Patent Ductus Arteriosus (PDA) Screening Trial
Primary Purpose
Ductus Arteriosus, Patent
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nondisclosure of screening echocardiogram results
Disclosure of screening echocardiogram results
Sponsored by
About this trial
This is an interventional screening trial for Ductus Arteriosus, Patent focused on measuring Echocardiography, Infant, Premature, Infant, Very Low Birth Weight
Eligibility Criteria
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)
Sites / Locations
- The Hospital of the University of Pennsylvania
- Pennsylvania Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nondisclosure
Disclosure
Arm Description
Outcomes
Primary Outcome Measures
Number of days to regain birth weight.
Secondary Outcome Measures
Treatment for a PDA with indomethacin or surgical ligation.
Necrotising enterocolitis (NEC) or >48 hours of NPO status for suspected NEC or feeding intolerance.
Number of days to 120ml/kg/day of enteral feedings (full feeds).
Ventilator days, number of days of positive airway pressure, and number of days in oxygen.
Worst grade of intraventricular hemorrhage and presence of periventricular leukomalacia.
Confirmed or suspected sepsis.
Worst stage of retinopathy of prematurity.
Day of death or discharge.
Full Information
NCT ID
NCT01031316
First Posted
December 1, 2009
Last Updated
December 31, 2013
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT01031316
Brief Title
Patent Ductus Arteriosus (PDA) Screening Trial
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ductus Arteriosus, Patent
Keywords
Echocardiography, Infant, Premature, Infant, Very Low Birth Weight
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nondisclosure
Arm Type
Experimental
Arm Title
Disclosure
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Nondisclosure of screening echocardiogram results
Intervention Description
Subjects will be randomized to nondisclosure of screening echocardiogram results.
Intervention Type
Other
Intervention Name(s)
Disclosure of screening echocardiogram results
Intervention Description
Subjects will be randomized to disclosure of screening echocardiogram results.
Primary Outcome Measure Information:
Title
Number of days to regain birth weight.
Time Frame
1-4 weeks
Secondary Outcome Measure Information:
Title
Treatment for a PDA with indomethacin or surgical ligation.
Time Frame
3-6 months
Title
Necrotising enterocolitis (NEC) or >48 hours of NPO status for suspected NEC or feeding intolerance.
Time Frame
3-6 months
Title
Number of days to 120ml/kg/day of enteral feedings (full feeds).
Time Frame
3-6 months
Title
Ventilator days, number of days of positive airway pressure, and number of days in oxygen.
Time Frame
3-6 months
Title
Worst grade of intraventricular hemorrhage and presence of periventricular leukomalacia.
Time Frame
3-6 months
Title
Confirmed or suspected sepsis.
Time Frame
3-6 months
Title
Worst stage of retinopathy of prematurity.
Time Frame
3-6 months
Title
Day of death or discharge.
Time Frame
3-6 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
72 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Schmidt, MD
Organizational Affiliation
University of Pennsylvania/Children's Hospital of Philadelphia
Official's Role
Study Director
Facility Information:
Facility Name
The Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
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Patent Ductus Arteriosus (PDA) Screening Trial
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