Health Condition 1: P84- Other problems with newborn
Conditions
Interventions
Intervention1: Continuous intravenous Dexmedetomidine infusion: All neonates more than equal to 26 weeks of gestation requiring sedation and analgesia while requiring mechanical ventilation due to an
Sponsors
AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: All neonates more than equal to 26 0/7 weeks of gestation Post menstrual age less than equal to 44 weeks On invasive mechanical ventilation and requiring sedation/analgesia (as decided by clinical team) Age at enrolment Index episode of ventilation till 44 weeks post menstrual age Each neonate will be enrolled only once in the study and a repeat enrolment during subsequent ventilation episodes will not be undertaken.
Exclusion criteria
Exclusion criteria: Neonates with shock requiring inotropes Neonates with diagnosed cardiac rhythm abnormalities Major chromosomal or genetic anomalies or congenital Anomalies (incompatible with life) Neonate who has received any opioid analgesic drug in last 72 hours Known allergy to fentanyl or dexmedetomidine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the total duration of sedation and analgesia among mechanically ventilated neonates between those receiving dexmedetomidine and those receiving fentanyl.Timepoint: Total duration of sedation and analgesia will be measured from initiation of infusion until successful discontinuation with right censoring at death or at the maximal follow up of 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the cumulative dose of rescue sedatives or analgesics (Fentanyl) required in neonatesTimepoint: From institution to removal of ventilatory support;To compare the duration of mechanical ventilationTimepoint: From intubation till successful extubation;To compare the total length of stay in neonatal intensive care unitTimepoint: From point of randomization till discharge;The incidence of adverse effects such as bradycardia (defined as HR less than 90 per min), hypotension (BP less than 5th centile as per gestational age appropriate threshold), oxygen desaturation (SpO2 less than 90 percent) and episodes of agitationTimepoint: From institution till end of drug infusion;To compare the incidence of withdrawalTimepoint: When the drug tapering is started till 72 hours of stoppage of drug;To compare the proportion of patients who achieve and maintain target sedation and analgesia; NPASS target of less than equal to 2 without more than equal to 1 episode of treatment failure or need for protocolized rescue within the total duration of drug infusionTimepoint: From institution till end of drug infusion | — |
Countries
India
Contacts
Public ContactSudhanshu Tiwari
AIIMS, New Delhi
Outcome results
None listed