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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
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.
Secondary ID [1] 280193 0
NIL
Universal Trial Number (UTN)
U1111-1129-1005
Trial acronym
PFNSSP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prematurity 286128 0
Endothelial function, intracellular adhesion and apopthosis function in perinatal period 286140 0
Condition category
Condition code
Public Health 286319 286319 0 0
Health service research
Reproductive Health and Childbirth 286332 286332 0 0
Complications of newborn
Neurological 286333 286333 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 284518 0
Early detection / Screening
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.
Control group
Active

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.
Timepoint [1] 286791 0
at three years after randomisation
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.
Timepoint [1] 296663 0
at three years after randomisation

Eligibility
Key inclusion criteria
Preterm infant
Parents must agree to assessment requirements (biomarker analysing, DENVER II development test) of the study
Minimum age
27 Weeks
Maximum age
37 Weeks
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
major congenital anomalies

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 4213 0
Azerbaijan
State/province [1] 4213 0
Baku

Funding & Sponsors
Funding source category [1] 284943 0
Government body
Name [1] 284943 0
Science Developmental Foundation Under the President of Azerbaijan Republic
Country [1] 284943 0
Azerbaijan
Primary sponsor type
University
Name
Azerbaijan Medical Unversity
Address
AZ 1022, Baku, Bakikhanov 23
Country
Azerbaijan
Secondary sponsor category [1] 283817 0
None
Name [1] 283817 0
Address [1] 283817 0
Country [1] 283817 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286954 0
Problem comittee on Pediatric investigations of Azerbaijan Medical Unversity
Ethics committee address [1] 286954 0
Ethics committee country [1] 286954 0
Azerbaijan
Date submitted for ethics approval [1] 286954 0
Approval date [1] 286954 0
17/06/2011
Ethics approval number [1] 286954 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33960 0
Address 33960 0
Country 33960 0
Phone 33960 0
Fax 33960 0
Email 33960 0
Contact person for public queries
Name 17207 0
Dr Huseynova Saadat
Address 17207 0
Azerbaijan Medical University, Neonatology Department
Az 1022, Baku, Bakikhanov 23
Country 17207 0
Azerbaijan
Phone 17207 0
+99 4 553536335
Fax 17207 0
Email 17207 0
[email protected]
Contact person for scientific queries
Name 8135 0
Dr Huseynova Saadat
Address 8135 0
Azerbaijan Medical University, Neonatology Department
Az 1022, Baku, Bakikhanov 23
Country 8135 0
Azerbaijan
Phone 8135 0
+99 4 553536335
Fax 8135 0
Email 8135 0
[email protected]

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
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Documents added automatically
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