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Opioid Analgesic

1 for Premature Babies

Phase 2
Waitlist Available
Led By John N. van den Anker, M.D., Ph.D.
Research Sponsored by John van den Anker
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

The purpose of this study is to improve the dosing of morphine in critically ill premature neonates.

Eligible Conditions
  • Premature Babies

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2015 Phase 4 trial • 84 Patients • NCT02009722
52%
Moderate to Severe Pruritus
40%
Moderate to Severe Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intrathecal Morphine
Intrathecal Hydromorphone

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2Experimental Treatment1 Intervention
Gestational Age\>= 29 weeks will be administered a loading dose of 0.1 mg/kg I.V. morphine over 30-minutes, followed by a continuous infusion of 0.01 mg/kg/h.
Group II: 1Experimental Treatment1 Intervention
Gestational Age\< 29 weeks will be administered a loading dose of 0.05 mg/kg I.V. morphine over 30-minutes, followed by a continuous infusion of 0.005 mg/kg/hr.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Morphine
FDA approved

Find a Location

Who is running the clinical trial?

Erasmus Medical CenterOTHER
675 Previous Clinical Trials
1,900,308 Total Patients Enrolled
John van den AnkerLead Sponsor
2 Previous Clinical Trials
91 Total Patients Enrolled
University of LouisvilleOTHER
342 Previous Clinical Trials
77,300 Total Patients Enrolled
~2 spots leftby Sep 2025
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