N/A
N=185
Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach
Neonatal Opiate Withdrawal Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04057820 ↗Enrolled (actual)
185
Serious AEs
1.2%
Results posted
Oct 2023
Primary outcome: Primary: Time From Birth Until Medically Ready for Discharge — 14.9; 8.2 days — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Finnegan Neonatal Abstinence Scoring Tool (Other); Eat, Sleep, Console (ESC) care tool (Other)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Birth Until Medically Ready for Discharge |
14.9; 8.2 | <0.0001 sig |
| SECONDARY Did Infant Receive Opioid Replacement Therapy (Yes/no) |
328; 145 | <0.0001 sig |
| SECONDARY Total Dose of Opioid Replacement Therapy Infant Received |
7.5; 5.3 | — |
| SECONDARY Time Until Initiation of Opioid Replacement |
53.0; 76 | — |
| SECONDARY Receipt of Adjuvant Therapy |
19.4; 15.7 | — |
| SECONDARY Maximum Percent Change in Weight During Initial Birth Hospitalization |
7.6; 8.0 | — |
| SECONDARY Feeding Type at Discharge (Exclusive Maternal Breast Milk) |
6.3; 12.1 | — |
| SECONDARY Any Direct Breast Feeding at Discharge |
19.5; 32.7 | — |
| SECONDARY Length of Hospital Stay |
14.0; 7.8 | — |
| SECONDARY Inpatient Composite Safety Outcome Which Includes Seizures, Accidental Trauma, Respiratory Insufficiency Due to Opioid Therapy (Present/Absent) |
1; 2 | — |
| SECONDARY Composite of the Following: Acute/Urgent Care and/or Emergency Room Visits, Hospital Readmissions |
113; 86 | — |
| SECONDARY Critical Safety Outcome |
5; 1 | — |
Summary
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.
Eligibility Criteria
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:
- Maternal history of prenatal opioid use
- Maternal toxicology screen positive for opioids during the second and/or third trimester of pregnancy
- Infant toxicology screen positive for opioids during the initial hospital stay
Exclusion Criteria
- 1. Infant has major birth defect(s) 2. Infant has neonatal encephalopathy (inclusive of hypoxic ischemic encephalopathy), a metabolic disorder, stroke, intracranial hemorrhage, or meningitis diagnosed by 60 hours of life 3. Infant was receiving respiratory support (any positive pressure or oxygen therapy) unrelated to pharmacologic treatment for NOWS at 60 hours of life 4. Infant was receiving antimicrobial(s) at 60 hours of life 5. Infant has received any major surgical intervention in the first 60 hours of life 6. Postnatal opioid exposure other than for treatment of NOWS in the first 60 hours of life 7. Outborn infants transferred at >60 hours of life or treated with opioids for NOWS at the transferring hospital
Data sourced from ClinicalTrials.gov (NCT04057820). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.