Post-ligation Cardiac SyndromePhase 3MIDASNCT06679855
Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial
A Phase 3 study testing Milrinone infusion in people with Post-ligation Cardiac Syndrome, run by NICHD Neonatal Research Network at 19 sites in United States.
Trial summary
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: 1. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Post-ligation Cardiac Syndrome
- What is being tested?
- Milrinone infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 316 participants
- Where
- 19 sitesUnited States
- Study dates
- 13 Jun 2025to 30 Jun 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age at birth ≤27 weeks (and 6 days) and postnatal age < 3 months at intervention
- Invasive or non-invasive positive pressure respiratory support (does not include low flow nasal cannula)
- Hemodynamically significant PDA with minimum transductal diameter ≥1.0 mm within 2 days of intervention
- Decision by clinical team to proceed with PDA closure via surgical ligation or percutaneous cardiac catheterization based on clinical and echocardiography features of hemodynamic significance.
Who cannot join
- Any major congenital malformation
- Congenital heart disease (except small (≤1mm) muscular ventricular septal defects, or small/moderate (<3mm) atrial septal defect)
- Acute renal failure defined by urine output < 0.5 mL/kg/hour OR rise of serum creatinine by 0.3 mg/dL within 48 hours OR rise of serum creatinine more than 40% above baseline serum creatinine within prior 72 hours.
- Systemic administration of vasodilator/inodilator agents
- Prior history of arrhythmia
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
United States19 sites, 19 recruiting
- Recruiting
University of New Mexico
Albuquerque, New Mexico, 87131
Janell Fuller, 505-272-6409, jafuller@salud.unm.edu
- Recruiting
Emory University
Atlanta, Georgia, 30322
Ravi M Patel, 404-727-5905, rmpatel@emory.edu
- Not yet recruiting
University of Alabama - Birmingham
Birmingham, Alabama, 35249
Waldemar A Carlo, 205-934-4680, wcarlo@peds.uab.edu
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Philip Levy, 617-919-2358, Philip.Levy@childrens.harvard.edu
- Recruiting
Northwestern Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Aaron Hamvas, 312-227-4190, ahamvas@luriechildrens.org
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Stephanie Merhar, 513-803-5180, Stephanie.Merhar@cchmc.org
- Recruiting
Case Western Reserve University
Cleveland, Ohio, 44106
Anna Maria Hibbs, 216-844-3387, annamaria.hibbs@cwru.edu
- Recruiting
University of Texas Southwestern
Dallas, Texas, 75390
Myra H Wyckoff, 214-590-4003, myra.wyckoff@utsouthwestern.edu
- Recruiting
Duke University
Durham, North Carolina, 27705
Michael Cotten, 919-681-0630, michael.cotten@duke.edu
- Recruiting
University of Texas at Houston
Houston, Texas, 77030
Matthew Rysavy, 713-500-6643, matthew.a.rysavy@uth.tmc.edu
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Tarah Colaizy, 319-356-3508, tarah-colaizy@uiowa.edu
- Not yet recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Abhay Bhatt, 601-984-5263, abhatt@umc.edu
- Recruiting
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
Mark Weems, 901-448-2262, mweems@uthsc.edu
- Recruiting
University of Oklahoma Health Sciences
Oklahoma City, Oklahoma, 73104
Marjorie Makoni, 405-271-5215, Marjorie-Makoni@ouhsc.edu
- Not yet recruiting
Children's Hospital of Orange County
Orange, California, 92868
Amir H Ashrafi, 714-509-4373, Aashrafi@choc.org
- Recruiting
Stanford University
Palo Alto, California, 94304
Valerie Chock, 650-723-5711, vchock@stanford.edu
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Sara DeMauro, 215-590-3730, demauro@email.chop.edu
- Recruiting
University of Utah
Salt Lake City, Utah, 84108
Robin Ohls, 801-213-1487, robin.ohls@hsc.utah.edu
- Not yet recruiting
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, 92123
Anup Katheria, 858-939-4170, anup.katheria@sharp.com
About this study
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:
- to determine if milrinone decreases the risk of death or PLCS within 7 days of the procedure, compared to standard treatment; and
- to determine the effects of milrinone on two-year survival and neurodevelopmental outcome.
Read the detailed description
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:
- Infant will start receiving either a low dose (0.33 μg/kg/min) of milrinone in the treatment group, OR saline solution in the control group through an intravenous (IV) line. The study drug will be started within 2 hours of the PDA closure procedure.
- For the first 2 to 4 hours, the study team will monitor very closely to see if there are any major side effects from the study drug.
- If the infant continues to have high blood pressure, which places an added stress on the heart, the dose will go up to 0.66 μg/kg/min. One more increase will be allowed to 0.75 μg/kg/min. The study drug will then stay at this dose. No more changes will happen to the dose. If there are side effects, then the study drug will be stopped and will not be started again.
- The study drug will be stopped after 24 hours if the infant only required the lowest drug and remains well. If the required higher doses of milrinone, it will take longer to wean them off the medication. Some infants may receive milrinone for 3-5 days. If the infant's heart starts to work better by using less oxygen from the breathing machine (ventilator), the study drug may be stopped before 3 days.
- Information will be collected from the infant's medical record including demographic information, gestational age, blood pressures, heart rates, respiratory rates, information about his or her breathing, medications, details of medical treatment for PDA, medical procedures including echocardiograms (ultrasound of the baby's heart), details of PDA closure (by surgery or transcatheter closure), head ultrasounds, and diagnoses. The investigators will also be collecting information from the maternal medical record including ultrasounds that may be relevant to the infant's course.
- Right after the study drug is stopped (which could be 5 days or less) the doctor may decide to give the infant the drug milrinone. This is a decision that will be made by the infant's doctor.
- After the infant goes home from the hospital, they will be scheduled for follow-up exams in the clinic. The follow-up visit will be done when the infant is about 2 years old. The visit will take about two hours to do. During the follow-up visit the investigators will test the infant's movement, behavior, and development. The investigators will also check the infant to make sure they do not have high blood pressure or any evidence of kidney disease.
- Conditions
- Post-ligation Cardiac Syndrome
- Being tested
- Milrinone infusion, Placebo infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milrinone infusionDrug
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).
Placebo infusionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Placebo infusion |
| 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). Receives: Drug: Milrinone infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Onset within 48 hours but may last up to 7 days
Secondary outcomes (24)
Systemic hypotension
Either systolic blood pressure below the 3rd percentile for gestational age or mean blood pressure below the postmenstrual age equivalent
Measured: Onset within 48 hours but may last up to 7 days
Systemic hypertension
Systolic blood pressure above the 97th percentile
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 36 weeks postmenstrual age
Post-intervention Periventricular Leukomalacia (PVL)
Presence of cystic white matter changes on cranial ultrasound
Measured: 36 weeks postmenstrual age
Post-intervention Necrotizing Enterocolitis
At least Bells stage IIb disease
Measured: 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)
Measured: 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)
Measured: 36 weeks postmenstrual age
Death between randomization and discharge from NICU
Death between randomization and discharge from NICU
Measured: 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
Measured: 22 to 26 months
Moderate-Severe neurodevelopmental impairment (NDI) or death
Moderate-Severe neurodevelopmental impairment (NDI) or death
Measured: 22 to 26 months
Moderate or severe cerebral palsy
Moderate or severe cerebral palsy
Measured: 22 to 26 months
Severe vision impairment
Severe vision impairment
Measured: 22 to 26 months
Severe hearing impairment
Severe hearing impairment
Measured: 22 to 26 months
Bayley-4 cognitive, language, motor scores
Bayley-4 cognitive, language, motor scores
Measured: 22 to 26 months
Gross Motor Function level ≥II
Gross Motor Function level ≥II
Measured: 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).
Measured: 22 to 26 months
Death before 22-26-month follow-up
Death before 22-26-month follow-up
Measured: 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)
Measured: 22 to 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start13 Jun 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-ligation Cardiac SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NICHD Neonatal Research Network
- Sponsor type
- Research network
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679855
- Sponsor's protocol ID
- NICHD-NRN-0066
- Other IDs
- U24HL166580
- Acronym
- MIDAS
- Status last verified
- Jun 2026
- First submitted
- 31 Oct 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 40858367
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial
- ClinicalTrials.gov ID
- NCT06679855
- Acronym / sponsor ID
- MIDAS / NICHD-NRN-0066
- Conditions
- Post-ligation Cardiac Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- NICHD Neonatal Research NetworkResearch network
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- to determine if milrinone decreases the risk of death or PLCS within 7 days of the procedure, compared to standard treatment; and
- to determine the effects of milrinone on two-year survival and neurodevelopmental outcome.
Detailed description
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:
- Infant will start receiving either a low dose (0.33 μg/kg/min) of milrinone in the treatment group, OR saline solution in the control group through an intravenous (IV) line. The study drug will be started within 2 hours of the PDA closure procedure.
- For the first 2 to 4 hours, the study team will monitor very closely to see if there are any major side effects from the study drug.
- If the infant continues to have high blood pressure, which places an added stress on the heart, the dose will go up to 0.66 μg/kg/min. One more increase will be allowed to 0.75 μg/kg/min. The study drug will then stay at this dose. No more changes will happen to the dose. If there are side effects, then the study drug will be stopped and will not be started again.
- The study drug will be stopped after 24 hours if the infant only required the lowest drug and remains well. If the required higher doses of milrinone, it will take longer to wean them off the medication. Some infants may receive milrinone for 3-5 days. If the infant's heart starts to work better by using less oxygen from the breathing machine (ventilator), the study drug may be stopped before 3 days.
- Information will be collected from the infant's medical record including demographic information, gestational age, blood pressures, heart rates, respiratory rates, information about his or her breathing, medications, details of medical treatment for PDA, medical procedures including echocardiograms (ultrasound of the baby's heart), details of PDA closure (by surgery or transcatheter closure), head ultrasounds, and diagnoses. The investigators will also be collecting information from the maternal medical record including ultrasounds that may be relevant to the infant's course.
- Right after the study drug is stopped (which could be 5 days or less) the doctor may decide to give the infant the drug milrinone. This is a decision that will be made by the infant's doctor.
- After the infant goes home from the hospital, they will be scheduled for follow-up exams in the clinic. The follow-up visit will be done when the infant is about 2 years old. The visit will take about two hours to do. During the follow-up visit the investigators will test the infant's movement, behavior, and development. The investigators will also check the infant to make sure they do not have high blood pressure or any evidence of kidney disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo infusionAn 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 | Drug: Milrinone infusionAn 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). |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gestational age at birth ≤27 weeks (and 6 days) and postnatal age < 3 months at intervention
- Invasive or non-invasive positive pressure respiratory support (does not include low flow nasal cannula)
- Hemodynamically significant PDA with minimum transductal diameter ≥1.0 mm within 2 days of intervention
- Decision by clinical team to proceed with PDA closure via surgical ligation or percutaneous cardiac catheterization based on clinical and echocardiography features of hemodynamic significance.
Key exclusion criteria (5 listed)
- Any major congenital malformation
- Congenital heart disease (except small (≤1mm) muscular ventricular septal defects, or small/moderate (<3mm) atrial septal defect)
- Acute renal failure defined by urine output < 0.5 mL/kg/hour OR rise of serum creatinine by 0.3 mg/dL within 48 hours OR rise of serum creatinine more than 40% above baseline serum creatinine within prior 72 hours.
- Systemic administration of vasodilator/inodilator agents
- Prior history of arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Milrinone infusionAn 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). | Drug | Milrinone |
| Placebo infusionAn 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. | Drug | Placebo |
Primary outcome
Post-ligation cardiac syndrome (PLCS) or death within 7 days of PDA closure
Time frame: 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.
24 secondary outcomes
Systemic hypotension
Time frame: Onset within 48 hours but may last up to 7 days
Systemic hypertension
Time frame: Onset within 48 hours but may last up to 7 days
Oxygenation failure
Time frame: Onset within 48 hours but may last up to 7 days
Ventilation failure
Time frame: Within 72 hours of PDA closure
Vasopressor score
Time frame: Within 7 days of PDA closure
Use of open-label milrinone or systemic vasodilator after cessation of study drug administration
Time frame: After study drug cessation and within 7 days of PDA closure
Time to successful extubation
Time frame: 36 weeks postmenstrual age
Post-intervention Moderate-severe bronchopulmonary dysplasia at 36 weeks' gestation
Time frame: 36 weeks postmenstrual age
Post-intervention Chronic Pulmonary hypertension
Time frame: 36 weeks postmenstrual age
Post-intervention Periventricular Leukomalacia (PVL)
Time frame: 36 weeks postmenstrual age
Post-intervention Necrotizing Enterocolitis
Time frame: 36 weeks postmenstrual age
Post-intervention Retinopathy of Prematurity (ROP) ≥ stage 3 (according to the international classification)
Time frame: 36 weeks postmenstrual age
Weight or head circumference z-score change at 36 weeks
Time frame: 36 weeks postmenstrual age
Death between randomization and discharge from NICU
Time frame: 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
Time frame: 22 to 26 months
Moderate-Severe neurodevelopmental impairment (NDI) or death
Time frame: 22 to 26 months
Moderate or severe cerebral palsy
Time frame: 22 to 26 months
Severe vision impairment
Time frame: 22 to 26 months
Severe hearing impairment
Time frame: 22 to 26 months
Bayley-4 cognitive, language, motor scores
Time frame: 22 to 26 months
Gross Motor Function level ≥II
Time frame: 22 to 26 months
CBCL Internalizing, Externalizing, and Total Problems aggregate T scores of >64 (clinical range) and 60-63 (borderline range).
Time frame: 22 to 26 months
Death before 22-26-month follow-up
Time frame: 22 to 26 months
Height, weight, or head circumference growth failure
Time frame: 22 to 26 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Derived from this study: PubMed 40858367McNamara 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Milrinone infusion in people with Post-ligation Cardiac Syndrome, run by NICHD Neonatal Research Network at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick J McNamara (319-467-7435, patrick-mcnamara@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-ligation cardiac syndrome (PLCS) or death within 7 days of PDA closure (time frame: Onset within 48 hours but may last up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06679855, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.