Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal, Neonatal Opioid Withdrawal Syndrome
Conditions
Keywords
morphine, Finnegan
Brief 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.
Interventions
DRUGMorphine PRN
Dose given every 3 hours as-needed for severe NAS, defined by a threshold Finnegan score.
DRUGMorphine scheduled
Dose given every 3 hours on a scheduled basis and slowly weaned once stabilized.
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment Rate | Prior to second dose of morphine, within 4 hours | Percentage of eligible subjects who were enrolled and randomized in the study |
| Drop Out Rate | Through final follow-up call at 6 weeks of age | Percentage of enrolled subjects who do not complete participation |
| Number of Study Group Subjects Switched to Standard Arm | 24 hours | Number of study group infants removed from study protocol and treated under standard care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay From Birth to Discharge | Until discharge, up to 6 weeks | Duration of hospitalization in days |
| Length of Morphine Treatment | Until discharge, up to 6 weeks | Duration of morphine treatment in days |
| Total Cumulative Morphine Exposure | Until discharge, up to 6 weeks | Per kilogram based on birth weight |
| Peak Morphine Dose | Until discharge, up to 6 weeks | Per kilogram based on birth weight |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard 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.
Morphine scheduled: Dose given every 3 hours on a scheduled basis and slowly weaned once stabilized. | 9 |
| Study 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.
Morphine PRN: Dose given every 3 hours as-needed for severe NAS, defined by a threshold Finnegan score. | 8 |
| Total | 17 |
Baseline characteristics
| Characteristic | Standard | Study | Total |
|---|---|---|---|
| Age, Customized | 37.8 weeks STANDARD_DEVIATION 1.4 | 37.8 weeks STANDARD_DEVIATION 1.8 | 37.8 weeks STANDARD_DEVIATION 1.5 |
| Breastfed during hospital stay | 2 Participants | 2 Participants | 4 Participants |
| Buprenorphine exposure | 7 Participants | 3 Participants | 10 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 6 Participants | 4 Participants | 10 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 8 |
| other Total, other adverse events | 2 / 9 | 0 / 8 |
| serious Total, serious adverse events | 0 / 9 | 0 / 8 |
Outcome results
Primary
Drop Out Rate
Percentage of enrolled subjects who do not complete participation
Time frame: Through final follow-up call at 6 weeks of age
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Patients | Drop Out Rate | 4 Participants |
Primary
Enrollment Rate
Percentage of eligible subjects who were enrolled and randomized in the study
Time frame: Prior to second dose of morphine, within 4 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Patients | Enrollment Rate | 17 Participants |
Primary
Number of Study Group Subjects Switched to Standard Arm
Number of study group infants removed from study protocol and treated under standard care.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Patients | Number of Study Group Subjects Switched to Standard Arm | 0 Participants |
Secondary
Length of Hospital Stay From Birth to Discharge
Duration of hospitalization in days
Time frame: Until discharge, up to 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eligible Patients | Length of Hospital Stay From Birth to Discharge | 14.6 days | Standard Deviation 4.2 |
| Study | Length of Hospital Stay From Birth to Discharge | 11.6 days | Standard Deviation 5.3 |
Secondary
Length of Morphine Treatment
Duration of morphine treatment in days
Time frame: Until discharge, up to 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eligible Patients | Length of Morphine Treatment | 11.5 days | Standard Deviation 2.8 |
| Study | Length of Morphine Treatment | 2.9 days | Standard Deviation 2.3 |
Secondary
Peak Morphine Dose
Per kilogram based on birth weight
Time frame: Until discharge, up to 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eligible Patients | Peak Morphine Dose | 0.09 mg/kg | Standard Deviation 0.06 |
| Study | Peak Morphine Dose | 0.05 mg/kg | Standard Deviation 0.02 |
Secondary
Total Cumulative Morphine Exposure
Per kilogram based on birth weight
Time frame: Until discharge, up to 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eligible Patients | Total Cumulative Morphine Exposure | 3.6 mg/kg | Standard Deviation 2.4 |
| Study | Total Cumulative Morphine Exposure | 0.2 mg/kg | Standard Deviation 0.2 |