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Trial record 54 of 1889 for:    Acetaminophen

Treatment of a PDA With Acetaminophen in Preterm Neonates: Exploring Various Indications

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ClinicalTrials.gov Identifier: NCT03289390
Recruitment Status : Recruiting
First Posted : September 21, 2017
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
Ronnelle King, Albany Medical College

Brief Summary:
This study will evaluate the use of acetaminophen in preterm infants when a patent ductus arteriosus (PDA) is of concern. We will perform two simultaneous prospective observational studies over a 3 year period. The first will be of infants with clinically significant PDAs beyond 14 days of life who are medically treated with acetaminophen as a means to avoid surgical ligation, and the second will be of infants who received acetaminophen for a PDA closure during the first 2 weeks of life as a result of ibuprofen, the current standard of care in our NICU, contraindication due to medical status.

Condition or disease Intervention/treatment
Patent Ductus Arteriosus Drug: Acetaminophen

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Study Type : Observational
Estimated Enrollment : 62 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment of a PDA With Acetaminophen in Preterm Neonates: Exploring Various Indications
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Acetaminophen to close PDA
Infants with PDA treated with acetaminophen beyond 14 days of life or in whom acetaminophen is used due to contraindication to ibuprofen
Drug: Acetaminophen
Acetaminophen given at discretion of medical team for PDA treatment. Research team to evaluate pre and post laboratory values and echocardiograms.




Primary Outcome Measures :
  1. Rate of PDA closure [ Time Frame: 3 days ]
    PDA will be evaluated by echocardiography to determined whether it has closed after treatment is complete.

  2. Change in PDA size [ Time Frame: 3 days ]
    Size of PDA will be measured by echocardiography to determine if the size has changed after treatment is complete.



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Ages Eligible for Study:   23 Weeks to 30 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Premature infants born between 23 0/7 weeks to 29 6/7 weeks gestational age.
Criteria

Inclusion Criteria:

  • Infants born at 23 0/7 to 29 6/7 weeks gestation, with PDA determined by medical team to need treatment and infant is beyond 14 days of life.

Exclusion Criteria:

  • Congenital heart disease Pneumonia Pulmonary hypertension Pulmonary hemorrhage ALT and AST ≥ 2X the upper limit of normal (=AST> 150 U/L, ALT>90 U/L) Sepsis/meningitis Abnormal chromosomes Hydrops Major congenital malformations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03289390


Contacts
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Contact: Ronnelle King, MD 518-262-5421 kingr2@mail.amc.edu
Contact: Kate Tauber, MD 518-262-5421 tauberk@mail.amc.edu

Locations
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United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Ronnelle King, MD    518-262-5421    kingr2@mail.amc.edu   
Contact: Kate Tauber, MD    518-262-5421    tauberk@mail.amc.edu   
Sponsors and Collaborators
Albany Medical College

Publications:
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Responsible Party: Ronnelle King, MD, Albany Medical College
ClinicalTrials.gov Identifier: NCT03289390     History of Changes
Other Study ID Numbers: 4846
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acetaminophen
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics