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

Neonatal Opiate Withdrawal Syndrome Clinical Trial

— OPTimize NOW  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05980260
• Other study ID #: HELP for NOWS 02
• Secondary ID: 1U24HD1076211UG1
• Status: Recruiting
• Phase: Phase 3
• Start date: March 25, 2024
• Est. completion date: May 15, 2025

Study information

• Verified date: April 2024
• Source: HELP for NOWS Consortium
• Contact: HELP for NOWS Consortium
• Phone: 202-974-7837
• Email: HELPforNOWS[@]rti.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

1. 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.

2. 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.

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:

• A three-week run-in period followed by a scheduled opioid taper approach for five months (Period 1) followed by a three-week washout period followed by a symptom-based dosing approach for five months (Period 2)

• A three-week run-in period followed by a symptom-based dosing approach for five months (Period 1) followed by a three-week washout period followed by scheduled opioid taper approach for five 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: May 15, 2025
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Hour to 48 Hours

Eligibility

Inclusion Criteria:

1. The infant is greater than or equal to 36 weeks gestation.

2. 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.

3. The infant is being assessed and managed for NOWS at an eligible study site.

4. 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:

1. The infant has major birth defect(s).

2. 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.

3. The infant is receiving respiratory support (any positive pressure or oxygen therapy) at 48 hours of age.

4. The infant has undergone major surgical intervention prior to or at 48 hours of age.

5. The infant has postnatal opioid exposure prior to the initiation of treatment for NOWS.

6. The infant was outborn and pharmacologic treatment was initiated at the transferring hospital.

7. The infant is assessed for eligibility during the study site's three-week washout period.

Related Conditions & MeSH terms

• Neonatal Opiate Withdrawal Syndrome
• Substance Withdrawal Syndrome
• Syndrome

Intervention

Other:
• Symptom-based Dosing Approach
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 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.
• Scheduled Opioid Taper Approach
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.

Locations

Country	Name	City	State
United States	University of New Mexico Health Sciences Center	Albuquerque	New Mexico
United States	AtlantiCare Regional Medical Center	Atlantic City	New Jersey
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Good Samaritan Hospital	Cincinnati	Ohio
United States	Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	St. Elizabeth Healthcare	Edgewood	Kentucky
United States	Sidney & Lois Eskenazi Hospital	Indianapolis	Indiana
United States	University of Louisville Hospital	Jeffersonville	Indiana
United States	University of Kansas Hospital	Kansas City	Kansas
United States	Kettering Health Main Campus	Kettering	Ohio
United States	Kentucky Children's Hospital	Lexington	Kentucky
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Norton Children's Hospital	Louisville	Kentucky
United States	Norton Women's and Children's Hospital	Louisville	Kentucky
United States	Oklahoma Children's Hospital OU Health	Oklahoma City	Oklahoma
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	University of Rochester Medical Center	Rochester	New York
United States	University of Utah Health	Salt Lake City	Utah
United States	University of South Florida Health	Tampa	Florida
United States	ChristianaCare	Wilmington	Delaware

Sponsors (3)

Lead Sponsor	Collaborator
HELP for NOWS Consortium	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	From date of birth until hospital discharge or 1 year, whichever comes first.
Secondary	Receipt of pharmacologic treatment	If the infant received opioid replacement therapy prior to hospital discharge.	From date of birth until hospital discharge or 1 year, whichever comes first.
Secondary	Length of hospital stay	Number of days infant remained in the hospital	From date of birth until hospital discharge or 1 year, whichever comes first.
Secondary	Safety outcomes	Safety outcomes including presence or absence of inpatient seizures, excessive weight loss of more than 15% from birthweight, and non-accidental trauma and death, and outpatient acute/urgent care or emergency room visits, hospital readmissions, and non-accidental trauma and death	From date of birth until 3 months of life
Secondary	Total number opioid doses	The total number of opioid doses administered among all infants pharmacologically treated during initial hospitalization.	From date of birth until hospital discharge or 1 year, whichever comes first.
Secondary	Receipt of secondary medications	The total number of secondary opioid doses administered among all infants pharmacologically treated during intital hospitalization.	From date of birth until hospital discharge or 1 year, whichever comes first.
Secondary	Transition from treatment with a symptom-based dosing approach to a scheduled opioid taper approach	The total number of infants pharmacologically treated during intital hospitalization who transitioned from a symptom-based dosing approach to a scheduled opioid taper approach	From date of birth until hospital discharge or 1 year, whichever comes first.
Secondary	Stopped scheduled opioid taper treatment	The total number of infants pharmacologically treated during intital hospitalization who were initially treated with a scheduled opioid taper but stopped treatment due to excessive sedation or respiratory depression	From date of birth until hospital discharge or 1 year, whichever comes first.
Secondary	Safety outcomes	Safety outcomes among infants pharmacologically treated during initial hospitalization including presence or absence of inpatient seizures, excessive weight loss of more than 15% from birthweight, and non-accidental trauma and death, and outpatient acute/urgent care or emergency room visits, hospital readmissions, and non-accidental trauma and death	From date of birth until hospital discharge or 1 year, whichever comes first.

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