inositol and Retinopathy of Prematurity

inositol has been researched along with Retinopathy of Prematurity in 7 studies

Inositol: An isomer of glucose that has traditionally been considered to be a B vitamin although it has an uncertain status as a vitamin and a deficiency syndrome has not been identified in man. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1379) Inositol phospholipids are important in signal transduction.
inositol : Any cyclohexane-1,2,3,4,5,6-hexol.
1D-chiro-inositol : Belonging to the inositol family of compounds, D-chiro-inositol (DCI) is an isomer of glucose. It is an important secondary messenger in insulin signal transduction.
muco-inositol : An inositol that is cyclohexane-1,2,3,4,5,6-hexol having a (1R,2R,3r,4R,5S,6r)-configuration.

Retinopathy of Prematurity: A bilateral retinopathy occurring in premature infants treated with excessively high concentrations of oxygen, characterized by vascular dilatation, proliferation, and tortuosity, edema, and retinal detachment, with ultimate conversion of the retina into a fibrous mass that can be seen as a dense retrolental membrane. Usually growth of the eye is arrested and may result in microophthalmia, and blindness may occur. (Dorland, 27th ed)

Research

Studies (7)

Authors

Clinical Trials (2)

Trial Overview

Trial Outcomes

Number of Participants With All Cause Death Before Retinopathy of Prematurity (ROP) Endpoint

Defined as death from any cause following randomization through primary study follow-up (up to 55 weeks postmenstrual age (PMA)) (NCT01954082)
Timeframe: by 55 weeks PMA age

Number of Participants With Any Retinopathy of Prematurity (ROP)

ROP was identified by routine ophthalmologic examinations beginning at the latter of 31 weeks PMA or 4-6 weeks chronologic age. Any ROP is defined as ROP of any severity that is observed on at least 2 independent examinations in either eye through the time that Acute/Final ROP status is reached (up to 55 weeks postmenstrual age (PMA)). (NCT01954082)
Timeframe: by 55 weeks PMA

Number of Participants With Bronchopulmonary Dysplasia (BPD)

BPD is defined as supplemental oxygen required to maintain an oxygenation saturation of >90% at 36 weeks postmenstrual age (PMA) (NICHD physiologic definition). (NCT01954082)
Timeframe: 36 weeks PMA

Number of Participants With Bronchopulmonary Dysplasia (BPD) or Death From BPD

BPD is defined as supplemental oxygen required to maintain an oxygenation saturation of >90% at 36 weeks PMA (NICHD physiologic definition). Death from BPD prior to 37 weeks postmenstrual age (PMA) is defined when the cause of death is certified by the Center PI as BPD being the primary cause, or a significant co-contributing cause of death. (NCT01954082)
Timeframe: prior to 37 weeks PMA

Number of Participants With Severe Intraventricular Hemorrhage (IVH)

Severe IVH is defined as IVH Grades 3 or 4 on either side of the brain. The evaluation for IVH occurs early (within 28 days from birth) via a cranial sonogram and is classified as described by Papile. (NCT01954082)
Timeframe: by 28 days PMA

Number of Participants With Type 2 or More Severe Retinopathy of Prematurity (ROP)

Defined as one or both eyes reaching Type 2 ROP (ETROP 2003) or the more severe Type 1 ROP (as defined previously) through the time that Acute/Final ROP status is reached (up to 55 weeks postmenstrual age (PMA)). Type 2 ROP is defined as (ETROP 2003): Stage 3 ROP without Plus Disease (i.e. Zone II) or Stage 1 or 2 ROP without Plus Disease (i.e. Zone I). (NCT01954082)
Timeframe: by 55 weeks PMA

Number of Participants With Unfavorable Outcome, Defined as Severe Retinopathy of Prematurity (ROP) or Death Prior to Reaching Acute/Final ROP Status

Death is defined as from any cause before Acute/Final ROP status is determined. ROP was identified by routine ophthalmologic examinations beginning at the latter of 31 weeks PMA or 4-6 weeks chronologic age. The favorable ROP endpoint requires that no ROP, or only mild ROP has occurred in both eyes and the eyes have matured beyond the risk of developing Type 1 ROP (severity meeting criteria for surgical intervention). The unfavorable ROP endpoint requires that one or both eyes reach Type 1 ROP. When ROP did not resolve by the time of discharge, participants were followed as outpatients until reaching an ROP endpoint, up to 55 weeks PMA. Since incomplete follow up is more likely among participants with mild or no ROP than for those with aggressive ROP, an independent adjudication process assigned an ROP endpoint of 'most likely never had Type 1 ROP', or 'most likely developed Type 1 ROP' based on clinical and ROP data review to reduce possible missing data bias. (NCT01954082)
Timeframe: by 55 weeks PMA

Number of Participants With Any Ophthalmologic Diagnosis

Any ophthalmologic diagnosis at 18-22 month corrected age (NCT01030575)
Timeframe: 18-22 month corrected age

Number of Participants With Any Ophthalmologic Medical Treatment

Any ophthalmologic medical treatment at 18-22 month corrected age (NCT01030575)
Timeframe: 18-22 month corrected age

Number of Participants With Any Ophthalmologic Surgical Treatment

Any ophthalmologic surgical treatment at 18-22 month corrected age (NCT01030575)
Timeframe: 18-22 month corrected age

Number of Participants With Any Ophthalmologic Treatment

Any ophthalmologic treatment at 18-22 month corrected age (NCT01030575)
Timeframe: 18-22 month corrected age

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 (NCT01030575)
Timeframe: 18-22 month corrected age

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 (NCT01030575)
Timeframe: 18-22 month corrected age

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 (NCT01030575)
Timeframe: 18-22 months corrected age.

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. (NCT01030575)
Timeframe: 18-22 months corrected age

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.) (NCT01030575)
Timeframe: 18 -22 months corrected age

Number of Participants With Moderate or Severe Cerebral Palsy

Cerebral palsy by severity category (absent/mild/moderate/severe). (NCT01030575)
Timeframe: 18-22 months corrected age.

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. (NCT01030575)
Timeframe: 18-22 month corrected age

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 (NCT01030575)
Timeframe: 8-22 months corrected age.

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. (NCT01030575)
Timeframe: 18-22 months corrected age.

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.)" (NCT01030575)
Timeframe: 18-22 Months Corrected Age

Population Pharmacokinetics: Cl - Clearance

(NCT01030575)
Timeframe: 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.

Population Pharmacokinetics: E - Concentration Due to Endogenous Infusion (R/Cl)

(NCT01030575)
Timeframe: 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.

Population Pharmacokinetics: k - Elimination Rate (Cl/V)

(NCT01030575)
Timeframe: 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.

Population Pharmacokinetics: R - Endogenous Infusion Rate

(NCT01030575)
Timeframe: 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.

Population Pharmacokinetics: t1/2 - Half-Life (0.693/k)

(NCT01030575)
Timeframe: 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.

Population Pharmacokinetics: V - Volume

(NCT01030575)
Timeframe: 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.

SD of Residual Error (mg/l)

(NCT01030575)
Timeframe: 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.

Reviews

2 reviews available for inositol and Retinopathy of Prematurity

Trials

3 trials available for inositol and Retinopathy of Prematurity

Other Studies

2 other studies available for inositol and Retinopathy of Prematurity