Ductus Arteriosus, PatentNCT01031316
Patent Ductus Arteriosus (PDA) Screening Trial
A study testing Nondisclosure of screening echocardiogram results and Disclosure of screening echocardiogram results in people with Ductus Arteriosus, Patent, run by University of Pennsylvania at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 72 hours
- Conditions the study is for
- Ductus Arteriosus, Patent
- What is being tested?
- Nondisclosure of screening echocardiogram results and Disclosure of screening echocardiogram results
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2009to Aug 2011
- Phase
- Interventional
- 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 Up to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- not considered viable
- dysmorphic features or congenital malformations that adversely affect growth
- have known or suspected congenital heart disease (other than PDA)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
About this study
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
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.
- Conditions
- Ductus Arteriosus, Patent
- Being tested
- Nondisclosure of screening echocardiogram results, Disclosure of screening echocardiogram results
- Keywords
- Echocardiography, Infant, Premature, Infant, Very Low Birth Weight
- Medical subject headings
- Ductus Arteriosus, Patent, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nondisclosure of screening echocardiogram resultsOther
Subjects will be randomized to nondisclosure of screening echocardiogram results.
Disclosure of screening echocardiogram resultsOther
Subjects will be randomized to disclosure of screening echocardiogram results.
| Study group | Role | What they receive |
|---|---|---|
| Nondisclosure | Experimental | Not described Receives: Other: Nondisclosure of screening echocardiogram results |
| Disclosure | Active comparator | Not described Receives: Other: Disclosure of screening echocardiogram results |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days to regain birth weight.
Measured: 1-4 weeks
Secondary outcomes (8)
Treatment for a PDA with indomethacin or surgical ligation.
Measured: 3-6 months
Necrotising enterocolitis (NEC) or >48 hours of NPO status for suspected NEC or feeding intolerance.
Measured: 3-6 months
Number of days to 120ml/kg/day of enteral feedings (full feeds).
Measured: 3-6 months
Ventilator days, number of days of positive airway pressure, and number of days in oxygen.
Measured: 3-6 months
Worst grade of intraventricular hemorrhage and presence of periventricular leukomalacia.
Measured: 3-6 months
Confirmed or suspected sepsis.
Measured: 3-6 months
Worst stage of retinopathy of prematurity.
Measured: 3-6 months
Day of death or discharge.
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study startOct 2009
- Primary completionApr 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductus Arteriosus, PatentStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara DeMauro, University of Pennsylvania
- Investigators
- Barbara Schmidt, MD, Study director, University of Pennsylvania/Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031316
- Sponsor's protocol ID
- 810241
- Status last verified
- Dec 2013
- First submitted
- 1 Dec 2009
- Last updated
- 3 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01031316
- Acronym / sponsor ID
- 810241
- Conditions
- Ductus Arteriosus, Patent
- Keywords
- Echocardiography, Infant, Premature, Infant, Very Low Birth Weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 14 Dec 2009 (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 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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nondisclosure | Experimental | Other: Nondisclosure of screening echocardiogram results |
| Disclosure | Active comparator | Other: Disclosure of screening echocardiogram results |
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- not considered viable
- dysmorphic features or congenital malformations that adversely affect growth
- have known or suspected congenital heart disease (other than PDA)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nondisclosure of screening echocardiogram resultsSubjects will be randomized to nondisclosure of screening echocardiogram results. | Other | Nondisclosure |
| Disclosure of screening echocardiogram resultsSubjects will be randomized to disclosure of screening echocardiogram results. | Other | Disclosure |
Primary outcome
Number of days to regain birth weight.
Time frame: 1-4 weeks
8 secondary outcomes
Treatment for a PDA with indomethacin or surgical ligation.
Time frame: 3-6 months
Necrotising enterocolitis (NEC) or >48 hours of NPO status for suspected NEC or feeding intolerance.
Time frame: 3-6 months
Number of days to 120ml/kg/day of enteral feedings (full feeds).
Time frame: 3-6 months
Ventilator days, number of days of positive airway pressure, and number of days in oxygen.
Time frame: 3-6 months
Worst grade of intraventricular hemorrhage and presence of periventricular leukomalacia.
Time frame: 3-6 months
Confirmed or suspected sepsis.
Time frame: 3-6 months
Worst stage of retinopathy of prematurity.
Time frame: 3-6 months
Day of death or discharge.
Time frame: 3-6 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 3 Jan 2014.
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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.
Barbara Schmidt, MD study director
University of Pennsylvania/Children's Hospital of Philadelphia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nondisclosure of screening echocardiogram results and Disclosure of screening echocardiogram results in people with Ductus Arteriosus, Patent, run by University of Pennsylvania at 2 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 4 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 3 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 days to regain birth weight. (time frame: 1-4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jan 2014.