- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01031316
Patent Ductus Arteriosus (PDA) Screening Trial
The Role of Serial Echocardiography to Detect an Asymptomatic Patent Ductus Arteriosus (PDA) in Very Low Birth Weight (VLBW) Infants: A Pilot Randomized Controlled Trial
The ductus arteriosus directs blood away from the pulmonary circulation and toward the systemic circulation during fetal life, then closes after birth. In preterm infants the incidence of spontaneous closure decreases with gestational age. Patent ductus arteriosus (PDA) increases the risks of bronchopulmonary dysplasia (BPD) and necrotizing enterocolitis (NEC). However, this association may not be a causal relationship.
Echocardiography is required to diagnose PDA. However, routine screening echocardiograms lead to detection of asymptomatic PDAs, for which the benefit of therapy remains unproven.
A randomized controlled trial has been designed in which 88 infants with birth weight less than or equal to 1250 grams and gestational age less than or equal to 30 weeks will be enrolled. The investigators' goal is to determine how screening echocardiography influences clinical management and outcomes in these infants.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- The Hospital of the University of Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Pennsylvania Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- birth weight less than or equal to 1250 grams
- gestational age less than or equal to 30 weeks
- postnatal age less than or equal to 72 hours
- have a guardian or acceptable surrogate capable of giving consent on his/her behalf
Exclusion Criteria:
- not considered viable
- dysmorphic features or congenital malformations that adversely affect growth
- have known or suspected congenital heart disease (other than PDA)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nondisclosure
|
Subjects will be randomized to nondisclosure of screening echocardiogram results.
|
Active Comparator: Disclosure
|
Subjects will be randomized to disclosure of screening echocardiogram results.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of days to regain birth weight.
Time Frame: 1-4 weeks
|
1-4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Treatment for a PDA with indomethacin or surgical ligation.
Time Frame: 3-6 months
|
3-6 months
|
Necrotising enterocolitis (NEC) or >48 hours of NPO status for suspected NEC or feeding intolerance.
Time Frame: 3-6 months
|
3-6 months
|
Number of days to 120ml/kg/day of enteral feedings (full feeds).
Time Frame: 3-6 months
|
3-6 months
|
Ventilator days, number of days of positive airway pressure, and number of days in oxygen.
Time Frame: 3-6 months
|
3-6 months
|
Worst grade of intraventricular hemorrhage and presence of periventricular leukomalacia.
Time Frame: 3-6 months
|
3-6 months
|
Confirmed or suspected sepsis.
Time Frame: 3-6 months
|
3-6 months
|
Worst stage of retinopathy of prematurity.
Time Frame: 3-6 months
|
3-6 months
|
Day of death or discharge.
Time Frame: 3-6 months
|
3-6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Barbara Schmidt, MD, University of Pennsylvania/Children's Hospital of Philadelphia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 810241
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ductus Arteriosus, Patent
-
PFM Medical, IncBright Research PartnersCompleted
-
Abbott Medical DevicesCompletedPatent Ductus Arteriosus (PDA)United States
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaCompletedPatent Ductus Arteriosus | Patent Ductus Arteriosus After Premature Birth | Patent Ductus Arteriosus - Delayed ClosureItaly, United Kingdom
-
Ankara UniversityCompletedPatent Ductus Arteriosus in Preterm InfantsTurkey
-
Nada YoussefCompletedPatent Ductus Arteriosus After Premature Birth | Patent Ductus Arteriosus Conservative ManagementEgypt
-
Abbott Medical DevicesNo longer availablePatent | Ductus | Arteriosus
-
University of FlorenceCompletedDuctus Arteriosus, PatentItaly
-
National Taiwan University HospitalCompletedPatent Ductus Arteriosus
-
Rambam Health Care CampusCompletedDuctus Arteriosus, PatentIsrael
-
Soha mahmoud Hussien mahdyAssiut UniversityNot yet recruiting
Clinical Trials on Nondisclosure of screening echocardiogram results
-
Universitätsklinikum Hamburg-EppendorfGerman Research FoundationCompletedDepression | Major Depressive DisorderGermany
-
Tampere University HospitalKarolinska Institutet; Tampere University; European UnionEnrolling by invitationCervical Intraepithelial Neoplasia Grade 2/3 | Adenocarcinoma in SituFinland
-
M.D. Anderson Cancer CenterCompleted
-
Africa Mental Health FoundationUniversity of British Columbia; Grand Challenges Canada; Nextgenu.org; CliniX Healthcare... and other collaboratorsCompletedSubstance-Related Disorders | Alcohol-Related Disorders | Social StigmaKenya
-
Guangdong Provincial People's HospitalCompletedBlood Pressure | Congenital Heart Disease in Children | Coarctation of Aorta | Interrupted Aortic Arch | Hypoplasia of Aorta
-
Foundation for Sarcoidosis ResearchRecruitingSarcoidosis | Cardiac Sarcoidosis | Boeck's Disease | Besnier-Boeck DiseaseUnited States, United Kingdom, Netherlands
-
Mount Sinai Hospital, CanadaUnknownDementia | Major Depressive DisorderCanada
-
ViiV HealthcareGlaxoSmithKlineCompletedInfection, Human Immunodeficiency VirusUnited Kingdom