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Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome

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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)

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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