Management and Outcomes of Congenital Anomalies in Low-, Middle- and High-Income Countries
1 other identifier
observational
3,850
1 country
1
Brief Summary
This study is a multi-centre, international, prospective cohort study of congenital anomalies to compare outcomes between LMICs and high-income countries (HICs) globally.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2018
CompletedFirst Posted
Study publicly available on registry
September 12, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 9, 2020
CompletedFebruary 24, 2020
February 1, 2020
9 months
September 10, 2018
February 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
All-cause, in-hospital mortality
This will include all patients in the study, both those who did not receive an intervention and those that did. For patient's hospitalised for over 30-days following primary intervention, a 30-day post-primary intervention mortality rate will be utilised. For patients who do not receive a primary intervention (conservative generic ward care only) but remain alive and hospitalised at 30-days following primary admission will have this time point used for recording their mortality status for the primary outcome.
Mortality whilst in hospital during primary admission, up to a maximum of 30-days following primary intervention or 30-days following presentation for those who do not receive an intervention and are still in hospital.
Secondary Outcomes (11)
Surgical site-infection
Occurring within 30-days of primary intervention
Wound dehiscence
Occurring within 30-days of primary intervention
Need for re-intervention
Occurring within 30-days of primary intervention
Condition specific complications
Occurring within 30-days of primary intervention
Condition specific outcome variables
Occurring within 30-days of primary intervention
- +6 more secondary outcomes
Study Arms (7)
Oesophageal atresia (OA) +/- tracheo-oesophageal fistula (TOF)
Congenital diaphragmatic hernia (CDH)
Intestinal atresia (IA)
Gastroschisis
Exomphalos
Anorectal malformation (ARM)
Hirschsprung's disease
Interventions
Countries will be defined as low, middle or high-income using the World Bank classification.
Eligibility Criteria
Neonates, infants and children up to 16-years of age presenting for the first time with one of the seven congenital anomalies in the study to institutions in low-, middle- and high-income countries globally. All institutions that provide surgical care for the patients being studied can contribute data. Participating institutions will be recruited through convenience sampling with snowballing.
You may qualify if:
- Any neonate, infant or child under the age of 16-years, presenting for the first time, with one of the study conditions can be included in the study.
- 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.
You may not qualify if:
- Any neonate, infant or child with one of the study conditions who has previously received surgery (including a stoma) for their condition
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King's College London
London, United Kingdom
Related Publications (1)
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.
PMID: 31481373DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Naomi J Wright, MBChB BSc MRCS DCH MSc
King's College London
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Miss Naomi Wright
Study Record Dates
First Submitted
September 10, 2018
First Posted
September 12, 2018
Study Start
October 1, 2018
Primary Completion
June 30, 2019
Study Completion
February 9, 2020
Last Updated
February 24, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Following publication of the main results.
Following publication of the main study results, the full anonymised dataset will be shared with all collaborators and made publicly available. At no time during presentation or publication of the study will individual collaborators, institutions or countries be independently identifiable. For the main study publication, all data within low, middle and high-income countries will be pooled for analysis. Following publication of the main study, collaborators from within a country can undertake a sub-analysis of the data from their country, but only if all collaborators who have contributed data from that country agree. Individual country names will not be identifiable on the dataset made publicly available - each country will be represented by a random number. The publicly available anonymised data will be identifiable by continent allowing for continental sub-analyses to be undertaken.