Trial · NCT04057820
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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 |
| Secondary | Composite of the Following: Acute/Urgent Care and/or Emergency Room Visits, Hospital Readmissions | at 3 months of age | Outpatient composite safety outcome which includes acute/urgent care and/or emergency room visits, hospital readmissions at 3 months (present/absent) |
| Secondary | Critical Safety Outcome | at 3 months of age. | any non-accidental trauma and death (yes/no) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04057820/registered