Evidence map›Paper›PMID 30867201›Full record

ArticleBMJ open2019

PEBBLES study protocol: a randomised controlled trial to prevent atopic dermatitis, food allergy and sensitisation in infants with a family history of allergic disease using a skin barrier improvement strategy.

Adrian Lowe, John Su, Mimi Tang, Caroline J Lodge, Melanie Matheson, Katrina J Allen, George Varigos, Arun Sasi, Noel Cranswick, Simone Hamilton and 5 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03667651 (THE PEBBLES STUDY), which is not on this map. Cited by 28 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03667651 phase3active not recruitingnot on this map

THE PEBBLES STUDY: A Randomised Controlled Trial to Prevent Eczema, Food Allergy and Sensitisation Using a Skin Barrier Improvement Strategy

TypeinterventionalSponsorUniversity of MelbourneRan2018 to 2027Enrolled760ConditionsEczema, Asthma, Allergy, FoodArmsEpiCeram
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Skin care interventions in infants for preventing eczema and food allergy.The Cochrane database of systematic reviews · 2022
    Pooled it
  2. Skin care interventions in infants for preventing eczema and food allergy.The Cochrane database of systematic reviews · 2021
    Pooled it
  3. Trial
  4. Article
  5. Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Article
  12. Skin surface biomarkers are associated with future development of atopic dermatitis in children with family history of allergic disease.Skin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI) · 2023
    Article
  13. Review
  14. A pragmatic approach to infant feeding for food allergy prevention.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2022
    Article
  15. Review
  16. Article
  17. Article
  18. Current Insights into Atopic March.Children (Basel, Switzerland) · 2021
    Review
  19. Review
  20. Real-World LEAP Implementation.Current allergy and asthma reports · 2021
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Adrian LoweAllergy and Lung Health Unit, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.ORCID 0000-0002-4691-8162
John SuMurdoch Children's Research Institute, Royal Children's Hospital, Parkville, Victoria, Australia.
Mimi TangMurdoch Children's Research Institute, Royal Children's Hospital, Parkville, Victoria, Australia.
Caroline J LodgeAllergy and Lung Health Unit, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.
Melanie MathesonAllergy and Lung Health Unit, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.
Katrina J AllenMurdoch Children's Research Institute, Royal Children's Hospital, Parkville, Victoria, Australia.
George VarigosDepartment of Dermatology, Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.
Arun SasiMercy Women's Hospital, Heidelberg, Victoria, Australia.
Noel CranswickMurdoch Children's Research Institute, Royal Children's Hospital, Parkville, Victoria, Australia.
Simone HamiltonAllergy and Lung Health Unit, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.
Colin F RobertsonMurdoch Children's Research Institute, Royal Children's Hospital, Parkville, Victoria, Australia.
Jennie HuiSchool of Population and Global Health, The University of Western Australia, Perth, Australia.
Michael AbramsonDepartment of Epidemiology & Preventive Medicine, School of Public Health & Preventive Medicine, Monash University, Melbourne, Australia.
Shaie O'BrienAllergy and Lung Health Unit, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.
Shyamali DharmageAllergy and Lung Health Unit, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe skin is an important barrier against environmental allergens, but infants have relatively impaired skin barrier function. There is evidence that impaired skin barrier function increases the risk of allergic sensitisation, atopic dermatitis (AD) and food allergy. We hypothesise that regular prophylactic use of emollients, particularly those that are designed to improve skin barrier structure and function, will help prevent these conditions. With the aim of determining if application of a ceramide-dominant emollient two times per day reduces the risk of AD and food allergy, we have commenced a multicentre phase III, outcome assessor blinded, randomised controlled trial of this emollient applied from birth to 6 months. METHODS AND ANALYSIS: Infants (n=760) with a family history of allergic disease will be recruited from maternity hospitals in Melbourne. The primary outcomes are as follows: the presence of AD, assessed using the UK Working Party criteria, and food allergy using food challenge, in the first 12 months of life as assessed by a blinded study outcome assessor. Secondary outcomes are as follows: food sensitisation (skin prick test), skin barrier function, AD severity, the presence of new onset AD after treatment cessation (between 6 and 12 months) and the presence of parent reported AD/eczema. Recruitment commenced in March 2018. ETHICS AND DISSEMINATION: The PEBBLES Study is approved by the Human Research Ethics Committees of the Royal Children's Hospital (RCH) (#37090A) and the Mercy Hospital for Women (2018-008). Parents or guardians will provide written informed consent. Outcomes will be disseminated through peer-reviewed publications and presented at scientific conferences. TRIAL REGISTRATION NUMBERS: ACTRN12617001380381 and NCT03667651.

Indexed as

CeramidesCholesterolDermatitis, AtopicDrug CombinationsEmollientsFatty AcidsFood HypersensitivityHumansInfantInfant, NewbornRandomized Controlled Trials as TopicSingle-Blind MethodCeramidesCholesterolDrug CombinationsEmollientsEpiCeramFatty Acidsallergyasthmaeczemapaediatric dermatology

Identifiers

PMID30867201
PMCPMC6430027

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.