Trial Outcomes & Findings for Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome (NCT NCT04298853)

NCT ID: NCT04298853

Last Updated: 2022-10-06

Results Overview

Percentage of eligible subjects who were enrolled and randomized in the study

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 17 participants
• Primary outcome timeframe: Prior to second dose of morphine, within 4 hours
• Results posted on: 2022-10-06

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	9	8
Overall Study COMPLETED	9	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Standard n=9 Participants 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.	Study n=8 Participants 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.	Total n=17 Participants Total of all reporting groups
Age, Customized	37.8 weeks STANDARD_DEVIATION 1.4 • n=9 Participants	37.8 weeks STANDARD_DEVIATION 1.8 • n=8 Participants	37.8 weeks STANDARD_DEVIATION 1.5 • n=17 Participants
Sex: Female, Male Female	6 Participants n=9 Participants	4 Participants n=8 Participants	10 Participants n=17 Participants
Sex: Female, Male Male	3 Participants n=9 Participants	4 Participants n=8 Participants	7 Participants n=17 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Buprenorphine exposure	7 Participants n=9 Participants	3 Participants n=8 Participants	10 Participants n=17 Participants
Breastfed during hospital stay	2 Participants n=9 Participants	2 Participants n=8 Participants	4 Participants n=17 Participants

PRIMARY outcome

Timeframe: Prior to second dose of morphine, within 4 hours

Percentage of eligible subjects who were enrolled and randomized in the study

Outcome measures

Measure	Eligible Patients n=34 Participants All eligible patients who were screened for enrollment.	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.
Enrollment Rate	17 Participants	—

PRIMARY outcome

Timeframe: Through final follow-up call at 6 weeks of age

Percentage of enrolled subjects who do not complete participation

Outcome measures

Measure	Eligible Patients n=17 Participants All eligible patients who were screened for enrollment.	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.
Drop Out Rate	4 Participants	—

PRIMARY outcome

Timeframe: 24 hours

Number of study group infants removed from study protocol and treated under standard care.

Outcome measures

Measure	Eligible Patients n=8 Participants All eligible patients who were screened for enrollment.	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.
Number of Study Group Subjects Switched to Standard Arm	0 Participants	—

SECONDARY outcome

Timeframe: Until discharge, up to 6 weeks

Duration of hospitalization in days

Outcome measures

Measure	Eligible Patients n=9 Participants All eligible patients who were screened for enrollment.	Study n=8 Participants 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.
Length of Hospital Stay From Birth to Discharge	14.6 days Standard Deviation 4.2	11.6 days Standard Deviation 5.3

SECONDARY outcome

Timeframe: Until discharge, up to 6 weeks

Per kilogram based on birth weight

Outcome measures

Measure	Eligible Patients n=9 Participants All eligible patients who were screened for enrollment.	Study n=8 Participants 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.
Total Cumulative Morphine Exposure	3.6 mg/kg Standard Deviation 2.4	0.2 mg/kg Standard Deviation 0.2

SECONDARY outcome

Timeframe: Until discharge, up to 6 weeks

Per kilogram based on birth weight

Outcome measures

Measure	Eligible Patients n=9 Participants All eligible patients who were screened for enrollment.	Study n=8 Participants 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.
Peak Morphine Dose	0.09 mg/kg Standard Deviation 0.06	0.05 mg/kg Standard Deviation 0.02

SECONDARY outcome

Timeframe: Until discharge, up to 6 weeks

Duration of morphine treatment in days

Outcome measures

Measure	Eligible Patients n=9 Participants All eligible patients who were screened for enrollment.	Study n=8 Participants 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.
Length of Morphine Treatment	11.5 days Standard Deviation 2.8	2.9 days Standard Deviation 2.3

Adverse Events

Standard

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Standard n=9 participants at risk 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.	Study n=8 participants at risk 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.
Nervous system disorders over-sedation	22.2% 2/9 • Number of events 2 • From enrollment to follow-up at 6 weeks post-discharge. Follow-up adverse events included hospital readmission for withdrawal symptoms, growth failure or failure to thrive. The timing of follow-up at 6 weeks post-discharge varied among participants as it was dependent on length of hospital stay.	0.00% 0/8 • From enrollment to follow-up at 6 weeks post-discharge. Follow-up adverse events included hospital readmission for withdrawal symptoms, growth failure or failure to thrive. The timing of follow-up at 6 weeks post-discharge varied among participants as it was dependent on length of hospital stay.

Additional Information

Anna Thomas, MD

Indiana University School of Medicine

Phone: 317-944-9392

Email: aeschwar@iu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place