Treatment of a PDA With Acetaminophen in Preterm Neonates: Exploring Various Indications

Patent Ductus Arteriosus Clinical Trial

Official title:

Treatment of a PDA With Acetaminophen in Preterm Neonates: Exploring Various Indications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03289390
• Other study ID #: 4846
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: January 2020
• Source: Albany Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Weeks to 30 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus

Intervention

Drug:
• Acetaminophen
Acetaminophen given at discretion of medical team for PDA treatment. Research team to evaluate pre and post laboratory values and echocardiograms.

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

References & Publications (2)

EL-Khuffash A, James AT, Cleary A, Semberova J, Franklin O, Miletin J. Late medical therapy of patent ductus arteriosus using intravenous paracetamol. Arch Dis Child Fetal Neonatal Ed. 2015 May;100(3):F253-6. doi: 10.1136/archdischild-2014-307930. Epub 2015 Feb 4. — View Citation

El-Mashad AE, El-Mahdy H, El Amrousy D, Elgendy M. Comparative study of the efficacy and safety of paracetamol, ibuprofen, and indomethacin in closure of patent ductus arteriosus in preterm neonates. Eur J Pediatr. 2017 Feb;176(2):233-240. doi: 10.1007/s00431-016-2830-7. Epub 2016 Dec 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of PDA closure	PDA will be evaluated by echocardiography to determined whether it has closed after treatment is complete.	3 days
Primary	Change in PDA size	Size of PDA will be measured by echocardiography to determine if the size has changed after treatment is complete.	3 days