NCT04298853

Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 28 Days
• Healthy volunteers: Not accepted

Summary

Randomized pilot trial comparing scheduled morphine dosing with a weaning protocol to intermittent morphine dosing on an as-needed basis for newborns with neonatal abstinence syndrome.

Conditions

• Neonatal Abstinence Syndrome
• Neonatal Opioid Withdrawal
• Neonatal Opioid Withdrawal Syndrome

Interventions

Type	Name	Description
DRUG	Morphine PRN	Dose given every 3 hours as-needed for severe NAS, defined by a threshold Finnegan score.
DRUG	Morphine scheduled	Dose given every 3 hours on a scheduled basis and slowly weaned once stabilized.

Timeline

• Start date: 2020-06-30
• Primary completion: 2021-10-01
• Completion: 2021-10-01
• First posted: 2020-03-06
• Last updated: 2022-10-06
• Results posted: 2022-09-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study