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

Congenital Diaphragmatic Hernia Clinical Trial

Official title:

Management and Outcomes of Congenital Anomalies in Low-, Middle- and High-Income Countries: A Multi-Centre, International, Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03666767
• Other study ID #: GPSv7.7/6/2018
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: February 9, 2020

Study information

• Verified date: February 2020
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3850
• Est. completion date: February 9, 2020
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anorectal Malformation
• Anorectal Malformations
• Congenital Abnormalities
• Congenital Diaphragmatic Hernia
• Esophageal Atresia
• Exomphalos
• Gastroschisis
• Hernia, Diaphragmatic
• Hernias, Diaphragmatic, Congenital
• Hirschsprung Disease
• Intestinal Atresia
• Oesophageal Atresia

Intervention

Other:
• Comparisons will be made between LMICs and HICs
Countries will be defined as low, middle or high-income using the World Bank classification.

Locations

Country	Name	City	State
United Kingdom	King's College London	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Surgical site-infection	This is defined by the Centre for Disease Control as including one or more of the following within 30-days of surgery: 1) purulent drainage from the superficial or deep (fascia or muscle) incision, but not within the organ/ space component of the surgical site OR 2) at least two of: pain or tenderness; localised swelling; redness; heat; fever; AND the incision is opened deliberately to manage infection, spontaneously dehisces or the clinician diagnoses a SSI (negative culture swab excludes this criterion) OR 3) there is an abscess within the wound (clinically or radiologically detected).	Occurring within 30-days of primary intervention
Secondary	Wound dehiscence	All layers of the wound open post-operatively	Occurring within 30-days of primary intervention
Secondary	Need for re-intervention	Need for a second unplanned intervention within 30-days of the primary intervention.	Occurring within 30-days of primary intervention
Secondary	Condition specific complications	OA: pneumonia, mediastinitis, pneumothorax, chylothorax, haemothorax, anastomotic leak, anastomotic stricture, recurrent TOF, other.; CDH: air leak, chylothorax, recurrence, adhesional obstruction.; IA: anastomotic leak/ stenosis, short-gut, missed additional atresia, adhesive bowel obstruction.; Gastroschisis: ischaemic bowel, abdominal compartment syndrome, necrotising enterocolitis.; Exomphalos: ruptured sac.; ARM: electrolyte disturbance, high stoma output (over 20mls/kg/day), stoma prolapse/ retraction/ herniation, peri-stoma skin breakdown (or perianal if primary reconstruction was undertaken without a covering stoma), anal stenosis.; Hirschsprung's disease: enterocolitis, electrolyte disturbance, high stoma output (over 20mls/kg/day), stoma prolapse/ retraction/ herniation, peri-stoma skin breakdown (or perianal if primary pull-through was undertaken without covering stoma), anal stenosis, post-operative obstruction, anastomotic leak.	Occurring within 30-days of primary intervention
Secondary	Condition specific outcome variables	Oesophageal atresia: time to first oral feed (in days) and time to full oral feeds (in days)	Occurring within 30-days of primary intervention
Secondary	Length of hospital stay	In days, including the first and last day. Time from admission to death in patients who do not survive.	Maximum 30-days post-intervention or following presentation for those who do not receive an intervention
Secondary	30-day post primary intervention mortality		Death within 30-days of primary intervention or 30-days of presentation in those who do not receive an intervention
Secondary	Ventilation requirement	Need for any ventilation (excluding during anaesthetic for interventions) and duration of ventilation in days	Occurring within 30-days of primary intervention or admission for those not receiving an intervention
Secondary	Time to first enteral feed	In days, including the day of the primary intervention and the day when enteral feeds were started.	Occurring within 30-days of primary intervention or admission for those not receiving an intervention
Secondary	Time to full enteral feeds	In days, including the day of the primary intervention and the day when full enteral feeds were achieved.	Occurring within 30-days of primary intervention or admission for those not receiving an intervention
Secondary	Parenteral nutrition requirement	Need for any parenteral nutrition and total duration of parenteral nutrition in days for those who receive it.	Occurring within 30-days of primary intervention or admission for those not receiving an intervention