Trial · NCT04772222
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 | Examine Safety Measures in Infants Receiving DMT to Those Receiving Morphine | First 96 hours of life | Safety will be evaluated during the first 4 days of life by comparing number of serious adverse events between two study arms. |
| Secondary | DMT Plasma Levels | one week | Two opportunistic PK samples (at time of routine laboratories) and a PK sample any time there is an adverse event will be obtained for measurement of DMT plasma concentrations as needed. Because these PK samples are done opportunistically, there are no pre-set defined time points for PK measurements. |
| Other | Number of Participants Who Experience Shivering | First 96 hours of life | Number of babies who experience shivering during therapeutic hypothermia will be compared between the two drug treatment regimens |
| Other | Number of Days Intubated | First week of life | Number of days each subject required invasive ventilator support will be compared between arms. |
| Other | Days to Full Oral Feedings by Bottle or Breast | Up to two months | Days to full oral feedings will be compared between the two drug treatment regimens |
| Other | Generalized Motor Assessment Scores at 3-4 Months of Age | 3-4 months of age | the GMA is a validated test that aids in early detection of neurological movement disorders by evaluating the quality of movements during a 2-minute video. Certified assessors will grade the quality of movements which include: normal writhing, poor repertoire, cramped synchronized, and chaotic movements. All movements other than normal writhing are considered atypical. The results will be compared between the two drug treatments. |
| Other | Hammersmith Infant Neurological Exam (HINE) Scores at 3-4 Months of Age | 3-4 months of age | The HINE is a 26 item exam that assesses different aspects of neurological function and these scores will be compared between the two drug treatment regimens. This assessment scores 5 different neurological development areas: Cranial nerve function, posture, movements, tone, and reflexes/reactions. The maximum score is 78 and lowest score is 0. Higher scores show better neurological development consistent with better outcomes. |
| Other | Hammersmith Infant Neurological Exam (HINE) Scores at 6-9 Months of Age | 6-9 months of age | The HINE is a 26 item exam that assesses different aspects of neurological function and these scores will be compared between the two drug treatment regimens. This assessment scores 5 different neurological development areas: Cranial nerve function, posture, movements, tone, and reflexes/reactions. The maximum score is 78 and lowest score is 0. Higher scores show better neurological development consistent with better outcomes. |
| Other | Test of Infant Motor Performance (TIMP) Scores at 3-4 Months of Corrected Age | 3-4 months of corrected age | This test evaluates posture and motor control and is designed to be used specifically in infants born prematurely. Results are given based on z-scores from normative values and are given as low average, below average, and far below average. Lower scores are more predictive of worse outcomes. These scores will be compared between the two drug treatment regimens. |
| Other | Peabody Developmental Motor Skills (PDMS-2) at 6-9 Months of Age | 6-9 months of age | This test evaluates fine motor, gross motor, and total motor skills. Results are converted to age equivalent rating and then quotient scores are given for each category. Minimum is 35 and maximum is 165. The average score is 90-110, with higher scores given in 3 SD above average performance and lower scores given in 3 SD below average performance.The higher the score, the better predicted outcome. These scores will be compared between the two drug treatment regimens. |
| Other | Ages and Stages Questionnaire at 6-9 Months of Age | 6-9 months of age | Parental survey that assesses communication, gross and fine motor skills, and social behaviors. Scores range from 0-60, and the higher the score, the better the outcome. These scores will be compared between the two drug treatment regimens |
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/NCT04772222/registered