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

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000342819
Acronym
PFNSSP
Enrollment
200
Registered
2012-03-26
Start date
2011-09-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Azerbaijan Medical Unversity
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
27 Weeks to 37 Weeks
Healthy volunteers
Yes

Inclusion criteria

Preterm infant Parents must agree to assessment requirements (biomarker analysing, DENVER II development test) of the study

Exclusion criteria

major congenital anomalies

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026