Health Condition 1: B968- Other specified bacterial agents as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Norepinephrine: during the management of fluid refractory septic shock in neonates ,whether norepinephrine in doses of 0.2-0.4mcg/kg/min as a primary vasoactive drug in first 45 min of
Sponsors
ABVIMS & Dr RML Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Preterm neonate 2. From birth till 28 days of life 3. Gender â?? both.
Exclusion criteria
Exclusion criteria: 1. Presence of lethal congenital malformations/chromosomal abnormalities . 2. Hypovolemic shock- setting of blood loss (antepartum hemorrhage, obvious blood loss) or clinical features suggestive of dehydration (i.e. depressed anterior fontanel, sunken eyeballs) in the setting of fluid loss 3. Clinically suspected or echocardiographically proven ductal dependent congenital heart disease 4. Obstructive shock- setting of airleak (tension pneumothorax), hydrops fetalis . 5. Shock due to transistional circulation in preterm babies ( 6. Severe perinatal asphyxia with evidence of HIE II or III as per Sarnat and Sarnat staging in near-term neonates (ï?³ 36 weeks gestational age) or moderate / severe encephalopathy (Levene classification) in preterm neonates ( 7. Baby already on vasopressors at the time of enrollment. 8. Study investigator to perform echocardiography is not available
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of preterm neonates achieving early (within 45 minutes of initiation) reversal of fluid refractory septic shock in both groups. Reversal of shock will be defined as achievement of therapeutic end points as a composite outcome of all of the following2: a. Mean arterial pressure (MAP) more than 5th centile in Zubrowâ??s chart based on gestational and postnatal age25 b. Heart rate within normal range (160 BPM), c. Capillary refill time less than 4 seconds, d. Warm hand and feet e. Normal pulses with no differential between peripheral and central pulse volume, f. Left ventricular output (150 ml/kg/min)4 Timepoint: 45 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total time to achieve hemodynamic stability will be defined after achieving reversal of shock (as defined above) as no further escalation of vasoactive drugsTimepoint: period of â?¥ 120 min.,;Acid-base status (blood pH, bicarbonate, base excess and serum lactate) and left ventricular outputTimepoint: baseline and 45 min after initiation of study drug,;IVH grade ï?³2, BPD at 36 weeks, NECï?³grade 2, ROP stageï?³2Timepoint: till discharge;Lactate clearanceTimepoint: baseline, 45 min, and 24 h after initiation of study drug;neonatal mortalityTimepoint: till 28 d of life;Physiological variablesTimepoint: baseline, 15 minutes, 30 minutes and 45 minutes;Proportion of neonates requiring additional vasoactive drugs,Timepoint: till reversal of shock;Total Duration of all vasoactive drug useTimepoint: till reversal of shock | — |
Countries
India
Contacts
Public ContactDr Ravendra Singh
Department of Neonatology ABVIMS and Dr. RML Hospital New Delhi
Outcome results
None listed