ATEF ALSHAFEI NICU, DUBAI HOSPITAL THIRD FLOOR. ALBARAHA, Alkornisch street No.1. DUBAI 7272. UAE
Country 93910 0
United Arab Emirates
Phone 93910 0
+971561924270
Fax 93910 0
Email 93910 0
[email protected]
Contact person for public queries
Name 93911 0
Dr Atef Alshafei
Address 93911 0
ATEF ALSHAFEI NICU, DUBAI HOSPITAL THIRD FLOOR. ALBARAHA, Alkornisch street No.1. DUBAI 7272. UAE
Country 93911 0
United Arab Emirates
Phone 93911 0
+971561924270
Fax 93911 0
Email 93911 0
[email protected]
Contact person for scientific queries
Name 93912 0
Dr Atef Alshafei
Address 93912 0
ATEF ALSHAFEI NICU, DUBAI HOSPITAL THIRD FLOOR. ALBARAHA, Alkornisch street No.1. DUBAI 7272. UAE
Country 93912 0
United Arab Emirates
Phone 93912 0
+971561924270
Fax 93912 0
Email 93912 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial.
When will data be available (start and end dates)?
One month following main results publication. No end dates.
Available to whom?
case by case basis
Available for what types of analyses?
Any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator, Contact email adress: [email protected]
-Contact mobile: 00971561924270


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.