Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT05980260

Title field or adapter rule

{'original_value': 'Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach', 'source_field': 'protocolSection.identificationModule.officialTitle'}

Ingested At

2026-10-30T01:05:27.834663+00:00

Published At

2026-10-29T00:00:00+00:00

Record Updated At

2026-10-29

Results Posted At

2026-10-29

Source Retrieved At

2026-10-30T01:05:26.713790+00:00

Timestamp Basis

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Date limitation

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions

["Neonatal Opiate Withdrawal Syndrome"]

protocolSection.statusModule.lastUpdatePostDateStruct

{"date": "2026-10-29", "type": "ACTUAL"}

protocolSection.identificationModule.nctId

"NCT05980260"

protocolSection.identificationModule.officialTitle

"Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach"

protocolSection.statusModule.overallStatus

"COMPLETED"

protocolSection.designModule.phases

["PHASE3"]

protocolSection.statusModule.resultsFirstPostDateStruct

{"date": "2026-10-29", "type": "ACTUAL"}

Study condition terms

• Neonatal Opiate Withdrawal Syndrome (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

• {'armGroupLabels': ['Sequence 1', 'Sequence 2'], 'description': "During this approach to care, all enrolled infants with NOWS at the study site will be treated with the symptom-based dosing approach if they meet the withdrawal threshold for pharmacologic treatment. Participants may receive up to 3 doses of the study site's preferred opioid during a 24-hour period to treat signs of withdrawal once the threshold for pharmacologic intervention is met. If a 4th dose is required within a 24-hour period, the study site will transition to the scheduled opioid taper algorithm used at the study site to complete the infant's pharmacologic treatment.", 'name': 'Symptom-based Dosing Approach', 'type': 'OTHER'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Sequence 1', 'Sequence 2'], 'description': "During this approach to care, all enrolled infants with NOWS at the study site will be treated with the study site's usual scheduled opioid taper approach, as detailed in each site's treatment algorithm, if they meet the withdrawal threshold for pharmacologic treatment.", 'name': 'Scheduled Opioid Taper Approach', 'type': 'OTHER'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

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