Therapeutic Controlled Hypothermia in the Treatment of Neonates With Severe Necrotizing Enterocolitis (CoolNEC)

NHS Foundation Trust

Status: Terminated

Conditions: Necrotizing Enterocolitis

Treatments: Procedure: Standard treatment of care at normothermia; Procedure: cooling blanket/mattress

Study type: Interventional

Funder types: Other

Identifiers

NCT01330576

06SG14

Details and patient eligibility

About

Hypothesis: Controlled hypothermia to 33.5C for 48 hours reduces the severity of critical illness in neonates with severe necrotizing enterocolitis.

Enrollment: 13 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• weight at diagnosis > 700 grams
• confirmed NEC (Bell's stage II or III)
• radiological evidence of pneumatosis coli
• systemic compromise as defined by increase in ventilation requirement and/or requiring inotopic support

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups, including a placebo group

Standard treatment of care at normothermia

Placebo Comparator group

Description:

Control group: Standard treatment of care at normothermia

Treatment:

Procedure: Standard treatment of care at normothermia

cooling blanket/mattress

Experimental group

Description:

Therapeutic controlled hypothermia (33.5C) using cooling blanket/mattress

Treatment:

Procedure: cooling blanket/mattress