Paracetamol (Acetaminophen) for Closure of PDA in Preterm Infants
NCT ID: NCT01755728
Last Updated: 2019-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
19 participants
INTERVENTIONAL
2013-01-01
2018-12-31
Brief Summary
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The investigators conducted this open label non randomized and non control study to try to support that report.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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No known PDA
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.
No interventions assigned to this group
Ibuprofen
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.
Ibuprofen
Per Gavage ibuprofen 10mg/kg x 3/d for up to 5 days Gold standard per literature
Surgical closure of PDA
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.
Closure of PDA
Open surgery for closure of PDA
Paracetamol
Infants with symptomatic PDA who could not be treated with ibuprofen, and their parents agreed and they could be treated with paracetamol.
Paracetamol
Per gavage paracetamol 15 mg/kg every 6 hours, for up to 7 days.
DA closed spontaneously
Infants with PDA, who did not get any treatment for it, and the duct was closed spontaneously.
No interventions assigned to this group
Interventions
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Paracetamol
Per gavage paracetamol 15 mg/kg every 6 hours, for up to 7 days.
Ibuprofen
Per Gavage ibuprofen 10mg/kg x 3/d for up to 5 days Gold standard per literature
Closure of PDA
Open surgery for closure of PDA
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
4 Months
ALL
No
Sponsors
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Hillel Yaffe Medical Center
OTHER_GOV
Responsible Party
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Erez Nadir, MD
Senior neonatologist
Principal Investigators
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Erez Nadir, MD
Role: PRINCIPAL_INVESTIGATOR
Hillel Yaffe medical center, Hadera, Israel
Locations
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Neonatal intensive care unit, Hillel Yaffe medical center
Hadera, , Israel
Countries
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References
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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.
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.
Other Identifiers
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77-12-HYMC-CTIL
Identifier Type: -
Identifier Source: org_study_id
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