Enterocolitis, NecrotizingNCT03860701
Remote Ischemic Conditioning in Necrotizing Enterocolitis
An observational study of Enterocolitis, Necrotizing, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 3 months
- Conditions the study is for
- Enterocolitis, Necrotizing
- What is being tested?
- Remote ischemic conditioning
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 17 Dec 2018to 20 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 3 months
- All sexes
- Child
Study population: Preterm infants < 36 weeks with NEC (stages I-III as per Bell's modified classification).
Who may be able to join
- Patients with NEC (stages I-III Bell's Classification)
- Weight greater or equal to 750 g.
- Gestational age < 36 weeks.
- Patients whose parents consent to participate in the study.
Who cannot join
- Patients with major congenital anomalies
- No antecedent of limb ischemia/limb thrombotic events.
- No antecedent diagnosis of occlusive arterial or venous thrombosis
- Hemodynamic instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remote Ischemic Conditioning in Necrotizing Enterocolitis: Feasibility and Safety Pilot Study.
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.
Read the detailed description
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.
- Conditions
- Enterocolitis, Necrotizing
- Being tested
- Remote ischemic conditioning
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioningProcedure or surgery
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 days
Secondary outcomes (2)
Cutaneous injury
Defined as new-onset skin breakdown, bruising, ecchymosis or petechiae.
Measured: 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.
Measured: 1 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start17 Dec 2018
- Primary completion20 Aug 2019
- Study completion20 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Enterocolitis, NecrotizingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Agostino Pierro, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860701
- Sponsor's protocol ID
- REB1000061144
- Status last verified
- Oct 2020
- First submitted
- 17 Jan 2019
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35940871
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Conditioning in Necrotizing Enterocolitis: Feasibility and Safety Pilot Study.
- ClinicalTrials.gov ID
- NCT03860701
- Acronym / sponsor ID
- REB1000061144
- Conditions
- Enterocolitis, Necrotizing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 3 months
- Sex
- All
- Age groups
- Child
- Study population
- Preterm infants < 36 weeks with NEC (stages I-III as per Bell's modified classification).
Key inclusion criteria (4 listed)
- Patients with NEC (stages I-III Bell's Classification)
- Weight greater or equal to 750 g.
- Gestational age < 36 weeks.
- Patients whose parents consent to participate in the study.
Key exclusion criteria (4 listed)
- Patients with major congenital anomalies
- No antecedent of limb ischemia/limb thrombotic events.
- No antecedent diagnosis of occlusive arterial or venous thrombosis
- Hemodynamic instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ischemic conditioningAn 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). | Procedure or surgery | – |
Primary outcome
Limb perfusion after Remote Ischemic Conditioning
Time frame: 1 days
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).
2 secondary outcomes
Cutaneous injury
Time frame: 1 days
Persistent pain
Time frame: 1 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Derived from this study: PubMed 35940871Zozaya 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enterocolitis, Necrotizing, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limb perfusion after Remote Ischemic Conditioning (time frame: 1 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03860701, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.