Trial · NCT01030575
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Population Pharmacokinetics: V - Volume | 8-10 blood samples per infant were drawn over 10 weeks for infant safety with the full study duration represented across all infants. Samples were drawn at baseline & on days 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 35, 42, 56, and 70. | |
| Primary | Population Pharmacokinetics: Cl - Clearance | 8-10 blood samples per infant were drawn over 10 weeks for infant safety with the full study duration represented across all infants. Samples were drawn at baseline & on days 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 35, 42, 56, and 70. | |
| Primary | Population Pharmacokinetics: R - Endogenous Infusion Rate | 8-10 blood samples per infant were drawn over 10 weeks for infant safety with the full study duration represented across all infants. Samples were drawn at baseline & on days 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 35, 42, 56, and 70. | |
| Primary | Population Pharmacokinetics: k - Elimination Rate (Cl/V) | 8-10 blood samples per infant were drawn over 10 weeks for infant safety with the full study duration represented across all infants. Samples were drawn at baseline & on days 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 35, 42, 56, and 70. | |
| Primary | Population Pharmacokinetics: t1/2 - Half-Life (0.693/k) | 8-10 blood samples per infant were drawn over 10 weeks for infant safety with the full study duration represented across all infants. Samples were drawn at baseline & on days 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 35, 42, 56, and 70. | |
| Primary | Population Pharmacokinetics: E - Concentration Due to Endogenous Infusion (R/Cl) | 8-10 blood samples per infant were drawn over 10 weeks for infant safety with the full study duration represented across all infants. Samples were drawn at baseline & on days 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 35, 42, 56, and 70. | |
| Primary | SD of Residual Error (mg/l) | 8-10 blood samples per infant were drawn over 10 weeks for infant safety with the full study duration represented across all infants. Samples were drawn at baseline & on days 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 35, 42, 56, and 70. | |
| Secondary | Number of Participants With Any Retinopathy of Prematurity (ROP) | 18-22 month corrected age | Any ROP is defined as ROP of any severity that is observed at 18-22 month corrected age |
| Secondary | Number of Participants With Any Retinopathy of Prematurity Through 18-22 Month Corrected Age or Death | 18-22 month corrected age | Number of participants with any Retinopathy of Prematurity (ROP) through 18-22 month corrected age or death |
| Secondary | Number of Participants With Any Ophthalmologic Diagnosis | 18-22 month corrected age | Any ophthalmologic diagnosis at 18-22 month corrected age |
| Secondary | Number of Participants With Any Ophthalmologic Treatment | 18-22 month corrected age | Any ophthalmologic treatment at 18-22 month corrected age |
| Secondary | Number of Participants With Any Ophthalmologic Surgical Treatment | 18-22 month corrected age | Any ophthalmologic surgical treatment at 18-22 month corrected age |
| Secondary | Number of Participants With Any Ophthalmologic Medical Treatment | 18-22 month corrected age | Any ophthalmologic medical treatment at 18-22 month corrected age |
| Secondary | Number of Participants With Moderate or Severe Neurodevelopmental Impairment at 18-22 Month Corrected Age | 18-22 month corrected age | A composite outcome that measures the occurrence of neurodevelopmental impairment between birth and 18-22 months corrected age. |
| Secondary | Number of Participants With Moderate or Severe Neurodevelopmental Impairment at 18-22 Month Corrected Age or Death | 8-22 months corrected age. | Moderate or Severe NDI defined as occurrence of any of the following: GMFCS level II or higher (severe is level 4 or 5), Bayley III cognitive composite score \< 85 (severe is \<70), Bayley III motor composite score \< 85 (severe is \<70), unilateral blind or bilateral blind, permanent hearing loss that does not permit child to understand directions of the examiner and communicate despite amplification with cochlear implant or hearing aid |
| Secondary | Number of Participants With Moderate or Severe Cerebral Palsy | 18-22 months corrected age. | Cerebral palsy by severity category (absent/mild/moderate/severe). |
| Secondary | Number of Participants With Composite Motor Score Less Than 70 | 18-22 months corrected age | This is measured as a scored of less than 70 on the Bayley Scale of Infant and Toddler Development (BSID)-III composite motor score. Higher scores indicate better performance. |
| Secondary | Number of Participants With Composite Cognitive Score Less Than 70 | 18-22 months corrected age. | This is measured as a score of less than 70 on the Bayley Scale of Infant and Toddler Development (BSID)-III composite cognitive score |
| Secondary | Number of Participants With Severe Hearing Impairment | 18-22 months corrected age. | Defined as permanent hearing loss that does not permit child to understand directions of the examiner and communicate despite amplification with cochlear implant or hearing aid. |
| Secondary | Number of Participants With Severe Vision Loss | 18-22 Months Corrected Age | Vision loss as diagnosed by an ophthalmologist as legally blind, and subdivided into "ophthalmic origin", or "not ophthalmic origin" (i.e., cortical blindness is non-ophthalmic in origin and indicates that there is no retinal detachment or other abnormal fundus or ocular finding, except optic atrophy. Such cases will be considered central \[neurologic\] in origin.) |
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.
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