Trial · NCT01030575
Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2)
NCT01030575, Phase 2, Completed, NICHD Neonatal Research Network; results first posted 2021-03-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2). Trials, record NCT01030575. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01030575
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2)
- NCT number
- NCT01030575
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 125 participants, actual
- Lead sponsor
- NICHD Neonatal Research Network
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Retinopathy of Prematurity, Bronchopulmonary Dysplasia (BPD)
- Interventions
- Inositol lower volume, Inositol mid-level volume, Inositol high volume, Placebo low volume
- First posted
- 2009-12-11
- Last updated
- 2022-06-14
- Results first posted
- 2021-03-12
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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. | 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. | l/kg | MEAN |
| 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. | 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. | (l/kg)/h | MEAN |
| 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. | 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. | (mg/kg)/h | MEAN |
| 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. | 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. | liter/hour | MEAN |
| 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. | 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. | hour | MEAN |
| 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. | 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. | miligrams/liter | MEAN |
| 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. | 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. | mg/l | MEAN |
| SECONDARY | Number of Participants With Any Retinopathy of Prematurity (ROP) | 18-22 month corrected age | ITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any Retinopathy of Prematurity Through 18-22 Month Corrected Age or Death | 18-22 month corrected age | ITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any Ophthalmologic Diagnosis | 18-22 month corrected age | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group63
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Population Pharmacokinetics: V - Volume | PK Population | 0.6572 | Standard Error 0.0707 | l/kg | |
| Population Pharmacokinetics: Cl - Clearance | PK Population | 0.0577 | Standard Error 0.0061 | (l/kg)/h | |
| Population Pharmacokinetics: R - Endogenous Infusion Rate | PK Population | 2.369 | Standard Error 0.3151 | (mg/kg)/h | |
| Population Pharmacokinetics: k - Elimination Rate (Cl/V) | PK Population | 0.0878 | Standard Error 0.0137 | liter/hour | |
| Population Pharmacokinetics: t1/2 - Half-Life (0.693/k) | PK Population | 7.90 | Standard Error 1.229 | hour | |
| Population Pharmacokinetics: E - Concentration Due to Endogenous Infusion (R/Cl) | PK Population | 41.06 | Standard Error 1.777 | miligrams/liter | |
| SD of Residual Error (mg/l) | PK Population | 24.77 | Standard Error 0.971 | mg/l | |
| Number of Participants With Any Retinopathy of Prematurity (ROP) | Inositol Low Volume | 11 | Participants | ||
| Number of Participants With Any Retinopathy of Prematurity (ROP) | Inositol Mid-level Volume | 11 | Participants | ||
| Number of Participants With Any Retinopathy of Prematurity (ROP) | Inositol High Volume | 14 | Participants |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Inositol Low Volume | 29 | |
| Overall Study | STARTED | Inositol Mid-level Volume | 30 | |
| Overall Study | STARTED | Inositol High Volume | 28 | |
| Overall Study | STARTED | Placebo | 35 | |
| Overall Study | COMPLETED | Inositol Low Volume | 29 | |
| Overall Study | COMPLETED | Inositol Mid-level Volume | 30 | |
| Overall Study | COMPLETED | Inositol High Volume | 28 | |
| Overall Study | COMPLETED | Placebo | 35 | |
| Overall Study | NOT COMPLETED | Inositol Low Volume | 0 | |
| Overall Study | NOT COMPLETED | Inositol Mid-level Volume | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events164
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Congestive heart failure | Cardiac disorders | Inositol Low Volume | 0 | 29 | |
| other | Congestive heart failure | Cardiac disorders | Inositol Mid-level Volume | 1 | 30 | |
| other | Congestive heart failure | Cardiac disorders | Inositol High Volume | 0 | 28 | |
| other | Congestive heart failure | Cardiac disorders | Placebo | 0 | 35 | |
| other | Hypertension | Cardiac disorders | Inositol Low Volume | 4 | 29 | |
| other | Hypertension | Cardiac disorders | Inositol Mid-level Volume | 3 | 30 | |
| other | Hypertension | Cardiac disorders | Inositol High Volume | 4 | 28 | |
| other | Hypertension | Cardiac disorders | Placebo | 5 | 35 | |
| other | Poor perfusion or hypotension | Cardiac disorders | Inositol Low Volume | 3 | 29 | |
| other | Poor perfusion or hypotension | Cardiac disorders | Inositol Mid-level Volume | 2 | 30 |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Inositol Low Volume | 2 | 29 |
| Total, all-cause mortality | Inositol Mid-level Volume | 5 | 30 |
| Total, all-cause mortality | Inositol High Volume | 1 | 28 |
| Total, all-cause mortality | Placebo | 6 | 35 |
| Total, other adverse events | Inositol Low Volume | 24 | 29 |
| Total, other adverse events | Inositol Mid-level Volume | 20 | 30 |
| Total, other adverse events | Inositol High Volume | 19 | 28 |
| Total, other adverse events | Placebo | 24 | 35 |
| Total, serious adverse events | Inositol Low Volume | 17 | 29 |
| Total, serious adverse events | Inositol Mid-level Volume | 20 | 30 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27074126 | RESULT |
Source PubMed
Grants21
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10HD036790 | Neonatal Research Network Data Coordinating Center (DCC) | DAS, ABHIK | RESEARCH TRIANGLE INSTITUTE | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2008 to 2017 | NIH RePORTER |
| U10HD021364 | Multicenter Network of Neonatal Intensive Care Units | WALSH, MICHELE | CASE WESTERN RESERVE UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1991 to 2015 | NIH RePORTER |
| U10HD021373 | Multicenter Network of Neonatal Intensive Care Units | KENNEDY, KATHLEEN A | UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1991 to 2015 | NIH RePORTER |
| U10HD021385 | Cooperative Multicenter Network of Neontal Intensive Care Units | SHANKARAN, SEETHA | WAYNE STATE UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1991 to 2015 | NIH RePORTER |
| U10HD027851 | Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal Research Network | CARLTON, DAVID | EMORY UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1991 to 2015 | NIH RePORTER |
| U10HD027853 | NICHD Cooperative Multicenter Neonatal Research Network | SCHIBLER, KURT R | CINCINNATI CHILDRENS HOSP MED CTR | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1991 to 2015 | NIH RePORTER |
| U10HD027856 | Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal Research Network | SOKOL, GREGORY M. | INDIANA UNIVERSITY INDIANAPOLIS | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1991 to 2015 | NIH RePORTER |
| U10HD027880 | NICHD Cooperative Multicenter Neonatal Research Network | VAN MEURS, KRISA PAGE | STANFORD UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1991 to 2015 | NIH RePORTER |
| U10HD027904 | NICHD Cooperative Multicenter Neonatal Research Network | LAPTOOK, ABBOT R | WOMEN AND INFANTS HOSPITAL-RHODE ISLAND | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1991 to 2015 | NIH RePORTER |
| U10HD034216 | Cooperative Multicenter Neonatal Research Network - UAB | CARLO FONT, WALDEMAR A. | UNIVERSITY OF ALABAMA AT BIRMINGHAM | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1996 to 2015 | NIH RePORTER |
1 to 10 of 21
See all 21 grantsTrial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01030575
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