Neonatal Abstinence SyndromePhase 4NCT04298853

Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome

A Phase 4 study testing Morphine PRN and Morphine scheduled in people with Neonatal Abstinence Syndrome and Neonatal Opioid Withdrawal, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages Up to 28 days
Conditions the study is for: Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal, Neonatal Opioid Withdrawal Syndrome
What is being tested?: Morphine PRN and Morphine scheduled
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteUnited States
Study dates: 30 Jun 2020to 1 Oct 2021
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 28 days
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202

Other trials in United States

About this study

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
Being tested: Morphine PRN, Morphine scheduled
Keywords: morphine, Finnegan
Medical subject headings: Neonatal Abstinence Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Morphine PRNDrug
Also called morphine, morphine sulfate
Dose given every 3 hours as-needed for severe NAS, defined by a threshold Finnegan score.
Morphine scheduledDrug
Also called morphine, morphine sulfate
Dose given every 3 hours on a scheduled basis and slowly weaned once stabilized.

Study groups in NCT04298853
Study group	Role	What they receive
Standard	Active comparator	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. Receives: Drug: Morphine scheduled
Study	Experimental	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. Receives: Drug: Morphine PRN

What is being measured

The primary outcome is the main question the study is designed to answer.

Enrollment Rate
Percentage of eligible subjects who were enrolled and randomized in the study
Measured: Prior to second dose of morphine, within 4 hours
Drop Out Rate
Percentage of enrolled subjects who do not complete participation
Measured: Through final follow-up call at 6 weeks of age
Number of Study Group Subjects Switched to Standard Arm
Number of study group infants removed from study protocol and treated under standard care.
Measured: 24 hours

Secondary outcomes (4)

Length of Hospital Stay From Birth to Discharge
Duration of hospitalization in days
Measured: Until discharge, up to 6 weeks
Total Cumulative Morphine Exposure
Per kilogram based on birth weight
Measured: Until discharge, up to 6 weeks
Peak Morphine Dose
Per kilogram based on birth weight
Measured: Until discharge, up to 6 weeks
Length of Morphine Treatment
Duration of morphine treatment in days
Measured: Until discharge, up to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 20201 Oct 2021

First posted6 Mar 2020
Study start30 Jun 2020
Primary completion1 Oct 2021
Study completion1 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Neonatal Abstinence SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04298853
Sponsor's protocol ID: 1910620136
Status last verified: Sep 2022
First submitted: 4 Mar 2020
Last updated: 6 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recorded Parent/Caregiver Voice for Infants With Neonatal Opioid Withdrawal Syndrome
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Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome
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An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
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Neurostimulation to Improve NOWS Outcomes
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All Neonatal Abstinence Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome
ClinicalTrials.gov ID: NCT04298853
Acronym / sponsor ID: 1910620136
Conditions: Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal, Neonatal Opioid Withdrawal Syndrome
Keywords: morphine, Finnegan
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Indiana UniversityUniversity, hospital or other
Study start: 30 Jun 2020 (actual)
Primary completion: 1 Oct 2021 (actual)
Study completion: 1 Oct 2021 (actual)
First posted: 6 Mar 2020 (actual)
Results: Posted 8 Sep 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard	Active comparator	Drug: Morphine scheduledInfants 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.
Study	Experimental	Drug: Morphine PRNInfants 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.

Who may qualify

Ages: Up to 28 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Morphine PRNAlso: morphine, morphine sulfateDose given every 3 hours as-needed for severe NAS, defined by a threshold Finnegan score.	Drug	Study
Morphine scheduledAlso: morphine, morphine sulfateDose given every 3 hours on a scheduled basis and slowly weaned once stabilized.	Drug	Standard

Primary outcome

Enrollment Rate
Time frame: Prior to second dose of morphine, within 4 hours
Percentage of eligible subjects who were enrolled and randomized in the study
Drop Out Rate
Time frame: 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
Time frame: 24 hours
Number of study group infants removed from study protocol and treated under standard care.

4 secondary outcomes

Length of Hospital Stay From Birth to Discharge
Time frame: Until discharge, up to 6 weeks
Total Cumulative Morphine Exposure
Time frame: Until discharge, up to 6 weeks
Peak Morphine Dose
Time frame: Until discharge, up to 6 weeks
Length of Morphine Treatment
Time frame: Until discharge, up to 6 weeks

Results and safety

Results posted to the registry on 8 Sep 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard	9	9
Study	8	8

Primary outcome: Enrollment Rate

Time frame: Prior to second dose of morphine, within 4 hours. Count of participants. Unit: Participants

Measure	Eligible Patients n = 34
Value	17

Primary outcome: Drop Out Rate

Time frame: Through final follow-up call at 6 weeks of age. Count of participants. Unit: Participants

Measure	All Enrolled Subjects n = 17
Value	4

Primary outcome: Number of Study Group Subjects Switched to Standard Arm

Time frame: 24 hours. Count of participants. Unit: Participants

Measure	Study n = 8
Value	0

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment to follow-up at 6 weeks post-discharge.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard	0 of 9 (0%)	2 of 9 (22.2%)	0 of 9
Study	0 of 8 (0%)	0 of 8 (0%)	0 of 8

Limitations and caveats (from the sponsor): The goal number of subjects was 24 and this was not achieved, which is a limitation. We found that social factors, such as adoption plans and foster placement, limited enrollment of otherwise eligible subjects and resulted in difficulty with follow-up.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Neonatal Abstinence Syndrome

Active, not recruiting
Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk Pregnant Women
Neonatal Abstinence Syndrome, Opioid-use Disorder
Not yet recruiting
Recorded Parent/Caregiver Voice for Infants With Neonatal Opioid Withdrawal Syndrome
Neonatal Opioid Withdrawal Syndrome, Prenatal Opioid Exposure
Recruiting
Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome
NAS
Recruiting
An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
Opioid Use Disorder, Neonatal Abstinence Syndrome
Active, not recruiting
Neurostimulation to Improve NOWS Outcomes
Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Morphine PRN and Morphine scheduled in people with Neonatal Abstinence Syndrome and Neonatal Opioid Withdrawal, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Enrollment Rate (time frame: Prior to second dose of morphine, within 4 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04298853.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.