Table 1

Generic data points

Generic questionsAnswers
During which month did the patient present to your hospital?October, November, December, January, February, March, April.
Please select the month that the patient presented to your hospital for the first time with this congenital anomaly. For example, if a baby was born with gastroschisis on the 29 September and presented to your hospital on 1 October you should select October.
Has consent been provided to include this patient in the study?
If no, which condition did the patient present with?
Yes, No, Patient consent is not required for this study at my institution.


Oesophageal atresia, Congenital diaphragmatic hernia, Intestinal atresia, Gastroschisis, Exomphalos, Omphalocele, Anorectal malformation, Hirschsprung's Disease.
Please select all the conditions that the patient presented with. Do not select a condition which the patient has already received surgical treatment for previously.
Demographics
Gestational age at birthNumber of weeks from the first day of the women's last menstrual cycle until birth. Round up or down to the nearest week.
Age at presentation (in hours)We understand this information may be difficult to obtain - please be as accurate as you can. Please round to the nearest hour. This number may be very large for patients who have a delayed presentation - please still enter it. For neonates born within your centre please enter 0. Enter unknown if unknown.
GenderMale, Female, Ambiguous, Unknown.
Weight at presentationIn kilograms (kg) on the day of presentation. Please provide a value to one decimal place.
Does the patient have another anomaly in addition to the study condition?Yes: Cardiovascular, Yes: Respiratory, Yes: Gastrointestinal, Yes: Neurological, Yes: Genito-urinary, Yes: Musculoskeletal, Yes: Down syndrome, Yes: Beckwith-Wiedemann syndrome, Yes: Cystic fibrosis, Yes: Chromosomal, Yes: Other, No.
Select all that apply. Include all anomalies diagnosed at any stage up until 30 days post-primary intervention or 30 days following presentation for those who did not receive an intervention. If you suspect an associated anomaly, but it has yet to be diagnosed, select 'Yes: Other'.
Distance from the patient's home to your hospitalIn kilometres (km). Please round to the nearest kilometre. Please enter 0 if born in your hospital.
Antenatal care and delivery
Antenatal ultrasound undertaken?
If the condition was diagnosed antenatally, at what gestational age?
Yes: study condition diagnosed, Yes: problem identified but study condition not diagnosed, Yes: no problem identified, No.


Please round up to the nearest week. If the patient has more than one study condition, please note the gestational age at which one or more of the conditions was first diagnosed.
Mode of transport to hospital?
Where did the patient present from? If other, please specify.
Ambulance, Other transport provided by the health service, Patient's own transport, Born within the hospital.
Home, Community Clinic, General Practice, District Hospital, Other, Unknown.
District hospital includes secondary-level healthcare, provincial hospital, general hospital, general mission hospital or regional hospital. It has general anaesthesia and can provide general surgical care.
Type of delivery:Vaginal (spontaneous), Vaginal (induced), Caesarean section (elective), Caesarean section (urgent/non-elective), Unknown. Vaginal delivery includes those requiring forceps and ventouse.
Clinical condition and patient care
Was the patient septic on arrival?


If yes, were appropriate antibiotics administered?
Yes, no.
Sepsis is SIRS with a suspected or confirmed bacterial, viral or fungal cause. SIRS is a response to a stimulus, which results in two or more of the following: temperature >38.5°C or <36°C, tachycardia*, bradycardia* in children <1 year old, tachypnoea*, leucopenia or leucocytosis*, hyperglycaemia*, altered mental status, hyperlactaemia*, increased central capillary refill time >2 seconds. Arrival is the time of birth for neonates born at your hospital. *Variables are defined as values outside the normal range for age.
Yes: within 1 hour of arrival, Yes: within the first day of arrival, No.
Appropriate antibiotics are defined as either broad spectrum covering gram negative, gram positive and anaerobic bacteria OR antibiotics that are the standard empirical treatment for that condition according to local guidelines OR are based on sensitivities provided by a microbiology sample.
Was the patient hypovolaemic on arrival?
If yes, was an intravenous fluid bolus given?
If yes, how much intravenous fluid was given?
Yes, No. Criteria for diagnosis include at least one of the following: prolonged central capillary refill time >2 seconds, *tachycardia, mottled skin, *reduced urine output, cyanosis, impaired consciousness, *hypotension. *Variables are defined as values outside the normal range for age.
Yes: within 1 hour of arrival, Yes: on the first day of arrival, No.


10–20 mL/kg, >20 mL/kg.
If <10 mL/kg was given, please select 'no' for the question asking if intravenous fluid was given.
Was the patient hypothermic on arrival?
If yes, was the patient warmed on arrival to within a normal temperature range?
Yes, No. Defined as <36.5°C core temperature. Arrival is the time of birth for neonates born at your hospital.


Yes, No. Only select yes if warming was commenced within 1 hour of arrival. Arrival is the time of birth for neonates born at your hospital.
Did the patient receive central venous access?
If yes, did the patient acquire central line sepsis?
Yes: umbilical catheter, Yes: peripherally inserted central catheter, Yes: percutaneously inserted central line with ultrasound guidance, Yes: surgically placed central line (open insertion), No.
Please select all that the patient received within 30 days of primary intervention or 30 days of presentation if no intervention was undertaken.
Yes: diagnosed clinically, Yes: confirmed on microbiology, No.
Within 30 days of primary intervention or 30 days of presentation if no intervention was undertaken.
Time from arrival at your hospital to primary intervention in hoursEnter 0 if no intervention was undertaken.
Primary intervention for each condition is defined as follows. Oesophageal atresia: surgery, either temporising or definitive, to manage the oesophageal atresia and/or tracheo-oesophageal fistula. Congenital diaphragmatic hernia: surgery to reduce the hernia and close the defect. Intestinal atresia: surgery, either temporising or definitive, to manage the obstruction including stoma formation and primary anastomosis. Gastroschisis: any procedure to either cover or reduce the bowel and/or close the defect. This includes application of a silo (regardless of whether or not they go on to require surgery). It excludes initial covering of the bowel in a plastic covering (bag or cling film) prior to intervention. Exomphalos: surgery or application of topical treatment to the sac in patients managed conservatively (regardless of whether or not they go on to require surgery). Hirschsprung's disease: surgery, either temporising or definitive, or rectal/distal bowel irrigation, laxatives or digital stimulation in patients managed conservatively. This does not include pre-operative washouts in patients planned to have surgery. Anorectal malformation: surgery, either temporising or definitive, or anal/fistula dilatation in patients with a low anorectal malformation managed conservatively.
American Society of Anesthesiologists Score at the time of primary intervention1.Healthy person, 2. Mild systemic disease, 3. Severe systemic disease, 4. Severe systemic disease that is a constant threat to life, 5. A moribund patient who is not expected to survive without the operation, Not applicable — no intervention.
What type of anaesthesia was used for the primary intervention?General anaesthesia with endotracheal tube, General anaesthesia with laryngeal airway, Ketamine anaesthesia, Spinal/caudal anaesthesia, Local anaesthesia only, No anaesthesia/just analgesia, No anaesthesia/no analgesia, Not applicable: no surgery or intervention undertaken.
Who undertook the anaesthetic for the primary intervention?Anaesthetic doctor, Anaesthetic nurse, Medical officer, Surgeon, Other healthcare professional, No anaesthetic undertaken.
If more than one of these personnel were present, please select the most senior.
Who undertook the primary intervention?Paediatric surgeon (or junior with paediatric surgeon assisting/in the room), General surgeon (or junior with paediatric surgeon assisting/in the room), Junior doctor, medical officer or other (without a paediatric or general surgeon assisting/in the room), Trainee surgeon (without a paediatric or general surgeon assisting or in the room), Not applicable — no surgery or primary intervention undertaken.
Was a Surgical Safety Checklist used at the time of primary intervention?Yes, No: but it was available, No: it was not available, Not applicable: a conservative primary intervention was undertaken, Not applicable: no surgery or primary intervention undertaken.
Total duration of antibiotics following primary interventionIn days (including the day of surgery and the day antibiotics were stopped. Include intravenous and oral antibiotics).
Did the patient receive a blood transfusion?Yes: not cross-matched, Yes: cross-matched, No: not required, No: it was required but not available.
Within 30 days of primary intervention or 30 days of presentation if no intervention was undertaken.
Did the patient require ventilation?
If yes, for how long did the patient remain on ventilation?
Yes: and it was given, Yes: but it was not available, No.
Within 30 days of primary intervention or 30 days of presentation if no intervention was undertaken. Please include all types of ventilation.


In days (include all days on ventilation within 30 days of primary intervention or 30 days of presentation if no intervention was undertaken).
Time to first enteral feed (post-primary intervention)In days (include the day of primary intervention and the day of first enteral feed in the calculation). Enter 0 if enteral feeds were not commenced. Enter 999 if feeds were not stopped, for example, in patients with Hirschsprung's Disease managed conservatively. Include all types of enteral feeding — oral, nasogastric, gastrostomy and other.
Time to full enteral feeds (post-primary intervention)In days (enter 0 if the patient died before reaching full enteral feeds or 30 if the patient had not reached full enteral feeds at 30 days post-primary intervention or 30 days following admission in patients who did not receive a primary intervention). Include all types of enteral feeding — oral, nasogastric, gastrostomy and other.
Did the patient require parenteral nutrition?
If yes, for how long did the patient receive parenteral nutrition?
Yes and it was given, Yes and it was sometimes available but less than required, Yes but it was not available, No.


In days. Include all days that the patient received parenteral nutrition (any volume) up until 30 days post-primary intervention or 30 days following presentation in patients who do not receive an intervention.
Outcomes
Did the patient survive to discharge?
If the patient was discharged prior, were they still alive at 30 days following primary intervention?
If no, cause of death?
Yes, No.
Select yes if the patient was still alive in your hospital 30 days after primary intervention or 30 days after presentation in patients who did not receive a primary intervention.


Yes, No: not followed-up after discharge, Followed-up but not until 30 days post-primary intervention.
This can include all reliable communication with the patient/patient’s family including in person, via telephone and other.


Sepsis, aspiration pneumonia, respiratory failure, cardiac failure, malnutrition, electrolyte disturbance, haemorrhage, lack of intravenous access, hypoglycaemia, recurrent tracheo-oesophageal fistula, recurrent diaphragmatic hernia, anastomotic leak, ischaemic bowel, ruptured exomphalos sac, enterocolitis, other. If other, please specify.
Duration of hospital stay (days)Please include the day of admission and the day of discharge in your calculation. For example, if a patient presented on 1 October and was discharged on the 5 October, their duration of hospital stay would be 5 days. If the patient died, please record the number of days from admission to death. Only include the duration of the primary admission, not subsequent admissions if the patient re-presented.
Did the patient have a surgical site infection?Yes, No, Not applicable: no surgical wound.
This is defined as 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 an SSI (negative culture swab excludes this criterion) OR (3) there is an abscess within the wound (clinically or radiologically detected).
Did the patient have a full thickness wound dehiscence?Yes, No, Not applicable — no surgical wound.
This is defined as all layers of the wound opening within 30 days of surgery.
Did the patient require a further unplanned intervention?Yes — percutaneous intervention, Yes — surgical intervention, No, Not applicable — no primary intervention undertaken.
Within 30 days of primary intervention. This does not include routine reduction and closure of the defect in neonates with gastroschisis receiving a preformed silo.
Was the patient followed up at 30 days post primary surgery or intervention to assess for complications?Yes: reviewed in person, Yes: via telephone consultation, Yes: via other means, Yes: still an in-patient at 30 days, No: data are based on in-patient observations only, No: follow-up was done but prior to 30 days.
If the patient had a complication, when was it diagnosed?During the primary admission, As an emergency re-attender, At routine follow-up as an outpatient, Not applicable: no complications.
What study condition does this patient have?Oesophageal atresia, Congenital diaphragmatic hernia, Intestinal atresia, Gastroschisis, Exomphalos/Omphalocele, Anorectal malformation, Hirschsprung's Disease.
If the patient has presented for the first time with more than one of these conditions, please select all that apply. If the patient presented on this occasion with one of these conditions, but previously had another condition managed then only select the condition they are presenting with on this occasion and enter that they have another anomaly in the demographics section above. For example, if the patient presents at 2 months with Hirschsprung's disease, but previously had a duodenal atresia repair, please select Hirschsprung's disease here (not intestinal atresia) and tick in the section above that they have another gastrointestinal anomaly.
  • SIRS, Systemic Inflammatory Response Syndrome.