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| ID | Type | Description | Link |
|---|---|---|---|
| 3U2COD023375-06S1 | U.S. NIH Grant/Contract | View source |
Not provided
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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The overall objective is to determine if the ESC care approach will reduce the time until infants being managed for NOWS are medically ready for discharge.
This study will randomize institutions in blocks to transition from usual institutional care for infants with NOWS to the ESC care approach at a randomly allocated transition period (from usual care to the ESC care approach).
During the initial birth hospitalization, the clinical site research team will collect data under waiver of consent for infants who meet eligibility criteria.
The site research team will obtain informed consent from the legal guardian(s) to obtain long-term outcomes for eligible infants and caregivers. Clinical site research team members may obtain this consent at any point during the hospital stay for infants who meet the trial's inclusion criteria. This data will allow the protocol study team to short- and long-term outcomes for infants managed with the ESC care approach compared to usual institutional care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care, Finnegan Neonatal Abstinence Scoring Tool | Active Comparator | Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) |
|
| Eat, Sleep, Console care tool | Active Comparator | New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Finnegan Neonatal Abstinence Scoring Tool | Other | The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time From Birth Until Medically Ready for Discharge | The number of days from birth until the infant is determined to be medically ready for discharge per protocol. The criteria for medical readiness were prospectively defined as an age of at least 96 hours, a period of at least 48 hours without receipt of an opioid, at least 24 hours with no respiratory support and with 100% oral feeding, and at least 24 hours from initiation of maximum caloric density. | from date of birth until hospital discharge or 1 year whichever comes first |
| Measure | Description | Time Frame |
|---|---|---|
| Did Infant Receive Opioid Replacement Therapy (Yes/no) | Review of hospital records to determine if infant received opioid replacement therapy prior to hospital discharge | From date of birth until hospital discharge or 1 year whichever comes first |
| Total Dose of Opioid Replacement Therapy Infant Received |
Not provided
Inclusion Criteria:
1. The infant is being managed for NOWS at an eligible site (i.e., receiving non-pharmacologic care, assessments for withdrawal severity, +/- pharmacologic care) 2. The infant is ≥ 36 weeks gestation 3. The infant satisfies at least 1 of the following criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chistiana Care Health Systems | Newark | Delaware | 19718 | United States | ||
| Tampa General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41110632 | Derived | Beauman SGS, Hu Z, Rice W, Devlin L, Merhar SL, Fung CM, Brown J, Osman A, Pahl A, Ramsey KW, Whalen B, MacMillan KDL, Ounpraseuth ST, Das A, Crawford MM, Trochinski L, Greenberg RG, Smith PB, Young LW, Maxwell JR; Eunice Kennedy Shriver NICHD Neonatal Research Network and the NIH ECHO Program IDeA States Pediatrics Clinical Trials Network. Antenatal Exposure to Medication for Opioid Use Disorder and Infant Outcomes in the Eat, Sleep, Console for Neonatal Opioid Withdrawal Randomized Controlled Trial. J Pediatr. 2026 Feb;289:114859. doi: 10.1016/j.jpeds.2025.114859. Epub 2025 Oct 17. | |
| 39133505 |
Not provided
Not provided
The in-hospital portion of the study was performed under waiver of informed consent. Only the newborn babies are considered enrolled participants. The number of participants to start a Period may not equal the number who completed a previous Period because at each subsequent Period a new cohort of newborn babies are enrolled at the respective sites. During the transition period for a given block, sites within the block are not enrolling participants.
The in-hospital and initial follow-up portions of the trial were conducted with a waiver of informed consent, as approved by central institutional review board.
| ID | Title | Description |
|---|---|---|
| FG000 | Block 1: Usual Care, Finnegan Neonatal Abstinence Scoring Tool | Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers. Block 1 contained four sites. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 28, 2022 |
Not provided
Stepped-wedge cluster randomized controlled trial with transition period.All sites start with usual care and are transitioned to using the ESC tool
Not provided
Not provided
The protocol study team will assure blinding of the electronically performed follow-up questionnaires through the use of a centralized computer scoring system. However, it will not be possible to blind responses to questionnaires that are performed with the assistance of research personnel at the participating sites. The protocol study team will note the method of questionnaire completion and will evaluate for bias in this context.
|
| Eat, Sleep, Console (ESC) care tool | Other | The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies. |
|
|
If infant received opioid replacement therapy, the units received (mg/kg). |
| From date of birth until hospital discharge or 1 year whichever comes first |
| Time Until Initiation of Opioid Replacement | If infant received opioid replacement therapy, the timing of the initiation of therapy | From date of birth until hospital discharge or 1 year whichever comes first |
| Receipt of Adjuvant Therapy | To see if the infant had to have any other type of therapy for NOWS (yes/no) | from date of birth until hospital discharge or 1 year whichever comes first |
| Maximum Percent Change in Weight During Initial Birth Hospitalization | Assess percent change in birthweight during hospitalization (i.e., [minimum weight - birth weight] / birth weight) | from date of birth until hospital discharge or 1 year whichever comes first |
| Feeding Type at Discharge (Exclusive Maternal Breast Milk) | Exclusive maternal breast milk feeding at the time of hospital discharge | from date of birth until hospital discharge or 1 year whichever comes first |
| Any Direct Breast Feeding at Discharge | Direct breastfeeding within 24 hours of hospital discharge (yes/no) | within 24 hours of hospital discharge |
| Length of Hospital Stay | Time from birth until infants being managed for NOWS are discharged from the hospital | from date of birth until hospital discharge or 1 year whichever comes first |
| Inpatient Composite Safety Outcome Which Includes Seizures, Accidental Trauma, Respiratory Insufficiency Due to Opioid Therapy (Present/Absent) | composite of the following: seizures, accidental trauma, respiratory insufficiency due to opioid therapy | from date of birth until hospital discharge or 1 year whichever comes first |
| Composite of the Following: Acute/Urgent Care and/or Emergency Room Visits, Hospital Readmissions | Outpatient composite safety outcome which includes acute/urgent care and/or emergency room visits, hospital readmissions at 3 months (present/absent) | at 3 months of age |
| Critical Safety Outcome | any non-accidental trauma and death (yes/no) | at 3 months of age. |
| Tampa |
| Florida |
| 33606 |
| United States |
| Kapiolani Hospital | Honolulu | Hawaii | 96826 | United States |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | United States |
| Shawnee Mission Medical Center | Shawnee Mission | Kansas | 66204 | United States |
| St. Elizabeth Healthcare/CCHMC | Edgewood | Kentucky | 41017 | United States |
| Norton Children's Hospital | Louisville | Kentucky | 40202 | United States |
| Tulane University School of Medicine | Metairie | Louisiana | 70001 | United States |
| Winchester Hospital | Winchester | Massachusetts | 01890 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-1205 | United States |
| University of New Mexico | Albuquerque | New Mexico | 87106 | United States |
| University of Buffalo | Buffalo | New York | 14203 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Duke Hospital | Durham | North Carolina | 27710 | United States |
| Good Samaritan Hospital | Cincinnati | Ohio | 45220 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45229 | United States |
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43215 | United States |
| Oklahoma University Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | United States |
| Sanford Health | Sioux Falls | South Dakota | 57105 | United States |
| University of Utah Medical Center | Salt Lake City | Utah | 84108 | United States |
| Derived |
| Merhar SL, Hu Z, Devlin LA, Ounpraseuth ST, Simon AE, Smith PB, Walsh MC, Lee JY, Das A, Higgins RD, Crawford MM, Rice W, Paul DA, Maxwell JR, Telang SD, Fung CM, Wright T, Reynolds AM, Hahn D, Ross J, McAllister JM, Crowley M, Shaikh SK, Christ L, Brown J, Riccio J, Wong Ramsey K, Braswell EF, Tucker L, McAlmon K, Dummula K, Weiner J, White JR, Howell MP, Newman S, Snowden JN, Young LW; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network National Institutes of Health Environmental Influences on Child Health Outcomes Program Institutional Development Award States Pediatric Clinical Tri; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network National Institutes of Health Environmental Influences on Child Health Outcomes Program Institutional Development Award States Pediatric Clinical Trials Network. Infant Feeding and Weight Trajectories in the Eat, Sleep, Console Trial: A Secondary Analysis of a Randomized Clinical Trial. JAMA Pediatr. 2024 Oct 1;178(10):976-984. doi: 10.1001/jamapediatrics.2024.2578. |
| 38619854 | Derived | Devlin LA, Hu Z, Merhar SL, Ounpraseuth ST, Simon AE, Lee JY, Das A, Crawford MM, Greenberg RG, Smith PB, Higgins RD, Walsh MC, Rice W, Paul DA, Maxwell JR, Fung CM, Wright T, Ross J, McAllister JM, Crowley M, Shaikh SK, Christ L, Brown J, Riccio J, Wong Ramsey K, Braswell EF, Tucker L, McAlmon K, Dummula K, Weiner J, White JR, Newman S, Snowden JN, Young LW; Eunice Kennedy Shriver NICHD Neonatal Research Network and NIH Environmental Influences on Child Health Outcomes (ECHO) Program Institutional Development Award States Pediatric Clinical Trials Network. Influence of Eat, Sleep, and Console on Infants Pharmacologically Treated for Opioid Withdrawal: A Post Hoc Subgroup Analysis of the ESC-NOW Randomized Clinical Trial. JAMA Pediatr. 2024 Jun 1;178(6):525-532. doi: 10.1001/jamapediatrics.2024.0544. |
| 37125831 | Derived | Young LW, Ounpraseuth ST, Merhar SL, Hu Z, Simon AE, Bremer AA, Lee JY, Das A, Crawford MM, Greenberg RG, Smith PB, Poindexter BB, Higgins RD, Walsh MC, Rice W, Paul DA, Maxwell JR, Telang S, Fung CM, Wright T, Reynolds AM, Hahn DW, Ross J, McAllister JM, Crowley M, Shaikh SK, Puopolo KM, Christ L, Brown J, Riccio J, Wong Ramsey K, Akshatha, Braswell EF, Tucker L, McAlmon KR, Dummula K, Weiner J, White JR, Howell MP, Newman S, Snowden JN, Devlin LA; ACT NOW Collaborative. Eat, Sleep, Console Approach or Usual Care for Neonatal Opioid Withdrawal. N Engl J Med. 2023 Jun 22;388(25):2326-2337. doi: 10.1056/NEJMoa2214470. Epub 2023 Apr 30. |
| FG001 |
| Block 1: Eat, Sleep, Console Care Tool |
New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies. Block 1 had four sites. |
| FG002 | Block 2: Usual Care, Finnegan Neonatal Abstinence Scoring Tool | Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers. Block 2 contained two sites. |
| FG003 | Block 2: Eat, Sleep, Console Care Tool | New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies. Block 2 had two sites. |
| FG004 | Block 3: Usual Care, Finnegan Neonatal Abstinence Scoring Tool | Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers. Block 3 contained three sites. |
| FG005 | Block 3: Eat, Sleep, Console Care Tool | New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies. Block 3 had three sites. |
| FG006 | Block 4: Usual Care, Finnegan Neonatal Abstinence Scoring Tool | Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers. Block 4 contained three sites. |
| FG007 | Block 4: Eat, Sleep, Console Care Tool | New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies. Block 4 had threesites. |
| FG008 | Block 5: Usual Care, Finnegan Neonatal Abstinence Scoring Tool | Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers. Block 5 contained four sites. |
| FG009 | Block 5: Eat, Sleep, Console Care Tool | New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies. Block 5 had four sites. |
| FG010 | Block 6: Usual Care, Finnegan Neonatal Abstinence Scoring Tool | Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers. Block 6 contained four sites. |
| FG011 | Block 6: Eat, Sleep, Console Care Tool | New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies. Block 6 had four sites. |
| FG012 | Block 7: Usual Care, Finnegan Neonatal Abstinence Scoring Tool | Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers. Block 7 contained threesites. |
| FG013 | Block 7: Eat, Sleep, Console Care Tool | New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies. Block 7 had three sites. |
| FG014 | Block 8: Usual Care, Finnegan Neonatal Abstinence Scoring Tool | Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers. Block 8 contained threesites. |
| FG015 | Block 8: Eat, Sleep, Console Care Tool | New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies. Block 8 had three sites. |
| COMPLETED |
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| NOT COMPLETED |
|
| Period 2 |
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| Period 3 |
|
| Period 4 |
|
| Period 5 |
|
| Period 6 |
|
| Period 7 |
|
| Period 8 |
|
| Period 9 |
|
| Period 10 |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care, Finnegan Neonatal Abstinence Scoring Tool | Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers. |
| BG001 | Eat, Sleep, Console Care Tool | New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | This information represents maternal age. | There were 11 observations with missing maternal age in the Usual Care group while the ESC group had 2 missing maternal age values. | Mean | Standard Deviation | years |
| |||||||||||||
| Age, Continuous | Gestational age at birth | Mean | Standard Deviation | weeks |
| ||||||||||||||
| Sex: Female, Male | This information represents the infant's sex. | Count of Participants | Participants |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Marital Status | Count of Participants | Participants |
| ||||||||||||||||
| Gravidity | There was one observation in the Usual Care group with missing gravidity value. | Median | Inter-Quartile Range | Pregnancies |
| ||||||||||||||
| Parity | There was one observation in the Usual Care group with missing parity value. | Median | Inter-Quartile Range | Births |
| ||||||||||||||
| Highest Level of Education | Count of Participants | Participants |
| ||||||||||||||||
| Mother's Medical Insurance | Medical insurance is a check "all that applies" question; therefore, the total number may exceed the group sample size. | Number | participants |
| |||||||||||||||
| Infant weight at birth | Mean | Standard Deviation | g |
| |||||||||||||||
| Head circumference at birth | Infant head circumference at birth | In the Usual Care group, 10 infants had missing head circumference values while 12 infants had missing observations in the ESC group. | Mean | Standard Deviation | cm |
| |||||||||||||
| Length at birth | This represents the infant's length at birth. | There were 4 infants in the Usual Care group with missing length at birth while 7 infants in the ESC group had missing observations. | Mean | Standard Deviation | cm |
| |||||||||||||
| 1-minute Apgar scores | Apgar stands for Appearance, Pulse, Grimace, Activity and Respiration with 5 categories (breathing effort, heart rate, muscle tone, reflexes, skin color) each measured on a scale of 0, 1, 2 (range 0 to 10 with higher scores representing better outcome). The 1-minute evaluation is used to determine how well the infant tolerated the birthing process. There were 13 infants with missing 1-min Apgar scores in the Usual Care group while 9 infants had missing observations in the ESC group. | Median | Inter-Quartile Range | Score on a scale |
| ||||||||||||||
| 5-minute Apgar scores | Apgar stands for Appearance, Pulse, Grimace, Activity and Respiration with 5 categories (breathing effort, heart rate, muscle tone, reflexes, skin color) each measured on a scale of 0, 1, 2 (range 0 to 10 with higher scores representing better outcome). The 5-minute score measures how well the infant is doing outside the mother's womb. There were 14 infants with missing 5-min Apgar scores in the Usual Care group while 7 infants had missing observations in the ESC group. | Median | Inter-Quartile Range | Score on a scale |
| ||||||||||||||
| 10-minute Apgar scores | Apgar stands for Appearance, Pulse, Grimace, Activity and Respiration with 5 categories (breathing effort, heart rate, muscle tone, reflexes, skin color) each measured on a scale of 0, 1, 2 (range 0 to 10 with higher scores representing better outcome). The Usual Care group had 668 infants with missing 10-min Apgar scores while ESC had 574 missing 10-min Apgar scores. | Median | Inter-Quartile Range | Score on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time From Birth Until Medically Ready for Discharge | The number of days from birth until the infant is determined to be medically ready for discharge per protocol. The criteria for medical readiness were prospectively defined as an age of at least 96 hours, a period of at least 48 hours without receipt of an opioid, at least 24 hours with no respiratory support and with 100% oral feeding, and at least 24 hours from initiation of maximum caloric density. | The primary analysis population only included those infants that met the definition of medically ready for discharge. | Posted | Least Squares Mean | 95% Confidence Interval | days | from date of birth until hospital discharge or 1 year whichever comes first |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Did Infant Receive Opioid Replacement Therapy (Yes/no) | Review of hospital records to determine if infant received opioid replacement therapy prior to hospital discharge | Posted | Count of Participants | Participants | From date of birth until hospital discharge or 1 year whichever comes first |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Dose of Opioid Replacement Therapy Infant Received | If infant received opioid replacement therapy, the units received (mg/kg). | The analysis population for this outcome include only infants who received opioid treatment. | Posted | Mean | 95% Confidence Interval | mg/kg | From date of birth until hospital discharge or 1 year whichever comes first |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time Until Initiation of Opioid Replacement | If infant received opioid replacement therapy, the timing of the initiation of therapy | The analysis population for this outcome include only infants who received opioid treatment. | Posted | Mean | 95% Confidence Interval | hours | From date of birth until hospital discharge or 1 year whichever comes first |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Receipt of Adjuvant Therapy | To see if the infant had to have any other type of therapy for NOWS (yes/no) | The analysis population for this outcome include only infants who received opioid treatment. | Posted | Number | 95% Confidence Interval | percentage who received adjuvant therapy | from date of birth until hospital discharge or 1 year whichever comes first |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Percent Change in Weight During Initial Birth Hospitalization | Assess percent change in birthweight during hospitalization (i.e., [minimum weight - birth weight] / birth weight) | Posted | Mean | 95% Confidence Interval | percentage of change in birth weight | from date of birth until hospital discharge or 1 year whichever comes first |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Feeding Type at Discharge (Exclusive Maternal Breast Milk) | Exclusive maternal breast milk feeding at the time of hospital discharge | Posted | Number | 95% Confidence Interval | percentage of exclusive breast milk | from date of birth until hospital discharge or 1 year whichever comes first |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Any Direct Breast Feeding at Discharge | Direct breastfeeding within 24 hours of hospital discharge (yes/no) | Posted | Number | 95% Confidence Interval | percentage of direct breast feeding | within 24 hours of hospital discharge |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Length of Hospital Stay | Time from birth until infants being managed for NOWS are discharged from the hospital | Posted | Least Squares Mean | 95% Confidence Interval | days | from date of birth until hospital discharge or 1 year whichever comes first |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Inpatient Composite Safety Outcome Which Includes Seizures, Accidental Trauma, Respiratory Insufficiency Due to Opioid Therapy (Present/Absent) | composite of the following: seizures, accidental trauma, respiratory insufficiency due to opioid therapy | Posted | Count of Participants | Participants | from date of birth until hospital discharge or 1 year whichever comes first |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Composite of the Following: Acute/Urgent Care and/or Emergency Room Visits, Hospital Readmissions | Outpatient composite safety outcome which includes acute/urgent care and/or emergency room visits, hospital readmissions at 3 months (present/absent) | Posted | Count of Participants | Participants | at 3 months of age |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Critical Safety Outcome | any non-accidental trauma and death (yes/no) | Posted | Number | number of non-accidental trauma/death | at 3 months of age. |
|
|
3-months post-hospital discharge
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care, Finnegan Neonatal Abstinence Scoring Tool | Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers. | 4 | 702 | 4 | 702 | 8 | 702 |
| EG001 | Eat, Sleep, Console Care Tool | New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies. | 0 | 603 | 12 | 603 | 18 | 603 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment | SAE during main study in-hospital prior to discharge. |
|
| Severe Weight Loss | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment | SAE during main study in-hospital prior to discharge. |
|
| Accidental trauma (infant dropped) | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment | SAE during main study in-hospital prior to discharge. |
|
| Respiratory insufficiency | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | SAE reported after discharge from hospital. |
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| Accidental Drug Ingestion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment | SAE reported after discharge from hospital. |
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| Failure to thrive | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment | SAE reported after discharge from hospital. |
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| Poor weight gain | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment | SAE reported after discharge from hospital. |
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| Abnormal echocardiogram | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment | SAE reported after discharge from hospital. |
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| Acute Covid-19 | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment | SAE reported after discharge from hospital. |
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| Tachypnea required readmission to hospital | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | SAE reported after discharge from hospital. |
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| Ventricular Septal Defect | Congenital, familial and genetic disorders | MedDRA (Unspecified) | Non-systematic Assessment | SAE reported after discharge from hospital. |
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| Viral Meningitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment | SAE reported after discharge from hospital. |
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| Vomiting R11.10 | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | SAE reported after discharge from hospital. |
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| Observation and evaluation of newborn sepsis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment | SAE reported after discharge from hospital. |
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| Severe Weight Loss | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment | SAE reported after discharge from hospital. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe Weight Loss | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment | AE during main study in-hospital prior to discharge. |
|
| Accidental trauma (infant dropped) | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment | AE during main study in-hospital prior to discharge. |
|
| Jaundice | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment | AE during main study in-hospital prior to discharge. |
|
| CMV | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment | AE during main study in-hospital prior to discharge. |
|
| Fall, caught before hitting floor | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment | AE during main study in-hospital prior to discharge. |
|
| Diaper Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | AE during main study after hospital discharge. |
|
| Non-accidental trauma | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment | AE during main study after hospital discharge. |
|
| PCP suspected resp. distress, not confirmed by ED | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | AE during main study after hospital discharge. |
|
| Frequent emesis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | AE during main study after hospital discharge. |
|
| Neonatal sleep myoclonus | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment | AE during main study after hospital discharge. |
|
| Attention to g-tube | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | AE during main study after hospital discharge. |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Songthip Ounpraseuth | University of Arkansas for Medical Sciences | 5016867233 | stounpraseuth@uams.edu |
| Jul 6, 2022 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: General Consent | Mar 9, 2020 | Jul 6, 2022 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Consent for parent and minor mother | Mar 9, 2020 | Jul 6, 2022 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Consent for caregiver only | Feb 18, 2021 | Jul 6, 2022 | ICF_003.pdf |
| ICF | No | No | Yes | Informed Consent Form: Consent for baby only | Jan 11, 2021 | Jul 6, 2022 | ICF_004.pdf |
| ID | Term |
|---|---|
| D004435 | Eating |
| D012890 | Sleep |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D004068 | Digestive System Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
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