Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U24HL166580 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
The goal of this Phase 3, randomized, masked clinical trial is to is to find out whether milrinone, when given to infants after PDA closure, will help the heart work better by supplying oxygen to the lungs and tissues.
The main questions it aims to answer are:
Researchers will compare milrinone to a placebo saline solution to see if it helps the heart work better by supplying oxygen to the lungs and tissues.
After randomization the following will happen in both the control and treatment groups:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | An iv infusion of placebo (0.9% saline) of equivalent volume will be administered. The infusion will be accompanied by an iv bolus of 10 mL/kg of 0.9% NaCl (administered over 60 minutes) to ensure blinding is maintained. |
|
| Milrinone | Active Comparator | An intravenous (iv) infusion of milrinone will be administered at an initial dose of 0.33 mcg/kg/min and accompanied by an iv bolus of 10 mL/kg of 0.9% NaCl (administered over 60 minutes). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milrinone infusion | Drug | An intravenous (iv) infusion of milrinone will be administered at an initial dose of 0.33 mcg/kg/min and accompanied by an iv bolus of 10 mL/kg of 0.9% NaCl (administered over 60 minutes). |
| Measure | Description | Time Frame |
|---|---|---|
| Post-ligation cardiac syndrome (PLCS) or death within 7 days of PDA closure | 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. | Onset within 48 hours but may last up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic hypotension | Either systolic blood pressure below the 3rd percentile for gestational age or mean blood pressure below the postmenstrual age equivalent | Onset within 48 hours but may last up to 7 days |
| Systemic hypertension |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick J McNamara | Contact | 319-467-7435 | patrick-mcnamara@uiowa.edu | |
| Valerie Chock | Contact | 650-723-5711 | vchock@stanford.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama - Birmingham | Not yet recruiting | Birmingham | Alabama | 35249 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40858367 | Derived | McNamara PJ, Chock VY, Rahde-Bischoff A, Gabrio J, Johnson KJ, Harmon HM, Montoya-Williams D, Colaizy TT, Katheria AC, Ines F, Sorrells K, Battersby C, Levy PT, Rysavy MA, Bhombal S, Laughon MM, Carper B, Hintz SR, Das A, Bell EF. Evaluating the efficacy and safety of milrinone for prevention of post-patent ductus arteriosus closure syndrome (the MIDAS trial) in extremely preterm infants: a multicentre, double-masked, randomised, placebo-controlled trial. BMJ Open. 2025 Aug 26;15(8):e105018. doi: 10.1136/bmjopen-2025-105018. |
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 11, 2026 | Jun 29, 2026 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo infusion | Drug | An iv infusion of placebo (0.9% saline) of equivalent volume will be administered. The infusion will be accompanied by an iv bolus of 10 mL/kg of 0.9% NaCl (administered over 60 minutes) to ensure blinding is maintained. |
|
Systolic blood pressure above the 97th percentile
| Onset within 48 hours but may last up to 7 days |
| Oxygenation failure | 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 | Onset within 48 hours but may last up to 7 days |
| Ventilation failure | 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 | Within 72 hours of PDA closure |
| Vasopressor score | 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) | Within 7 days of PDA closure |
| Use of open-label milrinone or systemic vasodilator after cessation of study drug administration | Number of participants using open-label milrinone or systemic vasodilator after cessation of study drug administration | After study drug cessation and within 7 days of PDA closure |
| Time to successful extubation | Time to successful extubation, which is defined as extubation for at least 7 days | 36 weeks postmenstrual age |
| Post-intervention Moderate-severe bronchopulmonary dysplasia at 36 weeks' gestation | Need for at least 2 liters of high flow nasal cannula at 36 weeks postmenstrual age | 36 weeks postmenstrual age |
| Post-intervention Chronic Pulmonary hypertension | 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. | 36 weeks postmenstrual age |
| Post-intervention Periventricular Leukomalacia (PVL) | Presence of cystic white matter changes on cranial ultrasound | 36 weeks postmenstrual age |
| Post-intervention Necrotizing Enterocolitis | At least Bells stage IIb disease | 36 weeks postmenstrual age |
| Post-intervention Retinopathy of Prematurity (ROP) ≥ stage 3 (according to the international classification) | Post-intervention Retinopathy of Prematurity (ROP) ≥ stage 3 (according to the international classification) | 36 weeks postmenstrual age |
| Weight or head circumference z-score change at 36 weeks | Weight or head circumference z-score change at 36 weeks (decline by two z-scores will be considered growth failure) | 36 weeks postmenstrual age |
| Death between randomization and discharge from NICU | Death between randomization and discharge from NICU | Randomization to 120 days' postnatal age, death, discharge, or transfer outside of the Study Center, whichever occurs first (an average of 112 days postnatal age) |
| Moderate-Severe neurodevelopmental impairment (NDI), using current NRN Follow-Up Study definition | Moderate-Severe neurodevelopmental impairment (NDI), using current NRN Follow-Up Study definition | 22 to 26 months |
| Moderate-Severe neurodevelopmental impairment (NDI) or death | Moderate-Severe neurodevelopmental impairment (NDI) or death | 22 to 26 months |
| Moderate or severe cerebral palsy | Moderate or severe cerebral palsy | 22 to 26 months |
| Severe vision impairment | Severe vision impairment | 22 to 26 months |
| Severe hearing impairment | Severe hearing impairment | 22 to 26 months |
| Bayley-4 cognitive, language, motor scores | Bayley-4 cognitive, language, motor scores | 22 to 26 months |
| Gross Motor Function level ≥II | Gross Motor Function level ≥II | 22 to 26 months |
| CBCL Internalizing, Externalizing, and Total Problems aggregate T scores of >64 (clinical range) and 60-63 (borderline range). | CBCL Internalizing, Externalizing, and Total Problems aggregate T scores of >64 (clinical range) and 60-63 (borderline range). | 22 to 26 months |
| Death before 22-26-month follow-up | Death before 22-26-month follow-up | 22 to 26 months |
| Height, weight, or head circumference growth failure | Height, weight, or head circumference growth failure (decline by >2 z-scores since discharge) | 22 to 26 months |
| Children's Hospital of Orange County | Not yet recruiting | Orange | California | 92868 | United States |
|
| Stanford University | Recruiting | Palo Alto | California | 94304 | United States |
|
| Sharp Mary Birch Hospital for Women & Newborns | Not yet recruiting | San Diego | California | 92123 | United States |
|
| Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
|
| Northwestern Lurie Children's Hospital of Chicago | Recruiting | Chicago | Illinois | 60611 | United States |
|
| University of Iowa | Recruiting | Iowa City | Iowa | 52242 | United States |
|
| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
|
| University of Mississippi Medical Center | Not yet recruiting | Jackson | Mississippi | 39216 | United States |
|
| University of New Mexico | Recruiting | Albuquerque | New Mexico | 87131 | United States |
|
| Duke University | Recruiting | Durham | North Carolina | 27705 | United States |
|
| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
|
| Case Western Reserve University | Recruiting | Cleveland | Ohio | 44106 | United States |
|
| University of Oklahoma Health Sciences | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
|
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| Le Bonheur Children's Hospital | Recruiting | Memphis | Tennessee | 38103 | United States |
|
| University of Texas Southwestern | Recruiting | Dallas | Texas | 75390 | United States |
|
| University of Texas at Houston | Recruiting | Houston | Texas | 77030 | United States |
|
| University of Utah | Recruiting | Salt Lake City | Utah | 84108 | United States |
|
| ICF_000.pdf |