Early hydrocortisone in neonatal shock versus standard care,a randomized control trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1)improvement in shock measured in terms of following parameters
研究概览
简要总结
PRIMARY OBJECTIVE : To study the effectiveness of Early hydrocortisone in Neonatal shock
SECONDARY OBJECTIVE: To assess baseline serum cortisol levels in neonatal shock
Source of data: INPATIENTS ADMITTED TO NICU , INDIRA GANDHI INSTITUTE OF
CHILD HEALTH
A. Study design:
Interventional : Prospective Randomized control trial
B. Study period: 1.5 years
C. Place of study : NICU ,INDIRA GANDHI INSTITUTE OF CHILD HEALTH
Total sample size 60 (30 in each group )
METHODOLOGY:
After obtaining approval and clearance from the institutional ethics committee, the patients
fulfilling the inclusion criteria will be enrolled for the study after obtaining informed
consent. Neonates fulfilling all the inclusion criteria and none of the exclusion criteria will be
included in the study .Enrolled Neonates will be randomized into the study once they have been
started on Dopamine 10mcg/kg/min ,depending upon the type of hypotension .Neonates
randomized to study group will receive 0.5mg/kg hydrocortisone every 12 hours for 48 hours
.Neonates randomized to control group will receive standard care of neonatal shock . Serum
cortisol levels estimated before initiation of hydrocortisone .2ml of Venous blood will be
collected under aseptic precautions and serum cortisol level measured using
electrochemiluminescence immunoassay (ECLIA) method in Cobas e analyzer.
Neonates in both groups will be monitored Serially,v ital parameters will be recorded hourly till
resolution of shock occurs .Arterial blood gas analysis will be done as per clinical indication .Urine
output will be assessed every 6 hourly .Further management of neonates done as per unit policy.
Randomization sequencing will be generated using computer based sequencing and allocation
concealment done by storage in serially numbered opaque envelopes.
Study end point :Till discharge /death
Primary outcome :
1)Improvement of shock
2)Duration of inotropes requirement
Secondary outcome :
1)Need for 2nd inotrope
2)Assess Baseline serum cortisol levels
3)Incidence of hyperglycemia,hypertension,
4)Incidence of SIPS (SPONTANEOUS INTESTINAL PERFORATION ) ,NEC (NECROTIZING
ENTEROCOLITIS ),Death
5)Duration of hospital stay
6)Incidence of culture positive sepsis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •Patient attenders willing to give informed consent 2)Neonates (age <28 days ) taken into consideration for study  3)Gestational age of 28 weeks to 40 weeks 4)Should fulfill criteria for neonatal shock Clinical features suggestive of shock:  Symptoms of decreased peripheral perfusion :Cold,pale skin with delayed capillary refill time ,tachycardia,weak peripheral pulses,Narrow pulse pressure,oliguria Hypotension : MAP <30 mmHg (MEAN ARTERIAL PRESSURE) or MAP < neonate’s gestational age in weeks at time of birth or BP less than fifth centile for gestational age 5) Maximum dose of dopamine 10 mcg/kg/min reached.
排除标准
- •Patient attenders not willing to give informed consent 2) Neonates with suspected Congenital adrenal hyperplasia 3) Major life threatening congenital malformations 4) Indomethacin usage for treatment of PDA 5) Suspected or proven NEC 6) Hypovolemic shock 7) Obstructive shock.
结局指标
主要结局
1)improvement in shock measured in terms of following parameters
时间窗: At Baseline
A) MAP-mean arterial pressure that lies between 50-90th centile
时间窗: At Baseline
2)CFT (CAPILLARY REFILL TIME ) less than three seconds
时间窗: At Baseline
3)Urine output more than 1ml per kg per hour
时间窗: At Baseline
次要结局
- 1)Need for 2nd inotrope(2)Assess Baseline serum cortisol levels)
研究者
Dr PRIYANKA RM
INDIRA GANDHI INSTITUTE OF CHILD HEALTH