Necrotising enterocolitis Pregnancy and Childbirth Necrotising enterocolitis of fetus and newborn
Conditions
Interventions
This will be a multicentre randomised controlled trial which means that 80 neonates (40 in each arm) will be allocated to receive one of these two types of operations which are both valid and used rou
Sponsors
Great Ormond Street Hospital for Children NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Suspected NEC 2. Need for laparotomy based on: 2.1. Radiological signs of intestinal perforation or 2.2. Failure of improvement with medical treatment 3. Aged 0 - 6 months, either sex
Exclusion criteria
Exclusion criteria: 1. No evidence of NEC (e.g. intestinal volvulus) 2. Focal intestinal perforation (since many surgeons would not perform a stoma) 3. Extensive NEC precluding intestinal anastomosis (intestinal resection will result in short bowel) 4. NEC affecting the colon that cannot be completely assessed because of risk of bleeding 5. Patient's instability during the operation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of parenteral nutrition (days), as this reflects the recovery of intestinal function after NEC and will be affected by complications and/or need for further procedures. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mortality at 1, 3 and 6 months after randomisation 2. Number and type of surgical procedures performed (including insertion of central venous lines) 3. Hospital stay (days) for survivors and non-survivors 4. Intestinal absorptive function. This will be assessed by measuring: 4.1. Calorie intake (kcal/kg/day) both enterally and parenterally 1 month and 6 months after randomisation 4.2. Weight gain at 1 month and 6 months after randomisation 4.3. Time (days) to full enteral feeding 4.4. Requirement for medication to slow intestinal transit time 5. Intestinal complications: 5.1. Stricture (of either anastomosis or remaining intestine, confirmed by a contrast study and/or histology) 5.2. Anastomotic leak 5.3. Prolapse of stoma 5.4. Stoma necrosis 5.5. Intestinal obstruction 5.6. High output stoma 5.7. Recurrence of NEC 6. Wound complication (infection, incisional hernia, dehiscence) 7. Days on antibiotics, incidence of sepsis (positive blood culture), intra-abdominal abscess requiring drainage or reoperation 8. Intraventricular haemorrhage (ultrasound scan of the brain at enrolment in the trial and 2 weeks after randomisation). Intraventricular haemorrhages will be graded (grade I to IV) according to their extent and severity. 9. Respiratory function. This will be assessed by recording the need for assisted ventilation or oxygen dependency at 1 and 6 months after randomisation 10. Cost of hospital treatment 11. Time to death (days) 12. Cause of death (related to abdominal sepsis/not related to abdomen [cardiac anomaly/cerebral haemorrhage/other]) | — |
Countries
Canada, Italy, Latvia, Netherlands, Serbia, Sweden, United Kingdom, United States of America
Outcome results
None listed