Polish Mother and Child Cohort Study (REPRO_PL) - Follow up of the Children.

NCT01861548 | Completed DMC

• 2 other identifiers: PBZ-MEiN-/8/2//2006PNRF-218-AI-1/07
• Study Type: observational
• Target: 479
• Locations: 1 country
• Sites: 2

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-dren's 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 children's 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 children's 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.

Conditions

Asthma; Atopic Dermatitis; Food Allergy; Wheezing

Outcome Measures

Primary Outcomes (1)

• Exposure of children to Environmental tobacco smoke(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 spectrometry/positive electrospray ionization (LC-ESI+MS/MS) and isotope dilution.

  Change from baseline of exposure of children to environmental tobacco smoke at 12 months

Secondary Outcomes (6)

• Exposure of children to polycyclic aromatic hydrocarbons (PAH)

  Change from baseline of exposure of children to polycyclic aromatic hydrocarbons at 12 months

• Exposure to lead, cadmium, mercury in children.

  Change from baseline of exposure to lead, cadmium, mercury in children at 12 months.

• Exposure to indoor allergens, endotoxins and glucans in children.

  Change from baseline of exposure to indoor allergens, endotoxins and glucans in children at 12 months.

• Questionnaires conducted with mothers.

  Change from baseline of questionnaires scores at 12 months.

• Determination of the prevalence of the upper and lower respiratory tract infections, middle ear diseases and allergy among the child.

  Change from baseline of the prevalence of infections and allergies at 12 months

Study Arms (1)

Children (up to 24 months after birth)

Investigators include into the study children delivered from women observed starting from between 8-12 weeks of single pregnancy, not assisted with reproductive technology, and not expected to be finished as spontaneous abor-tion. All women with the serious chronic diseases specified in study protocol such as diabetes, hypertension, nephrop-athy, epilepsy and cancer are excluded from the study. The same refers to suspicion of serious child malformations known to exist at the inclusion into the study.

Eligibility Criteria

• Age: 1 Minute - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Investigators include into the study children delivered from women observed starting from between 8-12 weeks of single pregnancy, not assisted with reproductive technology, and not expected to be finished as spontaneous abor-tion. All women with the serious chronic diseases specified in study protocol such as diabetes, hypertension, nephrop-athy, epilepsy and cancer are excluded from the study. The same refers to suspicion of serious child malformations known to exist at the inclusion into the study.

You may not qualify if:

• Children delivered from all women with the serious chronic diseases specified in study protocol such as diabetes, hypertension, nephrop-athy, epilepsy and cancer are excluded from the study.

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (2)

Nofer Institute of Occupational Medicine, Department of Environmental Epidemiology

Lodz, 91-348, Poland

Location

Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, Poland

Lodz, 93-513, Poland

Location

Related Publications (3)

• Podlecka D, Jerzynska J, Sanad K, Polanska K, Bobrowska-Korzeniowska M, Stelmach I, Brzozowska A. Micronutrients and the Risk of Allergic Diseases in School Children. Int J Environ Res Public Health. 2022 Sep 26;19(19):12187. doi: 10.3390/ijerph191912187.

  PMID: 36231487 DERIVED

• Stelmach I, Bobrowska-Korzeniowska M, Smejda K, Majak P, Jerzynska J, Stelmach W, Polanska K, Sobala W, Krysicka J, Hanke W. Risk factors for the development of atopic dermatitis and early wheeze. Allergy Asthma Proc. 2014 Sep-Oct;35(5):382-9. doi: 10.2500/aap.2014.35.3786.

  PMID: 25295805 DERIVED

• Stelmach I, Grzelewski T, Bobrowska-Korzeniowska M, Kopka M, Majak P, Jerzynska J, Stelmach W, Polanska K, Sobala W, Gromadzinska J, Wasowicz W, Hanke W. The role of zinc, copper, plasma glutathione peroxidase enzyme, and vitamins in the development of allergic diseases in early childhood: The Polish mother and child cohort study. Allergy Asthma Proc. 2014 May-Jun;35(3):227-32. doi: 10.2500/aap.2014.35.3748.

  PMID: 24801465 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood, urine, hair, saliva

MeSH Terms

Conditions

Asthma; Dermatitis, Atopic; Food Hypersensitivity; Respiratory Sounds

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Iwona Stelmach, MD,PhD,Prof.

  Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, Poland

  PRINCIPAL INVESTIGATOR

• Monika Kopka, MD

  Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, Poland

  PRINCIPAL INVESTIGATOR

• Wojciech Hanke, MD,PhD,Prof.

  Nofer Institute of Occupational Medicine, Department of Environmental Epidemiology

  PRINCIPAL INVESTIGATOR

• Kinga Polanska, MD, PhD

  Nofer Institute of Occupational Medicine, Department of Environmental Epidemiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Prof.

Study Record Dates

• First Submitted: May 17, 2013
• First Posted: May 23, 2013
• Study Start: January 1, 2007
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 23, 2013

Record last verified: 2013-05

Locations

PL (2)