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Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach (OPTimize NOW)

Primary Purpose

Neonatal Opiate Withdrawal Syndrome

Status
Not yet recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Symptom-based Dosing Approach
Scheduled Opioid Taper Approach
Sponsored by
HELP for NOWS Consortium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Opiate Withdrawal Syndrome focused on measuring NOWS

Eligibility Criteria

1 Hour - 48 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The infant is greater than or equal to 36 weeks gestation. The infant had antenatal opioid exposure identified by at least one of the following: History of maternal opioid use during pregnancy; Positive maternal toxicology screen for opioids during the second or third trimester of pregnancy; and/or Positive infant toxicology screen for opioids during the initial hospital stay. The infant is being assessed and managed for NOWS at an eligible study site. The infant is at risk for pharmacologic treatment for NOWS defined by either of the following At least 1 score ≥ 8 if assessed and managed with FNAST or modification thereof At least 1 "yes" if assessed and managed with the ESC care approach Exclusion Criteria: The infant has major birth defect(s). The infant has neonatal encephalopathy (inclusive of hypoxic ischemic encephalopathy), a metabolic disorder, stroke, intracranial hemorrhage, or meningitis diagnosed prior to the initiation of pharmacologic treatment. The infant is receiving respiratory support (any positive pressure or oxygen therapy) at 48 hours of age. The infant has undergone major surgical intervention prior to or at 48 hours of age. The infant has postnatal opioid exposure prior to the initiation of treatment for NOWS. The infant was outborn and pharmacologic treatment was initiated at the transferring hospital. The infant is assessed for eligibility during the study site's two-week washout period.

Sites / Locations

  • University of Alabama at Birmingham
  • University of Arkansas for Medical Sciences
  • Sidney & Lois Eskenazi Hospital
  • University of Louisville Hospital
  • St. Elizabeth Healthcare
  • Norton Children's Hospital
  • University of New Mexico Health Sciences Center
  • Good Samaritan Hospital
  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Sequence 1

Sequence 2

Arm Description

This sequence will assign eligible participants to scheduled opioid taper approach for 5 months followed by a 2-week washout period followed by symptom-based dosing approach for 5 months.

This sequence will assign eligible participants to symptom-based dosing approach for 5 months followed by a 2-week washout period followed by scheduled opioid taper approach for 5 months.

Outcomes

Primary Outcome Measures

Time from birth until medically ready for discharge
Time from birth until infant meets criteria for medically ready for discharge (days). An infant is considered medically ready for discharge when they are discharged by the medical provider or when they meet the following criteria the following criteria: ≥ 96 hours of age ≥ 48 hours since last dose of opioid treatment (i.e., morphine, methadone, or buprenorphine)

Secondary Outcome Measures

Receipt of pharmacologic treatment
If the infant received opioid replacement therapy, prior to hospital discharge
Length of hospital stay
Number of days infant remained in the hospital
Total number opioid doses
The total number of opioid doses administered among all infants pharmacologically treated during intital hospitilizatoin.
Receipt of secondary medications
The total number of opioid doses administered among all infants pharmacologically treated during intital hospitilizatoin.

Full Information

First Posted
July 27, 2023
Last Updated
July 27, 2023
Sponsor
HELP for NOWS Consortium
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05980260
Brief Title
Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach
Acronym
OPTimize NOW
Official Title
Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 15, 2024 (Anticipated)
Primary Completion Date
February 15, 2025 (Anticipated)
Study Completion Date
May 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HELP for NOWS Consortium
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This clinical trial will help us learn more about how to best care for babies with Neonatal Opioid Withdrawal Syndrome, also called NOWS. Babies with NOWS often have tremors, a hard time sleeping, excessive crying, and trouble feeding. Some babies that have NOWS need medicine. Doctors have two ways of providing medicine that are widely used today: Scheduled opioid taper approach. The baby gets medicine at regular times. As symptoms get better, the amount of medicine the baby gets decreases until the baby no longer needs medicine. This is called a medicine taper. Symptom-based approach. The baby will only get medicine when they show signs of NOWS, instead of at regular times. If the baby is showing no signs of NOWS, no medicine will be given. We are doing the OPTimize NOW study to figure out the best way to give medicine to babies with NOWS.
Detailed Description
This two-period cluster crossover clinical trial will compare the length of time from birth until medically ready for discharge between infants with neonatal opioid withdrawal syndrome (NOWS) who are ≥ 36 weeks' gestation, at risk for pharmacologic treatment, and treated for NOWS with either a symptom-based dosing approach or a scheduled opioid taper approach. Each study site (i.e., cluster) will be randomized in a 1:1 allocation ratio to one of two sequences: Scheduled opioid taper approach for 5 months (Period 1) followed by a two-week washout period following by symptom-based dosing approach for 5 months (Period 2) Symptom-based dosing approach for 5 months (Period 1) followed by a two-week washout period followed by scheduled opioid taper approach for 5 months (Period 2) The randomization scheme will be stratified by the assessment and management approach used at each study site (i.e., Finnegan or Eat, Seep and Console).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Opiate Withdrawal Syndrome
Keywords
NOWS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Model Description
A two-period cluster crossover design will be used in this study. Study sites will be randomized in a 1:1 allocation ratio to one of two sequences: A scheduled opioid taper approach for 5 months followed by a two-week washout period followed by a symptom-based dosing approach for 5 months. A symptom-based dosing approach for 5 months followed by a two-week washout period followed by a scheduled opioid taper approach for 5 months.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sequence 1
Arm Type
Other
Arm Description
This sequence will assign eligible participants to scheduled opioid taper approach for 5 months followed by a 2-week washout period followed by symptom-based dosing approach for 5 months.
Arm Title
Sequence 2
Arm Type
Other
Arm Description
This sequence will assign eligible participants to symptom-based dosing approach for 5 months followed by a 2-week washout period followed by scheduled opioid taper approach for 5 months.
Intervention Type
Other
Intervention Name(s)
Symptom-based Dosing Approach
Intervention Description
During this approach to care, all enrolled infants with NOWS at the study site will be treated with the symptom-based dosing approach if they meet the withdrawal threshold for pharmacologic treatment. Participants may receive up to 3 doses of the study site's preferred opioid during a 24-hour period (midnight to midnight) to treat signs of withdrawal once the threshold for pharmacologic intervention is met. If a 4th dose is required within a 24-hour period, the study site will transition to the scheduled opioid taper algorithm used at the study site to complete the infant's pharmacologic treatment.
Intervention Type
Other
Intervention Name(s)
Scheduled Opioid Taper Approach
Intervention Description
• During this approach to care, all enrolled infants with NOWS at the study site will be treated with the study site's usual scheduled opioid taper approach, as detailed in each site's treatment algorithm, if they meet the withdrawal threshold for pharmacologic treatment.
Primary Outcome Measure Information:
Title
Time from birth until medically ready for discharge
Description
Time from birth until infant meets criteria for medically ready for discharge (days). An infant is considered medically ready for discharge when they are discharged by the medical provider or when they meet the following criteria the following criteria: ≥ 96 hours of age ≥ 48 hours since last dose of opioid treatment (i.e., morphine, methadone, or buprenorphine)
Time Frame
From date of birth until hospital discharge or 1 year, whichever comes first.
Secondary Outcome Measure Information:
Title
Receipt of pharmacologic treatment
Description
If the infant received opioid replacement therapy, prior to hospital discharge
Time Frame
From date of birth until hospital discharge or 1 year, whichever comes first.
Title
Length of hospital stay
Description
Number of days infant remained in the hospital
Time Frame
From date of birth until hospital discharge or 1 year, whichever comes first.
Title
Total number opioid doses
Description
The total number of opioid doses administered among all infants pharmacologically treated during intital hospitilizatoin.
Time Frame
From date of birth until hospital discharge or 1 year, whichever comes first.
Title
Receipt of secondary medications
Description
The total number of opioid doses administered among all infants pharmacologically treated during intital hospitilizatoin.
Time Frame
From date of birth until hospital discharge or 1 year, whichever comes first.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
48 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The infant is greater than or equal to 36 weeks gestation. The infant had antenatal opioid exposure identified by at least one of the following: History of maternal opioid use during pregnancy; Positive maternal toxicology screen for opioids during the second or third trimester of pregnancy; and/or Positive infant toxicology screen for opioids during the initial hospital stay. The infant is being assessed and managed for NOWS at an eligible study site. The infant is at risk for pharmacologic treatment for NOWS defined by either of the following At least 1 score ≥ 8 if assessed and managed with FNAST or modification thereof At least 1 "yes" if assessed and managed with the ESC care approach Exclusion Criteria: The infant has major birth defect(s). The infant has neonatal encephalopathy (inclusive of hypoxic ischemic encephalopathy), a metabolic disorder, stroke, intracranial hemorrhage, or meningitis diagnosed prior to the initiation of pharmacologic treatment. The infant is receiving respiratory support (any positive pressure or oxygen therapy) at 48 hours of age. The infant has undergone major surgical intervention prior to or at 48 hours of age. The infant has postnatal opioid exposure prior to the initiation of treatment for NOWS. The infant was outborn and pharmacologic treatment was initiated at the transferring hospital. The infant is assessed for eligibility during the study site's two-week washout period.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HELP for NOWS Consortium
Phone
202-974-7837
Email
HELPforNOWS@rti.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori Devlin, MD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Namasivayam Ambalavanan, MD
First Name & Middle Initial & Last Name & Degree
Namasivayam Ambalavanan, MD
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Hall, MD
First Name & Middle Initial & Last Name & Degree
Richard Hall, MD
Facility Name
Sidney & Lois Eskenazi Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory Sokol, MD
First Name & Middle Initial & Last Name & Degree
Gregory Sokol, MD
Facility Name
University of Louisville Hospital
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Duncan, MD
First Name & Middle Initial & Last Name & Degree
Scott Duncan, MD
Facility Name
St. Elizabeth Healthcare
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Merhar, MD, MS
First Name & Middle Initial & Last Name & Degree
Stephanie Merhar, MD, MS
Facility Name
Norton Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sucheta Telang, MD
First Name & Middle Initial & Last Name & Degree
Sucheta Telang, MD
Facility Name
University of New Mexico Health Sciences Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lawrence Leeman, MD, MPH
First Name & Middle Initial & Last Name & Degree
Lawrence Leeman, MD, MPH
Facility Name
Good Samaritan Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45202
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Merhar, MD, MS
Phone
513-803-5180
First Name & Middle Initial & Last Name & Degree
Stephanie Merhar, MD, MS
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Merhar, MD, MS
Phone
513-803-5180
First Name & Middle Initial & Last Name & Degree
Stephanie Merhar, MD, MS

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data collected for this study will be analyzed and stored at the DCC, RTI International. NIH Helping to End Addiction Long-term Initiative (HEAL) and NICHD requirements for data-sharing will apply. NIH has had a long-standing policy to share and make available to the public the results and accomplishments of the activities that it funds. In accordance with these policies (available at HEAL Public Access and Data Sharing | NIH HEAL Initiative), we will share de-identified data collected for the study. After the study is completed, the de-identified, archived data will be transmitted to a NIH HEAL supported repository, for use by other researchers including those outside of the study.
IPD Sharing Time Frame
Within 1 year of study completion.
Links:
URL
http://helpfornows.rti.org
Description
Related Info

Learn more about this trial

Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach

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