Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
2701 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-12-14
Study Completion Date
2044-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Atopic Dermatitis (AD) and Food Allergy
NCT03168113
Atopic Dermatitis (AD)
Non-atopic Healthy Controls
COMPLETED
Prospective Longitudinal Observational Research in Atopic Dermatitis
NCT04240522
Atopic Dermatitis
Asthma
Atopic Dermatitis and Related Conditions
UNKNOWN
Effectiveness of Dupilumab in Food Allergic Patients With Moderate to Severe Atopic Dermatitis
NCT04462055
Food Allergy
TERMINATED
Dietary Intervention on Atopy
NCT06547372
Atopic Dermatitis
Atopic
RECRUITING
NA
Short-term Topical Application to Prevent Atopic Dermatitis
NCT03871998
Eczema Atopic Dermatitis
Eczema
Eczema, Infantile
+1 more
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The PreventADALL study is a long term prospective birth cohort study, with an intervention aspect designed as a randomized clinical trial (RCT), and an exploratory aspect, enrolling mother-child pairs by including pregnant women, allowing for intrauterine investigations of the baby and maternal factors during pregnancy, and thereafter including their new-born babies for long-term follow-up investigations.
With the knowledge that allergic diseases often manifest in early infancy, interventions will be carried out as early as possible to investigate if allergic diseases can be prevented. Two interventions, early and systematic introduction to common foods, and early skin care are carried out within the first four months and the first nine months of life, respectively.
Inclusion/Exclusion criteria:
Ante-natal inclusion, step 1: All mothers to-be at 18 weeks ultrasound investigation with sufficient language skills (Norwegian or Swedish), gestational age: at least 16-22 weeks. Exclusion: Plans to move further than reasonable travel distance from any of the participating hospitals within the first year of the offspring's life.
Inclusion of the child, step 2: Live-born babies of gestational age 35.0 weeks or more (including multiple pregnancies), maternal/parental willingness to participate in the study Exclusion criteria child: 1) severe neonatal cardiac, pulmonary, neurological, dermatological disease or other disease that may influence the outcomes 2), plans to move further than reasonable travel distance away from any of the participating hospitals within the first nine months of life.
3\) Non-willingness to participate 4) More than two fetuses
Overall 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 continuing to at least 6 moths and preferentially continuing thereafter. Observation only after nine months of age. Recruitment is done in two steps; first pregnant women at the 18-weeks ultrasound investigation and thereafter their new-born babies.
Randomisation into four groups is done by the postal code or "township" to ensure all four intervention-groups within each "township".
Electronic questionnaires will be completed by the mother at 18 and 34 weeks gestation, as well as for the baby at 3-6-9-12-18-24-30-36 months and annually thereafter. Also, an electronic diary will be completed each week from 2-26 weeks of age, to register weekly interventions, as well as symptoms of allergic diseases and food intake.
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 annually thereafter. It is a hope that the study can be maintained well into adulthood.
The study will be run in accordance with Good Clinical Practice (GCP).
Investigations:
Clinical investigations and biological sampling focuses on: General development, clinical assessments of health or disease, as well as diagnosing allergic disease and later also other non-communicable diseases (NCD)s.
These include:
* Fetal growth and respiratory development
* Somatic growth and status (anthropometric data)
* Blood pressure
* Skin, respiratory, gastrointestinal and other relevant organs
* Skin barrier (trans epidermal water loss (TEWL))
* Lung function and -development
* Microbiota/diversity (in and on the body and the environment)
* Viral infections
* Immune-deviation/tolerance development
* Specific allergen antibodies (IgE/IgG)
* Xenobiotics and interactions between exposures (microbiota/xenobiotics)
* Genetics/epi-genetics
Outcome measures:
Primary outcomes from birth to assessment times, first at 12 months of age for AD and at 36 months for food allergy to intervention allergens:
1. Atopic dermatitis (AD), Food allergy to any intervention allergen
2. Allergic sensitization (yes/no as well as quantitative, by skin prick test and s-IgE) Secondary outcomes: annually (ie 12, 24, 36, months and further follow-up investigations through childhood into adulthood): asthma (bronchial obstruction in year 1-2) and/or food allergy to any other allergen and/or anaphylaxis and/or allergic rhinitis Later outcomes for the exploratory part of the study will be defined in terms of obesity, cardiovascular diseases and diabetes.
For assessments of food allergy, first determined at three years of age, we will harmonize study protocols with similar studies.
Interventions:
Skin intervention (IS): Skin care is performed from week 2 through 8 months of age, supervised by study personnel prior to leaving the hospital.
Food intervention (IF): Major food allergens (cow's milk, peanut, wheat, egg) are introduced no later than 4.0 months of age as tastes, not interfering with nutrition.
Safety assessment: An external surveying committee to assess adverse events and main outcomes will be established prior to study start, to assess safety and potential needs for re-assessing interventions. The safety committee is offered free access to any data they need, at their discretion.
Statistical approaches: Stratum randomization, logistic regression analyses (primary outcomes), mixed models (continuous outcomes particularly of allergic sensitization by quantification) will be applied. An external surveillance committee will monitor the safety aspects with availability to reports whenever, and whatever clinical or other criteria they deem appropriate. Their assessment will have the potential to stop the trial in case of large differences in the groups. However, due to the short time span of observation before the interventions are completed, it is unlikely that intervention differences may be observed prior to completion.
Power analysis lack underlying data and is therefore based upon the prevalence Environment and Childhood Asthma study (ECA study) of AD at two years of age for skin barrier intervention only. The prevalence (%) of (ever) allergic disease in the ECA study were at 2, 10 and 16 years of age: Asthma: 8 (recurrent bronchial obstruction), 20 and 26.4%, Atopic eczema: 23.2, 33.2 and 34.8%, Allergic rhinitis (10 and 16 years): 19 and 32.1%, Allergic sensitization (10/16 years): 37.4 and 52.6%, respectively. Data on food allergy is lacking.
The investigators' pilot study suggested a prevalence reduction in AD from 16 to four % at 6-months of age in children with dry skin subjected to skin care from 2 weeks. Thus, an estimated reduction from 23.2 % to 18.2 % (five per cent points) in a general population would be highly clinically relevant, worthwhile and feasible and require 1030 children in each skin care versus observation group to attain an 80 % power at 5% significance level. A reduction to 19.2 % (four per cent points) requires 1638 children per group.
Recent publications demonstrated approximately 30 % reduction in atopic dermatitis at 32 weeks of age after daily use of skin care and 50% risk reduction at 6 months of age in 124 high risk children, respectively suggesting that approx. 1000 babies in each group would be sufficient to detect significant and relevant reductions in AD in a factorially 2x2 designed study. With many sub-studies we aim for 2400-2500 mother-child pairs.
In line with emerging study results (2015) the power-estimates will be repeated with potential modification of population size requirement until the target population is recruited.
Study Phases:
The first phase of the PreventADALL study; to establish the birth cohort study, collect information and biological samples, closely assess the children in the first 3 years of life, assess the impact of the two interventions and the impact of microbiota and xenobiotic exposure on early allergic disease presentation.
This phase will also create the foundation for a long-term follow-up study with careful assessments of potential risk or protective factors for allergic as well as other NCDs at the start of life. The PreventADALL study will lead to improved knowledge of the potential effect of primary prevention and of management of allergic diseases in early life as well as improving knowledge of risk factors for NCDs later in life.
With the knowledge that allergic diseases often manifest in early infancy, interventions will be carried out as early as possible to investigate if allergic diseases can be prevented. Two interventions, early and systematic introduction to common foods, and early skin care are carried out within the first four months and the first nine months of life, respectively.
Inclusion/Exclusion criteria:
Ante-natal inclusion, step 1: All mothers to-be at 18 weeks ultrasound investigation with sufficient language skills (Norwegian or Swedish), gestational age: at least 16-22 weeks. Exclusion: Plans to move further than reasonable travel distance from any of the participating hospitals within the first year of the offspring's life.
Inclusion of the child, step 2: Live-born babies of gestational age 35.0 weeks or more (including multiple pregnancies), maternal/parental willingness to participate in the study Exclusion criteria child: 1) severe neonatal cardiac, pulmonary, neurological, dermatological disease or other disease that may influence the outcomes 2), plans to move further than reasonable travel distance away from any of the participating hospitals within the first nine months of life.
3\) Non-willingness to participate 4) More than two fetuses
Overall 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 continuing to at least 6 moths and preferentially continuing thereafter. Observation only after nine months of age. Recruitment is done in two steps; first pregnant women at the 18-weeks ultrasound investigation and thereafter their new-born babies.
Randomisation into four groups is done by the postal code or "township" to ensure all four intervention-groups within each "township".
Electronic questionnaires will be completed by the mother at 18 and 34 weeks gestation, as well as for the baby at 3-6-9-12-18-24-30-36 months and annually thereafter. Also, an electronic diary will be completed each week from 2-26 weeks of age, to register weekly interventions, as well as symptoms of allergic diseases and food intake.
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 annually thereafter. It is a hope that the study can be maintained well into adulthood.
The study will be run in accordance with Good Clinical Practice (GCP).
Investigations:
Clinical investigations and biological sampling focuses on: General development, clinical assessments of health or disease, as well as diagnosing allergic disease and later also other non-communicable diseases (NCD)s.
These include:
* Fetal growth and respiratory development
* Somatic growth and status (anthropometric data)
* Blood pressure
* Skin, respiratory, gastrointestinal and other relevant organs
* Skin barrier (trans epidermal water loss (TEWL))
* Lung function and -development
* Microbiota/diversity (in and on the body and the environment)
* Viral infections
* Immune-deviation/tolerance development
* Specific allergen antibodies (IgE/IgG)
* Xenobiotics and interactions between exposures (microbiota/xenobiotics)
* Genetics/epi-genetics
Outcome measures:
Primary outcomes from birth to assessment times, first at 12 months of age for AD and at 36 months for food allergy to intervention allergens:
1. Atopic dermatitis (AD), Food allergy to any intervention allergen
2. Allergic sensitization (yes/no as well as quantitative, by skin prick test and s-IgE) Secondary outcomes: annually (ie 12, 24, 36, months and further follow-up investigations through childhood into adulthood): asthma (bronchial obstruction in year 1-2) and/or food allergy to any other allergen and/or anaphylaxis and/or allergic rhinitis Later outcomes for the exploratory part of the study will be defined in terms of obesity, cardiovascular diseases and diabetes.
For assessments of food allergy, first determined at three years of age, we will harmonize study protocols with similar studies.
Interventions:
Skin intervention (IS): Skin care is performed from week 2 through 8 months of age, supervised by study personnel prior to leaving the hospital.
Food intervention (IF): Major food allergens (cow's milk, peanut, wheat, egg) are introduced no later than 4.0 months of age as tastes, not interfering with nutrition.
Safety assessment: An external surveying committee to assess adverse events and main outcomes will be established prior to study start, to assess safety and potential needs for re-assessing interventions. The safety committee is offered free access to any data they need, at their discretion.
Statistical approaches: Stratum randomization, logistic regression analyses (primary outcomes), mixed models (continuous outcomes particularly of allergic sensitization by quantification) will be applied. An external surveillance committee will monitor the safety aspects with availability to reports whenever, and whatever clinical or other criteria they deem appropriate. Their assessment will have the potential to stop the trial in case of large differences in the groups. However, due to the short time span of observation before the interventions are completed, it is unlikely that intervention differences may be observed prior to completion.
Power analysis lack underlying data and is therefore based upon the prevalence Environment and Childhood Asthma study (ECA study) of AD at two years of age for skin barrier intervention only. The prevalence (%) of (ever) allergic disease in the ECA study were at 2, 10 and 16 years of age: Asthma: 8 (recurrent bronchial obstruction), 20 and 26.4%, Atopic eczema: 23.2, 33.2 and 34.8%, Allergic rhinitis (10 and 16 years): 19 and 32.1%, Allergic sensitization (10/16 years): 37.4 and 52.6%, respectively. Data on food allergy is lacking.
The investigators' pilot study suggested a prevalence reduction in AD from 16 to four % at 6-months of age in children with dry skin subjected to skin care from 2 weeks. Thus, an estimated reduction from 23.2 % to 18.2 % (five per cent points) in a general population would be highly clinically relevant, worthwhile and feasible and require 1030 children in each skin care versus observation group to attain an 80 % power at 5% significance level. A reduction to 19.2 % (four per cent points) requires 1638 children per group.
Recent publications demonstrated approximately 30 % reduction in atopic dermatitis at 32 weeks of age after daily use of skin care and 50% risk reduction at 6 months of age in 124 high risk children, respectively suggesting that approx. 1000 babies in each group would be sufficient to detect significant and relevant reductions in AD in a factorially 2x2 designed study. With many sub-studies we aim for 2400-2500 mother-child pairs.
In line with emerging study results (2015) the power-estimates will be repeated with potential modification of population size requirement until the target population is recruited.
Study Phases:
The first phase of the PreventADALL study; to establish the birth cohort study, collect information and biological samples, closely assess the children in the first 3 years of life, assess the impact of the two interventions and the impact of microbiota and xenobiotic exposure on early allergic disease presentation.
This phase will also create the foundation for a long-term follow-up study with careful assessments of potential risk or protective factors for allergic as well as other NCDs at the start of life. The PreventADALL study will lead to improved knowledge of the potential effect of primary prevention and of management of allergic diseases in early life as well as improving knowledge of risk factors for NCDs later in life.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Atopic Dermatitis
Food Allergy in Children
Asthma
Rhinitis, Allergic
Non-communicable Diseases
Obesity
Cardiovascular Disease
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
FACTORIAL
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
Primary Study Purpose
PREVENTION
Blinding Strategy
SINGLE
Investigators
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.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Observation only
Observation only
Group Type
NO_INTERVENTION
No interventions assigned to this group
Food intervention
Intervention; systematic introduction of egg, milk, wheat and peanut by 4 months of age
Group Type
EXPERIMENTAL
Food intervention
Intervention Type
OTHER
Intervention; systematic introduction of egg, milk, wheat and peanut by 4 months of age
Skin care
Intervention: regular baths with bath-oil 0.5-9 months of age
Group Type
EXPERIMENTAL
Skin care
Intervention Type
OTHER
Bath with bath-oil aim and Ceridal face cream for least 5 times/ week from 0.5-9 months of age.
Food intervention and skin care
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
Group Type
EXPERIMENTAL
Food intervention
Intervention Type
OTHER
Intervention; systematic introduction of egg, milk, wheat and peanut by 4 months of age
Skin care
Intervention Type
OTHER
Bath with bath-oil aim and Ceridal face cream for least 5 times/ week from 0.5-9 months of age.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Food intervention
Intervention; systematic introduction of egg, milk, wheat and peanut by 4 months of age
Intervention Type
OTHER
Skin care
Bath with bath-oil aim and Ceridal face cream for least 5 times/ week from 0.5-9 months of age.
Intervention Type
OTHER
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
PreventADALL bath oil
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1\. Ante-natal inclusion, step 1: All mothers to-be at 18 weeks ultrasound investigation with sufficient language skills (Norwegian or Swedish), gestational age: at least 16-22 weeks.
1\. Exclusion: Plans to move further than reasonable travel distance from any of the participating hospitals within the first year of the offspring's life.
1\. Inclusion of the child, step 2: Live-born babies of gestational age 35.0 weeks or more (including multiple pregnancies), maternal/parental willingness to participate in the study
1\. Exclusion: Plans to move further than reasonable travel distance from any of the participating hospitals within the first year of the offspring's life.
1\. Inclusion of the child, step 2: Live-born babies of gestational age 35.0 weeks or more (including multiple pregnancies), maternal/parental willingness to participate in the study
Exclusion Criteria
3\) Non-willingness to participate, 4) More than two foetuses
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Oslo
OTHER
Sponsor Role
collaborator
Karolinska Institutet
OTHER
Sponsor Role
collaborator
Helsinki University Central Hospital
OTHER
Sponsor Role
collaborator
University of Lausanne Hospitals
OTHER
Sponsor Role
collaborator
Norwegian Institute of Public Health
OTHER_GOV
Sponsor Role
collaborator
University Hospital, Akershus
OTHER
Sponsor Role
collaborator
Ostfold Hospital Trust
OTHER
Sponsor Role
collaborator
ThermoFisher Scientific Brahms Biomarkers France
INDUSTRY
Sponsor Role
collaborator
University of Southampton
OTHER
Sponsor Role
collaborator
Imperial College London
OTHER
Sponsor Role
collaborator
Norwegian University of Life Sciences
OTHER
Sponsor Role
collaborator
Diakonova University College
OTHER
Sponsor Role
collaborator
Norwegian Department of Health and Social Affairs
OTHER_GOV
Sponsor Role
collaborator
University Medical Center Groningen
OTHER
Sponsor Role
collaborator
Furst Medical Laboratory
UNKNOWN
Sponsor Role
collaborator
Oslo University Hospital
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Karin C. Lødrup Carlsen
Professor MD, PhD
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Karin C. Lødrup Carlsen, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Oslo University Hospital and University of Oslo
Oslo, , Norway
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Norway
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014-15118
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Frequency of Food Allergy Confirm by Oral Food Challenge Among Foods Avoidance in Atopic Dermatitis Children
NCT06947252
ENROLLING_BY_INVITATION
NA
Efficacy of Topical Coal Tar in Children With Atopic Dermatitis
NCT03461302
UNKNOWN
PHASE4
A Study to Determine the Safety and Tolerability of Dupilumab (REGN668/SAR231893) in Patients Aged ≥6 to <18 Years With Atopic Dermatitis (Eczema)
NCT02407756
COMPLETED
PHASE2
Bronchial Hyperreactivity in Atopic Dermatitis Patients - a 10 Year Follow-up
NCT00795496
COMPLETED
Preventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis
NCT01745159
COMPLETED
PHASE4
Observational Evaluation of Atopic Dermatitis in Pediatric Patients
NCT03687359
ACTIVE_NOT_RECRUITING
Skin Barrier Abnormalities and Oxidative Stress Response
NCT04606615
UNKNOWN
Study of Immunoadsorption to Treat Severe Atopical Dermatitis Associated With Excessively High Serum IgE Levels
NCT00616096
COMPLETED
NA
Systems Biology of Early Atopy
NCT04798079
RECRUITING
Prevention of Development of Transcutaneous Sensitization in Children With Atopic Dermatitis During Their First Year of Life
NCT04900948
COMPLETED
PHASE4
A Long-term Data Collection Study of Participants in France Aged 6 Years Old or More With Atopic Dermatitis Receiving Dupilumab
NCT06169527
ACTIVE_NOT_RECRUITING
Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy
NCT03089476
WITHDRAWN
NA
Asthma, Missed Immunizations, and Vitamin D Deficiency in Atopic Dermatitis
NCT01234909
TERMINATED
Daily Use of Lipikar Balm AP From Birth in Infants at High Risk of Developing Atopic Dermatitis
NCT01577628
TERMINATED
NA
Moisturizer to Prevent Atopic Dermatitis
NCT03808532
WITHDRAWN
PHASE2
Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis
NCT05042258
RECRUITING
PHASE4
Taking Into Account the Patient/Parent Preference in the Galenic Choice in Atopic Dermatitis. Feasibility and Impact on Treatment Adherence
NCT02193230
COMPLETED
Defining the Skin and Blood Biomarkers of Pediatric Atopic Dermatitis
NCT01782703
ACTIVE_NOT_RECRUITING
Comprehending Atopic Risk Elements
NCT04325451
UNKNOWN
A Study to Evaluate Adex Gel in the Treatment of Atopic Eczema.
NCT05454722
COMPLETED
NA
Study in Paediatric Patients With Atopic Dermatitis Treated With Dupilumab in Spain
NCT06415175
RECRUITING
Systemic Therapies for Pediatric Atopic Dermatitis
NCT01447381
UNKNOWN
A Study to Assess Subcutaneous Lirentelimab (AK002) in Atopic Dermatitis
NCT05155085
TERMINATED
PHASE2