Patent Ductus Arteriosus (PDA) Screening Trial

Ductus Arteriosus, Patent Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01031316
• Other study ID #: 810241
• Status: Completed
• Phase: N/A
• First received: December 1, 2009
• Last updated: December 31, 2013
• Start date: October 2009
• Est. completion date: August 2011

Study information

• Verified date: December 2013
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: August 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 72 Hours

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent

Intervention

Other:
• Nondisclosure of screening echocardiogram results
Subjects will be randomized to nondisclosure of screening echocardiogram results.
• Disclosure of screening echocardiogram results
Subjects will be randomized to disclosure of screening echocardiogram results.

Locations

Country	Name	City	State
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	The Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days to regain birth weight.		1-4 weeks	Yes
Secondary	Treatment for a PDA with indomethacin or surgical ligation.		3-6 months	Yes
Secondary	Necrotising enterocolitis (NEC) or >48 hours of NPO status for suspected NEC or feeding intolerance.		3-6 months	Yes
Secondary	Number of days to 120ml/kg/day of enteral feedings (full feeds).		3-6 months	Yes
Secondary	Ventilator days, number of days of positive airway pressure, and number of days in oxygen.		3-6 months	Yes
Secondary	Worst grade of intraventricular hemorrhage and presence of periventricular leukomalacia.		3-6 months	Yes
Secondary	Confirmed or suspected sepsis.		3-6 months	Yes
Secondary	Worst stage of retinopathy of prematurity.		3-6 months	Yes
Secondary	Day of death or discharge.		3-6 months	Yes