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Paracetamol (Acetaminophen) for Closure of PDA in Preterm Infants

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ClinicalTrials.gov Identifier: NCT01755728
Recruitment Status : Completed
First Posted : December 24, 2012
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Erez Nadir, MD, Hillel Yaffe Medical Center

Tracking Information
First Submitted Date  ICMJE December 16, 2012
First Posted Date  ICMJE December 24, 2012
Last Update Posted Date August 6, 2019
Actual Study Start Date  ICMJE January 1, 2013
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2012)
Closure of arterial duct - yes / No [ Time Frame: 1 week ]
Echo-cardiogram that will give exact answer to the question: "was the arterial duct closed"?
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2012)
Need for surgical closure of arterial duct [ Time Frame: 1 week ]
The clinical state of the infant will guide the team to ask the parents and the chest surgeon to surgically close the arterial duct
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 19, 2012)
Death or deterioration [ Time Frame: 1 week ]
The infant state deteriorates so quickly that it will die, either because of complication of the arterial duct, or because other causes, such as sepsis, metabolic disorder, etc...
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Paracetamol (Acetaminophen) for Closure of PDA in Preterm Infants
Official Title  ICMJE Paracetamol (Acetaminophen) for Closure of PDA in Preterm Infants
Brief 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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE PDA
Intervention  ICMJE
  • Drug: Paracetamol
    Per gavage paracetamol 15 mg/kg every 6 hours, for up to 7 days.
    Other Name: Acetaminophen
  • Drug: Ibuprofen
    Per Gavage ibuprofen 10mg/kg x 3/d for up to 5 days Gold standard per literature
  • Procedure: Closure of PDA
    Open surgery for closure of PDA
Study Arms  ICMJE
  • No Intervention: 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.
  • Active Comparator: 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.
    Intervention: Drug: Ibuprofen
  • Active Comparator: 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.
    Intervention: Procedure: Closure of PDA
  • Experimental: Paracetamol
    Infants with symptomatic PDA who could not be treated with ibuprofen, and their parents agreed and they could be treated with paracetamol.
    Intervention: Drug: Paracetamol
  • No Intervention: DA closed spontaneously
    Infants with PDA, who did not get any treatment for it, and the duct was closed spontaneously.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 5, 2019)
19
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2012)
20
Actual Study Completion Date  ICMJE December 31, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 4 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01755728
Other Study ID Numbers  ICMJE 77-12-HYMC-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Erez Nadir, MD, Hillel Yaffe Medical Center
Study Sponsor  ICMJE Hillel Yaffe Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Erez Nadir, MD Hillel Yaffe medical center, Hadera, Israel
PRS Account Hillel Yaffe Medical Center
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP