Trial · NCT06679855
Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial
NCT06679855, Phase 3, Recruiting, NICHD Neonatal Research Network
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial. Trials, record NCT06679855. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06679855
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial
- NCT number
- NCT06679855
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 316 participants, estimated
- Lead sponsor
- NICHD Neonatal Research Network
- Conditions
- Post-ligation Cardiac Syndrome
- Interventions
- Milrinone infusion, Placebo infusion
- First posted
- 2024-11-08
- Last updated
- 2026-07-01
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Post-ligation cardiac syndrome (PLCS) or death within 7 days of PDA closure | Onset within 48 hours but may last up to 7 days | Composite outcome of post-ligation cardiac syndrome (PLCS) or death within 7 days of PDA closure. Onset within 48 hours but may last up to 7 days. |
| Secondary | Systemic hypotension | Onset within 48 hours but may last up to 7 days | Either systolic blood pressure below the 3rd percentile for gestational age or mean blood pressure below the postmenstrual age equivalent |
| Secondary | Systemic hypertension | Onset within 48 hours but may last up to 7 days | Systolic blood pressure above the 97th percentile |
| Secondary | Oxygenation failure | Onset within 48 hours but may last up to 7 days | An absolute increase of at least 20% in the fraction of inspired oxygen or mean airway pressure compared with the one-hour post-intervention value that persists for a minimum of 1 hour and occurs within 72 hours of PDA closure |
| Secondary | Ventilation failure | Within 72 hours of PDA closure | Need for high frequency oscillatory ventilation when conventional ventilation strategies fail or a 20% rise in amplitude compared with the one-hour post-intervention value that persists for a minimum of 1 hour and occurs within 72 hours of PDA closure |
| Secondary | Vasopressor score | Within 7 days of PDA closure | Vasopressor score. Minimum score is zero. Higher score is worse, meaning need for higher level of support. VISmax will be calculated as follows: (VIS=dopamine dose \[μg kg-1 min-1\]+dobutamine \[μg kg-1 min-1\]+100×epinephrine dose \[μg kg-1 min-1\]+50×levosimendan dose \[μg kg-1 min-1\]+10×milrinone dose \[μg kg-1 min-1\]+10 000×vasopressin \[units kg-1 min-1\]+100×norepinephrine dose \[μg kg-1 min-1\]) using the maximum dosing rates of vasoactive and inotropic medications (μg kg-1 min-1 or IU kg-1 min-1) |
| Secondary | Use of open-label milrinone or systemic vasodilator after cessation of study drug administration | After study drug cessation and within 7 days of PDA closure | Number of participants using open-label milrinone or systemic vasodilator after cessation of study drug administration |
| Secondary | Time to successful extubation | 36 weeks postmenstrual age | Time to successful extubation, which is defined as extubation for at least 7 days |
| Secondary | Post-intervention Moderate-severe bronchopulmonary dysplasia at 36 weeks' gestation | 36 weeks postmenstrual age | Need for at least 2 liters of high flow nasal cannula at 36 weeks postmenstrual age |
| Secondary | Post-intervention Chronic Pulmonary hypertension | 36 weeks postmenstrual age | presence of septal flattening (or eccentricity index \> 1.3, right ventricular systolic pressure greater than 40 mmHg, or exclusive right to left atrial level shunt on 36-week echocardiography assessment. The presence of a large atrial septal defect, pulmonary vein stenosis or left ventricular diastolic dysfunction will be recorded. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40858367 | DERIVED |
Source PubMed
Grants1
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 |
|---|---|---|---|---|---|
| U24HL166580 | 2/2 Milrinone for Prevention of Post-Patent Ductus Arteriosus Closure Syndrome in Extremely Preterm Infants (MIDAS Trial) - DCC Resubmission | DAS, ABHIK | RESEARCH TRIANGLE INSTITUTE | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2024 to 2025 |
Source NIH RePORTER
Trial 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/NCT06679855
GET https://conductscience.org/api/trials/v1/NCT06679855/registered?page=2