Patent Ductus Arteriosus (PDA) Screening Trial

14:41 EDT 1st September 2014 | BioPortfolio

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.

Study Design

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

Conditions

Ductus Arteriosus, Patent

Intervention

Nondisclosure of screening echocardiogram results, Disclosure of screening echocardiogram results

Location

The Hospital of the University of Pennsylvania
Philadelphia
Pennsylvania
United States
19104

Status

Recruiting

Source

University of Pennsylvania

Results (where available)

View Results

Links

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Medical and Biotech [MESH] Definitions

The identification of selected parameters in newborn infants by various tests, examinations, or other procedures. Screening may be performed by clinical or laboratory measures. A screening test is designed to sort out healthy neonates (INFANT, NEWBORN) from those not well, but the screening test is not intended as a diagnostic device, rather instead as epidemiologic.

Measures for assessing the results of diagnostic and screening tests. Sensitivity represents the proportion of truly diseased persons in a screened population who are identified as being diseased by the test. It is a measure of the probability of correctly diagnosing a condition. Specificity is the proportion of truly nondiseased persons who are so identified by the screening test. It is a measure of the probability of correctly identifying a nondiseased person. (From Last, Dictionary of Epidemiology, 2d ed)

Positive test results in subjects who do not possess the attribute for which the test is conducted. The labeling of healthy persons as diseased when screening in the detection of disease. (Last, A Dictionary of Epidemiology, 2d ed)

Negative test results in subjects who possess the attribute for which the test is conducted. The labeling of diseased persons as healthy when screening in the detection of disease. (Last, A Dictionary of Epidemiology, 2d ed)

Testing or screening required by federal, state, or local law or other agencies for the diagnosis of specified conditions. It is usually limited to specific populations such as categories of health care providers, members of the military, and prisoners or to specific situations such as premarital examinations or donor screening.

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