| Primary | Population Pharmacokinetics: V - Volume | | All 4 arms of the study are used in the Pop-PK analysis population. 1 infant randomized to the placebo arm incorrectly received the low dose. The infant was included in the low dose arm for the pharmacokinetics analyses and as randomized to the placebo arm for all other analyzes. | Posted | | Mean | Standard Error | l/kg | | 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. | | | | ID | Title | Description |
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| OG000 | PK Population | A population pharmacokinetics (Pop-PK) model was used to combine the serum inositol concentrations measured at the sparse sampling time points described under Time Frame. A 1-compartment multiple-administration intravenous infusion model with linear elimination and an added term for a steady state infusion rate of inositol from feeding and endogenous synthesis. The model is used to estimate typical (fixed effect) values of volume of distribution (V), clearance (Cl) and endogenous infusion rate (R). It is not possible to include separate estimates of the Pop-PK parameters by arm since the same values are used across all arms combined with the dosage of inositol received by an infant applied separately in the Pop-PK model. |
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| Primary | Population Pharmacokinetics: Cl - Clearance | | All 4 arms of the study are used in the Pop-PK analysis population. 1 infant randomized to the placebo arm incorrectly received the low dose. The infant was included in the low dose arm for the pharmacokinetics analyses and as randomized to the placebo arm for all other analyzes. | Posted | | Mean | Standard Error | (l/kg)/h | | 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. | | | | ID | Title | Description |
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| OG000 | PK Population | A population pharmacokinetics (Pop-PK) model was used to combine the serum inositol concentrations measured at the sparse sampling time points described under Time Frame. A 1-compartment multiple-administration intravenous infusion model with linear elimination and an added term for a steady state infusion rate of inositol from feeding and endogenous synthesis. The model is used to estimate typical (fixed effect) values of volume of distribution (V), clearance (Cl) and endogenous infusion rate (R). It is not possible to include separate estimates of the Pop-PK parameters by arm since the same values are used across all arms combined with the dosage of inositol received by an infant applied separately in the Pop-PK model. |
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| Primary | Population Pharmacokinetics: R - Endogenous Infusion Rate | | All 4 arms of the study are used in the Pop-PK analysis population. 1 infant randomized to the placebo arm incorrectly received the low dose. The infant was included in the low dose arm for the pharmacokinetics analyses and as randomized to the placebo arm for all other analyzes. | Posted | | Mean | Standard Error | (mg/kg)/h | | 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. | | | | ID | Title | Description |
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| OG000 | PK Population | A population pharmacokinetics (Pop-PK) model was used to combine the serum inositol concentrations measured at the sparse sampling time points described under Time Frame. A 1-compartment multiple-administration intravenous infusion model with linear elimination and an added term for a steady state infusion rate of inositol from feeding and endogenous synthesis. The model is used to estimate typical (fixed effect) values of volume of distribution (V), clearance (Cl) and endogenous infusion rate (R). It is not possible to include separate estimates of the Pop-PK parameters by arm since the same values are used across all arms combined with the dosage of inositol received by an infant applied separately in the Pop-PK model. |
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| Primary | Population Pharmacokinetics: k - Elimination Rate (Cl/V) | | All 4 arms of the study are used in the Pop-PK analysis population. 1 infant randomized to the placebo arm incorrectly received the low dose. The infant was included in the low dose arm for the pharmacokinetics analyses and as randomized to the placebo arm for all other analyzes. | Posted | | Mean | Standard Error | liter/hour | | 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. | | | | ID | Title | Description |
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| OG000 | PK Population | A population pharmacokinetics (Pop-PK) model was used to combine the serum inositol concentrations measured at the sparse sampling time points described under Time Frame. A 1-compartment multiple-administration intravenous infusion model with linear elimination and an added term for a steady state infusion rate of inositol from feeding and endogenous synthesis. The model is used to estimate typical (fixed effect) values of volume of distribution (V), clearance (Cl) and endogenous infusion rate (R). It is not possible to include separate estimates of the Pop-PK parameters by arm since the same values are used across all arms combined with the dosage of inositol received by an infant applied separately in the Pop-PK model. |
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| Primary | Population Pharmacokinetics: t1/2 - Half-Life (0.693/k) | | All 4 arms of the study are used in the Pop-PK analysis population. 1 infant randomized to the placebo arm incorrectly received the low dose. The infant was included in the low dose arm for the pharmacokinetics analyses and as randomized to the placebo arm for all other analyzes. | Posted | | Mean | Standard Error | hour | | 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. | | | | ID | Title | Description |
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| OG000 | PK Population | A population pharmacokinetics (Pop-PK) model was used to combine the serum inositol concentrations measured at the sparse sampling time points described under Time Frame. A 1-compartment multiple-administration intravenous infusion model with linear elimination and an added term for a steady state infusion rate of inositol from feeding and endogenous synthesis. The model is used to estimate typical (fixed effect) values of volume of distribution (V), clearance (Cl) and endogenous infusion rate (R). It is not possible to include separate estimates of the Pop-PK parameters by arm since the same values are used across all arms combined with the dosage of inositol received by an infant applied separately in the Pop-PK model. |
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| Primary | Population Pharmacokinetics: E - Concentration Due to Endogenous Infusion (R/Cl) | | All 4 arms of the study are used in the Pop-PK analysis population. 1 infant randomized to the placebo arm incorrectly received the low dose. The infant was included in the low dose arm for the pharmacokinetics analyses and as randomized to the placebo arm for all other analyzes. | Posted | | Mean | Standard Error | miligrams/liter | | 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. | | | | ID | Title | Description |
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| OG000 | PK Population | A population pharmacokinetics (Pop-PK) model was used to combine the serum inositol concentrations measured at the sparse sampling time points described under Time Frame. A 1-compartment multiple-administration intravenous infusion model with linear elimination and an added term for a steady state infusion rate of inositol from feeding and endogenous synthesis. The model is used to estimate typical (fixed effect) values of volume of distribution (V), clearance (Cl) and endogenous infusion rate (R). It is not possible to include separate estimates of the Pop-PK parameters by arm since the same values are used across all arms combined with the dosage of inositol received by an infant applied separately in the Pop-PK model. |
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| Primary | SD of Residual Error (mg/l) | | All 4 arms of the study are used in the Pop-PK analysis population. 1 infant randomized to the placebo arm incorrectly received the low dose. The infant was included in the low dose arm for the pharmacokinetics analyses and as randomized to the placebo arm for all other analyzes. | Posted | | Mean | Standard 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. | | | | ID | Title | Description |
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| OG000 | PK Population | A population pharmacokinetics (Pop-PK) model was used to combine the serum inositol concentrations measured at the sparse sampling time points described under Time Frame. A 1-compartment multiple-administration intravenous infusion model with linear elimination and an added term for a steady state infusion rate of inositol from feeding and endogenous synthesis. The model is used to estimate typical (fixed effect) values of volume of distribution (V), clearance (Cl) and endogenous infusion rate (R). It is not possible to include separate estimates of the Pop-PK parameters by arm since the same values are used across all arms combined with the dosage of inositol received by an infant applied separately in the Pop-PK model. |
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| Secondary | Number of Participants With Any Retinopathy of Prematurity (ROP) | Any ROP is defined as ROP of any severity that is observed at 18-22 month corrected age | | Posted | | Count of Participants | | Participants | | 18-22 month corrected age | | | | ID | Title | Description |
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| OG000 | Inositol Low Volume | 10 mg/kg/day Intravenous inositol 5% Inositol lower volume: 5 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG001 | Inositol Mid-level Volume | 40 mg/kg/day Intravenous inositol 5% Inositol mid-level volume: 20 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG002 | Inositol High Volume | 80 mg/kg/day Intravenous inositol 5% Inositol high volume: 40 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG003 | Placebo | Glucose 5% given in volumes equal to that of the comparator drug Placebo low volume: Glucose 5% given in volumes equal to that of the comparator drug |
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| Secondary | Number of Participants With Any Retinopathy of Prematurity Through 18-22 Month Corrected Age or Death | Number of participants with any Retinopathy of Prematurity (ROP) through 18-22 month corrected age or death | | Posted | | Count of Participants | | Participants | | 18-22 month corrected age | | | | ID | Title | Description |
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| OG000 | Inositol Low Volume | 10 mg/kg/day Intravenous inositol 5% Inositol lower volume: 5 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG001 | Inositol Mid-level Volume | 40 mg/kg/day Intravenous inositol 5% Inositol mid-level volume: 20 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG002 | Inositol High Volume | 80 mg/kg/day Intravenous inositol 5% Inositol high volume: 40 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG003 | Placebo | Glucose 5% given in volumes equal to that of the comparator drug Placebo low volume: Glucose 5% given in volumes equal to that of the comparator drug |
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| Secondary | Number of Participants With Any Ophthalmologic Diagnosis | Any ophthalmologic diagnosis at 18-22 month corrected age | | Posted | | Count of Participants | | Participants | | 18-22 month corrected age | | | | ID | Title | Description |
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| OG000 | Inositol Low Volume | 10 mg/kg/day Intravenous inositol 5% Inositol lower volume: 5 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG001 | Inositol Mid-level Volume | 40 mg/kg/day Intravenous inositol 5% Inositol mid-level volume: 20 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG002 | Inositol High Volume | 80 mg/kg/day Intravenous inositol 5% Inositol high volume: 40 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG003 | Placebo | Glucose 5% given in volumes equal to that of the comparator drug Placebo low volume: Glucose 5% given in volumes equal to that of the comparator drug |
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| Secondary | Number of Participants With Any Ophthalmologic Treatment | Any ophthalmologic treatment at 18-22 month corrected age | | Posted | | Count of Participants | | Participants | | 18-22 month corrected age | | | | ID | Title | Description |
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| OG000 | Inositol Low Volume | 10 mg/kg/day Intravenous inositol 5% Inositol lower volume: 5 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG001 | Inositol Mid-level Volume | 40 mg/kg/day Intravenous inositol 5% Inositol mid-level volume: 20 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG002 | Inositol High Volume | 80 mg/kg/day Intravenous inositol 5% Inositol high volume: 40 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG003 | Placebo | Glucose 5% given in volumes equal to that of the comparator drug Placebo low volume: Glucose 5% given in volumes equal to that of the comparator drug |
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| Secondary | Number of Participants With Any Ophthalmologic Surgical Treatment | Any ophthalmologic surgical treatment at 18-22 month corrected age | | Posted | | Count of Participants | | Participants | | 18-22 month corrected age | | | | ID | Title | Description |
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| OG000 | Inositol Low Volume | 10 mg/kg/day Intravenous inositol 5% Inositol lower volume: 5 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG001 | Inositol Mid-level Volume | 40 mg/kg/day Intravenous inositol 5% Inositol mid-level volume: 20 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG002 | Inositol High Volume | 80 mg/kg/day Intravenous inositol 5% Inositol high volume: 40 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG003 | Placebo | Glucose 5% given in volumes equal to that of the comparator drug Placebo low volume: Glucose 5% given in volumes equal to that of the comparator drug |
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| Secondary | Number of Participants With Any Ophthalmologic Medical Treatment | Any ophthalmologic medical treatment at 18-22 month corrected age | | Posted | | Count of Participants | | Participants | | 18-22 month corrected age | | | | ID | Title | Description |
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| OG000 | Inositol Low Volume | 10 mg/kg/day Intravenous inositol 5% Inositol lower volume: 5 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG001 | Inositol Mid-level Volume | 40 mg/kg/day Intravenous inositol 5% Inositol mid-level volume: 20 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG002 | Inositol High Volume | 80 mg/kg/day Intravenous inositol 5% Inositol high volume: 40 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG003 | Placebo | Glucose 5% given in volumes equal to that of the comparator drug Placebo low volume: Glucose 5% given in volumes equal to that of the comparator drug |
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| Secondary | Number of Participants With Moderate or Severe Neurodevelopmental Impairment at 18-22 Month Corrected Age | A composite outcome that measures the occurrence of neurodevelopmental impairment between birth and 18-22 months corrected age. | | Posted | | Count of Participants | | Participants | | 18-22 month corrected age | | | | ID | Title | Description |
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| OG000 | Inositol Low Volume | 10 mg/kg/day Intravenous inositol 5% Inositol lower volume: 5 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG001 | Inositol Mid-level Volume | 40 mg/kg/day Intravenous inositol 5% Inositol mid-level volume: 20 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG002 | Inositol High Volume | 80 mg/kg/day Intravenous inositol 5% Inositol high volume: 40 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG003 | Placebo | Glucose 5% given in volumes equal to that of the comparator drug Placebo low volume: Glucose 5% given in volumes equal to that of the comparator drug |
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| Secondary | Number of Participants With Moderate or Severe Neurodevelopmental Impairment at 18-22 Month Corrected Age or Death | 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 | | Posted | | Count of Participants | | Participants | | 8-22 months corrected age. | | | | ID | Title | Description |
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| OG000 | Inositol Low Volume | 10 mg/kg/day Intravenous inositol 5% Inositol lower volume: 5 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG001 | Inositol Mid-level Volume | 40 mg/kg/day Intravenous inositol 5% Inositol mid-level volume: 20 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG002 | Inositol High Volume | 80 mg/kg/day Intravenous inositol 5% Inositol high volume: 40 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes |
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| Secondary | Number of Participants With Moderate or Severe Cerebral Palsy | Cerebral palsy by severity category (absent/mild/moderate/severe). | | Posted | | Count of Participants | | Participants | | 18-22 months corrected age. | | | | ID | Title | Description |
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| OG000 | Inositol Low Volume | 10 mg/kg/day Intravenous inositol 5% Inositol lower volume: 5 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG001 | Inositol Mid-level Volume | 40 mg/kg/day Intravenous inositol 5% Inositol mid-level volume: 20 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG002 | Inositol High Volume | 80 mg/kg/day Intravenous inositol 5% Inositol high volume: 40 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG003 | Placebo | Glucose 5% given in volumes equal to that of the comparator drug Placebo low volume: Glucose 5% given in volumes equal to that of the comparator drug |
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| Secondary | Number of Participants With Composite Motor Score Less Than 70 | 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. | | Posted | | Count of Participants | | Participants | | 18-22 months corrected age | | | | ID | Title | Description |
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| OG000 | Inositol Low Volume | 10 mg/kg/day Intravenous inositol 5% Inositol lower volume: 5 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG001 | Inositol Mid-level Volume | 40 mg/kg/day Intravenous inositol 5% Inositol mid-level volume: 20 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG002 | Inositol High Volume | 80 mg/kg/day Intravenous inositol 5% Inositol high volume: 40 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG003 | Placebo | Glucose 5% given in volumes equal to that of the comparator drug Placebo low volume: Glucose 5% given in volumes equal to that of the comparator drug |
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| Secondary | Number of Participants With Composite Cognitive Score Less Than 70 | This is measured as a score of less than 70 on the Bayley Scale of Infant and Toddler Development (BSID)-III composite cognitive score | | Posted | | Count of Participants | | Participants | | 18-22 months corrected age. | | | | ID | Title | Description |
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| OG000 | Inositol Low Volume | 10 mg/kg/day Intravenous inositol 5% Inositol lower volume: 5 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG001 | Inositol Mid-level Volume | 40 mg/kg/day Intravenous inositol 5% Inositol mid-level volume: 20 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG002 | Inositol High Volume | 80 mg/kg/day Intravenous inositol 5% Inositol high volume: 40 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG003 | Placebo | Glucose 5% given in volumes equal to that of the comparator drug Placebo low volume: Glucose 5% given in volumes equal to that of the comparator drug |
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| Secondary | Number of Participants With Severe Hearing Impairment | 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. | | Posted | | Count of Participants | | Participants | | 18-22 months corrected age. | | | | ID | Title | Description |
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| OG000 | Inositol Low Volume | 10 mg/kg/day Intravenous inositol 5% Inositol lower volume: 5 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG001 | Inositol Mid-level Volume | 40 mg/kg/day Intravenous inositol 5% Inositol mid-level volume: 20 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG002 | Inositol High Volume | 80 mg/kg/day Intravenous inositol 5% Inositol high volume: 40 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG003 | Placebo | Glucose 5% given in volumes equal to that of the comparator drug Placebo low volume: Glucose 5% given in volumes equal to that of the comparator drug |
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| Secondary | Number of Participants With Severe Vision Loss | 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.) | | Posted | | Count of Participants | | Participants | | 18-22 Months Corrected Age | | | | ID | Title | Description |
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| OG000 | Inositol Low Volume | 10 mg/kg/day Intravenous inositol 5% Inositol lower volume: 5 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG001 | Inositol Mid-level Volume | 40 mg/kg/day Intravenous inositol 5% Inositol mid-level volume: 20 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG002 | Inositol High Volume | 80 mg/kg/day Intravenous inositol 5% Inositol high volume: 40 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG003 | Placebo |
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| Secondary | Number of Participants With Gross Motor Function Greater Than or Equal to 2 | A Gross Motor Function Classification System (GMFCS) level of at least II (on a scale from level I to V, with I indicating normal gross motor function and higher levels indicating greater impairment). Level II is defined as Infants maintain floor sitting but may need to use their hands for support to maintain balance. Infants creep on their stomach or crawl on hands and knees with reciprocal leg movement. Infants may pull to stand and take steps holding on to furniture.) | | Posted | | Count of Participants | | Participants | | 18 -22 months corrected age | | | | ID | Title | Description |
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| OG000 | Inositol Low Volume | 10 mg/kg/day Intravenous inositol 5% Inositol lower volume: 5 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG001 | Inositol Mid-level Volume | 40 mg/kg/day Intravenous inositol 5% Inositol mid-level volume: 20 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes | | OG002 | Inositol High Volume | 80 mg/kg/day Intravenous inositol 5% Inositol high volume: 40 mg/kg/dose inositol every 12 hours, given intravenously over 20 minutes |
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