Patent Ductus Arteriosus (PDA) Screening Trial

NCT01031316 | Completed

• 1 other identifier: 810241
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

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.

Conditions

Ductus Arteriosus, Patent

Keywords

Echocardiography; Infant, Premature; Infant, Very Low Birth Weight

Outcome Measures

Primary Outcomes (1)

• Number of days to regain birth weight.

  1-4 weeks

Secondary Outcomes (8)

• Treatment for a PDA with indomethacin or surgical ligation.

  3-6 months

• Necrotising enterocolitis (NEC) or >48 hours of NPO status for suspected NEC or feeding intolerance.

  3-6 months

• Number of days to 120ml/kg/day of enteral feedings (full feeds).

  3-6 months

• Ventilator days, number of days of positive airway pressure, and number of days in oxygen.

  3-6 months

• Worst grade of intraventricular hemorrhage and presence of periventricular leukomalacia.

  3-6 months

Study Arms (2)

Nondisclosure

EXPERIMENTAL

Other: Nondisclosure of screening echocardiogram results

Disclosure

ACTIVE COMPARATOR

Other: Disclosure of screening echocardiogram results

Interventions

Nondisclosure of screening echocardiogram results OTHER

Subjects will be randomized to nondisclosure of screening echocardiogram results.

Nondisclosure

Disclosure of screening echocardiogram results OTHER

Subjects will be randomized to disclosure of screening echocardiogram results.

Disclosure

Eligibility Criteria

• Age: Up to 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• not considered viable
• dysmorphic features or congenital malformations that adversely affect growth
• have known or suspected congenital heart disease (other than PDA)

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (2)

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Ductus Arteriosus, Patent; Premature Birth

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Barbara Schmidt, MD

  University of Pennsylvania/Children's Hospital of Philadelphia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 14, 2009
• Study Start: October 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: August 1, 2011
• Last Updated: January 3, 2014

Record last verified: 2013-12

Locations

US (2)