Ignite Creation Date:
2024-05-06 @ 1:39 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01861548
Status:
COMPLETED
Last Update Posted:
2013-05-23
First Post:
2013-05-17
Brief Title:
Polish Mother and Child Cohort Study REPRO_PL - Follow up of the Children
Sponsor:
Medical University of Lodz
Organization:
Medical University of Lodz
Study Overview
Official Title:
Polish Mother and Child Cohort Study REPRO_PLFollow up of the Children
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REPRO_PL
Brief Summary:
The Polish Mother and Child Cohort is multicentre prospective study on different exposures
Prospective cohort study design enables identification of exposures that may influence pregnancy outcome and chil-drens health verification of such exposures by biomarker measurements and notification of any changes in exposure levels
The aim of the study is to evaluate the impact of exposure to different environmental factors during pregnancy and after birth on pregnancy outcome and childrens health Specific research hypotheses refer to the role of heavy metals exposure to polycyclic aromatic hydrocar-bons PAHs and environmental tobacco smoke ETS in the aetiology of intrauterine growth retardation IUGR preterm delivery PD and the risk of respiratory diseases allergy and poor mental and physical development It is also intended to explain the role of oxidative stress and nutritional status of the pregnant women The impact of occupational exposures and stressful situations on pregnancy outcome will be evaluated from question-naire data
The results of the study will help to determine levels of child prenatal and postnatal exposure in several areas of Poland and their im-pact on course and outcome of pregnancy and childrens health
This protocol concerns the children that are followed-up from birth to the age of 2 years to determine long term effects of pre- and postnatal environmental exposures
Prospective cohort study design enables identification of exposures that may influence pregnancy outcome and chil-drens health verification of such exposures by biomarker measurements and notification of any changes in exposure levels
The aim of the study is to evaluate the impact of exposure to different environmental factors during pregnancy and after birth on pregnancy outcome and childrens health Specific research hypotheses refer to the role of heavy metals exposure to polycyclic aromatic hydrocar-bons PAHs and environmental tobacco smoke ETS in the aetiology of intrauterine growth retardation IUGR preterm delivery PD and the risk of respiratory diseases allergy and poor mental and physical development It is also intended to explain the role of oxidative stress and nutritional status of the pregnant women The impact of occupational exposures and stressful situations on pregnancy outcome will be evaluated from question-naire data
The results of the study will help to determine levels of child prenatal and postnatal exposure in several areas of Poland and their im-pact on course and outcome of pregnancy and childrens health
This protocol concerns the children that are followed-up from birth to the age of 2 years to determine long term effects of pre- and postnatal environmental exposures
Detailed Description:
The Polish Mother and Child Cohort is multicentre prospective study on different exposures
Prospective cohort study design enables identification of exposures that may influence pregnancy outcome and chil-drens health verification of such exposures by biomarker measurements and notification of any changes in exposure levels
The aim of the study is to evaluate the impact of exposure to different environmental factors during pregnancy and after birth on pregnancy outcome and childrens health Specific research hypotheses refer to the role of heavy metals exposure to polycyclic aromatic hydrocar-bons PAHs and environmental tobacco smoke ETS in the aetiology of intrauterine growth retardation IUGR preterm delivery PD and the risk of respiratory diseases allergy and poor mental and physical development It is also intended to explain the role of oxidative stress and nutritional status of the pregnant women The impact of occupational exposures and stressful situations on pregnancy outcome will be evaluated from question-naire data
The results of the study will help to determine levels of child prenatal and postnatal exposure in several areas of Poland and their im-pact on course and outcome of pregnancy and childrens health
This protocol concerns the children that are followed-up from birth to the age of 2 years to deter-mine long term effects of pre- and postnatal environmental exposures
Exposure of children to ETS Postnatal children exposure to ETS at 12 and 24 months after birth is assessed From the children urine sample and saliva samples from mothers who will declare smoking abstinence are collected The saliva and urine cotinine level is analysed using high performance liquid chromatography coupled with tandem mass spectrometrypositive electrospray ionization LC-ESIMSMS and isotope dilution
Exposure of children to PAH The HPLC technique is used for the analysis of the level of 1-hydroksypyrene in urine as the biomarker of PAH exposure 12 and 24 months
Exposure to lead cadmium mercury in children Blood and hair are collected for about 100 children Total and inorganic mercury is analyzed using cold vapour atomic fluorescence spectrophotometry The lead and cadmium concentrations in blood is determined by graphite-furnance atomic-absorption spectrometry
Exposure to indoor allergens endotoxins and glucans The analyzis is covered approx 50 family homes of children The settled dust is collected from floors in leaving rooms and in children beds mattresses and blankets To determine allergens concentrations in dust samples the commercially available enzymelinked immunosorbent assey ELISA kits ispplied according to the protocolTo determine endotoxins and 13-β-D-glucans concentrations the LAL test will be applied The questionnaire study is performed among parents in order to obtain the data about demographic factors and home conditions
Questionnaires conducted with mothers 12 and 24 months after delivery Mothers of all children are interviewed The questionnaires investigate the childrens health and development the nutrition of the small child and their contacts with other children The smoking status of the parents and other potential sources of childrens ETS exposure are identified Information about proximity to heavy traffic is inquired Additionally the information from the closets to hisher place of living air pollution monitoring station is collected Exposure to other environmental factors including domestic animals home dust household cleaning agents and indoor used pesticides is evaluated by the questionnaire
Determination of the prevalence of the upper and lower respiratory tract infections middle ear diseases and allergy among the child The incidence of the upper and lower respiratory tract infections middle ear diseases and symptoms of allergy among the child is identified based on the detailed interview with the mothers in 12 and 24 month after child birth This interviews is conducted by paediatricians For each child upper and lower respiratory tract infections tonsillitis laryngitis bronchitis and pneumonia as well as middle ear diseases and allergy to food and inhalant allergens is identified based on the review of their medical charts The duration of each infection and disease medications taken and hospitalization is identified The current health status of the chid and child anthropometry high weight is preformed by pediatrician
Determination of the neurodevelopment of the children BSID-III is used for assessment of child neurodevelopment The tests is scheduled on 12 and 24 months of live and is conducted by psychologist or child development specialist The test assesses five developmental areas of the child cognitive motor fine and gross motor language receptive expressive social-emotional and adaptive behavior
Prospective cohort study design enables identification of exposures that may influence pregnancy outcome and chil-drens health verification of such exposures by biomarker measurements and notification of any changes in exposure levels
The aim of the study is to evaluate the impact of exposure to different environmental factors during pregnancy and after birth on pregnancy outcome and childrens health Specific research hypotheses refer to the role of heavy metals exposure to polycyclic aromatic hydrocar-bons PAHs and environmental tobacco smoke ETS in the aetiology of intrauterine growth retardation IUGR preterm delivery PD and the risk of respiratory diseases allergy and poor mental and physical development It is also intended to explain the role of oxidative stress and nutritional status of the pregnant women The impact of occupational exposures and stressful situations on pregnancy outcome will be evaluated from question-naire data
The results of the study will help to determine levels of child prenatal and postnatal exposure in several areas of Poland and their im-pact on course and outcome of pregnancy and childrens health
This protocol concerns the children that are followed-up from birth to the age of 2 years to deter-mine long term effects of pre- and postnatal environmental exposures
Exposure of children to ETS Postnatal children exposure to ETS at 12 and 24 months after birth is assessed From the children urine sample and saliva samples from mothers who will declare smoking abstinence are collected The saliva and urine cotinine level is analysed using high performance liquid chromatography coupled with tandem mass spectrometrypositive electrospray ionization LC-ESIMSMS and isotope dilution
Exposure of children to PAH The HPLC technique is used for the analysis of the level of 1-hydroksypyrene in urine as the biomarker of PAH exposure 12 and 24 months
Exposure to lead cadmium mercury in children Blood and hair are collected for about 100 children Total and inorganic mercury is analyzed using cold vapour atomic fluorescence spectrophotometry The lead and cadmium concentrations in blood is determined by graphite-furnance atomic-absorption spectrometry
Exposure to indoor allergens endotoxins and glucans The analyzis is covered approx 50 family homes of children The settled dust is collected from floors in leaving rooms and in children beds mattresses and blankets To determine allergens concentrations in dust samples the commercially available enzymelinked immunosorbent assey ELISA kits ispplied according to the protocolTo determine endotoxins and 13-β-D-glucans concentrations the LAL test will be applied The questionnaire study is performed among parents in order to obtain the data about demographic factors and home conditions
Questionnaires conducted with mothers 12 and 24 months after delivery Mothers of all children are interviewed The questionnaires investigate the childrens health and development the nutrition of the small child and their contacts with other children The smoking status of the parents and other potential sources of childrens ETS exposure are identified Information about proximity to heavy traffic is inquired Additionally the information from the closets to hisher place of living air pollution monitoring station is collected Exposure to other environmental factors including domestic animals home dust household cleaning agents and indoor used pesticides is evaluated by the questionnaire
Determination of the prevalence of the upper and lower respiratory tract infections middle ear diseases and allergy among the child The incidence of the upper and lower respiratory tract infections middle ear diseases and symptoms of allergy among the child is identified based on the detailed interview with the mothers in 12 and 24 month after child birth This interviews is conducted by paediatricians For each child upper and lower respiratory tract infections tonsillitis laryngitis bronchitis and pneumonia as well as middle ear diseases and allergy to food and inhalant allergens is identified based on the review of their medical charts The duration of each infection and disease medications taken and hospitalization is identified The current health status of the chid and child anthropometry high weight is preformed by pediatrician
Determination of the neurodevelopment of the children BSID-III is used for assessment of child neurodevelopment The tests is scheduled on 12 and 24 months of live and is conducted by psychologist or child development specialist The test assesses five developmental areas of the child cognitive motor fine and gross motor language receptive expressive social-emotional and adaptive behavior
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PNRF-218-AI-107 | OTHER_GRANT | Norwegian Financial Mechanism | None |