Clinical Trial: Patent Ductus Arteriosus (PDA) Screening Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: University of Pennsylvania

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: University of Pennsylvania

Dates:
Date Received: December 1, 2009
Date Started: October 2009
Date Completion:
Last Updated: December 31, 2013
Last Verified: December 2013