Management and Outcomes of Congenital Anomalies in Low-, Middle- and High-Income Countries

King's College London

Status: Completed

Conditions: Hirschsprung Disease; Oesophageal Atresia; Exomphalos; Anorectal Malformation; Gastroschisis; Intestinal Atresia; Congenital Diaphragmatic Hernia

Treatments: Other: Comparisons will be made between LMICs and HICs

Study type: Observational

Funder types: Other

Identifiers

NCT03666767

GPSv7.7/6/2018

Details and patient eligibility

About

This study is a multi-centre, international, prospective cohort study of congenital anomalies to compare outcomes between LMICs and high-income countries (HICs) globally.

Full description

Background: Congenital anomalies have risen to become the 5th leading cause of death in children under 5-years of age globally, yet limited literature exists, particularly from low- and middle-income countries (LMICs) where most of these deaths occur.

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.

Enrollment: 3,850 patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

3,850 participants in 7 patient groups

Oesophageal atresia (OA) +/- tracheo-oesophageal fistula (TOF)

Treatment:

Other: Comparisons will be made between LMICs and HICs

Congenital diaphragmatic hernia (CDH)

Treatment:

Other: Comparisons will be made between LMICs and HICs

Intestinal atresia (IA)

Treatment:

Other: Comparisons will be made between LMICs and HICs

Gastroschisis

Treatment:

Other: Comparisons will be made between LMICs and HICs

Exomphalos

Treatment:

Other: Comparisons will be made between LMICs and HICs

Anorectal malformation (ARM)

Treatment:

Other: Comparisons will be made between LMICs and HICs

Hirschsprung's disease

Treatment:

Other: Comparisons will be made between LMICs and HICs