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NCT06679855RECRUITINGIRB Ready

Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial

(MIDAS)

Sponsored by NICHD Neonatal Research Network

Quick Self-Assessment

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1 of 316 participants interested
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Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

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: 1. to determine if milrinone decreases the risk of death or PLCS within 7 days of the procedure, compared to standard treatment; and 2. to determine the effects of milrinone on two-year survival and neurodevelopmental outcome.

Who Can Participate

Inclusion Criteria

Gestational age at birth โ‰ค27 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 โ‰ฅ1.0 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.

Exclusion Criteria

Any major congenital malformation
Congenital heart disease (except small (โ‰ค1mm) 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

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

316 participants

โšง

Gender

ALL

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Sponsor

NICHD Neonatal Research Network

Study Locations

Choose your preferred location or select flexible during enrollment

NOT_YET_RECRUITING

Birmingham

Alabama

Location available
View Birmingham location page
NOT_YET_RECRUITING

Orange

California

Location available
View Orange location page
NOT_YET_RECRUITING

Palo Alto

California

Location available
View Palo Alto location page
NOT_YET_RECRUITING

San Diego

California

Location available
View San Diego location page
NOT_YET_RECRUITING

Atlanta

Georgia

Location available
View Atlanta location page
RECRUITING

Chicago

Illinois

Location available
View Chicago location page
NOT_YET_RECRUITING

Iowa City

Iowa

Location available
View Iowa City location page
NOT_YET_RECRUITING

Boston

Massachusetts

Location available
View Boston location page
NOT_YET_RECRUITING

Jackson

Mississippi

Location available
View Jackson location page

๐Ÿ“ And 10 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Post-ligation Cardiac Syndrome Treatment in Birmingham?

Join others in Alabama exploring innovative treatment options through clinical research

Post-ligation Cardiac Syndrome Treatment Options in Birmingham, Alabama

If you're searching for Post-ligation Cardiac Syndrome treatment in Birmingham, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Birmingham, Orange, Palo Alto and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Post-ligation Cardiac Syndrome. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 316 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Post-ligation Cardiac Syndrome?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Post-ligation Cardiac Syndrome

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Post-ligation Cardiac Syndrome Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06679855. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.