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NCT Number: NCT03666767

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

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

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Key information

Conditions

Oesophageal Atresia Anorectal Malformation Anorectal Malformations Colonic Diseases Congenital Abnormalities Congenital Diaphragmatic Hernia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Esophageal Atresia Esophageal Diseases Exomphalos Gastrointestinal Diseases Gastroschisis Hernia Hernia, Abdominal Hernia, Diaphragmatic Hernia, Umbilical Hernia, Ventral Hernias, Diaphragmatic, Congenital Hirschsprung Disease Infant, Newborn, Diseases Internal Hernia Intestinal Atresia Intestinal Diseases Megacolon Musculoskeletal Abnormalities Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

King's College London

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Comparisons will be made between LMICs and HICs

Other

Countries will be defined as low, middle or high-income using the World Bank classification.

Primary outcomes

  1. All-cause, in-hospital mortality

    Time frame: 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.

    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.

Secondary outcomes

  1. Surgical site-infection

    Time frame: Occurring within 30-days of primary intervention

    This is defined by the Centre for Disease Control as including one or more of the following within 30-days of surgery:

    • 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).

  2. Wound dehiscence

    Time frame: Occurring within 30-days of primary intervention

    All layers of the wound open post-operatively

  3. Need for re-intervention

    Time frame: Occurring within 30-days of primary intervention

    Need for a second unplanned intervention within 30-days of the primary intervention.

  4. Condition specific complications

    Time frame: Occurring within 30-days of primary intervention

    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.

  5. Condition specific outcome variables

    Time frame: Occurring within 30-days of primary intervention

    Oesophageal atresia: time to first oral feed (in days) and time to full oral feeds (in days)

  6. Length of hospital stay

    Time frame: Maximum 30-days post-intervention or following presentation for those who do not receive an intervention

    In days, including the first and last day. Time from admission to death in patients who do not survive.

  7. 30-day post primary intervention mortality

    Time frame: Death within 30-days of primary intervention or 30-days of presentation in those who do not receive an intervention

  8. Ventilation requirement

    Time frame: Occurring within 30-days of primary intervention or admission for those not receiving an intervention

    Need for any ventilation (excluding during anaesthetic for interventions) and duration of ventilation in days

  9. Time to first enteral feed

    Time frame: Occurring within 30-days of primary intervention or admission for those not receiving an intervention

    In days, including the day of the primary intervention and the day when enteral feeds were started.

  10. Time to full enteral feeds

    Time frame: Occurring within 30-days of primary intervention or admission for those not receiving an intervention

    In days, including the day of the primary intervention and the day when full enteral feeds were achieved.

  11. Parenteral nutrition requirement

    Time frame: Occurring within 30-days of primary intervention or admission for those not receiving an intervention

    Need for any parenteral nutrition and total duration of parenteral nutrition in days for those who receive it.

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Sep 12, 2018
Registry last updated
Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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