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Clinical Trials/EUCTR2011-001783-21-NL
EUCTR2011-001783-21-NL
Active, Not Recruiting
N/A

Optimizing Pain Treatment in Pre-Term Neonates - Morphine study

Childrens's Research Institute0 sites60 target enrollmentDecember 29, 2011
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DrugsMorfine HCL

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
Childrens's Research Institute
Enrollment
60
Status
Active, Not Recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 29, 2011
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Childrens's Research Institute

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Not specified

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