Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants

NCT03982342 | Terminated Results FDA Device

• 1 other identifier: STUDY00000295
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

Brief Summary

This is a pilot study to collect preliminary data for a larger, multicenter clinical trial proposal. The study will examine two strategies commonly used to treat preterm infants diagnosed with a patent ductus arteriosus (PDA). The PDA closes after birth for most term infants, but in many preterm infants, it remains open (patent). A PDA may present a complication for a number of short-term problems faced by preterm infants. Longer-term issues include the development of pulmonary hypertension and changes in the size and performance of the heart. There is ongoing debate as to whether or not the PDA requires intervention.

Conditions

Patent Ductus Arteriosus

Keywords

catheter closure; conservative treatment; percutaneous closure

Outcome Measures

Primary Outcomes (2)

• Time on Ventilatory Support Required

  Period the participant is in need of ventilator support \[Synchronized Intermittent Mandatory Ventilation (SIMV), High Frequency Oscillatory Ventilation (HFOV), or similar\]

  Weekly for 1 month pre-closure (intervention group) or corresponding time point (non-intervention group); Weekly for 1 month post-closure (intervention group) or corresponding time point (non-intervention group); 36 weeks corrected gestational age

• Supplemental Oxygen Need

  Weekly supplemental oxygen support required (in % fraction of inspired oxygen, FiO2)

  Post-randomization (up to 6 weeks) for participants in both groups.

Secondary Outcomes (1)

• Number of Subjects Requiring Catheter-based Closure Due to Failed Conservative Management (Applies to Conservative Management Group Only)

  6 weeks post-randomization (to conservative management group)

Study Arms (2)

Catheter-closure of PDA

ACTIVE COMPARATOR

Infants randomized to this group will undergo a catheter procedure to close hemodynamically-significant patent ductus arteriosus (HSPDA).

Device: Cather closure of patent ductus arteriosus (PDA)

Conservative management of PDA

ACTIVE COMPARATOR

Infants randomized to this group will be treated to reduce the symptoms of a hemodynamically-significant patent ductus arteriosus (HSPDA), in the hopes that over time the HSPDA will become reduced in size (to the point of no longer meeting criteria for being "hemodynamically significant") or close naturally. Infants in this group with declining health status attributable to a PDA which meet qualifying criteria may receive catheter closure (intervention) if deemed medically necessary.

Device: Cather closure of patent ductus arteriosus (PDA); Other: Conservative management of patent ductus arteriosus (PDA)

Interventions

Cather closure of patent ductus arteriosus (PDA) DEVICE

Infants assigned to this group will have a catheter run from a blood vessel in the upper leg / groin area to the heart, where an FDA-approved device will be placed within the patent ductus arteriosus to occlude or plug it, thereby closing the ductus.

Also known as: Percutaneous closure of patent ductus arteriosus (PDA)

Catheter-closure of PDA; Conservative management of PDA

Conservative management of patent ductus arteriosus (PDA) OTHER

Infants with a hemodynamically-significant patent ductus arteriosus randomized to this group will be treated by fluid restriction and possible diuretic use to reduce PDA symptoms, and allow time to permit the PDA to close or become reduced in size to the point where it is no longer considered "hemodynamically-significant".

Conservative management of PDA

Eligibility Criteria

• Age: 14 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants ≤28 weeks gestational age with hemodynamically-significant patent ductus arteriosus (PDA) at 2 - 4 weeks of age.
• Body weight greater than or equal to 700 grams

You may not qualify if:

• Significant genetic (ex.- Trisomy) or physiological (ex. - Omphalocele) abnormalities
• Other cardiac disease NOT INCLUDING atrial-septal defects or ventricular septal defects (ex. Tetrology of Fallot, Single ventricle physiology)
• Body weight less than 700 grams

Sponsors & Collaborators

• Nationwide Children's Hospital: lead
• University of Tennessee: collaborator

Study Sites (2)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

Related Publications (1)

• Shah ZS, Clark RH, Patt HA, Backes CH Jr, Tolia VN. Trends in Procedural Closure of the Patent Ductus Arteriosus among Infants Born at 22 to 30 Weeks' Gestation. J Pediatr. 2023 Dec;263:113716. doi: 10.1016/j.jpeds.2023.113716. Epub 2023 Aug 31.

  PMID: 37659585 DERIVED

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

The trial only enrolled a single patient prior to the COVID-19 epidemic. Due to subsequent COVID-19 restrictions placed upon clinical trials, the study was terminated early.

Results Point of Contact

• Title: Carl Backes, MD
• Organization: Nationwide Children's Hospital

Carl.Backes@nationwidechildrens.org

1-614-355-6729

Study Officials

• Carl H Backes, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Neonatology

Model Details: Enrolled participants will be randomly assigned to one of two PDA treatment approaches, both receiving treatment at the same time.

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: June 11, 2019
• Study Start: October 10, 2020
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: February 7, 2024
• Results First Posted: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)