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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nondisclosure | Experimental |
| |
| Disclosure | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nondisclosure of screening echocardiogram results | Other | Subjects will be randomized to nondisclosure of screening echocardiogram results. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of days to regain birth weight. | 1-4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Schmidt, MD | University of Pennsylvania/Children's Hospital of Philadelphia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States | ||
| Pennsylvania Hospital |
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| ID | Term |
|---|---|
| D004374 | Ductus Arteriosus, Patent |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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| Disclosure of screening echocardiogram results | Other | Subjects will be randomized to disclosure of screening echocardiogram results. |
|
| 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 |
| Confirmed or suspected sepsis. | 3-6 months |
| Worst stage of retinopathy of prematurity. | 3-6 months |
| Day of death or discharge. | 3-6 months |
| Philadelphia |
| Pennsylvania |
| 19107 |
| United States |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |