Evidence map›Paper›PMID 34629091›Full record

ArticleTrials2021

Study of montelukast in children with sickle cell disease (SMILES): a study protocol for a randomised controlled trial.

Anna M Hood, Hanne Stotesbury, Melanie Kölbel, Michelle DeHaan, Michelle Downes, Jamie M Kawadler, Satwinder Sahota, Dagmara Dimitriou, Baba Inusa, Olu Wilkey and 14 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04351698 (Study of Montelukast In ChiLdrEn With Sickle Cell Disease), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 37% of its field
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.

NCT04351698 phase2 / phase3unknown statusnot on this mapstarted 2023, after this paper: background citation

Study of Montelukast In ChiLdrEn With Sickle Cell Disease (SMILES)

TypeinterventionalSponsorGreat Ormond Street Hospital for Children NHS Foundation TrustRan2023 to 2024Enrolled200ConditionsAnemia, Sickle Cell, Sleep-Disordered BreathingArmsMontelukast, Oral Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. 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

24 authors at 12 institutions in 3 countries.

Anna M HoodDevelopmental Neurosciences Unit and Biomedical Research Centre, UCL Great Ormond Street Institute of Child Health, 30 Guilford Street, London, WC1N 1EH, UK. a.hood@ucl.ac.uk.
Hanne StotesburyDevelopmental Neurosciences Unit and Biomedical Research Centre, UCL Great Ormond Street Institute of Child Health, 30 Guilford Street, London, WC1N 1EH, UK.
Melanie KölbelDevelopmental Neurosciences Unit and Biomedical Research Centre, UCL Great Ormond Street Institute of Child Health, 30 Guilford Street, London, WC1N 1EH, UK.
Michelle DeHaanDevelopmental Neurosciences Unit and Biomedical Research Centre, UCL Great Ormond Street Institute of Child Health, 30 Guilford Street, London, WC1N 1EH, UK.
Michelle DownesSchool of Psychology, University College Dublin, Dublin, Ireland.
Jamie M KawadlerDevelopmental Neurosciences Unit and Biomedical Research Centre, UCL Great Ormond Street Institute of Child Health, 30 Guilford Street, London, WC1N 1EH, UK.
Satwinder SahotaDevelopmental Neurosciences Unit and Biomedical Research Centre, UCL Great Ormond Street Institute of Child Health, 30 Guilford Street, London, WC1N 1EH, UK.
Dagmara DimitriouDepartment of Psychology and Human Development, UCL Institute of Education, London, UK.
Baba InusaChildren's Sickle Cell and Thalassaemia Centre, Evelina London Children's Hospital, Guy's and St Thomas' NHS Trust, London, UK.
Olu WilkeyNorth Middlesex Hospital National Health Service Trust, London, UK.
Maria PelidisDepartment of Paediatric Haematology, Evelina London Children's Hospital, Guy's and St Thomas' NHS Trust, London, UK.
Sara TrompeterUniversity College London Hospitals NHS Foundation Trust, London, UK.
Andrea LeighUniversity College London Hospitals NHS Foundation Trust, London, UK.
Janine YounisWhittington Health NHS Trust, London, UK.
Emma DrasarWhittington Health NHS Trust, London, UK.
Subarna ChakravortyPaediatric Haematology, King's College Hospital NHS Trust, London, UK.
David C ReesDepartment of Haematological Medicine, King's College Hospital NHS Trust, London, UK.
Sue HeightPaediatric Haematology, King's College Hospital NHS Trust, London, UK.
Sarah LawsonBirmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.
Johanna GavlakDepartment of Child Health, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Atul GuptaDepartment of Paediatric Respiratory Medicine, King's College Hospital NHS Foundation Trust, London, UK.
Deborah RidoutPopulation, Policy and Practice Programme, UCL Great Ormond Street Institute of Child Health, London, UK.
Christopher A ClarkDevelopmental Neurosciences Unit and Biomedical Research Centre, UCL Great Ormond Street Institute of Child Health, 30 Guilford Street, London, WC1N 1EH, UK.
Fenella J KirkhamDevelopmental Neurosciences Unit and Biomedical Research Centre, UCL Great Ormond Street Institute of Child Health, 30 Guilford Street, London, WC1N 1EH, UK.ORCID http://orcid.org/0000-0002-2443-7958
Great Ormond Street Hospital · GBKing's College Hospital · GBUniversity College London Hospitals NHS Foundation Trust · GBEvelina London Children's Healthcare · GBBirmingham Women’s and Children’s NHS Foundation Trust · GBKing's College Hospital NHS Foundation Trust · GBNational Health Service · GBNHS Blood and Transplant · GBUniversity College Dublin · IEUniversity College London · GBUniversity Hospital Southampton NHS Foundation Trust · GBWhittington Health NHS Trust · GB

Funding

White Matter Structural Integrity and Cognition in Children with Sickle Cell DiseaseF32HL143915 · NHLBI · UNIVERSITY COLLEGE LONDON · PI HOOD, ANNA · 2018 to 2021
$167k
NHLBI NIH HHS F32 HL143915
6 · The paper itself

Abstract

backgroundYoung children with sickle cell anaemia (SCA) often have slowed processing speed associated with reduced brain white matter integrity, low oxygen saturation, and sleep-disordered breathing (SDB), related in part to enlarged adenoids and tonsils. Common treatments for SDB include adenotonsillectomy and nocturnal continuous positive airway pressure (CPAP), but adenotonsillectomy is an invasive surgical procedure, and CPAP is rarely well-tolerated. Further, there is no current consensus on the ability of these treatments to improve cognitive function. Several double-blind, randomised controlled trials (RCTs) have demonstrated the efficacy of montelukast, a safe, well-tolerated anti-inflammatory agent, as a treatment for airway obstruction and reducing adenoid size for children who do not have SCA. However, we do not yet know whether montelukast reduces adenoid size and improves cognition function in young children with SCA.

methodsThe Study of Montelukast In Children with Sickle Cell Disease (SMILES) is a 12-week multicentre, double-blind, RCT. SMILES aims to recruit 200 paediatric patients with SCA and SDB aged 3-7.99 years to assess the extent to which montelukast can improve cognitive function (i.e. processing speed) and sleep and reduce adenoidal size and white matter damage compared to placebo. Patients will be randomised to either montelukast or placebo for 12 weeks. The primary objective of the SMILES trial is to assess the effect of montelukast on processing speed in young children with SCA. At baseline and post-treatment, we will administer a cognitive evaluation; caregivers will complete questionnaires (e.g. sleep, pain) and measures of demographics. Laboratory values will be obtained from medical records collected as part of standard care. If a family agrees, patients will undergo brain MRIs for adenoid size and other structural and haemodynamic quantitative measures at baseline and post-treatment, and we will obtain overnight oximetry. DISCUSSION: Findings from this study will increase our understanding of whether montelukast is an effective treatment for young children with SCA. Using cognitive testing and MRI, the SMILES trial hopes to gain critical knowledge to help develop targeted interventions to improve the outcomes of young children with SCA.

trial registrationClinicalTrials.gov NCT04351698 . Registered on April 17, 2020. European Clinical Trials Database (EudraCT No. 2017-004539-36). Registered on May 19, 2020.

Indexed as

Anemia, Sickle CellQuinolinesAcetatesAnti-Inflammatory AgentsChildChild, PreschoolCyclopropanesHumansRandomized Controlled Trials as TopicSulfidesAcetatesAnti-Inflammatory AgentsCyclopropanesmontelukastQuinolinesSulfidesExecutive functionhypoxiaProcessing speedRandomised control trialSickle cell anaemiaSleep-disordered breathing

Identifiers

PMID34629091
PMCPMC8502503
OpenAlexW3206450682

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.