Page last updated: 2024-10-19

inositol and Infant, Newborn, Diseases

inositol has been researched along with Infant, Newborn, Diseases in 3 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.

Infant, Newborn, Diseases: Diseases of newborn infants present at birth (congenital) or developing within the first month of birth. It does not include hereditary diseases not manifesting at birth or within the first 30 days of life nor does it include inborn errors of metabolism. Both HEREDITARY DISEASES and METABOLISM, INBORN ERRORS are available as general concepts.

Research Excerpts

ExcerptRelevanceReference
"Previous studies of myo-inositol in preterm infants with respiratory distress found reduced severity of retinopathy of prematurity (ROP) and less frequent ROP, death, and intraventricular hemorrhage."9.27Effects of Myo-inositol on Type 1 Retinopathy of Prematurity Among Preterm Infants <28 Weeks' Gestational Age: A Randomized Clinical Trial. ( Ambalavanan, N; Bell, EF; Bremer, DL; Brion, LP; Carlo, WA; Carlton, DP; Chess, PR; Chung, M; Cogen, MS; Colaizy, TT; Cole, CA; Cotten, CM; Das, A; DeMauro, SB; Donahue, JP; Garg, M; Gaynon, M; Graf, A; Haider, KM; Harmon, HM; He, YG; Hibbs, AM; Higgins, RD; Hug, D; Hutchinson, AK; Kennedy, KA; Kicklighter, SD; Kumar, K; Lacy, CB; Lakshminrusimha, S; Laptook, AR; Laughon, MM; Lucas, WR; McGowan, EC; Mintz-Hittner, H; Nolen, TL; Oh, W; Olson, RJ; Orge, FH; Phelps, DL; Poindexter, BB; Quinn, G; Schibler, K; Scorsone, AM; Shankaran, S; Sokol, GM; Truog, WE; Tsui, I; Van Meurs, KP; Wallace, DK; Walsh, MC; Watterberg, KL; Winter, TW; Yang, MB; Zaterka-Baxter, KM, 2018)
"Previous studies of myo-inositol in preterm infants with respiratory distress found reduced severity of retinopathy of prematurity (ROP) and less frequent ROP, death, and intraventricular hemorrhage."5.27Effects of Myo-inositol on Type 1 Retinopathy of Prematurity Among Preterm Infants <28 Weeks' Gestational Age: A Randomized Clinical Trial. ( Ambalavanan, N; Bell, EF; Bremer, DL; Brion, LP; Carlo, WA; Carlton, DP; Chess, PR; Chung, M; Cogen, MS; Colaizy, TT; Cole, CA; Cotten, CM; Das, A; DeMauro, SB; Donahue, JP; Garg, M; Gaynon, M; Graf, A; Haider, KM; Harmon, HM; He, YG; Hibbs, AM; Higgins, RD; Hug, D; Hutchinson, AK; Kennedy, KA; Kicklighter, SD; Kumar, K; Lacy, CB; Lakshminrusimha, S; Laptook, AR; Laughon, MM; Lucas, WR; McGowan, EC; Mintz-Hittner, H; Nolen, TL; Oh, W; Olson, RJ; Orge, FH; Phelps, DL; Poindexter, BB; Quinn, G; Schibler, K; Scorsone, AM; Shankaran, S; Sokol, GM; Truog, WE; Tsui, I; Van Meurs, KP; Wallace, DK; Walsh, MC; Watterberg, KL; Winter, TW; Yang, MB; Zaterka-Baxter, KM, 2018)
"gov ID: Inositol to Reduce Retinopathy of Prematurity Trial: NCT01954082."4.31Relationships between retinopathy of prematurity without ophthalmologic intervention and neurodevelopment and vision at 2 years. ( Adams-Chapman, IS; Bell, EF; Brumbaugh, JE; Colaizy, TT; Crenshaw, EG; DeMauro, SB; Harmon, HM; Hintz, SR; Hirsch, SC; Lowe, JR; Natarajan, G; Vohr, BR; Watterberg, KL; Wyckoff, MH, 2023)

Research

Studies (3)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's2 (66.67)24.3611
2020's1 (33.33)2.80

Authors

AuthorsStudies
Brumbaugh, JE1
Bell, EF2
Hirsch, SC1
Crenshaw, EG1
DeMauro, SB2
Adams-Chapman, IS1
Lowe, JR1
Natarajan, G1
Wyckoff, MH1
Vohr, BR1
Colaizy, TT2
Harmon, HM2
Watterberg, KL2
Hintz, SR1
Phelps, DL1
Nolen, TL1
Cole, CA1
Cotten, CM1
Oh, W1
Poindexter, BB1
Zaterka-Baxter, KM1
Das, A1
Lacy, CB1
Scorsone, AM1
Walsh, MC1
Kennedy, KA1
Schibler, K1
Sokol, GM1
Laughon, MM1
Lakshminrusimha, S1
Truog, WE1
Garg, M1
Carlo, WA1
Laptook, AR1
Van Meurs, KP1
Carlton, DP1
Graf, A1
Brion, LP1
Shankaran, S1
Orge, FH1
Olson, RJ1
Mintz-Hittner, H1
Yang, MB1
Haider, KM1
Wallace, DK1
Chung, M1
Hug, D1
Tsui, I1
Cogen, MS1
Donahue, JP1
Gaynon, M1
Hutchinson, AK1
Bremer, DL1
Quinn, G1
He, YG1
Lucas, WR1
Winter, TW1
Kicklighter, SD1
Kumar, K1
Chess, PR1
Hibbs, AM1
Ambalavanan, N1
McGowan, EC1
Higgins, RD1
Barberini, L1
Noto, A1
Fattuoni, C1
Grapov, D1
Casanova, A1
Fenu, G1
Gaviano, M1
Carboni, R1
Ottonello, G1
Crisafulli, M1
Fanos, V1
Dessì, A1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
INS-3: A Phase 3, Randomized, Double-Masked, Placebo-Controlled Study of the Efficacy and Safety of Myo-Inositol 5% Injection to Increase Survival Without Severe Retinopathy of Prematurity (Reduce-ROP) in Extremely Premature Infants[NCT01954082]Phase 3638 participants (Actual)Interventional2014-04-17Terminated (stopped due to Study terminated due to safety concerns; participant follow up will continue until March 2018)
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

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

InterventionParticipants (Count of Participants)
Myo-Inositol 5% Injection50
5% Glucose(Dextrose)33

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

InterventionParticipants (Count of Participants)
Myo-Inositol 5% Injection171
5% Glucose(Dextrose)183

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

InterventionParticipants (Count of Participants)
Myo-Inositol 5% Injection159
5% Glucose(Dextrose)165

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

InterventionParticipants (Count of Participants)
Myo-Inositol 5% Injection203
5% Glucose(Dextrose)195

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

InterventionParticipants (Count of Participants)
Myo-Inositol 5% Injection51
5% Glucose(Dextrose)50

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

InterventionParticipants (Count of Participants)
Myo-Inositol 5% Injection125
5% Glucose(Dextrose)142

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

InterventionParticipants (Count of Participants)
Myo-Inositol 5% Injection91
5% Glucose(Dextrose)66

Trials

1 trial available for inositol and Infant, Newborn, Diseases

ArticleYear
Effects of Myo-inositol on Type 1 Retinopathy of Prematurity Among Preterm Infants <28 Weeks' Gestational Age: A Randomized Clinical Trial.
    JAMA, 2018, 10-23, Volume: 320, Issue:16

    Topics: Cerebral Intraventricular Hemorrhage; Double-Blind Method; Female; Follow-Up Studies; Gestational Ag

2018

Other Studies

2 other studies available for inositol and Infant, Newborn, Diseases

ArticleYear
Relationships between retinopathy of prematurity without ophthalmologic intervention and neurodevelopment and vision at 2 years.
    Pediatric research, 2023, Volume: 94, Issue:5

    Topics: Child; Gestational Age; Humans; Infant; Infant, Newborn; Infant, Newborn, Diseases; Infant, Prematur

2023
Urinary metabolomics (GC-MS) reveals that low and high birth weight infants share elevated inositol concentrations at birth.
    The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians, 2014, Volume: 27 Suppl 2

    Topics: Biomarkers; Birth Weight; Female; Fetal Growth Retardation; Gas Chromatography-Mass Spectrometry; Ge

2014