Anti-inflammatory Treatment at the Onset of NEC in Preterm Infants- a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- CRP Level
研究概览
简要总结
Despite modern medical advances, necrotizing enterocolitis (NEC) remains a significant problem in neonatal intensive care units (ICUs). Although research has shown NEC to be an inflammatory necrosis of the bowels, to date no study has examined the effect of anti-inflammatory therapy on this dreaded disease once it is diagnosed. The investigators propose a multi-center, randomized, placebo-controlled, double-blinded pilot study to examine the effect of hydrocortisone in infants diagnosed with stages II and III NEC. The investigators will follow C-reactive protein (CRP) levels as a marker of systemic inflammation for the primary outcome in this study.
详细描述
Given the extensive inflammatory response inherent to NEC, anti-inflammatory treatment may be of benefit, to both reduce inflammation and as a potential therapy to improve outcome. To date, there is no specific therapy for NEC that has been found to improve outcome, but corticosteroids have yet to be investigated in that capacity. Therefore, we propose to examine the effect of hydrocortisone for treatment of NEC in a randomized, blinded, placebo-controlled pilot study, focusing on a primary outcome of C-reactive protein levels at 3 and 7 days of therapy as a measure of inflammation. In addition, we will follow several secondary outcome measures to determine the possibility of improved outcome in those infants assigned to hydrocortisone.
The investigators hypothesize that infants diagnosed with NEC who receive hydrocortisone will have significantly lower C-reactive protein levels at 3 and 7 days of treatment versus infants who receive placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Days 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant born at gestational age less than 34 weeks
- •Birth weight less than 2500 grams
- •Diagnosis of stage II or III NEC made by attending neonatologist, neonatology fellow, or pediatric hospitalist
- •Legally authorized representative is able to provide written informed consent prior to the performance of an protocol-specified evaluations or procedures
- •Consent can be obtained and study drug can be administered within 6 hours of diagnosis
排除标准
- •congenital gastrointestinal anomaly
- •subject is already receiving parenteral steroid therapy or subject has received parenteral steroids within one week prior to study entry
- •subject has received indomethacin therapy within 48 hours prior to being diagnosed with NEC
研究组 & 干预措施
hydrocortisone
Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
干预措施: hydrocortisone (Drug)
Placebo
Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
干预措施: placebo (Drug)
结局指标
主要结局
CRP Level
时间窗: 7 days
C-reactive protein (CRP) is a non-specific measure of inflammation, usually elevated in infants diagnosed with NEC
次要结局
- Spontaneous Intestinal Perforation(at 36 weeks corrected gestational age)
- Time on Parenteral Nutrition(at 40 weeks corrected gestational age)
- Time to Full Enteral Feeds(at 40 weeks corrected gestational age)
- Need for Gastrointestinal Surgery(at 36 weeks corrected gestational age)
- Growth Velocity(at 40 weeks CGA)
- Mortality(at 40 weeks corrected gestational age)
- Gastrointestinal (GI) Failure (Defined as Not Being on Full Enteral Feeds of 120kcal/kg/Day at 36 Weeks Corrected Age)(36 weeks corrected gestational age)
- Incidence of Sepsis(at 40 weeks corrected gestational age)
- Length of Stay(at 40 weeks corrected gestational age)
研究者
Brandy Frost
Clinician Educator and Attending Neonatologist
NorthShore University HealthSystem