Oesophageal AtresiaNCT03666767
Management and Outcomes of Congenital Anomalies in Low-, Middle- and High-Income Countries
An observational study of Oesophageal Atresia and Congenital Diaphragmatic Hernia, run by King's College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Oesophageal Atresia, Congenital Diaphragmatic Hernia, Intestinal Atresia
- What is being tested?
- Comparisons will be made between LMICs and HICs
- How many people
- 3,850 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2018to 9 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Management and Outcomes of Congenital Anomalies in Low-, Middle- and High-Income Countries: A Multi-Centre, International, Prospective Cohort Study
This study is a multi-centre, international, prospective cohort study of congenital anomalies to compare outcomes between LMICs and high-income countries (HICs) globally.
Read the detailed 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.
- Conditions
- Oesophageal Atresia, Congenital Diaphragmatic Hernia, Intestinal Atresia, Gastroschisis, Exomphalos, Anorectal Malformation
- Being tested
- Comparisons will be made between LMICs and HICs
- Medical subject headings
- Esophageal Atresia, Hernias, Diaphragmatic, Congenital, Intestinal Atresia, Gastroschisis, Hernia, Umbilical, Anorectal Malformations, Hirschsprung Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparisons will be made between LMICs and HICsOther
Countries will be defined as low, middle or high-income using the World Bank classification.
| Study group | Role | What they receive |
|---|---|---|
| Oesophageal atresia (OA) +/- tracheo-oesophageal fistula (TOF) | Not described Receives: Other: Comparisons will be made between LMICs and HICs | |
| Congenital diaphragmatic hernia (CDH) | Not described Receives: Other: Comparisons will be made between LMICs and HICs | |
| Intestinal atresia (IA) | Not described Receives: Other: Comparisons will be made between LMICs and HICs | |
| Gastroschisis | Not described Receives: Other: Comparisons will be made between LMICs and HICs | |
| Exomphalos | Not described Receives: Other: Comparisons will be made between LMICs and HICs | |
| Anorectal malformation (ARM) | Not described Receives: Other: Comparisons will be made between LMICs and HICs | |
| Hirschsprung's disease | Not described Receives: Other: Comparisons will be made between LMICs and HICs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: Occurring within 30-days of primary intervention
Wound dehiscence
All layers of the wound open post-operatively
Measured: Occurring within 30-days of primary intervention
Need for re-intervention
Need for a second unplanned intervention within 30-days of the primary intervention.
Measured: Occurring within 30-days of primary intervention
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.
Measured: Occurring within 30-days of primary intervention
Condition specific outcome variables
Oesophageal atresia: time to first oral feed (in days) and time to full oral feeds (in days)
Measured: Occurring within 30-days of primary intervention
Length of hospital stay
In days, including the first and last day. Time from admission to death in patients who do not survive.
Measured: Maximum 30-days post-intervention or following presentation for those who do not receive an intervention
30-day post primary intervention mortality
Measured: Death within 30-days of primary intervention or 30-days of presentation in those who do not receive an intervention
Ventilation requirement
Need for any ventilation (excluding during anaesthetic for interventions) and duration of ventilation in days
Measured: Occurring within 30-days of primary intervention or admission for those not receiving an intervention
Time to first enteral feed
In days, including the day of the primary intervention and the day when enteral feeds were started.
Measured: Occurring within 30-days of primary intervention or admission for those not receiving an intervention
Time to full enteral feeds
In days, including the day of the primary intervention and the day when full enteral feeds were achieved.
Measured: Occurring within 30-days of primary intervention or admission for those not receiving an intervention
Parenteral nutrition requirement
Need for any parenteral nutrition and total duration of parenteral nutrition in days for those who receive it.
Measured: Occurring within 30-days of primary intervention or admission for those not receiving an intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start1 Oct 2018
- Primary completion30 Jun 2019
- Study completion9 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oesophageal AtresiaStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,850 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miss Naomi Wright, King's College London
- Investigators
- Naomi J Wright, MBChB BSc MRCS DCH MSc, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666767
- Sponsor's protocol ID
- GPSv7.7/6/2018
- Status last verified
- Feb 2020
- First submitted
- 10 Sep 2018
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 31481373
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management and Outcomes of Congenital Anomalies in Low-, Middle- and High-Income Countries: A Multi-Centre, International, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03666767
- Acronym / sponsor ID
- GPSv7.7/6/2018
- Conditions
- Oesophageal Atresia, Congenital Diaphragmatic Hernia, Intestinal Atresia, Gastroschisis, Exomphalos, Anorectal Malformation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,850 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 9 Feb 2020 (actual)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multi-centre, international, prospective cohort study of congenital anomalies to compare outcomes between LMICs and high-income countries (HICs) globally.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Oesophageal atresia (OA) +/- tracheo-oesophageal fistula (TOF) | – | Other: Comparisons will be made between LMICs and HICs |
| Congenital diaphragmatic hernia (CDH) | – | Other: Comparisons will be made between LMICs and HICs |
| Intestinal atresia (IA) | – | Other: Comparisons will be made between LMICs and HICs |
| Gastroschisis | – | Other: Comparisons will be made between LMICs and HICs |
| Exomphalos | – | Other: Comparisons will be made between LMICs and HICs |
| Anorectal malformation (ARM) | – | Other: Comparisons will be made between LMICs and HICs |
| Hirschsprung's disease | – | Other: Comparisons will be made between LMICs and HICs |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparisons will be made between LMICs and HICsCountries will be defined as low, middle or high-income using the World Bank classification. | Other | Anorectal malformation (ARM), Congenital diaphragmatic hernia (CDH), Exomphalos, Gastroschisis, Hirschsprung's disease, Intestinal atresia (IA), Oesophageal atresia (OA) +/- tracheo-oesophageal fistula (TOF) |
Primary outcome
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.
11 secondary outcomes
Surgical site-infection
Time frame: Occurring within 30-days of primary intervention
Wound dehiscence
Time frame: Occurring within 30-days of primary intervention
Need for re-intervention
Time frame: Occurring within 30-days of primary intervention
Condition specific complications
Time frame: Occurring within 30-days of primary intervention
Condition specific outcome variables
Time frame: Occurring within 30-days of primary intervention
Length of hospital stay
Time frame: Maximum 30-days post-intervention or following presentation for those who do not receive an intervention
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
Ventilation requirement
Time frame: Occurring within 30-days of primary intervention or admission for those not receiving an intervention
Time to first enteral feed
Time frame: Occurring within 30-days of primary intervention or admission for those not receiving an intervention
Time to full enteral feeds
Time frame: Occurring within 30-days of primary intervention or admission for those not receiving an intervention
Parenteral nutrition requirement
Time frame: Occurring within 30-days of primary intervention or admission for those not receiving an intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Derived from this study: PubMed 31481373Wright 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naomi J Wright, MBChB BSc MRCS DCH MSc principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oesophageal Atresia and Congenital Diaphragmatic Hernia, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03666767, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020; AzTrials last refreshed its copy on 8 Nov 2026.