Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12612000342819
Ethics application status
Approved
Date submitted
22/03/2012
Date registered
26/03/2012
Date last updated
26/03/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
Role of perinatal factors in formation of neurologic and somatic status at an early age of preterm infants
Query!
Scientific title
Endothelial function, intracellular adhesion and apopthosis in perinatal period and their role in formation of neurologic and somatic status at an early age of preterm infants.
Query!
Secondary ID [1]
280193
0
NIL
Query!
Universal Trial Number (UTN)
U1111-1129-1005
Query!
Trial acronym
PFNSSP
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Prematurity
286128
0
Query!
Endothelial function, intracellular adhesion and apopthosis function in perinatal period
286140
0
Query!
Condition category
Condition code
Public Health
286319
286319
0
0
Query!
Health service research
Query!
Reproductive Health and Childbirth
286332
286332
0
0
Query!
Complications of newborn
Query!
Neurological
286333
286333
0
0
Query!
Studies of the normal brain and nervous system
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
We are planning to carry out the scientific research in 4 stages.
First stage-maternity hospital (three months long). The first stage of study will be carried out at the maternity hospital. We will create special investigation history for women of each preterm and low birth weighing delivery. All information about pregnancy (health status, working rejime, family and living environment and ets.) and examination results of women will be fixed in maternal part of history. Physical exam outline and biomarker analysis results of each infant will be included to child part of history. It is planning to detect the level of following biomarkers, which are sensitive to injury of different organs and systems of fetus and specific proteins characterizing changes of pathologic reactions:
- markers of endothelial disfunction:endothelin-1, nitric oxide, endothelial nitric oxide synthase;
-adhesion molecules: soluble intracellular adhesion molecule -1, soluble vascular cellular adhesion molecule-1;
-apoptosis marker: caspasae 9.
The level of this markers will be detected in umbilical cord blood and peripheral blood of newborn infants in early neonatal period. Getting the umbilical cord blood is quite safe and nontraumatic for infants, because blood samples will be collected just after birth from placenta side of cord. Peripheral blood samples will not be collected for research, but from other analisis of maternity hospital or neonatal care unit (bilirubin fractions, intrauterine infectious and ets.).
Preterm babies will be categorised as less than 30 weeks of gestational age (including 30th week) and more than 30 weeks of gestational age. Intrauterine growth restricted babies will form the subgroup of each group.
Second stage – neonatal intensive care unit. This stage will last three months. We will add the diagnosis, examination results, all information about somatic and neural status to investigation history of infant transported from maternity hospital to neonatal intensive care unit.
Third stage - polyclinic. This stage will last approximately one year and six months. All infants discharged home from maternity hospital and from neonatal intensive care unit will be controled in polyclinic stage. We will contact directly to polyclinic doctors in appropriate polyclinic and contact to parents of children on telephone conversation. For more attentively control of changes in neurologic and somatic status we are planning personally control of each infant every six week. We will perform this control with our follow up team consisted of pediatrician, neurologist and child psychologist. We will add all information about neuro-somatic status of infants collecting from follow up team and also from polyclinic doctors and parents to investigation history of each infant.
Forth stage – statistical analysis of collecting materials and getting reliable results (six months long). We will find the statistical correlations and connects among different pregnancy factors, specific markers of umbilical cord and peripheral blood of infants and neuro-somatic status changes from neonatal till 3 year age of children. Statistical analysis will be realized by non-parametric and parametric methods.
Query!
Intervention code [1]
284518
0
Early detection / Screening
Query!
Comparator / control treatment
50 term healthy infants from normal pregnancies will be included to control group. In addition to special markers of research all the examination results (clinic and biochemical analisis, ultrasound and doppler results and etc.) performing in hospital will be fixed in investigation history of each infant.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
286791
0
Detecting the correlations between the level of organ and endothelial disfunction markers (detected in umbilical cord blood and peripheral blood of infants in early neonatal period) and illness appearing till 3 year of age on the base of statistical analysis.
Query!
Assessment method [1]
286791
0
Query!
Timepoint [1]
286791
0
at three years after randomisation
Query!
Secondary outcome [1]
296663
0
Prognosing early age changes of neuro-somatic status on the background of detected perinatal risk factors and performing follow up control. Perinatal risk factors will be assesed on the base of maternal and neonatal health status referring to investigation history of every infant. The severity of hypoxic ischemic encephalopathy will be based on the Levene classification. Cranial ultrasound will be performed for all infants at the 2-nd and 6-th days of life with 5 and 7, 5 MHz vector transducers. The neurological assessment will be performed according to Dubowitz/Ballard scale during neonatal period. Behavior, motor and sensor development from 1-st month till 3-nd year of life will be assesed by DENVER II test.
Query!
Assessment method [1]
296663
0
Query!
Timepoint [1]
296663
0
at three years after randomisation
Query!
Eligibility
Key inclusion criteria
Preterm infant
Parents must agree to assessment requirements (biomarker analysing, DENVER II development test) of the study
Query!
Minimum age
27
Weeks
Query!
Query!
Maximum age
37
Weeks
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
major congenital anomalies
Query!
Study design
Purpose of the study
Diagnosis
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
1/09/2011
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
200
Query!
Accrual to date
Query!
Final
Query!
Recruitment outside Australia
Country [1]
4213
0
Azerbaijan
Query!
State/province [1]
4213
0
Baku
Query!
Funding & Sponsors
Funding source category [1]
284943
0
Government body
Query!
Name [1]
284943
0
Science Developmental Foundation Under the President of Azerbaijan Republic
Query!
Address [1]
284943
0
AZ 1069, Baku, Ataturk avenue 48B
Query!
Country [1]
284943
0
Azerbaijan
Query!
Primary sponsor type
University
Query!
Name
Azerbaijan Medical Unversity
Query!
Address
AZ 1022, Baku, Bakikhanov 23
Query!
Country
Azerbaijan
Query!
Secondary sponsor category [1]
283817
0
None
Query!
Name [1]
283817
0
Query!
Address [1]
283817
0
Query!
Country [1]
283817
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
286954
0
Problem comittee on Pediatric investigations of Azerbaijan Medical Unversity
Query!
Ethics committee address [1]
286954
0
AZ 1022, Baku, Bakikhanov 23
Query!
Ethics committee country [1]
286954
0
Azerbaijan
Query!
Date submitted for ethics approval [1]
286954
0
Query!
Approval date [1]
286954
0
17/06/2011
Query!
Ethics approval number [1]
286954
0
Query!
Summary
Brief summary
The aim of this project is to study the effect of different pathologies of mother-placenta-newborn system on future development and health status of children, the prognosing of developing pathologies and achieving some methods of their prophylaxis.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
33960
0
Query!
Address
33960
0
Query!
Country
33960
0
Query!
Phone
33960
0
Query!
Fax
33960
0
Query!
Email
33960
0
Query!
Contact person for public queries
Name
17207
0
Dr Huseynova Saadat
Query!
Address
17207
0
Azerbaijan Medical University, Neonatology Department
Az 1022, Baku, Bakikhanov 23
Query!
Country
17207
0
Azerbaijan
Query!
Phone
17207
0
+99 4 553536335
Query!
Fax
17207
0
Query!
Email
17207
0
[email protected]
Query!
Contact person for scientific queries
Name
8135
0
Dr Huseynova Saadat
Query!
Address
8135
0
Azerbaijan Medical University, Neonatology Department
Az 1022, Baku, Bakikhanov 23
Query!
Country
8135
0
Azerbaijan
Query!
Phone
8135
0
+99 4 553536335
Query!
Fax
8135
0
Query!
Email
8135
0
[email protected]
Query!
No information has been provided regarding IPD availability
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.
Download to PDF