Optimizing Pain Treatment in Pre-Term Neonates

Phase 2

Completed

• Conditions: prematuur geboren kinderen; pain; criticall illness prematurity

• Registration Number: NL-OMON38405
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified