Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT04057820
Status:
COMPLETED
Last Update Posted:
2025-02-14
First Post:
2019-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach
Sponsor:
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
Organization:
Study Overview
Official Title:
Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
(ESC-NOW)
Brief 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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 3U2COD023375-06S1 | NIH | None | https://reporter.nih.gov/quic… | View |