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Paracetamol (Acetaminophen) for Closure of PDA in Preterm Infants

Information source: Hillel Yaffe Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: PDA

Intervention: Paracetamol (Drug); Ibuprofen (Drug); Closure of PDA (Procedure)

Phase: Phase 3

Status: Recruiting

Sponsored by: Hillel Yaffe Medical Center

Official(s) and/or principal investigator(s):
Erez Nadir, MD, Principal Investigator, Affiliation: Hillel Yaffe medical center, Hadera, Israel

Overall contact:
Erez Nadir, MD, Phone: +97246304320, Email: erezn@hy.health.gov.il

Summary

There is a report that acetaminophen may have a role in pharmacological closure of PDA (Patent arterial duct) in preterm infants. The investigators conducted this open label non randomized and non control study to try to support that report.

Clinical Details

Official title: Paracetamol (Acetaminophen) for Closure of PDA in Preterm Infants

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Closure of arterial duct - yes / No

Secondary outcome: Need for surgical closure of arterial duct

Detailed description: In-uteri, the arterial duct connects between the aorta and the main pulmonary artery, thus bypassing the lungs. Since the high pulmonary pressure and the low systemic pressure, the shunt trough the arterial duct in that time is right to left. After birth, systemic pressure rises and pulmonary pressure declines. As oxygen saturation rises, and prostaglandin secretion, the arterial duct closes, usually. In preterm infants, the arterial duct may remain open after birth. At this tume the shunt would be left to right, that would cause pulmonary congestion, and systemic hypoperfusion. Ibuprofen is the treatment of choice for PDA in preterm infants. Yet, ibuprofen is not effective after two weeks of age. Moreover, there are situations that prevent treatment with ibuprofen, such as thrombocytopenia or renal failure. Surgical closure of arterial duct is an alternative treatment, if ibuprofen is contraindicated, or if it fails. Lastly, there was a report that acetaminophen may have a role in pharmacological closure of PDA in preterm infants. The investigators conducted this open label non randomized and non control study to try to support that report.

Eligibility

Minimum age: N/A. Maximum age: 4 Months. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Preterm infants with symptomatic PDA who could not be treated with ibuprofen

Exclusion Criteria:

- None

Locations and Contacts

Erez Nadir, MD, Phone: +97246304320, Email: erezn@hy.health.gov.il

Neonatal intensive care unit, Hillel Yaffe medical center, Hadera 38100, Israel; Recruiting
Erez Nadir, MD, Phone: +97246304320, Email: erezn@hy.health.gov.il
Michael Feldman, MD, Phone: +97246304320, Email: feldman@hy.health.gov.il
Erez Nadir, MD, Principal Investigator
Additional Information

Related publications:

Hammerman C, Bin-Nun A, Markovitch E, Schimmel MS, Kaplan M, Fink D. Ductal closure with paracetamol: a surprising new approach to patent ductus arteriosus treatment. Pediatrics. 2011 Dec;128(6):e1618-21. doi: 10.1542/peds.2011-0359. Epub 2011 Nov 7.

Hammerman C, Bin-Nun A, Kaplan M. Managing the patent ductus arteriosus in the premature neonate: a new look at what we thought we knew. Semin Perinatol. 2012 Apr;36(2):130-8. doi: 10.1053/j.semperi.2011.09.023. Review.

Oncel MY, Yurttutan S, Uras N, Altug N, Ozdemir R, Ekmen S, Erdeve O, Dilmen U. An alternative drug (paracetamol) in the management of patent ductus arteriosus in ibuprofen-resistant or contraindicated preterm infants. Arch Dis Child Fetal Neonatal Ed. 2013 Jan;98(1):F94. doi: 10.1136/archdischild-2012-302044. Epub 2012 May 18.

Peterson RG. Consequences associated with nonnarcotic analgesics in the fetus and newborn. Fed Proc. 1985 Apr;44(7):2309-13. Review.

Rudolph AM. Effects of aspirin and acetaminophen in pregnancy and in the newborn. Arch Intern Med. 1981 Feb 23;141(3 Spec No):358-63.

Simbi KA, Secchieri S, Rinaldo M, Demi M, Zanardo V. In utero ductal closure following near-term maternal self-medication with nimesulide and acetaminophen. J Obstet Gynaecol. 2002 Jul;22(4):440-1.

Weintraub A, Mankuta D. Dipyrone-induced oligohydramnios and ductus arteriosus restriction. Isr Med Assoc J. 2006 Oct;8(10):722-3.

Burdan F, Starosławska E, Szumiło J. Prenatal tolerability of acetaminophen and other over-the-counter non-selective cyclooxygenase inhibitors. Pharmacol Rep. 2012;64(3):521-7. Review.

Starting date: January 2013
Last updated: March 17, 2015

Page last updated: August 23, 2015

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