Comparison · NCT04057820-c8792884
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)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. 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, record NCT04057820-c8792884. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04057820-c8792884
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.00332 | 0.00091 | 0.012 | wilson | |
| Risk in group 2 | 0.00142 | 0.000252 | 0.00802 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00189 | -0.00513 | 0.0107 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.33 | 0.212 | 25.6 | log | |
| Odds ratio, group 1 over group 2 | 2.33 | 0.211 | 25.8 | log | |
| Number needed to treat, for one more participant with the outcome on Eat, Sleep, Console Care Tool than on Usual Care, Finnegan Neonatal Abstinence Scoring Tool | 528 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: usual care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 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. | 2 | 603 | OG001 |
| Group 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. | 1 | 702 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Inpatient Composite Safety Outcome Which Includes Seizures, Accidental Trauma, Respiratory Insufficiency Due to Opioid Therapy (Present/Absent)
- Description
- composite of the following: seizures, accidental trauma, respiratory insufficiency due to opioid therapy
- Time frame
- from date of birth until hospital discharge or 1 year whichever comes first
- Population
Source ClinicalTrials.gov
Trial
- Title
- Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach
- NCT number
- NCT04057820
- Phases
- NA
- Conditions
- Neonatal Opiate Withdrawal Syndrome
- Interventions
- Finnegan Neonatal Abstinence Scoring Tool, Eat, Sleep, Console (ESC) care tool
- Lead sponsor
- Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
- Results first posted
- 2023-10-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04057820?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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