Trial · NCT01958476
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Length of Hospital Stay (LOS) | Participants will be monitored during their entire hospitalization, expected mean 22 days. | Participants were monitored for the duration of their hospitalization, an expected mean of 22 days. |
| Secondary | Length of Hospital Stay (LOS) Due to Neonatal Abstinence Syndrome (NAS) | Participants were monitored for the duration of their hospitalization, expected mean 22 days. | Participants were monitored for the duration of their hospitalization attributable to NAS only. |
| Secondary | Length of Treatment (LOT) | Participants were monitored for the duration of their hospitalization. | Total number of days infant treated with replacement opioids while admitted to the hospital. |
| Secondary | Maximum Daily Dose of Replacement Opioid | Participants were monitored for the duration of their hospitalization. | Maximum daily dose of neonatal morphine solution or methadone during the hospitalization |
| Secondary | Mean Finnegan Score (FS) | Participants were monitored during their entire hospitalization | Mean Finnegan withdrawal score during the duration of hospitalization. |
| Secondary | Number of Infants Needing a Second NAS Medication | Participants were monitored for the duration of their hospitalization, an average of 22 days. | Number of infants treated with a second medication following protocol, phenobarbital. If the Finnegan Score remained elevated (still scored ≥8 two times consecutively, or still scored once ≥12) despite increasing to a predetermined maximal opioid dose (methadone or morphine), phenobarbital was administered (20-mg/kg loading dose followed by 4-5 mg/kg daily). |
| Secondary | Growth Outcome: Weight Change From Birth to 18 Months | Birth to 18 month follow-up visit | Growth outcome weight (lbs) depicted as difference in averaged weights from birth to 18 month follow-up visit. Standard deviations were averaged between birth and 18 mo time points. |
| Secondary | Growth Outcome: Head Circumference at 18 Months | 18 month follow-up visit | Average head circumference growth outcome at 18 month follow-up visit. |
| Secondary | Maximum Finnegan Score | Participants monitored for the duration of their hospitalization. | Maximum Finnegan score during the hospitalization |
| Secondary | Growth Outcome: Length at 18 Months | 18 month follow-up visit | Average length (cm) at 18 month follow-up visit. |
| Other | Cognitive, Language, and Motor Development From 18 Month Bayley III Neurodevelopmental Assessment | Assessment at 18 month follow-up visit | The Bayley Scales of Infant and Toddler Development (BSID-III) assesses the development of infants and children (1-42 months) through a series of developmental play tasks, identifying children with developmental delay. Raw scores of completed items are summarized within three distinct scale scores (Cognitive Scale, Language Scale, Motor Scale). Scale scores are each converted to composite scores to determine the child's performance compared with scores of age-matched children of typical development (percentile rank). A higher composite score indicates more ideal developmental outcome (range 40-160). At 18 month follow-up visit, participants were assessed using the BSID-III for cognitive, language and motor scale composite score outcomes. |
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
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GET https://conductscience.org/api/trials/v1/NCT01958476/registered