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Intervention (RIC + standard of care for NEC) for Necrotizing Enterocolitis (RIC-NEC Trial)

Phase 2
Recruiting
Led By Agostino Pierro, OBE, MD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current weight ≥750 g
Preterm neonates with gestational age at birth <33 weeks.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month +/- 1 week
Awards & highlights

RIC-NEC Trial Summary

This trial is looking at a serious intestinal disease called necrotizing enterocolitis (NEC) in newborn babies. NEC can cause the intestines to fail and is a major problem in pediatric medicine

Who is the study for?
This trial is for preterm babies born before 33 weeks of gestation, currently weighing at least 750 grams, and diagnosed with 'medical' NEC by two experts within the last day. It's not specified who can't join.Check my eligibility
What is being tested?
The study tests if adding Remote Ischemic Conditioning (RIC) to standard care improves outcomes in neonates with NEC compared to standard care alone. RIC involves cycles of controlled blood flow interruption to a limb.See study design
What are the potential side effects?
While specific side effects are not detailed here, RIC has been shown safe in prior studies on preterm neonates with NEC. Standard care side effects would depend on the treatments used.

RIC-NEC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My current weight is at least 750 grams.
Select...
My baby was born before 33 weeks of pregnancy.

RIC-NEC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months +/- 1 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months +/- 1 week for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The proportion (% total) of eligible patients that give consent and are randomized.
The proportion (% total) of randomized patients assessed for NEC-related outcomes.
The proportion (% total) of randomized patients receiving masked allocated intervention.
+2 more
Secondary outcome measures
Number of patients developing chronic lung disease (CLD)
Number of patients developing severe neurological injury
Number of patients developing severe retinopathy of prematurity (ROP)
+5 more

RIC-NEC Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention (RIC + standard of care for NEC)Experimental Treatment1 Intervention
Neonates randomized to the intervention arm will receive RIC and will continue to receive the standard of care for NEC.
Group II: Control (Standard of care for NEC)Placebo Group1 Intervention
Neonates randomized to the control arm will receive the standard of care for NEC. The research fellow or nurse responsible for performing RIC will be performing sham inflation/deflation of the blood pressure cuff connected to a dummy arm to mimic the noise of the cuff for neonates in the control arm.

Find a Location

Who is running the clinical trial?

UCL Great Ormond Street Institute of Child HealthUNKNOWN
4 Previous Clinical Trials
1,230 Total Patients Enrolled
Sunnybrook Health Sciences CentreOTHER
656 Previous Clinical Trials
1,551,229 Total Patients Enrolled
Karolinska University HospitalOTHER
477 Previous Clinical Trials
1,305,120 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for potential participants in this research study?

"Indeed, as stated on clinicaltrials.gov, this study is currently seeking eligible participants. The trial was initially posted on February 9th, 2023 and last updated on January 8th, 2024."

Answered by AI

What are the eligibility criteria for individuals who can participate in this medical research study?

"This study is currently enrolling 78 participants diagnosed with necrotizing enterocolitis (NEC) between the ages of 0 weeks and 33 weeks. Eligible applicants must meet the following criteria: they need to be preterm neonates born before 33 weeks gestation, have a current weight equal to or greater than 750g, have received confirmation of their NEC diagnosis from two experts in the field (either two neonatologists or one neonatologist and one pediatric surgeon), and finally, this diagnosis should have been made within the previous 24 hours."

Answered by AI

Is the age criterion for this clinical trial limited to individuals below 55 years old?

"To participate in this research study, individuals must be between 0 weeks and 33 weeks of age."

Answered by AI

What is the current number of participants enrolled in this clinical research study?

"Indeed, the information available on clinicaltrials.gov confirms that this study is actively seeking suitable participants. The initial posting of the trial was recorded on February 9th, 2023 and it was most recently updated on January 8th, 2024. For successful completion of the trial, a total of 78 patients are required to be enrolled across four distinct locations."

Answered by AI

Has the intervention of combining RIC with standard care for NEC been given approval by the FDA?

"Based on our team's evaluation at Power, the safety of the Intervention (RIC + standard of care for NEC) is scored as 2. This rating reflects that while there is some existing data supporting its safety, there is currently no data available regarding efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
RIC-NEC Randomized Controlled Trial
Agostino Pierro 2023. "RIC-NEC Randomized Controlled Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05279664.
~52 spots leftby Feb 2027
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