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

NCT03289390 | Completed FDA Drug

• 1 other identifier: 4846
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Patent Ductus Arteriosus

Outcome Measures

Primary Outcomes (2)

• Rate of PDA closure

  PDA will be evaluated by echocardiography to determined whether it has closed after treatment is complete.

  3 days

• 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

Study Arms (1)

Acetaminophen to close PDA

Infants with PDA treated with acetaminophen beyond 14 days of life or in whom acetaminophen is used due to contraindication to ibuprofen

Drug: Acetaminophen

Interventions

Acetaminophen DRUG

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

Acetaminophen to close PDA

Eligibility Criteria

• Age: 23 Weeks - 30 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Premature infants born between 23 0/7 weeks to 29 6/7 weeks gestational age.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Albany Medical Center

Albany, New York, 12208, United States

Location

Related Publications (2)

• 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.

  PMID: 28004188 BACKGROUND

• 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.

  PMID: 25653299 BACKGROUND

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 21, 2017
• Study Start: August 1, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)