Patent Ductus Arteriosus (PDA) Screening Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sara DeMauro, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01031316
First received: December 1, 2009
Last updated: December 31, 2013
Last verified: December 2013

December 1, 2009
December 31, 2013
October 2009
April 2011   (final data collection date for primary outcome measure)
Number of days to regain birth weight. [ Time Frame: 1-4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01031316 on ClinicalTrials.gov Archive Site
  • Treatment for a PDA with indomethacin or surgical ligation. [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
  • Necrotising enterocolitis (NEC) or >48 hours of NPO status for suspected NEC or feeding intolerance. [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
  • Number of days to 120ml/kg/day of enteral feedings (full feeds). [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
  • Ventilator days, number of days of positive airway pressure, and number of days in oxygen. [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
  • Worst grade of intraventricular hemorrhage and presence of periventricular leukomalacia. [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
  • Confirmed or suspected sepsis. [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
  • Worst stage of retinopathy of prematurity. [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
  • Day of death or discharge. [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Ductus Arteriosus, Patent
  • Other: Nondisclosure of screening echocardiogram results
    Subjects will be randomized to nondisclosure of screening echocardiogram results.
  • Other: Disclosure of screening echocardiogram results
    Subjects will be randomized to disclosure of screening echocardiogram results.
  • Experimental: Nondisclosure
    Intervention: Other: Nondisclosure of screening echocardiogram results
  • Active Comparator: Disclosure
    Intervention: Other: Disclosure of screening echocardiogram results
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
August 2011
April 2011   (final data collection date for primary outcome measure)

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)
Both
up to 72 Hours
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01031316
810241
No
Sara DeMauro, University of Pennsylvania
University of Pennsylvania
Not Provided
Study Director: Barbara Schmidt, MD University of Pennsylvania/Children's Hospital of Philadelphia
University of Pennsylvania
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP