Hydrocortisone Treatment of Cardiovascular Insufficiency in Term and Late Preterm Infants: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 18
- 主要终点
- Number of Participants With Neurodevelopmental Impairment
研究概览
简要总结
This trial will evaluate the effects of a 7-day course of hydrocortisone therapy on short-term morbidity, cardiovascular function, long-term neurodevelopment, and mortality in critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
详细描述
Cardiovascular insufficiency is common and potentially life-threatening in critically ill term and late preterm newborns admitted to the newborn intensive care unit (NICU) in the first few days of age.
This study proposes to conduct a multicenter, randomized, masked, placebo-controlled trial within the Neonatal Research Network (NRN). This trial will evaluate the effects of a 7-day course of hydrocortisone therapy on short-term morbidity, cardiovascular function, long-term neurodevelopment, and mortality in critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
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
- 34 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age greater than or equal to 34 weeks at birth
- •Admitted to the center NICU by 48 hours of age
- •Intubated and mechanically ventilated for a minimum of 2 hours before 72 hours postnatal age
排除标准
- •Receiving ECMO
- •Intubated for the sole purpose of anticipated surgery or airway anomalies
- •Treatment will be limited based on poor prognosis
- •Receiving dexamethasone or hydrocortisone
- •Receiving ibuprofen or indomethacin
- •Congenital heart disease
- •Hypotension thought to result from specific, immediately remediable factors including placental hemorrhage, acute hemorrhage or tension pneumothorax
- •Pituitary hypoplasia or congenital adrenal hyperplasia
- •Any chromosomal disorder
- •Hypertension in the absence of inotrope therapy as defined by mean arterial blood pressure > 95th percentile
- •Initiation of whole body cooling for moderate or severe neonatal encephalopathy
- •Brain disorders or any other known structural abnormality
- •Major anomalies
研究组 & 干预措施
Hydrocortisone
hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line
干预措施: Hydrocortisone (Drug)
Placebo
Saline placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Neurodevelopmental Impairment
时间窗: Birth to 22-26 months corrected gestational age
This is measured as Yes if an any hearing impairment or visual impairment is noted, if non-normal gross motor function level is noted, any seizures have been noted, or if the cognitive, language, or motor scores of the Bayley III score are more than 1 standard deviation below the average; Otherwise, No.
Death
时间窗: Birth to 22-26 months corrected gestational age
This is measured as Yes if an infant died between birth and 22-26 months corrected gestational age; Otherwise, No.
Number of Participants With Death or Neurodevelopmental Impairment
时间窗: Birth to 22-26 months corrected gestational age
A composite outcome that measures the occurrence of death or neurodevelomental impairment between birth and 22-26 months corrected gestational age.
次要结局
- Number of Participants With Need for Gastronomy Tube(Birth to 60 days of life)
- Number of Participants With Necrotizing Enterocolitis(Birth to 60 days of life)
- Maximum Inotrope Dose(From start of study drug administration (7 days) through 3 days post study drug administration.)
- Duration of Mechanical Ventilation(Birth to 60 days of life)
- Inotrope Duration(24 hours prior to study drug administration through 3 days post study drug administration.)
- Days to Full Feeds(Birth to 60 days of life)
- Duration of Oxygen Requirement(Birth to 60 days of life)
- Number of Participants With Need for Home Oxygen(Birth to 60 days of life)
- Number of Participants With Renal Insufficiency(Birth to 60 days of life)
- Oxygenation Index(Birth to 60 days of life)
- Number of Participants With Fluid Boluses Given(Birth to 60 days of life)
- Number of Boluses Given(Birth to 60 days of life)
- Respiratory Severity(Birth to 60 days of life)
- Hospital Length of Stay(Birth to 60 days of life)
- Number of Participants With Need for ECMO Therapy(Birth to 60 days of life)
- Number of Participants With Inotrope Exposure(24 hours prior to study drug administration through 3 days post study drug administration.)