Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome

Indiana University

Status and phase: Completed; Phase 4

Conditions: Neonatal Opioid Withdrawal; Neonatal Abstinence Syndrome; Neonatal Opioid Withdrawal Syndrome

Treatments: Drug: Morphine scheduled; Drug: Morphine PRN

Study type: Interventional

Funder types: Other

Identifiers

NCT04298853

1910620136

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• newborn greater than or equal to 35 weeks gestation
• intrauterine opioid exposure
• signs and symptoms of opioid withdrawal

Exclusion criteria

• congenital anomalies or suspected genetic condition
• co-morbid conditions that require sedation or analgesia due to clinical condition
• ongoing need for respiratory support

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Standard

Active Comparator group

Description:

Infants randomized to the standard arm will receive morphine based on the current institutional treatment protocol: oral morphine 0.05 mg/kg/dose given every 3 hours, initiated if threshold Finnegan score is met. Once stabilized, dose will be weaned by 10% of peak dose per day until discontinuation.

Treatment:

Drug: Morphine scheduled

Study

Experimental group

Description:

Infants randomized to the study arm will receive oral morphine 0.05 mg/kg/dose as needed for an elevated Finnegan score. May receive morphine as frequently as every 3 hours if needed.

Treatment:

Drug: Morphine PRN