NCT01755728|CompletedPhase 3
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Sponsor study identifier
interventional
19
1 country
1
Study Start
January 1, 2013
Actual (reported)Primary Completion
December 31, 2018
Actual (reported)Study Completion
December 31, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 16, 2012
Actual (reported)December 24, 2012
Actual (reported)January 1, 2013
Actual (reported)December 31, 2018
Actual (reported)December 31, 2018
Actual (reported)Closure of arterial duct - yes / No
Echo-cardiogram that will give exact answer to the question: "was the arterial duct closed"?
1 week
Need for surgical closure of arterial duct
1 week
Death or deterioration
1 week
For all infants, we do echo cardiogram study only if they are suspected of having PDA, due to sings and symptoms. Hence, we do not do echo cardiogram study to most of the infants.
If there is a PDA, that should be treated, and the infant is less than 2 weeks of age, we use ibuprofen, as this is the gold standard in literature.
Infants with symptomatic PDA, who had to be treated, but could not be treated by ibuprofen, either due to age (\> 2 weeks) or due ibuprofen contraindications (thrombocytopenia or renal failure), whose could not be treated by paracetamol (either because of parents' refuse or because they were on nothing per os protocol due to other disease), for whom surgery was the treatment of choice to close the arterial duct.
Per gavage paracetamol 15 mg/kg every 6 hours, for up to 7 days.
Per Gavage ibuprofen 10mg/kg x 3/d for up to 5 days Gold standard per literature
Neonatal intensive care unit, Hillel Yaffe medical center
Hadera, 38100, Israel
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.
Erez Nadir, MD
Hillel Yaffe medical center, Hadera, Israel
19 participants (actual enrollment reported by the registry).
First Submitted
December 16, 2012
First Posted
December 24, 2012
Study Start
January 1, 2013
Actual (reported)Maxigesic 325 Acute Dental Pain Study
Infants with symptomatic PDA who could not be treated with ibuprofen, and their parents agreed and they could be treated with paracetamol.
Infants with PDA, who did not get any treatment for it, and the duct was closed spontaneously.
Contact the study team to confirm eligibility.
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. No abstract available.
Peterson RG. Consequences associated with nonnarcotic analgesics in the fetus and newborn. Fed Proc. 1985 Apr;44(7):2309-13.
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. doi: 10.1001/archinte.141.3.358.
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. doi: 10.1080/01443610220141489. No abstract available.
Weintraub A, Mankuta D. Dipyrone-induced oligohydramnios and ductus arteriosus restriction. Isr Med Assoc J. 2006 Oct;8(10):722-3. No abstract available.
Burdan F, Staroslawska E, Szumilo J. Prenatal tolerability of acetaminophen and other over-the-counter non-selective cyclooxygenase inhibitors. Pharmacol Rep. 2012;64(3):521-7. doi: 10.1016/s1734-1140(12)70847-2.
Primary Completion
December 31, 2018
Actual (reported)Study Completion
December 31, 2018
Actual (reported)Last Updated
August 6, 2019
Record last verified: 2019-08
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