Management and Outcomes of Congenital Anomalies in Low-, Middle- and High-Income Countries
NCT ID: NCT03666767
Last Updated: 2020-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3850 participants
OBSERVATIONAL
2018-10-01
2020-02-09
Brief Summary
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Detailed Description
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Aim: To undertake a multi-centre prospective cohort study of congenital anomalies to compare outcomes between LMICs and high-income countries (HICs) globally.
Methods: The Global PaedSurg Research Collaboration will be established consisting of children's surgical care providers from around the world to participate in the study; collaborators will be co-authors of resulting presentations and publication(s). Data will be collected on patients presenting primarily with seven congenital anomalies (oesophageal atresia, congenital diaphragmatic hernia, intestinal atresia, gastroschisis, exomphalos, anorectal malformation and Hirschsprung's disease) for a minimum of one month between Oct 2018 - April 2019. Anonymous data will be collected on patient demographics, clinical status, interventions and outcome. Data will be captured using the secure, online data collection tool REDCap.
The primary outcome will be all-cause in-hospital mortality and the secondary outcomes will be occurrence of post-operative complications. Chi-squared analysis will be used to compare mortality between LMICs and HICs. Multilevel, multivariate logistic regression analysis will be undertaken to identify patient level and hospital level factors affecting outcomes with adjustment for confounding factors. P\<0.05 will be deemed significant. Study approval will be sought from all participating centres. Funding has been granted by the Wellcome Trust.
Outcomes: The study aims to be the first large-scale, geographically comprehensive, multi-centre prospective cohort study of a selection of common congenital anomalies to define current management and outcomes globally. Results will be used to aid advocacy and global health prioritisation and inform future interventional studies aimed at improving outcomes.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Oesophageal atresia (OA) +/- tracheo-oesophageal fistula (TOF)
Comparisons will be made between LMICs and HICs
Countries will be defined as low, middle or high-income using the World Bank classification.
Congenital diaphragmatic hernia (CDH)
Comparisons will be made between LMICs and HICs
Countries will be defined as low, middle or high-income using the World Bank classification.
Intestinal atresia (IA)
Comparisons will be made between LMICs and HICs
Countries will be defined as low, middle or high-income using the World Bank classification.
Gastroschisis
Comparisons will be made between LMICs and HICs
Countries will be defined as low, middle or high-income using the World Bank classification.
Exomphalos
Comparisons will be made between LMICs and HICs
Countries will be defined as low, middle or high-income using the World Bank classification.
Anorectal malformation (ARM)
Comparisons will be made between LMICs and HICs
Countries will be defined as low, middle or high-income using the World Bank classification.
Hirschsprung's disease
Comparisons will be made between LMICs and HICs
Countries will be defined as low, middle or high-income using the World Bank classification.
Interventions
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Comparisons will be made between LMICs and HICs
Countries will be defined as low, middle or high-income using the World Bank classification.
Eligibility Criteria
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Inclusion Criteria
* Children who have NOT previously received any surgery for their condition.
* Children who have received basic resuscitative and supportive care for their condition at a different healthcare facility and then been transferred to the study centre.
* Patients presenting primarily with one of the study conditions who receive palliative care or no care must be included within the study to reflect true outcomes.
Exclusion Criteria
* If they have recently received surgery for their condition, were discharged and then represented with a complication of the surgery during the study period they should NOT be included in the study.
16 Years
ALL
No
Sponsors
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King's College London
OTHER
Responsible Party
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Miss Naomi Wright
Miss Naomi Wright
Principal Investigators
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Naomi J Wright, MBChB BSc MRCS DCH MSc
Role: PRINCIPAL_INVESTIGATOR
King's College London
Locations
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King's College London
London, , United Kingdom
Countries
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References
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Wright NJ; Global PaedSurg Research Collaboration. Management and outcomes of gastrointestinal congenital anomalies in low, middle and high income countries: protocol for a multicentre, international, prospective cohort study. BMJ Open. 2019 Sep 3;9(8):e030452. doi: 10.1136/bmjopen-2019-030452.
Other Identifiers
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GPSv7.7/6/2018
Identifier Type: -
Identifier Source: org_study_id
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