Patent Ductus ArteriosusPDANCT02750228
PDA Post NICU Discharge
An observational study of Patent Ductus Arteriosus, run by Pediatrix at 16 sites in United States.
Trial summary
The purpose of this study is to track post-discharge outcomes on prematurely born infants who are discharged from the NICU with a patent ductus arteriosus (PDA). Investigators plan to report on the spontaneous closure rate as well as the incidence of pulmonary and/or cardiac events in these infants. Read more about this study
- Who is it for?
- Ages 22 to 32 weeks
- Conditions the study is for
- Patent Ductus Arteriosus
- How many people
- 208 participants
- Where
- 16 sitesUnited States
- Study dates
- May 2016to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 22 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Study population: This is a prospective multicenter descriptive study to collect data on neonatal outcomes and treatment modalities of neonates diagnosed with a patent ductus arteriosus by echocardiogram and have an active diagnosis of a PDA at discharge from the hospital.
Who may be able to join
- Documentation of informed consent and authorization for participation.
- Estimated gestational age of 32 weeks or less.
- Active diagnosis of a PDA at discharge.
- At least one echocardiogram obtained during hospital stay documenting/ confirming PDA diagnosis.
- Parental agreement to provide follow-up information on their child.
- Cardiologist and/or Pediatrician willing to provide follow-up information on enrolled infants.
Who cannot join
- No known major congenital anomalies (inborn error of metabolism, cyanotic congenital heart disease, gastroschisis, omphalocele, diaphragmatic hernia or other major gastrointestinal anomalies, major neurological injury or anomaly, multiple congenital anomalies).
- Chromosomal / genetic disorders - Inherited metabolic disorders (Aa, fat or carbohydrate), Trisomies, Turner's syndrome,Vater's syndrome, CHARGE, DiGeorge or other 22q11 deletions, Major chromosomal duplications, deletions detectable on high resolution karyotype (not microarray).
- Parent(s) unwilling to participate in follow-up.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Providence Alaska Medical Center
Anchorage, Alaska, 99508
Northside Hospital
Atlanta, Georgia, 30328
Seton Medical Center
Austin, Texas, 78705
Dell Children's Medical Center
Austin, Texas, 78723
Baylor University Medical Center
Dallas, Texas, 75246
Cook Children's Medical Center
Fort Worth, Texas, 76104
Greenvillle Memorial Hospital
Greenville, South Carolina, 29605
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144
Winnie Palmer Hospital for Women & Babies
Orlando, Florida, 32806
St. Joseph's Hospital & Medical Center
Phoenix, Arizona, 85013
Children's Hospital of San Antonio
San Antonio, Texas, 78229
Methodist Children's Hospital
San Antonio, Texas, 78229
Memorial Hospital of South Bend
South Bend, Indiana, 46601
MEDNAX Center for Research, Education and Quality
Sunrise, Florida, 33323
Tacoma General Hospital
Tacoma, Washington, 98405
Tucson Medical Center
Tucson, Arizona, 85712
About this study
Official title: Patent Ductus Arteriosus Post NICU Discharge in Premature Infants: A Prospective Registry
The purpose of this study is to track post-discharge outcomes on prematurely born infants who are discharged from the NICU with a patent ductus arteriosus (PDA). Investigators plan to report on the spontaneous closure rate as well as the incidence of pulmonary and/or cardiac events in these infants. The goal is to identify risk factors associated with adverse outcomes in prematurely born infants who are sent home with a PDA.
- Conditions
- Patent Ductus Arteriosus
- Medical subject headings
- Ductus Arteriosus, Patent
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects that have a report of a spontaneous closure of PDA, medication intervention for closure of PDA or surgical intervention for closure of PDA
Measured: 18 months
Secondary outcomes (1)
Number of subjects with or without a closure of PDA that have heart failure, pulmonary arterial hypertension, a need for respiratory support and death
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startMay 2016
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
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 Patent Ductus ArteriosusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatrix
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750228
- Sponsor's protocol ID
- PDX-002-15
- Acronym
- PDA
- Status last verified
- Jun 2020
- First submitted
- 23 Mar 2016
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Tolia VN, Powers GC, Kelleher AS, Walker MW, Herrman KK, Ahmad KA, Buchh B, Egalka MC, Hinkes M, Ma M, Richards M, Rudine AC, Sato RY, Shaffer KM, Clark RH. Low Rate of Spontaneous Closure in Premature Infants Discharged with a Patent Ductus Arteriosus: A Multicenter Prospective Study. J Pediatr. 2022 Jan;240:31-36.e2. doi: 10.1016/j.jpeds.2021.07.035. Epub 2021 Jul 20.
PubMed 34293369
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patent Ductus Arteriosus Post NICU Discharge in Premature Infants: A Prospective Registry
- ClinicalTrials.gov ID
- NCT02750228
- Acronym / sponsor ID
- PDA / PDX-002-15
- Conditions
- Patent Ductus Arteriosus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- PediatrixUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 25 Apr 2016 (estimated)
- 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 purpose of this study is to track post-discharge outcomes on prematurely born infants who are discharged from the NICU with a patent ductus arteriosus (PDA). Investigators plan to report on the spontaneous closure rate as well as the incidence of pulmonary and/or cardiac events in these infants. The goal is to identify risk factors associated with adverse outcomes in prematurely born infants who are sent home with a PDA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This is a prospective multicenter descriptive study to collect data on neonatal outcomes and treatment modalities of neonates diagnosed with a patent ductus arteriosus by echocardiogram and have an active diagnosis of a PDA at discharge from the hospital.
Key inclusion criteria (6 listed)
- Documentation of informed consent and authorization for participation.
- Estimated gestational age of 32 weeks or less.
- Active diagnosis of a PDA at discharge.
- At least one echocardiogram obtained during hospital stay documenting/ confirming PDA diagnosis.
- Parental agreement to provide follow-up information on their child.
Key exclusion criteria (3 listed)
- No known major congenital anomalies (inborn error of metabolism, cyanotic congenital heart disease, gastroschisis, omphalocele, diaphragmatic hernia or other major gastrointestinal anomalies, major neurological injury or anomaly, multiple congenital anomalies).
- Chromosomal / genetic disorders - Inherited metabolic disorders (Aa, fat or carbohydrate), Trisomies, Turner's syndrome,Vater's syndrome, CHARGE, DiGeorge or other 22q11 deletions, Major chromosomal duplications, deletions detectable on high resolution karyotype (not microarray).
- Parent(s) unwilling to participate in follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of subjects that have a report of a spontaneous closure of PDA, medication intervention for closure of PDA or surgical intervention for closure of PDA
Time frame: 18 months
1 secondary outcome
Number of subjects with or without a closure of PDA that have heart failure, pulmonary arterial hypertension, a need for respiratory support and death
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Derived from this study: PubMed 34293369Tolia VN, Powers GC, Kelleher AS, Walker MW, Herrman KK, Ahmad KA, Buchh B, Egalka MC, Hinkes M, Ma M, Richards M, Rudine AC, Sato RY, Shaffer KM, Clark RH. Low Rate of Spontaneous Closure in Premature Infants Discharged with a Patent Ductus Arteriosus: A Multicenter Prospective Study. J Pediatr. 2022 Jan;240:31-36.e2. doi: 10.1016/j.jpeds.2021.07.035. Epub 2021 Jul 20.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Ductus Arteriosus, run by Pediatrix at 16 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects that have a report of a spontaneous closure of PDA, medication intervention for closure of PDA or surgical intervention for closure of PDA (time frame: 18 months). 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 NCT02750228, 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 30 Jun 2020.