NET (Necrotising Enterocolitis Trial) - primary peritoneal drainage in necrotising enterocolitis: randomised controlled multi-centre trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18282954

Enrollment

208

Registered

2004-04-13

Start date

2002-11-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotising enterocolitis or isolated intestinal perforation Digestive System Enterocolitis

Interventions

Primary peritoneal drain or laparotomy.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Extremely low birth weight (ELBW) infants (weight less than or equal to 1000g) with perforated necrotising enterocolitis or isolated perforation.

Exclusion criteria

Exclusion criteria: 1. Bilateral grade 4 intraventricular haemorrhages 2. Previous laparotomy 3. Previous peritoneal drain 4. Recurrent NEC

Design outcomes

Primary

Measure	Time frame
Survival at 1 and 6 months after randomisation.	—

Secondary

Measure	Time frame
1. Time to death (days) 2. Cause of death (related to abdominal sepsis/not related to abdomen [cardiac anomaly/cerebral haemorrhage/other]) 3. Hospital stay for survivors and non survivors (days) 4. Intestinal absorptive function. This will be assessed by measuring: 4.1. The calorie intake (kcal/kg/day) both enterally and parenterally 1 month and 6 months after randomisation 4.2. The weight gain at 1 month and 6 months after randomisation 4.3. The duration of parenteral nutrition (days) 4.4. The time to full enteral feeding (days) 5. Long term intestinal complications: 5.1. Intestinal stricture (confirmed by a contrast study and/or histology) 5.2. Persistent entero-cutaneous fistula 6. 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 7. Respiratory function. This will be assessed by assessing the need for assisted ventilation or oxygen dependency at 1 and 6 months after randomisation.	—

Measure

Time frame

1. Time to death (days) 2. Cause of death (related to abdominal sepsis/not related to abdomen [cardiac anomaly/cerebral haemorrhage/other]) 3. Hospital stay for survivors and non survivors (days) 4. Intestinal absorptive function. This will be assessed by measuring: 4.1. The calorie intake (kcal/kg/day) both enterally and parenterally 1 month and 6 months after randomisation 4.2. The weight gain at 1 month and 6 months after randomisation 4.3. The duration of parenteral nutrition (days) 4.4. The time to full enteral feeding (days) 5. Long term intestinal complications: 5.1. Intestinal stricture (confirmed by a contrast study and/or histology) 5.2. Persistent entero-cutaneous fistula 6. 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 7. Respiratory function. This will be assessed by assessing the need for assisted ventilation or oxygen dependency at 1 and 6 months after randomisation.

—

Countries

Australia, Belgium, France, Hong Kong, Ireland, Italy, Japan, Korea, South, Netherlands, New Zealand, South Africa, Spain, Switzerland, United Kingdom, United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 5, 2026