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| ID | Type | Description | Link |
|---|---|---|---|
| 1U24HD107621 | U.S. NIH Grant/Contract | View source | |
| 1UG1HD107628 | U.S. NIH Grant/Contract | View source | |
| 1UG1HD107580 | U.S. NIH Grant/Contract | View source | |
| 1UG1HD107649 | U.S. NIH Grant/Contract | View source | |
| 1UG1HD107650 | U.S. NIH Grant/Contract | View source | |
| 1UG1HD107653 | U.S. NIH Grant/Contract | View source | |
| 1UG1HD107627 | U.S. NIH Grant/Contract | View source | |
| 1UG1HD107631 | U.S. NIH Grant/Contract | View source | |
| 1UG1HD107616 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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:
We are doing the OPTimize NOW study to figure out the best way to give medicine to babies with NOWS.
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Other | This sequence will assign eligible participants to a three-week run-in period followed by a scheduled opioid taper approach for five months followed by a three-week washout period followed by symptom-based dosing approach for five months. |
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| Sequence 2 | Other | This sequence will assign eligible participants to a three-week run-in period followed by a symptom-based dosing approach for five months followed by a three-week washout period followed by scheduled opioid taper approach for five months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symptom-based Dosing Approach | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time from birth until medically ready for discharge (ESC cohort only) | 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:
This primary outcome is for infants assessed and managed using ESC. | From date of birth until hospital discharge or 1 year, whichever comes first. |
| Measure | Description | Time Frame |
|---|---|---|
| Time from birth until medically ready for discharge (Finnegan Cohort only) | 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:
This secondary outcome is for infants assessed and managed using Finnegan. |
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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:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lori Devlin, MD | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of Arkansas for Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42033722 | Derived | Devlin LA, Babineau DC, Merhar SL, DeMauro SB, Kraft WK, Lorch SA, Das A, McDonald SA, Rhodes E, Schmidt AF, Trochinski L, Crawford M, Sithisarn T, Leeman L, Kovatis KZ, Ambalavanan N, Smith RW, Telang S, Tioseco JA, McAllister JM, Wexelblatt SL, Muniyappa B, Williams PK, Adeniyi-Jones SC, Hill CD, Wright T, Sokol GM, Johnson L, Hall RW, Duncan SD, Puopolo K, Dummula K, Anderson-Berry A, Davis JM, Poindexter B, Young LW; HEAL Evaluation of Limited Pharmacotherapies for Neonatal Opioid Withdrawal Syndrome (HELP for NOWS) Consortium. Symptom-Based Dosing for Neonatal Opioid Withdrawal: The OPTimize NOW Randomized Clinical Trial. JAMA. 2026 Apr 25:e265782. doi: 10.1001/jama.2026.5782. Online ahead of print. | |
| 40866977 |
| Label | URL |
|---|---|
| Related Info | View source |
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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.
Within 1 year of study completion.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 30, 2026 | |
| Reset | Jun 25, 2026 |
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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:
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| Scheduled Opioid Taper Approach | Other | 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. |
|
| From date of birth until hospital discharge or 1 year, whichever comes first. |
| Receipt of pharmacologic treatment (ESC Cohort) | If the infant received opioid replacement therapy prior to hospital discharge and was managed using ESC. | From date of birth until hospital discharge or 1 year, whichever comes first. |
| Length of hospital stay (ESC Cohort) | Number of days infant remained in the hospital and managed with ESC. | From date of birth until hospital discharge or 1 year, whichever comes first. |
| Total number opioid doses (ESC Cohort) | The total number of opioid doses administered among infants managed with ESC and pharmacologically treated during initial hospitalization. | From date of birth until hospital discharge or 1 year, whichever comes first. |
| Receipt of secondary medications (ESC Cohort) | The total number of secondary opioid doses administered among infants managed with ESC and pharmacologically treated during initial hospitalization. | From date of birth until hospital discharge or 1 year, whichever comes first. |
| Transition from treatment with a symptom-based dosing approach to a scheduled opioid taper approach (ESC Cohort) | The total number of infants managed with ESC and pharmacologically treated during initial 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. |
| Stopped scheduled opioid taper treatment (ESC Cohort) | The total number of infants managed with ESC and pharmacologically treated during initial 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. |
| Receipt of pharmacologic treatment (Finnegan Cohort) | If the infant received opioid replacement therapy prior to hospital discharge and was managed using Finnegan. | From date of birth until hospital discharge or 1 year, whichever comes first. |
| Length of hospital stay (Finnegan Cohort) | Number of days infant remained in the hospital and managed with Finnegan. | From date of birth until hospital discharge or 1 year, whichever comes first. |
| Total number opioid doses (Finnegan Cohort) | The total number of opioid doses administered among infants managed with Finnegan and pharmacologically treated during initial hospitalization. | From date of birth until hospital discharge or 1 year, whichever comes first. |
| Receipt of secondary medications (Finnegan Cohort) | The total number of secondary opioid doses administered among infants managed with Finnegan and pharmacologically treated during initial hospitalization. | From date of birth until hospital discharge or 1 year, whichever comes first. |
| Transition from treatment with a symptom-based dosing approach to a scheduled opioid taper approach (Finnegan Cohort) | The total number of infants managed with Finnegan and pharmacologically treated during initial 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. |
| Stopped scheduled opioid taper treatment (Finnegan Cohort) | The total number of infants managed with Finnegan and pharmacologically treated during initial 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. |
| Inpatient Composite Safety Outcome for infants at risk for pharmacologic treatment, managed with ESC (present/absent) | A composite safety outcome for infants at risk for pharmacologic treatment, managed with ESC, defined as the occurrence of any of the following events between birth and hospital discharge: Seizures, Excessive weight loss >15% from birthweight | From date of birth until hospital discharge |
| Inpatient Composite Safety Outcome for infants at risk for pharmacologic treatment, managed with Finnegan (present/absent) | A composite safety outcome for infants at risk for pharmacologic treatment, managed with Finnegan defined as the occurrence of any of the following events between birth and hospital discharge: Seizures, Excessive weight loss >15% from birthweight | From birth until hospital discharge |
| Inpatient Composite Critical Safety Outcome for infants at risk for pharmacologic treatment, managed with ESC (present/absent) | A composite critical safety outcome for infants at risk for pharmacologic treatment, managed with ESC defined as the occurrence of any of the following events between birth and hospital discharge: Non accidental trauma, Death | From birth until hospital discharge |
| Inpatient Composite Critical Safety Outcome for infants at risk for pharmacologic treatment, managed with Finnegan (present/absent) | From birth until hospital discharge | A composite critical safety outcome for infants at risk for pharmacologic treatment, managed with Finnegan defined as the occurrence of any of the following events between birth and hospital discharge: Non accidental trauma, Death |
| Outpatient Composite Safety Outcome at risk for pharmacologic treatment, managed with ESC (present/absent) | A composite outpatient safety outcome for infants at risk for pharmacologic treatment, managed with ESC defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Acute/urgent care or emergency room visits, Hospital readmissions | From hospital discharge to 3 months of age |
| Outpatient Composite Safety Outcome at risk for pharmacologic treatment, managed with Finnegan (present/absent) | A composite outpatient safety outcome for infants at risk for pharmacologic treatment, managed with Finnegan defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Acute/urgent care or emergency room visits, Hospital readmissions | From hospital discharge to 3 months of age |
| Outpatient Composite Critical Safety Outcome at risk for pharmacologic treatment, managed with ESC (present/absent) | A composite critical outpatient safety outcome for infants at risk for pharmacologic treatment, managed with ESC defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Non accidental trauma, Death | From hospital discharge to 3 months of age |
| Outpatient Composite Critical Safety Outcome at risk for pharmacologic treatment, managed with Finnegan (present/absent) | A composite critical outpatient safety outcome for infants at risk for pharmacologic treatment, managed with Finnegan defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Non accidental trauma, Death | From hospital discharge to 3 months of age |
| Inpatient Composite Safety Outcome for infants treated pharmacologically, managed with ESC (present/absent) | A composite safety outcome for infants treated pharmacologically, managed with ESC, defined as the occurrence of any of the following events between birth and hospital discharge: Seizures; Excessive weight loss >15% from birthweight | From birth to hospital discharge |
| Inpatient Composite Safety Outcome for infants treated pharmacologically, managed with Finnegan (present/absent) | A composite safety outcome for infants treated pharmacologically, managed with Finnegan, defined as the occurrence of any of the following events between birth and hospital discharge: Seizures; Excessive weight loss >15% from birthweight. | From birth to hospital discharge |
| Inpatient Composite Critical Safety Outcome for infants treated pharmacologically, managed with ESC (present/absent) | A composite critical safety outcome for infants treated pharmacologically, managed with ESC, defined as the occurrence of any of the following events between birth and hospital discharge: Non accidental trauma; Death. | From birth to hospital discharge |
| Inpatient Composite Critical Safety Outcome for infants treated pharmacologically, managed with Finnegan (present/absent) | A composite critical safety outcome for infants treated pharmacologically, managed with Finnegan, defined as the occurrence of any of the following events between birth and hospital discharge: Non accidental trauma; Death. | From birth to hospital discharge |
| Outpatient Composite Safety Outcome for infants treated pharmacologically, managed with ESC (present/absent) | A composite outpatient safety outcome for infants treated pharmacologically, managed with ESC, defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Acute/urgent care or emergency room visits; Hospital readmissions. | From hospital discharge to 3 months of age |
| Outpatient Composite Safety Outcome for infants treated pharmacologically, managed with Finnegan (present/absent | A composite outpatient safety outcome for infants treated pharmacologically, managed with Finnegan, defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Acute/urgent care or emergency room visits; Hospital readmissions. | From hospital discharge to 3 months of age |
| Outpatient Composite Critical Safety Outcome for infants treated pharmacologically, managed with ESC (present/absent) | A composite critical outpatient safety outcome for infants treated pharmacologically, managed with ESC, defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Non accidental trauma; Death. | From hospital discharge to 3 months of age |
| Outpatient Composite Critical Safety Outcome for infants treated pharmacologically, managed with Finnegan (present/absent) | A composite critical outpatient safety outcome for infants treated pharmacologically, managed with Finnegan, defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Non accidental trauma; Death. | From hospital discharge to 3 months of age |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| ChristianaCare | Wilmington | Delaware | 19801 | United States |
| University of South Florida Health | Tampa | Florida | 33606 | United States |
| Sidney & Lois Eskenazi Hospital | Indianapolis | Indiana | 46202 | United States |
| University of Louisville Hospital | Jeffersonville | Indiana | 47130 | United States |
| University of Kansas Hospital | Kansas City | Kansas | 66160 | United States |
| St. Elizabeth Healthcare | Edgewood | Kentucky | 41017 | United States |
| Kentucky Children's Hospital | Lexington | Kentucky | 40536 | United States |
| Norton Children's Hospital | Louisville | Kentucky | 40202 | United States |
| Norton Women's and Children's Hospital | Louisville | Kentucky | 40207 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| AtlantiCare Regional Medical Center | Atlantic City | New Jersey | 08401 | United States |
| University of New Mexico Health Sciences Center | Albuquerque | New Mexico | 87131 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Good Samaritan Hospital | Cincinnati | Ohio | 45202 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Kettering Health Main Campus | Kettering | Ohio | 45429 | United States |
| Oklahoma Children's Hospital OU Health | Oklahoma City | Oklahoma | 73104 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| University of Utah Health | Salt Lake City | Utah | 84158 | United States |
| Derived |
| Young LW, Babineau DC, Das A, DeMauro S, Kraft WK, Lorch S, Walsh MC, Merhar S, Devlin LA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research and the National Institutes of Health (NIH) Helping to End Addiction Long-term (HEAL) Initiative. Optimizing pharmacologic treatment for neonatal opioid withdrawal syndrome (OPTimize NOW): a symptom-based dosing approach study protocol for a multi-center, cluster crossover design randomized controlled trial. Trials. 2025 Aug 27;26(1):317. doi: 10.1186/s13063-025-09035-x. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 30, 2026 | Jun 25, 2026 | |||
| Jul 9, 2026 |