RIC-NEC Randomized Controlled Trial

Launched by THE HOSPITAL FOR SICK CHILDREN · Mar 6, 2022

Keywords

ClinConnect Summary

The RIC-NEC Randomized Controlled Trial is studying a new approach to help treat a serious intestinal disease called necrotizing enterocolitis (NEC) in newborns. NEC mainly affects premature babies and can lead to severe complications or even death. Researchers are exploring a treatment called Remote Ischemic Conditioning (RIC), which involves briefly interrupting blood flow to a limb to protect the intestines from damage. This trial aims to determine if RIC is a feasible and safe treatment for babies diagnosed with medical NEC.

To participate in this trial, babies must be preterm, weigh at least 750 grams, and have been diagnosed with medical NEC within the last 24 hours, confirmed by two doctors. Unfortunately, babies who need immediate surgery for NEC or have certain other health conditions cannot join. Families who take part can expect close monitoring and support throughout the study. This trial is an important step toward improving care for infants with NEC, as there have been very few new treatments for this condition in recent years.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Preterm neonates with all gestational age at birth.
• • 2. Current weight ≥750 g
• • 3. Confirmed diagnosis of "medical" NEC based on the joint opinion of two attending experts in the field (two neonatologists or one neonatologist and one pediatric surgeon).
• • 4. NEC diagnosis established within the previous 24 hours.
• Exclusion Criteria:
• • 1. Indication for surgery in the joint opinion of the attending neonatologist and pediatric surgeon (i.e. surgical NEC). This diagnosis is based on the presence of pneumoperitoneum in the abdominal radiograph and/or failure of medical treatment for NEC
• • 2. Previous episodes of NEC
• • 3. Diagnosis of NEC established \>24 hours ago
• • 4. Major congenital heart disease which needs surgical repair
• • 5. Antecedent limb ischemia/limb thrombotic events, occlusive arterial or venous thrombosis
• • 6. Associated gastrointestinal anomalies including gastroschisis or congenital diaphragmatic hernia.