Patent Ductus Arteriosus
Conditions
Brief summary
This study will evaluate the use of acetaminophen in preterm infants when a patent ductus arteriosus (PDA) is of concern. We will perform two simultaneous prospective observational studies over a 3 year period. The first will be of infants with clinically significant PDAs beyond 14 days of life who are medically treated with acetaminophen as a means to avoid surgical ligation, and the second will be of infants who received acetaminophen for a PDA closure during the first 2 weeks of life as a result of ibuprofen, the current standard of care in our NICU, contraindication due to medical status.
Interventions
DRUGAcetaminophen
Acetaminophen given at discretion of medical team for PDA treatment. Research team to evaluate pre and post laboratory values and echocardiograms.
Sponsors
Albany Medical College
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
23 Weeks to 30 Weeks
Healthy volunteers
No
Inclusion criteria
* Infants born at 23 0/7 to 29 6/7 weeks gestation, with PDA determined by medical team to need treatment and infant is beyond 14 days of life.
Exclusion criteria
* Congenital heart disease Pneumonia Pulmonary hypertension Pulmonary hemorrhage ALT and AST ≥ 2X the upper limit of normal (=AST\> 150 U/L, ALT\>90 U/L) Sepsis/meningitis Abnormal chromosomes Hydrops Major congenital malformations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of PDA closure | 3 days | PDA will be evaluated by echocardiography to determined whether it has closed after treatment is complete. |
| Change in PDA size | 3 days | Size of PDA will be measured by echocardiography to determine if the size has changed after treatment is complete. |
Countries
United States
Outcome results
None listed