NL-OMON38405
Completed
Phase 2
Optimizing Pain Treatment in Pre-Term Neonates - Morphine study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- prematuur geboren kinderen
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 30
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Preterm neonates of both genders and all races between 23 and 32 weeks
- •postnatal age less than 30 days
- •an indwelling (peripheral or umbilical) arterial line, and
- •a clinical indication for intravenous morphine administration
Exclusion Criteria
- •Neonates with severe asphyxia, grade III or IV intraventricular hemorrhage, major congenital malformations/facial malformations, neurological disorders, and those receiving continuous or intermittent neuromuscular blockers.
- •clinical or biochemical evidence of hepatic and renal compromise (including systemic hypoperfusion) or
- •received drugs that are UGT2B7 substrates (including Lorazepam, ibuprofen, valproic acid, naloxone and other morphine derivatives or propanolol)
Outcomes
Primary Outcomes
Not specified
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