Preventing Atopic Dermatitis and ALLergies in Children

NCT02449850 | Active Not Recruiting

• 1 other identifier: 2014-15118
• Study Type: interventional
• Target: 2,701
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is of the PreventADALL study is to test if primary prevention of allergic diseases is possible by simple and low cost strategies, and secondary to asses the impact of xenobiotic exposure and microbiota in and on the body and the environment on allergic disease development. The secondary objective is an exploratory focus to investigate early life risk factors for development of non-communicable diseases, including asthma and allergic diseases as well as for diseases that may share common risk factors, including cardiovascular disease, obesity and diabetes. Design: A multi-national population-based prospective birth cohort with a factorial designed randomized controlled intervention trial of two clinical interventions; skin care 0-9 months and early food introduction by 3-4 months, thereafter observation only. Recruitment in three cities (Oslo, Ostfold and Stockholm) of approximately 2500 mother-child pairs is done in two steps; first pregnant women are recruited and enrolled at the 18-weeks ultrasound investigation (n=approximately 2700) and thereafter their new-born babies are included. Randomization into four groups is done by the postal code or "township" to ensure all four intervention-groups within each "township". Visits for biological and environmental sampling, observations and investigations will be at the relevant pediatric departments (at 3-6-12-24-36 months of age) and through childhood into adulthood thereafter, provided sufficient funding.

Conditions

Atopic Dermatitis; Food Allergy in Children; Asthma; Rhinitis, Allergic; Non-communicable Diseases; Obesity; Cardiovascular Disease

Keywords

In-utero environment; Asthma; Allergic diseases; Food allergy; Birth cohort study; Primary prevention; Intervention study; Atopic dermatitis; Rhinitis; Allergy; Lung function; Non-communicable diseases; Foetal growth; Obesity; Cardiovascular disease; Diabetes; Blood pressure; Anthropometric; Trans epidermic water loss

Outcome Measures

Primary Outcomes (2)

• Atopic dermatitis (AD)

  AD by international standards,

  AD 0-12 months, with follow-up investigations at 2 and 3 yrs and at intervals up to year 2044, provided funding

• Food allergy to any intervention allergen

  By clinical relevant reactions, intolerance to foods and food challenges, when needed

  0-36 months, assessed first at 36 months, with follow-up investigations at intervals up to year 2044, provided funding

Secondary Outcomes (5)

• Allergic sensitisation (yes/no as well as quantitative, by skin prick test and s-IgE)

  first at 6 months, with follow-up investigations at 2 and 3 yrs and at intervals up to year 2044, provided funding

• Asthma (bronchial obstruction in year 1-2)

  first at 0-12 months, with follow-up investigations at 2 and 3 yrs and at intervals up to year 2044, provided funding

• Food allergy to any other allergen

  0-36 months, assessed first at 36 months of age, with follow-up investigations at intervals up to year 2044, provided funding

• Anaphylaxis

  0-36 months, assessed first at 36 months of age, with follow-up investigations at intervals up to year 2044, provided funding

• Rhinitis/Allergic rhinitis

  12-36 months, with follow-up investigations at intervals up to year 2044, provided funding

Other Outcomes (4)

• Cardiovascular diseases

  Blood pressure 3-12 months of age, with follow-up investigations at 2 and 3 yrs and at intervals up to year 2044, provided funding

• Diabetes

  at 36 months and with follow-up investigations at intervals up to year 2044, provided funding

• Obesity

  0-12 months, with follow-up investigations at 2 and 3 yrs and at intervals up to year 2044, provided funding

Study Arms (4)

Observation only

NO INTERVENTION

Observation only

Food intervention

EXPERIMENTAL

Intervention; systematic introduction of egg, milk, wheat and peanut by 4 months of age

Other: Food intervention

Skin care

EXPERIMENTAL

Intervention: regular baths with bath-oil 0.5-9 months of age

Other: Skin care

Food intervention and skin care

EXPERIMENTAL

Intervention; systematic introduction of egg, milk, wheat and peanut by 4 months of age Intervention: regular baths with bath-oil 0.5-9 months of age

Other: Food intervention; Other: Skin care

Interventions

Food intervention OTHER

Intervention; systematic introduction of egg, milk, wheat and peanut by 4 months of age

Food intervention; Food intervention and skin care

Skin care OTHER

Bath with bath-oil aim and Ceridal face cream for least 5 times/ week from 0.5-9 months of age.

Also known as: PreventADALL bath oil

Food intervention and skin care; Skin care

Eligibility Criteria

• Gender Eligibility Details: Enrollment of pregnant women, including their newborn babies of both sexes
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• \) Non-willingness to participate, 4) More than two foetuses

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator
• Karolinska Institutet: collaborator
• Helsinki University Central Hospital: collaborator
• University of Lausanne Hospitals: collaborator
• Norwegian Institute of Public Health: collaborator
• University Hospital, Akershus: collaborator
• Ostfold Hospital Trust: collaborator
• ThermoFisher Scientific Brahms Biomarkers France: collaborator
• University of Southampton: collaborator
• Imperial College London: collaborator
• Norwegian University of Life Sciences: collaborator
• Diakonova University College: collaborator
• Norwegian Department of Health and Social Affairs: collaborator
• University Medical Center Groningen: collaborator
• Furst Medical Laboratory: collaborator

Study Sites (1)

Oslo University Hospital and University of Oslo

Oslo, 0424, Norway

Location

Related Publications (9)

• Lodrup Carlsen KC, Rehbinder EM, Skjerven HO, Carlsen MH, Fatnes TA, Fugelli P, Granum B, Haugen G, Hedlin G, Jonassen CM, Landro L, Lunde J, Marsland BJ, Nordlund B, Rudi K, Sjoborg K, Soderhall C, Staff AC, Vettukattil R, Carlsen KH; study group. Preventing Atopic Dermatitis and ALLergies in Children-the PreventADALL study. Allergy. 2018 Oct;73(10):2063-2070. doi: 10.1111/all.13468. Epub 2018 Jun 19. No abstract available.

  PMID: 29710408 BACKGROUND

• Rehbinder EM, Lodrup Carlsen KC, Staff AC, Angell IL, Landro L, Hilde K, Gaustad P, Rudi K. Is amniotic fluid of women with uncomplicated term pregnancies free of bacteria? Am J Obstet Gynecol. 2018 Sep;219(3):289.e1-289.e12. doi: 10.1016/j.ajog.2018.05.028. Epub 2018 May 29.

  PMID: 29852156 BACKGROUND

• Rehbinder EM, Winger AJ, Landro L, Asarnoj A, Berents TL, Carlsen KH, Hedlin G, Jonassen CM, Nordlund B, Sandvik L, Skjerven HO, Soderhall C, Vettukattil R, Carlsen KCL; PreventADALL study group. Dry skin and skin barrier in early infancy. Br J Dermatol. 2019 Jul;181(1):218-219. doi: 10.1111/bjd.17626. Epub 2019 Apr 12. No abstract available.

  PMID: 30637724 BACKGROUND

• Kreyberg I, Bains KES, Carlsen KH, Granum B, Gudmundsdottir HK, Haugen G, Hedlin G, Hilde K, Jonassen CM, Nordhagen LS, Nordlund B, Sjoborg KD, Skjerven HO, Staff AC, Soderhall C, Vettukatil RM, Lodrup Carlsen KC. Stopping when knowing: use of snus and nicotine during pregnancy in Scandinavia. ERJ Open Res. 2019 Apr 8;5(2):00197-2018. doi: 10.1183/23120541.00197-2018. eCollection 2019 Apr.

  PMID: 30972353 BACKGROUND

• Vaernesbranden MR, Staff AC, Wiik J, Sjoborg K, Rueegg CS, Sugulle M, Carlsen KCL, Granum B, Haugen G, Hedlin G, Hilde K, Nordlund B, Rehbinder EM, Rudi K, Skjerven HO, Sundet BK, Soderhall C, Vettukattil R, Jonassen CM. Human papillomavirus infections during pregnancy and adverse pregnancy outcomes: a Scandinavian prospective mother-child cohort study. BMC Pregnancy Childbirth. 2024 Nov 19;24(1):764. doi: 10.1186/s12884-024-06958-2.

  PMID: 39563227 DERIVED

• Despriee AW, Smastuen MC, Glavin K, Lodrup Carlsen KC, Magi CAO, Soderhall C, Hedlin G, Nordhagen L, Jonassen CM, Rehbinder EM, Nordlund B, Skjerven H. Infant colic and abdominal pain; associations with infant multimorbidity and maternal perceived stress up to 3 months postpartum-A cross-sectional/cohort study in the PreventADALL study. J Clin Nurs. 2023 Oct;32(19-20):7605-7617. doi: 10.1111/jocn.16825. Epub 2023 Jul 18.

  PMID: 37462350 DERIVED

• Wiik J, Vaernesbranden MR, Jonassen CM, Staff AC, Carlsen KCL, Granum B, Haugen G, Hedlin G, Hilde K, Jacobsson B, Nilsson S, Nordlund B, Rangberg A, Rehbinder EM, Sengpiel V, Skjerven H, Sundet BK, Soderhall C, Vettukattil R, Sjoborg K. Maternal human papillomavirus infection during pregnancy and preterm delivery: A mother-child cohort study in Norway and Sweden. Acta Obstet Gynecol Scand. 2023 Mar;102(3):344-354. doi: 10.1111/aogs.14509. Epub 2023 Jan 16.

  PMID: 36647213 DERIVED

• Skjerven HO, Lie A, Vettukattil R, Rehbinder EM, LeBlanc M, Asarnoj A, Carlsen KH, Despriee AW, Fardig M, Gerdin SW, Granum B, Gudmundsdottir HK, Haugen G, Hedlin G, Haland G, Jonassen CM, Landro L, Magi CO, Olsen IC, Rudi K, Saunders CM, Skram MK, Staff AC, Soderhall C, Tedner SG, Aadalen S, Aaneland H, Nordlund B, Lodrup Carlsen KC. Early food intervention and skin emollients to prevent food allergy in young children (PreventADALL): a factorial, multicentre, cluster-randomised trial. Lancet. 2022 Jun 25;399(10344):2398-2411. doi: 10.1016/S0140-6736(22)00687-0.

  PMID: 35753340 DERIVED

• Skjerven HO, Rehbinder EM, Vettukattil R, LeBlanc M, Granum B, Haugen G, Hedlin G, Landro L, Marsland BJ, Rudi K, Sjoborg KD, Soderhall C, Staff AC, Carlsen KH, Asarnoj A, Bains KES, Carlsen OCL, Endre KMA, Granlund PA, Hermansen JU, Gudmundsdottir HK, Hilde K, Haland G, Kreyberg I, Olsen IC, Magi CO, Nordhagen LS, Saunders CM, Skrindo I, Tedner SG, Vaernesbranden MR, Wiik J, Jonassen CM, Nordlund B, Carlsen KCL. Skin emollient and early complementary feeding to prevent infant atopic dermatitis (PreventADALL): a factorial, multicentre, cluster-randomised trial. Lancet. 2020 Mar 21;395(10228):951-961. doi: 10.1016/S0140-6736(19)32983-6. Epub 2020 Feb 19.

  PMID: 32087121 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic; Asthma; Rhinitis, Allergic; Noncommunicable Diseases; Obesity; Cardiovascular Diseases; Food Hypersensitivity; Rhinitis; Hypersensitivity; Diabetes Mellitus

Interventions

Skin Care

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Immune System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Respiratory Tract Infections; Infections; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hygiene; Therapeutics

Study Officials

• Karin C. Lødrup Carlsen, MD PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: At all investigations, skin scoring is performed prior to any information from the study participants parents of intervention group. Also, no baths are allowed within 24 hours of investigation, to fascilitate blinding of the investigator to interventional allocation.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor MD, PhD

Model Details: International, multi-center, prospective 2x2 factorially designed randomized controlled trial of primary prevention in children of enrolled mother-child pairs, with an additional exploratory aim

Study Record Dates

• First Submitted: May 18, 2015
• First Posted: May 20, 2015
• Study Start: December 14, 2014
• Primary Completion: July 1, 2020
• Study Completion (Estimated): June 1, 2044
• Last Updated: August 29, 2019

Record last verified: 2019-08

Locations

NO (1)