Trial · NCT01088997
Pharmacokinetic Study of Milrinone in Babies With Persistent Pulmonary Hypertension of the Newborn
NCT01088997, Not applicable, Terminated, Children's Hospital of Philadelphia; results first posted 2016-07-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pharmacokinetic Study of Milrinone in Babies With Persistent Pulmonary Hypertension of the Newborn. Trials, record NCT01088997. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01088997
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetic Study of Milrinone in Babies With Persistent Pulmonary Hypertension of the Newborn
- NCT number
- NCT01088997
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 12 participants, actual
- Lead sponsor
- Children's Hospital of Philadelphia
- Conditions
- Persistent Fetal Circulation Syndrome
- Interventions
- Milrinone Lactate
- First posted
- 2010-03-18
- Last updated
- 2016-07-12
- Results first posted
- 2016-07-12
- Limitations and caveats
- Study enrollment was terminated early resulting in a small number of evaluable subjects for analysis.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Define Plasma Concentration-time Profile of Milrinone in Neonates With Persistent Pulmonary Hypertension of the Newborn (PPHN) - Clearance (CL, mL/Min) | End of bolus dose, 15 minutes prior to end of infusion (EOI), at four time points after EOI with final sample at 12-15 hours after EOI (timing based on infant's weight) | The schedule of milrinone pharmacokinetic (PK) sampling varied by weight to minimize blood sampling. For babies weighing less than 3kg, samples were drawn at the end of the bolus, 15 minutes prior to the end of infusion (EOI) and 20 minutes, 1, 2, 6 and 12 hours after EOI. For babies weighing 3kg or more, samples were drawn at the end of the bolus, 6 hours after start of infusion, 15 minutes prior to the EOI and 30 minutes, 1, 3, 9 and 15 hours after EOI. Milrinone plasma concentrations were determined using a validated high-performance mass spectrometry assay. |
| Secondary | Change in Oxygenation Index (OI) From Baseline to up to 24 Hours After Start of Milrinone Infusion | for up to 24 hours after start of infusion | Oxygenation Index (mean airway pressure\*Fraction of Inspired Oxygen/Partial Pressure of Oxygen in the blood) was calculated at baseline and every 6 hours after start of infusion until 12-24 hours after initiation of milrinone infusion. |
| Secondary | Change in Myocardial Performance Index (MPI) From Baseline to up to 24 Hours After Start of Milrinone Infusion | Up to 24 hours after start of infusion | An echocardiogram obtained while on milrinone was obtained with the goal of attempting to look for improvements in parameters associated with pulmonary hypertension. The primary parameter measured was the myocardial performance index (MPI). An Echocardiogram was performed at baseline (pre-infusion) and repeated 12-24 hours ater the initiation of the Milrinone infusion. Also known as the Tei index, the MPI is an index that incorporates both systolic and diastolic time intervals in expressing global systolic and diastolic ventricular function. Systolic dysfunction prolongs preejection (isovolumic contraction time, IVCT) and a shortening of the ejection time (ET). Both systolic and diastolic dysfunction result in abnormality in myocardial relaxation which prolongs the relaxation period (isovolumic relaxation time, IVRT). Normal value for MPI is 0.39+/-0.05 with dilated cardiomyopathy value of MPI at 0.59+/-0.10 (both units on a scale) |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Change in Oxygenation Index (OI) From Baseline to up to 24 Hours After Start of Milrinone Infusion | for up to 24 hours after start of infusion | OI was calculated every 6 hours after start of infusion for 24 hours. | units on a scale | MEAN |
| PRIMARY | Define Plasma Concentration-time Profile of Milrinone in Neonates With Persistent Pulmonary Hypertension of the Newborn (PPHN) - Clearance (CL, mL/Min) | End of bolus dose, 15 minutes prior to end of infusion (EOI), at four time points after EOI with final sample at 12-15 hours after EOI (timing based on infant's weight) | The pharmacokinetic analysis, including the primary outcome parameter, Clearance, was planned a priori to include all the participants pooled together. A PK analysis by arm wouldn't be appropriate. The randomization arms were only created to explore the secondary clinical and pharmacodynamic outcomes. | mL/min/3.4 kg | MEAN |
| SECONDARY | Change in Myocardial Performance Index (MPI) From Baseline to up to 24 Hours After Start of Milrinone Infusion | Up to 24 hours after start of infusion | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Oxygenation Index (OI) From Baseline to up to 24 Hours After Start of Milrinone Infusion | High Dose Milrinone | 4.9 | Standard Deviation 11.5 | units on a scale | |
| Change in Oxygenation Index (OI) From Baseline to up to 24 Hours After Start of Milrinone Infusion | Low Dose Milrinone | 36.5 | Standard Deviation 27.0 | units on a scale | |
| Define Plasma Concentration-time Profile of Milrinone in Neonates With Persistent Pulmonary Hypertension of the Newborn (PPHN) - Clearance (CL, mL/Min) | Milrinone Population | 7.65 | Standard Error 18.8 | mL/min/3.4 kg | |
| Change in Myocardial Performance Index (MPI) From Baseline to up to 24 Hours After Start of Milrinone Infusion | High Dose Milrinone | -.12 | Standard Deviation 0.29 | units on a scale | |
| Change in Myocardial Performance Index (MPI) From Baseline to up to 24 Hours After Start of Milrinone Infusion | Low Dose Milrinone | -.09 | Standard Deviation 0 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | High Dose Milrinone | 7 | |
| Overall Study | STARTED | Low Dose Milrinone | 5 | |
| Overall Study | COMPLETED | High Dose Milrinone | 4 | |
| Overall Study | COMPLETED | Low Dose Milrinone | 2 | |
| Overall Study | NOT COMPLETED | High Dose Milrinone | 3 | |
| Overall Study | NOT COMPLETED | Low Dose Milrinone | 3 |
Source ClinicalTrials.gov
Adverse events10
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 | Hypoxia requiring ECMO | Respiratory, thoracic and mediastinal disorders | High Dose Milrinone | 1 | 7 | |
| other | Hypoxia requiring ECMO | Respiratory, thoracic and mediastinal disorders | Low Dose Milrinone | 1 | 5 | |
| other | Renal insufficiency | Renal and urinary disorders | High Dose Milrinone | 0 | 7 | |
| other | Renal insufficiency | Renal and urinary disorders | Low Dose Milrinone | 1 | 5 | |
| other | Hyperglycemia | Metabolism and nutrition disorders | High Dose Milrinone | 2 | 7 | |
| other | Hyperglycemia | Metabolism and nutrition disorders | Low Dose Milrinone | 0 | 5 | |
| other | Hyponatremia | Renal and urinary disorders | High Dose Milrinone | 0 | 7 | |
| other | Hyponatremia | Renal and urinary disorders | Low Dose Milrinone | 1 | 5 | |
| other | Elevated Liver Function Tests | Hepatobiliary disorders | High Dose Milrinone | 1 | 7 | |
| other | Elevated Liver Function Tests | Hepatobiliary disorders | Low Dose Milrinone | 0 | 5 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | High Dose Milrinone | ||
| Total, all-cause mortality | Low Dose Milrinone | ||
| Total, other adverse events | High Dose Milrinone | 4 | 7 |
| Total, other adverse events | Low Dose Milrinone | 3 | 5 |
| Total, serious adverse events | High Dose Milrinone | 0 | 7 |
| Total, serious adverse events | Low Dose Milrinone | 0 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| High Dose Milrinone vs Low Dose Milrinone: serious adverse events |
Source Trial comparisons
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/NCT01088997
GET https://conductscience.org/api/trials/v1/NCT01088997/registered