RIC-NEC Phase II Randomized Controlled Trial Study Design

Study Design

 

This is a Phase II multicenter, masked, randomized controlled feasibility trial consisting of two arms: RIC (intervention) and no RIC (control).

Hypothesis

 

 The hypothesis of this study is that it is feasible to conduct a multicenter masked randomized controlled trial to evaluate the effects of RIC in babies with NEC.

Objectives

 

The objectives of this phase II Feasibility RCT are to determine:  

  1.  Feasibility of identifying, recruiting, randomizing, and applying masked intervention to neonates within 24 hours from confirmed diagnosis of medical NEC;

  2.  Feasibility of recording NEC outcome measures to calculate sample size for the future phase III RCT;

  3. Satisfaction of key trial stakeholders (parents and healthcare workers) with the recruitment process and the intervention.

Inclusion Criteria

 

The inclusion criteria for this study are as follows:

  1. Preterm neonates with gestational age <33 weeks

  2. Current weight ≥750 g.

  3. Confirmed diagnosis of “medical” NEC based on the joint opinion of two attending physicians (two neonatologists or one neonatologist and one pediatric surgeon). The criteria that will be used to diagnose“medical” NEC will be that at least two of the following clinical signs and one of the radiological signs need to be present:

    1. Clinical signs (1. abdominal distension; 2. abdominal tenderness; 3. abdominal discoloration; 4. blood in stool);

    2. Radiological signs (1. pneumatosis; 2. portal venous gas)

  4. NEC diagnosis established 24 hours before receiving study intervention.

Exclusion Criteria

 

 The exclusion criteria for this study are:

  1. Patients who have indication for surgical intervention 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 confirmed 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, or occlusive arterial or venous thrombosis;

  6. Associated gastrointestinal anomalies including gastroschisis or congenital diaphragmatic hernia.