The Cleft Collective: protocol for a longitudinal prospective cohort study
Introduction Cleft lip and/or palate (CL/P) affects 1 in 700 live births globally. Children born with CL/P and their families face various challenges throughout the child’s development. Extant research is often limited by small numbers and single-centre data. The Cleft Collective, a national cohort...
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BMJ Publishing Group
2024-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/7/e084737.full |
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| author | Sarah J Lewis Karen Ho Kerry Humphries Yvonne Wren Amy J V Davies Jonathan R Sandy |
| author_facet | Sarah J Lewis Karen Ho Kerry Humphries Yvonne Wren Amy J V Davies Jonathan R Sandy |
| author_sort | Sarah J Lewis |
| collection | DOAJ |
| description | Introduction Cleft lip and/or palate (CL/P) affects 1 in 700 live births globally. Children born with CL/P and their families face various challenges throughout the child’s development. Extant research is often limited by small numbers and single-centre data. The Cleft Collective, a national cohort study in the UK, aims to build a resource, available to collaborators across the globe, to understand causes, best treatments and long-term outcomes for those born with CL/P, ultimately seeking to enhance their quality of life through improved understanding and care.Methods and analysis A longitudinal prospective cohort study of children born with CL/P and their families. Recruitment occurs across the UK and started in November 2013. Recruitment will continue until September 2027 with an estimated final sample of 4822 children born with CL/P (1157 cleft lip including/excluding the alveolus; 2112 cleft palate only; 1042 unilateral cleft lip and palate and 511 bilateral cleft lip and palate). Biological samples are collected from all recruited members of the family. Parental and child questionnaires are collected at key time points throughout the child’s development. Surgical data are collected at the time of surgical repair of the child’s cleft. Consent is obtained to link to external data sources. Nested substudies can be hosted within the cohort. Regular engagement with participants takes place through birthday cards for the children, social media posts and newsletters. Patient and Public Involvement is conducted through the Cleft Lip And Palate Association and Cleft Collective Patient Consultation Group who provide insightful and essential guidance to the Cleft Collective throughout planning and conducting research.Ethics and dissemination The Cleft Collective was ethically approved by the National Research Ethics Service committee South West—Central Bristol (REC13/SW/0064). Parental informed consent is required for participation. Findings from the Cleft Collective are disseminated through peer-reviewed publications, conference presentations, newsletters and social media. |
| format | Article |
| id | doaj-art-7ead4202f8ff48d992c71e40cb3a6769 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-7ead4202f8ff48d992c71e40cb3a67692025-08-20T02:13:15ZengBMJ Publishing GroupBMJ Open2044-60552024-07-0114710.1136/bmjopen-2024-084737The Cleft Collective: protocol for a longitudinal prospective cohort studySarah J Lewis0Karen Ho1Kerry Humphries2Yvonne Wren3Amy J V Davies4Jonathan R Sandy52 Bristol Medical School, University of Bristol Faculty of Health Sciences, Bristol, UK3 Bristol Bioresource Laboratories, University of Bristol Faculty of Health Sciences, Bristol, UK1 Bristol Dental School, The Cleft Collective, University of Bristol Faculty of Health Sciences, Bristol, UK1 Bristol Dental School, The Cleft Collective, University of Bristol Faculty of Health Sciences, Bristol, UK1 Bristol Dental School, The Cleft Collective, University of Bristol Faculty of Health Sciences, Bristol, UK1 Bristol Dental School, The Cleft Collective, University of Bristol Faculty of Health Sciences, Bristol, UKIntroduction Cleft lip and/or palate (CL/P) affects 1 in 700 live births globally. Children born with CL/P and their families face various challenges throughout the child’s development. Extant research is often limited by small numbers and single-centre data. The Cleft Collective, a national cohort study in the UK, aims to build a resource, available to collaborators across the globe, to understand causes, best treatments and long-term outcomes for those born with CL/P, ultimately seeking to enhance their quality of life through improved understanding and care.Methods and analysis A longitudinal prospective cohort study of children born with CL/P and their families. Recruitment occurs across the UK and started in November 2013. Recruitment will continue until September 2027 with an estimated final sample of 4822 children born with CL/P (1157 cleft lip including/excluding the alveolus; 2112 cleft palate only; 1042 unilateral cleft lip and palate and 511 bilateral cleft lip and palate). Biological samples are collected from all recruited members of the family. Parental and child questionnaires are collected at key time points throughout the child’s development. Surgical data are collected at the time of surgical repair of the child’s cleft. Consent is obtained to link to external data sources. Nested substudies can be hosted within the cohort. Regular engagement with participants takes place through birthday cards for the children, social media posts and newsletters. Patient and Public Involvement is conducted through the Cleft Lip And Palate Association and Cleft Collective Patient Consultation Group who provide insightful and essential guidance to the Cleft Collective throughout planning and conducting research.Ethics and dissemination The Cleft Collective was ethically approved by the National Research Ethics Service committee South West—Central Bristol (REC13/SW/0064). Parental informed consent is required for participation. Findings from the Cleft Collective are disseminated through peer-reviewed publications, conference presentations, newsletters and social media.https://bmjopen.bmj.com/content/14/7/e084737.full |
| spellingShingle | Sarah J Lewis Karen Ho Kerry Humphries Yvonne Wren Amy J V Davies Jonathan R Sandy The Cleft Collective: protocol for a longitudinal prospective cohort study BMJ Open |
| title | The Cleft Collective: protocol for a longitudinal prospective cohort study |
| title_full | The Cleft Collective: protocol for a longitudinal prospective cohort study |
| title_fullStr | The Cleft Collective: protocol for a longitudinal prospective cohort study |
| title_full_unstemmed | The Cleft Collective: protocol for a longitudinal prospective cohort study |
| title_short | The Cleft Collective: protocol for a longitudinal prospective cohort study |
| title_sort | cleft collective protocol for a longitudinal prospective cohort study |
| url | https://bmjopen.bmj.com/content/14/7/e084737.full |
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