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PDA | Paracetamol (Acetaminophen) for Closure of PDA in Preterm Infants

PDA research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - Preterm infants with symptomatic PDA who could not be treated with ibuprofen Exclusion Criteria:

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

PDA

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:ParacetamolPer gavage paracetamol 15 mg/kg every 6 hours, for up to 7 days.

Drug:IbuprofenPer Gavage ibuprofen 10mg/kg x 3/d for up to 5 days Gold standard per literature

Procedure:Closure of PDAOpen surgery for closure of PDA

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

No known PDAFor 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.

IbuprofenIf 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.

Surgical closure of PDAInfants 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.

ParacetamolInfants with symptomatic PDA who could not be treated with ibuprofen, and their parents agreed and they could be treated with paracetamol.

DA closed spontaneouslyInfants with PDA, who did not get any treatment for it, and the duct was closed spontaneously.

Study Status

Recruiting

Start Date: January 1, 2013

Completed Date: December 31, 2020

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Closure of arterial duct - yes / No

Secondary Outcome: Need for surgical closure of arterial duct

Study sponsors, principal investigator, and references

Principal Investigator: Erez Nadir, MD

Lead Sponsor: Hillel Yaffe Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01755728

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.

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