Is NCT05547165 recruiting in Birmingham, AL?

Yes, NCT05547165 is currently recruiting participants at its Birmingham, AL location. This ductus arteriosus, patent clinical trial is actively enrolling qualified participants.

How do I join the ductus arteriosus, patent clinical trial in Birmingham?

To join this clinical trial in Birmingham, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Birmingham clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Ductus Arteriosus, Patent Clinical Trial in Birmingham, AL

About This Ductus Arteriosus, Patent Study in Birmingham

Patent Ductus Arteriosus is a developmental condition commonly observed among preterm infants. It is a condition where the opening between the two major blood vessels leading from the heart fail to close after birth. In the womb, the opening (ductus arteriosus) is the normal part of the circulatory system of the baby, but is expected to close at full term birth. If the opening is tiny, the condition can be self-limiting. If not, medications/surgery are options for treatment. There are two ways to treat patent ductus arteriosus - one is through closure of the opening with an FDA approved device called PICCOLO, the other is through supportive management (medications). No randomized controlled trials have been done previously to see if one of better than the other. Through our PIVOTAL study, the investigators aim to determine is one is indeed better than the other - if it is found that the percutaneous closure with PICCOLO is better, then it would immediately lead to a new standard of care. If not, then the investigators avoid an invasive costly procedure going forward.

Sponsor: Nationwide Children's Hospital

Who Can Participate

Inclusion Criteria

EPIs born between 22-weeks+0 days (220/7 wks) and 27-weeks+6 days (276/7 wks) gestation, inclusive

Admitted to a study NICU

Birth weight ≥700-grams

Mechanically ventilated at time of consent and randomization

HSPDA ("PDA Score" ≥6) noted on echocardiogram (ECHO)

Randomization is able to be performed within 5 days of the qualifying ECHO and when infant is 7-32 days postnatal

Exclusion Criteria

Clinical Exclusion Criteria

Life-threatening congenital defects (including congenital heart disease such as aortic coarctation or pulmonary artery stenosis). PDA and small atrial/ventricular septal defects are permitted;

Congenital lung abnormalities, (e.g. restrictive lung disease);

Pharyngeal or airway anomalies (tracheal stenosis, choanal atresia);

Treatment for acute abdominal process (e.g., necrotizing enterocolitis);

Infants with planned surgery;

Active infection requiring treatment;

Chromosomal defects (e.g., Trisomy 18);

Neuromuscular disorders;

Infants whose parents have chosen to allow natural death (do not resuscitate order) or for whom limitation of intensive care treatment is being considered (e.g. severe intraventricular hemorrhage)

Physician deems that the infant would not be a Percutaneous PDA Closure candidate due to clinical instability; however, if the infant's clinical status improves before 30-days postnatal and all inclusion criteria are still met, then the infant may be enrolled. ECHO-based Exclusion Criteria

Pulmonary hypertension (defined by ductal right to left shunting for \>33% of the cardiac cycle) in which early PDA closure may increase right ventricular afterload and compromise pulmonary and systemic blood flow;

Evidence of cardiac thrombus that might interfere with device placement;

PDA diameter larger than 4 mm at the narrowest portion (consistent with FDA-approved instructions for Piccolo™ device use).

PDA length smaller than 3 mm (consistent with FDA-approved instructions for Piccolo™ device use).

PDA that does not meet inclusion requirements ("PDA Score" \<6).\

If a potential participant is found to have a PDA meeting eligibility requirements on a subsequent ECHO during the required period of 7 - 30 postnatal days of age, they may then be declared eligible to participate and enrolled, provided all other inclusion criteria are met and exclusion criteria are not met. Other Exclusion Criteria 1\. Parents or legal guardian do not speak English or Spanish

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Birmingham?

Yes, this clinical trial (NCT05547165) has an active research site in Birmingham, AL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

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

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

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

Ductus Arteriosus, Patent Treatment Options in Birmingham, AL

If you're searching for ductus arteriosus, patent treatment options in Birmingham, AL, this clinical trial (NCT05547165) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Birmingham research site is actively enrolling participants for this clinical trial. You'll receive care from experienced ductus arteriosus, patent specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all ductus arteriosus, patent clinical trials near you to find additional studies recruiting in your area.

Ductus Arteriosus, Patent Clinical Trial in Birmingham, AL

Expert Care in Birmingham

IRB Approved

No-Cost Care

Apply for This Birmingham Location

Why Participate?

Simple Process