Optimizing the Use of Morphine in Pre-Term Neonates

Completed · Phase 2

Conditions studied: Premature Neonates

In brief

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

Key facts

Study ID

NCT00494429

Run by

John van den Anker

People needed

33

Starts

2005-05-01

Expected to finish

2015-11-01

Last updated by the study team

2016-07-27

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Children's National Medical Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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