EUCTR2011-001783-21-NLActive, not recruitingNot Applicable
Optimizing Pain Treatment in Pre-Term Neonates - Morphine study
Childrens's Research Institute0 sites60 target enrollmentStarted: December 29, 2011Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Preterm neonates of both genders and all races
- •postnatal age less than 30 days
- •an indwelling (peripheral or umbilical) arterial line, and
- •a clinical indication for intravenous morphine administration
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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)
Investigators
Similar Trials
Completed
Phase 2
Optimizing Pain Treatment in Pre-Term Neonatesprematuur geboren kinderencriticall illness prematuritypainNL-OMON38405Erasmus MC, Universitair Medisch Centrum Rotterdam30
Completed
Not Applicable
Morphine study.Preterm NeonatesMorphineCritically illPainNL-OMON24146Children's National Medical Center Washington30
Completed
Phase 2
Optimizing the Use of Morphine in Pre-Term NeonatesPremature NeonatesNCT00494429John van den Anker33
Completed
Not Applicable
Therapeutic Touch for procedural pain in preterm neonates less than 28 weeks gestational ageISRCTN13204272SickKids Foundation (Canada)52
Recruiting
Not Applicable
Pain Relief in Premature Newborns Through Maternal Intervention During VenipuncturePremature NewbornsNCT06200662University Hospital, Strasbourg, France48