Morphine study.

Completed

• Conditions: Preterm NeonatesMorphineCritically illPain

• Registration Number: NL-OMON24146
• Lead Sponsor: Children's National Medical Center Washington

Brief Summary

/A

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

Primary Outcome Measures

Name	Time	Method
Safety:<br /><br>Infants will have continuous monitoring of vital signs, oxygen saturation, movements and adverse events to determine the<br>safety of morphine. <br><br /><br /><br>Pharmacodynamics: <br /><br>The Neonatal Infant Pain (NIP) and Premature Infant Pain Profile (PIPP) will be<br>performed at baseline, (prior to drug administration) and at pre-determined time intervals after the dose to assess pain for the<br>efficacy of morphine. <br><br /><br /><br>Pharmacokinetics: <br /><br>The concentrations of morphine and its metabolites will be measured in plasma and<br>urine at pre-determined time points and will be used to calculate the formation and elimination clearances of morphine and its<br>metabolites. <br><br /><br /><br>Pharmacogenetics: <br /><br>Impact of genetic variation in the UGT2B7 gene on the formation clearances of the morphine<br>metabolites will be studied as well as the genetic variation in the ¥ì-opioid receptor, COMT, and ©¬-arrestin 2 genes on the PD of<br>morphine use.