ORCID Profile
0000-0002-8672-5349
Current Organisations
Royal College of Paediatrics and Child Health
,
King's College London
,
King's Health Partners
,
University of Cambridge
,
University of London
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Publications
The CoDiNOS trial protocol: an international randomised controlled trial of intravenous sildenafil versus inhaled nitric oxide for the treatment of pulmonary hypertension in neonates with congenital d
Publisher: BMJ
Date: 11-2019
DOI: 10.1136/BMJOPEN-2019-032122
Abstract: Congenital diaphragmatic hernia (CDH) is a developmental defect of the diaphragm that impairs normal lung development, causing pulmonary hypertension (PH). PH in CDH newborns is the main determinant for morbidity and mortality. Different therapies are still mainly based on ‘trial and error’. Inhaled nitric oxide (iNO) is often the drug of first choice. However, iNO does not seem to improve mortality. Intravenous sildenafil has reduced mortality in newborns with PH without CDH, but prospective data in CDH patients are lacking. In an open label, multicentre, international randomised controlled trial in Europe, Canada and Australia, 330 newborns with CDH and PH are recruited over a 4-year period (2018–2022). Patients are randomised for intravenous sildenafil or iNO. Sildenafil is given in a loading dose of 0.4 mg/kg in 3 hours followed by continuous infusion of 1.6 mg/kg/day, iNO is dosed at 20 ppm. Primary outcome is absence of PH on day 14 without pulmonary vasodilator therapy and/or absence of death within the first 28 days of life. Secondary outcome measures include clinical and echocardiographic markers of PH in the first year of life. We hypothesise that sildenafil gives a 25% reduction in the primary outcome from 68% to 48% on day 14, for which a s le size of 330 patients is needed. An intention-to-treat analysis will be performed. A p-value (two-sided) .05 is considered significant in all analyses. Ethics approval has been granted by the ethics committee in Rotterdam (MEC-2017-324) and the central Committee on Research Involving Human Subjects (NL60229.078.17) in the Netherlands. The principles of the Declaration of Helsinki, the Medical Research Involving Human Subjects Act and the national rules and regulations on personal data protection will be used. Parental informed consent will be obtained. NTR6982 Pre-results.
Foetal lung volumes in pregnant women who deliver very preterm: a pilot study
Publisher: Springer Science and Business Media LLC
Date: 07-12-2019
Global molecular diversity of RSV – the “INFORM RSV” study
Publisher: Springer Science and Business Media LLC
Date: 26-06-2020
DOI: 10.1186/S12879-020-05175-4
Abstract: Respiratory syncytial virus (RSV) is a global cause of severe respiratory morbidity and mortality in infants. While preventive and therapeutic interventions are being developed, including antivirals, vaccines and monoclonal antibodies, little is known about the global molecular epidemiology of RSV. INFORM is a prospective, multicenter, global clinical study performed by ReSViNET to investigate the worldwide molecular ersity of RSV isolates collected from children less than 5 years of age. The INFORM study is performed in 17 countries spanning all inhabited continents and will provide insight into the molecular epidemiology of circulating RSV strains worldwide. Sequencing of 4000 RSV-positive respiratory s les is planned to detect temporal and geographical molecular patterns on a molecular level over five consecutive years. Additionally, RSV will be cultured from a subset of s les to study the functional implications of specific mutations in the viral genome including viral fitness and susceptibility to different monoclonal antibodies. The sequencing and functional results will be used to investigate susceptibility and resistance to novel RSV preventive or therapeutic interventions. Finally, a repository of globally collected RSV strains and a database of RSV sequences will be created.
Core outcomes in neonatology: development of a core outcome set for neonatal research
Publisher: BMJ
Date: 15-11-2019
DOI: 10.1136/ARCHDISCHILD-2019-317501
Abstract: Neonatal research evaluates many different outcomes using multiple measures. This can prevent synthesis of trial results in meta-analyses, and selected outcomes may not be relevant to former patients, parents and health professionals. To define a core outcome set (COS) for research involving infants receiving neonatal care in a high-income setting. Outcomes reported in neonatal trials and qualitative studies were systematically reviewed. Stakeholders were recruited for a three-round international Delphi survey. A consensus meeting was held to confirm the final COS, based on the survey results. Four hundred and fourteen former patients, parents, healthcare professionals and researchers took part in the eDelphi survey 173 completed all three rounds. Sixteen stakeholders participated in the consensus meeting. The literature reviews identified 104 outcomes these were included in round 1. Participants proposed 10 additional outcomes 114 outcomes were scored in rounds 2 and 3. Round 1 scores showed different stakeholder groups prioritised contrasting outcomes. Twelve outcomes were included in the final COS: survival, sepsis, necrotising enterocolitis, brain injury on imaging, general gross motor ability, general cognitive ability, quality of life, adverse events, visual impairment/blindness, hearing impairment/deafness, retinopathy of prematurity and chronic lung disease/bronchopulmonary dysplasia. A COS for clinical trials and other research studies involving infants receiving neonatal care in a high-income setting has been identified. This COS for neonatology will help standardise outcome selection in clinical trials and ensure these are relevant to those most affected by neonatal care.
Inconsistent outcome reporting in large neonatal trials: a systematic review
Publisher: BMJ
Date: 13-05-2019
DOI: 10.1136/ARCHDISCHILD-2019-316823
Abstract: Inconsistent outcome selection and reporting in clinical trials are important sources of research waste it is not known how common this problem is in neonatal trials. Our objective was to determine whether large clinical trials involving infants receiving neonatal care report a consistent set of outcomes, how composite outcomes are used and whether parents or former patients were involved in outcome selection. A literature search of CENTRAL, CINAHL, EMBASE and MEDLINE was conducted randomised trials published between 1 July 2012 and 1 July 2017 and involving at least 100 infants in each arm were included. Outcomes and outcome measures were extracted and categorised by physiological system reported former patient and parent involvement in outcome selection was extracted. Seventy-six trials involving 43 126 infants were identified 216 different outcomes with 889 different outcome measures were reported. Outcome reporting covered all physiological systems but was variable between in idual trials: only 67/76 (88%) of trials reported survival and 639 outcome measures were only reported in a single trial. Thirty-three composite outcomes were used in 41 trials. No trials reported former patient or parent involvement in outcome selection. Inconsistent outcome reporting and a lack of parent and former patient involvement in outcome selection in neonatal clinical trials limits the ability of such trials to answer clinically meaningful questions. Developing and implementing a core outcome set for future neonatal trials, with input from all stakeholders, should address these issues.
Nirsevimab binding-site conservation in respiratory syncytial virus fusion glycoprotein worldwide between 1956 and 2021: an analysis of observational study sequencing data
Publisher: Elsevier BV
Date: 07-2023
Related Organisations
Royal College Of Paediatrics And Child Health
Location: United Kingdom of Great Britain and Northern Ireland
King's College London
Location: United Kingdom of Great Britain and Northern Ireland
King's Health Partners
Location: United Kingdom of Great Britain and Northern Ireland
University Of Cambridge
Location: United Kingdom of Great Britain and Northern Ireland
University Of London
Location: United Kingdom of Great Britain and Northern Ireland
Related Funding Activities
No related grants have been discovered for Anne Greenough.