Trial · NCT04057820
Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach
NCT04057820, Not applicable, Completed, Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program; results first posted 2023-10-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach. Trials, record NCT04057820. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04057820
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach
- NCT number
- NCT04057820
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,305 participants, actual
- Lead sponsor
- Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
- Conditions
- Neonatal Opiate Withdrawal Syndrome
- Interventions
- Finnegan Neonatal Abstinence Scoring Tool, Eat, Sleep, Console (ESC) care tool
- First posted
- 2019-08-15
- Last updated
- 2025-02-14
- Results first posted
- 2023-10-04
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time From Birth Until Medically Ready for Discharge | from date of birth until hospital discharge or 1 year whichever comes first | 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. |
| Secondary | Did Infant Receive Opioid Replacement Therapy (Yes/no) | From date of birth until hospital discharge or 1 year whichever comes first | Review of hospital records to determine if infant received opioid replacement therapy prior to hospital discharge |
| Secondary | Total Dose of Opioid Replacement Therapy Infant Received | From date of birth until hospital discharge or 1 year whichever comes first | If infant received opioid replacement therapy, the units received (mg/kg). |
| Secondary | Time Until Initiation of Opioid Replacement | From date of birth until hospital discharge or 1 year whichever comes first | If infant received opioid replacement therapy, the timing of the initiation of therapy |
| Secondary | Receipt of Adjuvant Therapy | from date of birth until hospital discharge or 1 year whichever comes first | To see if the infant had to have any other type of therapy for NOWS (yes/no) |
| Secondary | Maximum Percent Change in Weight During Initial Birth Hospitalization | from date of birth until hospital discharge or 1 year whichever comes first | Assess percent change in birthweight during hospitalization (i.e., \[minimum weight - birth weight\] / birth weight) |
| Secondary | Feeding Type at Discharge (Exclusive Maternal Breast Milk) | from date of birth until hospital discharge or 1 year whichever comes first | Exclusive maternal breast milk feeding at the time of hospital discharge |
| Secondary | Any Direct Breast Feeding at Discharge | within 24 hours of hospital discharge | Direct breastfeeding within 24 hours of hospital discharge (yes/no) |
| Secondary | Length of Hospital Stay | from date of birth until hospital discharge or 1 year whichever comes first | Time from birth until infants being managed for NOWS are discharged from the hospital |
| Secondary | Inpatient Composite Safety Outcome Which Includes Seizures, Accidental Trauma, Respiratory Insufficiency Due to Opioid Therapy (Present/Absent) | from date of birth until hospital discharge or 1 year whichever comes first | composite of the following: seizures, accidental trauma, respiratory insufficiency due to opioid therapy |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time From Birth Until Medically Ready for Discharge | from date of birth until hospital discharge or 1 year whichever comes first | The primary analysis population only included those infants that met the definition of medically ready for discharge. | days | LEAST_SQUARES_MEAN |
| SECONDARY | Did Infant Receive Opioid Replacement Therapy (Yes/no) | From date of birth until hospital discharge or 1 year whichever comes first | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Total Dose of Opioid Replacement Therapy Infant Received | From date of birth until hospital discharge or 1 year whichever comes first | The analysis population for this outcome include only infants who received opioid treatment. | mg/kg | MEAN |
| SECONDARY | Time Until Initiation of Opioid Replacement | From date of birth until hospital discharge or 1 year whichever comes first | The analysis population for this outcome include only infants who received opioid treatment. | hours | MEAN |
| SECONDARY | Receipt of Adjuvant Therapy | from date of birth until hospital discharge or 1 year whichever comes first | The analysis population for this outcome include only infants who received opioid treatment. | percentage who received adjuvant therapy | NUMBER |
| SECONDARY | Maximum Percent Change in Weight During Initial Birth Hospitalization | from date of birth until hospital discharge or 1 year whichever comes first | percentage of change in birth weight | MEAN | |
| SECONDARY | Feeding Type at Discharge (Exclusive Maternal Breast Milk) | from date of birth until hospital discharge or 1 year whichever comes first | percentage of exclusive breast milk | NUMBER | |
| SECONDARY | Any Direct Breast Feeding at Discharge | within 24 hours of hospital discharge | percentage of direct breast feeding | NUMBER | |
| SECONDARY | Length of Hospital Stay | from date of birth until hospital discharge or 1 year whichever comes first | days | LEAST_SQUARES_MEAN | |
| SECONDARY | Inpatient Composite Safety Outcome Which Includes Seizures, Accidental Trauma, Respiratory Insufficiency Due to Opioid Therapy (Present/Absent) | from date of birth until hospital discharge or 1 year whichever comes first | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time From Birth Until Medically Ready for Discharge | Usual Care, Finnegan Neonatal Abstinence Scoring Tool | 14.9 | 95% Confidence Interval 13.1 to 16.7 | days | |
| Time From Birth Until Medically Ready for Discharge | Eat, Sleep, Console Care Tool | 8.2 | 95% Confidence Interval 7.2 to 9.2 | days | |
| Did Infant Receive Opioid Replacement Therapy (Yes/no) | Usual Care, Finnegan Neonatal Abstinence Scoring Tool | 328 | Participants | ||
| Did Infant Receive Opioid Replacement Therapy (Yes/no) | Eat, Sleep, Console Care Tool | 145 | Participants | ||
| Total Dose of Opioid Replacement Therapy Infant Received | Usual Care, Finnegan Neonatal Abstinence Scoring Tool | 7.5 | 95% Confidence Interval 5.0 to 10.1 | mg/kg | |
| Total Dose of Opioid Replacement Therapy Infant Received | Eat, Sleep, Console Care Tool | 5.3 | 95% Confidence Interval 3.2 to 7.4 | mg/kg | |
| Time Until Initiation of Opioid Replacement | Usual Care, Finnegan Neonatal Abstinence Scoring Tool | 53.0 | 95% Confidence Interval 48.7 to 57.3 | hours | |
| Time Until Initiation of Opioid Replacement | Eat, Sleep, Console Care Tool | 76 | 95% Confidence Interval 63.0 to 89.0 | hours | |
| Receipt of Adjuvant Therapy | Usual Care, Finnegan Neonatal Abstinence Scoring Tool | 19.4 | 95% Confidence Interval 8.5 to 30.4 | percentage who received adjuvant therapy | |
| Receipt of Adjuvant Therapy | Eat, Sleep, Console Care Tool | 15.7 | 95% Confidence Interval 5.5 to 25.8 | percentage who received adjuvant therapy |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow480
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Block 1: Usual Care, Finnegan Neonatal Abstinence Scoring Tool | 27 | 4 |
| Period 1 | STARTED | Block 1: Eat, Sleep, Console Care Tool | 0 | 0 |
| Period 1 | STARTED | Block 2: Usual Care, Finnegan Neonatal Abstinence Scoring Tool | 8 | 2 |
| Period 1 | STARTED | Block 2: Eat, Sleep, Console Care Tool | 0 | 0 |
| Period 1 | STARTED | Block 3: Usual Care, Finnegan Neonatal Abstinence Scoring Tool | 23 | 3 |
| Period 1 | STARTED | Block 3: Eat, Sleep, Console Care Tool | 0 | 0 |
| Period 1 | STARTED | Block 4: Usual Care, Finnegan Neonatal Abstinence Scoring Tool | 23 | 3 |
| Period 1 | STARTED | Block 4: Eat, Sleep, Console Care Tool | 0 | 0 |
| Period 1 | STARTED | Block 5: Usual Care, Finnegan Neonatal Abstinence Scoring Tool | 41 | 4 |
| Period 1 | STARTED | Block 5: Eat, Sleep, Console Care Tool | 0 | 0 |
1 to 10 of 480Source ClinicalTrials.gov
See all 480 participant flowAdverse events52
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Severe Weight Loss | Metabolism and nutrition disorders | Usual Care, Finnegan Neonatal Abstinence Scoring Tool | 5 | 702 | 5 |
| other | Severe Weight Loss | Metabolism and nutrition disorders | Eat, Sleep, Console Care Tool | 12 | 603 | 12 |
| other | Accidental trauma (infant dropped) | Injury, poisoning and procedural complications | Usual Care, Finnegan Neonatal Abstinence Scoring Tool | 0 | 702 | 0 |
| other | Accidental trauma (infant dropped) | Injury, poisoning and procedural complications | Eat, Sleep, Console Care Tool | 1 | 603 | 1 |
| other | Jaundice | Hepatobiliary disorders | Usual Care, Finnegan Neonatal Abstinence Scoring Tool | 1 | 702 | 1 |
| other | Jaundice | Hepatobiliary disorders | Eat, Sleep, Console Care Tool | 0 | 603 | 0 |
| other | CMV | Infections and infestations | Usual Care, Finnegan Neonatal Abstinence Scoring Tool | 0 | 702 | 0 |
| other | CMV | Infections and infestations | Eat, Sleep, Console Care Tool | 2 | 603 | 2 |
| other | Fall, caught before hitting floor | Injury, poisoning and procedural complications | Usual Care, Finnegan Neonatal Abstinence Scoring Tool | 0 | 702 | 0 |
| other | Fall, caught before hitting floor | Injury, poisoning and procedural complications | Eat, Sleep, Console Care Tool | 1 | 603 | 1 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Usual Care, Finnegan Neonatal Abstinence Scoring Tool | 4 | 702 |
| Total, all-cause mortality | Eat, Sleep, Console Care Tool | 0 | 603 |
| Total, other adverse events | Usual Care, Finnegan Neonatal Abstinence Scoring Tool | 8 | 702 |
| Total, other adverse events | Eat, Sleep, Console Care Tool | 18 | 603 |
| Total, serious adverse events | Usual Care, Finnegan Neonatal Abstinence Scoring Tool | 4 | 702 |
| Total, serious adverse events | Eat, Sleep, Console Care Tool | 12 | 603 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U2COD023375 | Environmental influences on Child Health Outcomes (ECHO) Coordinating Center | SMITH, PHILLIP BRIAN; ADAIR, LINDA S | DUKE UNIVERSITY | OFFICE OF THE DIRECTOR, NATIONAL INSTITUTES OF HEALTH | 2016 to 2025 |
Source NIH RePORTER
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Eat, Sleep, Console Care Tool vs Usual Care, Finnegan Neonatal Abstinence Scoring Tool: Composite of the Following: Acute/Urgent Care and/or Emergency Room Visits, Hospital Readmissions | Trial comparisons |
Eat, Sleep, Console Care Tool vs Usual Care, Finnegan Neonatal Abstinence Scoring Tool: Inpatient Composite Safety Outcome Which Includes Seizures, Accidental Trauma, Respiratory Insufficiency Due to Opioid Therapy (Present/Absent) | Trial comparisons |
| Eat, Sleep, Console Care Tool vs Usual Care, Finnegan Neonatal Abstinence Scoring Tool: deaths from any cause | Trial comparisons |
| Eat, Sleep, Console Care Tool vs Usual Care, Finnegan Neonatal Abstinence Scoring Tool: Did Infant Receive Opioid Replacement Therapy (Yes/no) | Trial comparisons |
| Eat, Sleep, Console Care Tool vs Usual Care, Finnegan Neonatal Abstinence Scoring Tool: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04057820
GET https://conductscience.org/api/trials/v1/NCT04057820/results?page=2