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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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Necrotizing enterocolitis (NEC) affects up to 10% of very preterm infants. NEC mortality is high (30-50 %) and has remained unchanged over the last decades. New treatments are urgently needed. NEC pathogenesis is multifactorial, but bowel ischemia plays an essential role in NEC development. Remote ischemic conditioning (RIC) consists in inducing brief periods of non-lethal ischemia in a limb distant to an organ suffering from ischemia. RIC has been used in adults, children and term neonates with a variety of diagnosis. However, no study has been done including preterm infants with NEC.
An appropriately sized blood pressure cuff will be applied to an arm or leg and inflated to promote RIC. This study will be conducted in three phases to assess the feasibility and safety of RIC in relation to duration of ischemia time, number of cycles of RIC and whether it is feasible and safe to perform RIC on consecutive days.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic conditioning | Procedure | An appropriately sized blood pressure cuff will be inflated around a limb (systolic blood pressure + 15 mmHg) for different periods of time (1 to up to 4 minutes), times (1 to up to 4 times) and consecutive days (1 to up to 2). |
| Measure | Description | Time Frame |
|---|---|---|
| Limb perfusion after Remote Ischemic Conditioning | Limb perfusion will be assessed before (baseline) and after Remote Ischemic Conditioning (RIC). Limb perfusion will be determined by oxygen saturation using pulse oximetry. RIC will be considered feasible and safe if the procedure is completed as planned with no failure of limb re-perfusion. Failure is defined as no return of limb arterial oxygen saturation to baseline 4 minutes after the ischemic phase (re-perfusion time). | 1 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cutaneous injury | Defined as new-onset skin breakdown, bruising, ecchymosis or petechiae. | 1 days |
| Persistent pain | Pain measured according to the premature infant pain profile (PIPP) scores (range 0-21). Pain scores will be obtained immediately before (baseline) and 6 hours after RIC. Persistent pain will be defined as a PIPP score higher than the baseline score. |
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Inclusion Criteria:
Exclusion Criteria:
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Preterm infants < 36 weeks with NEC (stages I-III as per Bell's modified classification).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35940871 | Derived | Zozaya C, Ganji N, Li B, Janssen Lok M, Lee C, Koike Y, Gauda E, Offringa M, Eaton S, Shah PS, Pierro A. Remote ischaemic conditioning in necrotising enterocolitis: a phase I feasibility and safety study. Arch Dis Child Fetal Neonatal Ed. 2023 Jan;108(1):69-76. doi: 10.1136/archdischild-2022-324174. Epub 2022 Aug 8. |
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| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| 1 days |
| D007410 |
| Intestinal Diseases |