Page last updated: 2024-10-19

inositol and Bronchopulmonary Dysplasia

inositol has been researched along with Bronchopulmonary Dysplasia in 6 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.

Bronchopulmonary Dysplasia: A chronic lung disease developed after OXYGEN INHALATION THERAPY or mechanical ventilation (VENTILATION, MECHANICAL) usually occurring in certain premature infants (INFANT, PREMATURE) or newborn infants with respiratory distress syndrome (RESPIRATORY DISTRESS SYNDROME, NEWBORN). Histologically, it is characterized by the unusual abnormalities of the bronchioles, such as METAPLASIA, decrease in alveolar number, and formation of CYSTS.

Research Excerpts

ExcerptRelevanceReference
"Preterm infants with respiratory distress syndrome (RDS) given inositol had reduced bronchopulmonary dysplasia (BPD), death and severe retinopathy of prematurity (ROP)."5.22Safety and pharmacokinetics of multiple dose myo-inositol in preterm infants. ( Ball, MB; Bell, EF; Carlo, WA; Carlton, DP; Chess, PR; Cotten, CM; Das, A; Ehrenkranz, RA; Faix, RG; Fennell, T; Frantz, ID; Goedecke, M; Hallman, M; Higgins, RD; Lacy, CB; Nolen, TL; Oh, W; Phelps, DL; Poindexter, BB; Sánchez, PJ; Shankaran, S; Walsh, MC; Ward, RM; Watterberg, KL; Williams, RL; Zaterka-Baxter, KM, 2016)
"The administration of inositol to premature infants with respiratory distress syndrome who are receiving parenteral nutrition during the first week of life is associated with increased survival without bronchopulmonary dysplasia and with a decreased incidence of retinopathy of prematurity."5.07Inositol supplementation in premature infants with respiratory distress syndrome. ( Bry, K; Hallman, M; Hoppu, K; Lappi, M; Pohjavuori, M, 1992)
"To assess the effectiveness and safety of supplementary inositol in preterm infants with or without respiratory distress syndrome (RDS) in reducing adverse neonatal outcomes including: death (neonatal and infant deaths), bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP), intraventricular haemorrhage (IVH), periventricular leukomalacia (PVL), necrotizing enterocolitis (NEC) and sepsis."5.01Inositol in preterm infants at risk for or having respiratory distress syndrome. ( Howlett, A; Ohlsson, A; Plakkal, N, 2019)

Research

Studies (6)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's1 (16.67)18.2507
2000's2 (33.33)29.6817
2010's3 (50.00)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Howlett, A1
Ohlsson, A1
Plakkal, N1
Phelps, DL1
Ward, RM1
Williams, RL1
Nolen, TL1
Watterberg, KL1
Oh, W1
Goedecke, M1
Ehrenkranz, RA1
Fennell, T1
Poindexter, BB1
Cotten, CM1
Hallman, M2
Frantz, ID1
Faix, RG1
Zaterka-Baxter, KM1
Das, A1
Ball, MB1
Lacy, CB1
Walsh, MC1
Carlo, WA1
Sánchez, PJ1
Bell, EF1
Shankaran, S1
Carlton, DP1
Chess, PR1
Higgins, RD1
Ma, L1
Zhou, P1
Neu, J1
Lin, HC1
Van Marter, LJ1
Atkinson, SA1
Bry, K1
Hoppu, K1
Lappi, M1
Pohjavuori, M1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Phase II Randomized, Double-Masked, Placebo-Controlled, Safety, Pharmacokinetic, and Dose-Ranging Study of Multiple Doses of Inositol in Premature Infants[NCT01030575]Phase 2125 participants (Actual)Interventional2010-01-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Number of Participants With Any Ophthalmologic Diagnosis

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

InterventionParticipants (Count of Participants)
Inositol Low Volume9
Inositol Mid-level Volume6
Inositol High Volume10
Placebo5

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

InterventionParticipants (Count of Participants)
Inositol Low Volume2
Inositol Mid-level Volume1
Inositol High Volume1
Placebo2

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

InterventionParticipants (Count of Participants)
Inositol Low Volume3
Inositol Mid-level Volume4
Inositol High Volume0
Placebo4

Number of Participants With Any Ophthalmologic Treatment

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

InterventionParticipants (Count of Participants)
Inositol Low Volume4
Inositol Mid-level Volume4
Inositol High Volume2
Placebo5

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

InterventionParticipants (Count of Participants)
Inositol Low Volume11
Inositol Mid-level Volume11
Inositol High Volume14
Placebo12

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

InterventionParticipants (Count of Participants)
Inositol Low Volume13
Inositol Mid-level Volume17
Inositol High Volume15
Placebo18

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.

InterventionParticipants (Count of Participants)
Inositol Low Volume0
Inositol Mid-level Volume1
Inositol High Volume1
Placebo2

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

InterventionParticipants (Count of Participants)
Inositol Low Volume1
Inositol Mid-level Volume1
Inositol High Volume2
Placebo6

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

InterventionParticipants (Count of Participants)
Inositol Low Volume0
Inositol Mid-level Volume2
Inositol High Volume3
Placebo4

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.

InterventionParticipants (Count of Participants)
Inositol Low Volume0
Inositol Mid-level Volume1
Inositol High Volume1
Placebo2

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

InterventionParticipants (Count of Participants)
Inositol Low Volume8
Inositol Mid-level Volume9
Inositol High Volume11
Placebo13

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.

InterventionParticipants (Count of Participants)
Inositol Low Volume10
Inositol Mid-level Volume15
Inositol High Volume13
Placebo20

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.

InterventionParticipants (Count of Participants)
Inositol Low Volume0
Inositol Mid-level Volume0
Inositol High Volume0
Placebo0

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

InterventionParticipants (Count of Participants)
Inositol Low Volume0
Inositol Mid-level Volume0
Inositol High Volume0
Placebo0

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.

Intervention(l/kg)/h (Mean)
PK Population0.0577

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.

Interventionmiligrams/liter (Mean)
PK Population41.06

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.

Interventionliter/hour (Mean)
PK Population0.0878

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.

Intervention(mg/kg)/h (Mean)
PK Population2.369

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.

Interventionhour (Mean)
PK Population7.90

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.

Interventionl/kg (Mean)
PK Population0.6572

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.

Interventionmg/l (Mean)
PK Population24.77

Reviews

4 reviews available for inositol and Bronchopulmonary Dysplasia

ArticleYear
Inositol in preterm infants at risk for or having respiratory distress syndrome.
    The Cochrane database of systematic reviews, 2019, 07-08, Volume: 7

    Topics: Bronchopulmonary Dysplasia; Dietary Supplements; Enterocolitis, Necrotizing; Humans; Infant, Newborn

2019
Potential Nutrients for Preventing or Treating Bronchopulmonary Dysplasia.
    Paediatric respiratory reviews, 2017, Volume: 22

    Topics: Acetylcysteine; Antioxidants; Arginine; Bronchopulmonary Dysplasia; Citrulline; Cysteine; Fatty Acid

2017
Strategies for preventing bronchopulmonary dysplasia.
    Current opinion in pediatrics, 2005, Volume: 17, Issue:2

    Topics: Adrenal Cortex Hormones; Antioxidants; Bronchopulmonary Dysplasia; Continuous Positive Airway Pressu

2005
Special nutritional needs of infants for prevention of and recovery from bronchopulmonary dysplasia.
    The Journal of nutrition, 2001, Volume: 131, Issue:3

    Topics: Bronchopulmonary Dysplasia; Calcification, Physiologic; Dexamethasone; Dietary Supplements; Fatty Ac

2001

Trials

2 trials available for inositol and Bronchopulmonary Dysplasia

ArticleYear
Safety and pharmacokinetics of multiple dose myo-inositol in preterm infants.
    Pediatric research, 2016, Volume: 80, Issue:2

    Topics: Bronchopulmonary Dysplasia; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; I

2016
Inositol supplementation in premature infants with respiratory distress syndrome.
    The New England journal of medicine, 1992, May-07, Volume: 326, Issue:19

    Topics: Bronchopulmonary Dysplasia; Double-Blind Method; Enteral Nutrition; Female; Follow-Up Studies; Gesta

1992