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Patent Ductus Arteriosus (PDA) Screening Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01031316
Recruitment Status : Completed
First Posted : December 14, 2009
Last Update Posted : January 3, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Ductus Arteriosus, Patent Other: Nondisclosure of screening echocardiogram results Other: Disclosure of screening echocardiogram results

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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 Start Date : October 2009
Primary Completion Date : April 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Nondisclosure Other: Nondisclosure of screening echocardiogram results
Subjects will be randomized to nondisclosure of screening echocardiogram results.
Active Comparator: Disclosure Other: Disclosure of screening echocardiogram results
Subjects will be randomized to disclosure of screening echocardiogram results.

Outcome Measures

Primary Outcome Measures :
  1. Number of days to regain birth weight. [ Time Frame: 1-4 weeks ]

Secondary Outcome Measures :
  1. Treatment for a PDA with indomethacin or surgical ligation. [ Time Frame: 3-6 months ]
  2. Necrotising enterocolitis (NEC) or >48 hours of NPO status for suspected NEC or feeding intolerance. [ Time Frame: 3-6 months ]
  3. Number of days to 120ml/kg/day of enteral feedings (full feeds). [ Time Frame: 3-6 months ]
  4. Ventilator days, number of days of positive airway pressure, and number of days in oxygen. [ Time Frame: 3-6 months ]
  5. Worst grade of intraventricular hemorrhage and presence of periventricular leukomalacia. [ Time Frame: 3-6 months ]
  6. Confirmed or suspected sepsis. [ Time Frame: 3-6 months ]
  7. Worst stage of retinopathy of prematurity. [ Time Frame: 3-6 months ]
  8. Day of death or discharge. [ Time Frame: 3-6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01031316

United States, Pennsylvania
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
University of Pennsylvania
Study Director: Barbara Schmidt, MD University of Pennsylvania/Children's Hospital of Philadelphia
More Information

Responsible Party: Sara DeMauro, Assistant Professor of Pediatrics, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01031316     History of Changes
Other Study ID Numbers: 810241
First Posted: December 14, 2009    Key Record Dates
Last Update Posted: January 3, 2014
Last Verified: December 2013

Keywords provided by Sara DeMauro, University of Pennsylvania:
Infant, Premature
Infant, Very Low Birth Weight

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities