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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05340582
Registration number
NCT05340582
Ethics application status
Date submitted
16/03/2022
Date registered
22/04/2022
Date last updated
25/03/2025
Titles & IDs
Public title
Co-administration of Acetaminophen with Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants
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Scientific title
Co-administration of Acetaminophen with Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants - the ACEDUCT Trial
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Secondary ID [1]
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CTO 1875
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Patent Ductus Arteriosus After Premature Birth
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Condition category
Condition code
Reproductive Health and Childbirth
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Complications of newborn
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Reproductive Health and Childbirth
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Childbirth and postnatal care
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Reproductive Health and Childbirth
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Fetal medicine and complications of pregnancy
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Acetaminophen Injection
Treatment: Drugs - Ibuprofen 20 mg/mL oral suspension or Ibuprofen lysine 10 mg/mL injection solution (Neoprofen)
Other interventions - Sodium chloride 0.9% injection
Experimental: Combination Therapy - Intravenous or enteral ibuprofen, as decided by clinical team, in the standard clinical dose used in participating NICUs (typically, for neonates \< 7 days old - 10 mg/kg/dose on day 1, 5 mg/kg/dose q24h on days 2 and 3; for neonates \> 7 days old - 20 mg/kg/dose on day 1, 10 mg/kg/dose q24h on days 2 and 3) And study drug (intravenous acetaminophen 15 mg/kg/dose IV q6h for 3 days).
Placebo comparator: Standard Clinical Practice - Monotherapy - Intravenous or enteral ibuprofen, as decided by clinical team, in the standard clinical dose used in participating NICUs (typically, for neonates \< 7 days old - 10 mg/kg/dose on day 1, 5 mg/kg/dose q24h on days 2 and 3; for neonates \> 7 days old - 20 mg/kg/dose on day 1, 10 mg/kg/dose q24h on days 2 and 3) And Placebo \[(0.9% saline IV q6h for 3 days).
Treatment: Drugs: Acetaminophen Injection
Acetaminophen injection solution 1000 mg/100 mL (10 mg/mL) latex-free plastic bag - dosage for this protocol is 15mg/kg/dose IV four times a day for 3 days
Treatment: Drugs: Ibuprofen 20 mg/mL oral suspension or Ibuprofen lysine 10 mg/mL injection solution (Neoprofen)
Ibuprofen is not a study drug - standard of care in participating NICUs in the standard clinical dose for neonates (typically, for neonates \< 7 days old - 10 mg/kg/dose on day 1, 5 mg/kg/dose q24h on days 2 and 3; for neonates \> 7 days old - 20 mg/kg/dose on day 1, 10 mg/kg/dose q24h on days 2 and 3)
Other interventions: Sodium chloride 0.9% injection
Placebo- IV q6h for 3 days
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Composite of pre-discharge mortality or any grade BPD
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Assessment method [1]
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Need for oxygen or positive pressure respiratory support at 36 weeks postmenstrual age (PMA)
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Timepoint [1]
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36 weeks PMA
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Secondary outcome [1]
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PDA treatment success
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Assessment method [1]
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Defined as PDA closure or becoming insignificant \[diameter \<1.5 mm\]
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Timepoint [1]
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6-10 days post treatment initiation
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Secondary outcome [2]
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Renal or hepatic dysfunction
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Assessment method [2]
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Renal dysfunction defined as urine output \< 1ml/kg/hour for the previous 24 hours or serum creatinine \> 100 micromol/L; hepatic dysfunction defined as serum aminotransferase (ALT) \> 100 units/L
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Timepoint [2]
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Occurring within 7 days of treatment initiation
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Secondary outcome [3]
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Further exposure to pharmacological PDA treatments
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Assessment method [3]
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As per units' standard practice (not part of study procedures)
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Timepoint [3]
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From date of randomization until death, discharge home or discharge to a community hospital (whichever comes first) assessed up to a maximum of 250 days after randomization
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Secondary outcome [4]
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Procedure for PDA closure
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Assessment method [4]
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Surgical closure for PDA
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Timepoint [4]
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From date of randomization until death, discharge home or discharge to a community hospital (whichever comes first) assessed up to a maximum of 250 days after randomization
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Secondary outcome [5]
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Mortality
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Assessment method [5]
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Death during initial tertiary NICU stay
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Timepoint [5]
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From date of randomization until date of death (assessed up to a maximum of 250 days after randomization)
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Secondary outcome [6]
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Severity of BPD at 36 weeks PDM using Jensen's criteria
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Assessment method [6]
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Grade 1, nasal cannula =2 L/min; grade 2, nasal cannula \>2 L/min or noninvasive positive airway pressure; grade 3, invasive mechanical ventilation
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Timepoint [6]
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At 36 weeks PDM
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Secondary outcome [7]
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NEC = stage 2A
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Assessment method [7]
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NEC = stage 2A during NICU stay
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Timepoint [7]
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From date of randomization until death, discharge home or discharge to a community hospital (whichever comes first) assessed up to a maximum of 250 days after randomization
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Secondary outcome [8]
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Duration (days) of invasive or non-invasive respiratory support
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Assessment method [8]
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Days of invasive or non invasive support during NICU say
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Timepoint [8]
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From date of randomization until death, discharge home or discharge to a community hospital (whichever comes first) assessed up to a maximum of 250 days after randomization
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Secondary outcome [9]
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Need for diuretic use
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Assessment method [9]
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Diuretic use for BPD treatment
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Timepoint [9]
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From date of randomization until death, discharge home or discharge to a community hospital (whichever comes first) assessed up to a maximum of 250 days after randomization
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Secondary outcome [10]
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Need for systemic steroids
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Assessment method [10]
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Use for BPD treatment
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Timepoint [10]
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From date of randomization until death, discharge home or discharge to a community hospital (whichever comes first) assessed up to a maximum of 250 days after randomization
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Secondary outcome [11]
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Sepsis
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Assessment method [11]
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Diagnosis of sepsis during NICU stay
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Timepoint [11]
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From date of randomization until death, discharge home or discharge to a community hospital (whichever comes first) assessed up to a maximum of 250 days after randomization
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Eligibility
Key inclusion criteria
* Preterm infants born <27+0 weeks gestational age
* Permission given by the attending clinician to approach and then consent obtained from parents
* Diagnosis of PDA = 1.5 mm on echocardiography with unrestrictive predominantly left to right shunt
* Designated to receive first treatment course with intravenous or enteral ibuprofen, as decided by the attending team.
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Minimum age
No limit
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Maximum age
27
Weeks
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Chromosomal anomaly
* Pre-treatment renal dysfunction defined as urine output < 1ml/kg/hour for the previous 24 hours or serum creatinine > 100 micromol/L
* Pre-treatment hepatic dysfunction defined as serum aminotransferase (ALT) > 100 units/L94
* Platelet count <50,000 per microliter
* Permission denied by the attending clinician to approach parents
* Parental consent not available
* Previous exposure to PDA medical treatment with any drug (prophylactic indomethacin use for prevention of intraventricular hemorrhage will not be considered as PDA treatment).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/12/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2027
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Actual
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Sample size
Target
310
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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John Hunter Hospital - Newcastle
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Recruitment hospital [2]
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Royal North Shore Hospital - St Leonards
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Recruitment postcode(s) [1]
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2300 - Newcastle
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Ontario
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Country [2]
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Canada
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State/province [2]
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Quebec
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Country [3]
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Hong Kong
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State/province [3]
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NT
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Country [4]
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Ireland
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State/province [4]
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Dublin
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Funding & Sponsors
Primary sponsor type
Other
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Name
Mount Sinai Hospital, Canada
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Sunnybrook Health Sciences Centre
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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McMaster Children's Hospital
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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The Rotunda Hospital
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Address [3]
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Country [3]
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Other collaborator category [4]
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Government body
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Name [4]
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John Hunter Hospital
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Address [4]
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Country [4]
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Other collaborator category [5]
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Other
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Name [5]
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Royal Alexandra Hospital
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Address [5]
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Country [5]
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Other collaborator category [6]
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Other
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Name [6]
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Centre Hospitalier de l'Universite Laval (CHUL)
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Address [6]
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Country [6]
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Other collaborator category [7]
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Other
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Name [7]
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Royal North Shore Hospital
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Address [7]
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Country [7]
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Other collaborator category [8]
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Other
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Name [8]
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Prince of Wales Hospital, Shatin, Hong Kong
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Address [8]
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Country [8]
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Ethics approval
Ethics application status
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Summary
Brief summary
Patent ductus arteriosus (PDA), the most common cardiovascular complication of prematurity, is associated with higher mortality and morbidities in extremely low gestational age neonates (ELGANs, \< 27+0 weeks). Ibuprofen and acetaminophen, which act by reducing prostaglandin synthesis, are the most commonly used first and second line agents for PDA treatment across Canada. However, initial treatment failure with monotherapy is a major problem, occurring in \>60% ELGANs. Treatment failure is associated with worsening rates of mortality and bronchopulmonary dysplasia (BPD), while early treatment success can achieve rates comparable to neonates without PDA. Treatment failure resulting in prolonged disease exposure is thought to be a major contributor. Recently, combination therapy with acetaminophen and ibuprofen has emerged as a new treatment regime. Acetaminophen exerts anti-prostaglandin effect through a different receptor site than ibuprofen, providing a biological rationale for their synergistic action. The objective of this study is to evaluate the clinical impact, efficacy and safety of combination regime (Ibuprofen + IV Acetaminophen) for the first treatment course for PDA in ELGANs vs. Ibuprofen alone (current standard treatment).
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Trial website
https://clinicaltrials.gov/study/NCT05340582
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Amish Jain, MD PhD
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Address
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MOUNT SINAI HOSPITAL
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Laura Thomas, MSc
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Address
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Country
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Phone
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416-586-4800
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05340582
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