Role of perinatal factors in formation of neurologic and somatic status at an early age of preterm infants

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12612000342819
• Date of registration: 26/03/2012
• Prospective Registration: No
• Primary sponsor: Azerbaijan Medical Unversity
• 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.
• Date of first enrolment: 01/09/2011
• Target sample size: 200
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12612000342819.aspx
• Study type: Interventional
• Study design: Purpose: Diagnosis; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Azerbaijan

Contacts

• Name: Dr Huseynova Saadat

• Name: Dr Huseynova Saadat

Key inclusion & exclusion criteria

Inclusion criteria: Preterm infant
Parents must agree to assessment requirements (biomarker analysing, DENVER II development test) of the study
Exclusion criteria: major congenital anomalies

Age minimum: 27 Weeks
Age maximum: 37 Weeks
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Neurological - Studies of the normal brain and nervous system

Reproductive Health and Childbirth - Complications of newborn

Public Health - Health service research

Prematurity;Endothelial function, intracellular adhesion and apopthosis function in perinatal period;
Prematurity
Endothelial function, intracellular adhesion and apopthosis function in perinatal period

Intervention(s)

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.

Primary Outcome(s)

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.[at three years after randomisation]

Secondary Outcome(s)

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.[at three years after randomisation]

Secondary ID(s)

NIL

Source(s) of Monetary Support

Science Developmental Foundation Under the President of Azerbaijan Republic

Ethics review

Status: Approved
Approval date:
Contact:

Problem comittee on Pediatric investigations of Azerbaijan Medical Unversity