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Extremely Low Gestatonal Age Infants' Paracetamol Study (Paras)

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ClinicalTrials.gov Identifier: NCT03641209
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Outi Aikio, University of Oulu

Tracking Information
First Submitted Date  ICMJE August 3, 2018
First Posted Date  ICMJE August 21, 2018
Last Update Posted Date January 10, 2019
Actual Study Start Date  ICMJE September 3, 2018
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2018)
Ductal closure [ Time Frame: Neonatal intensive care unit (NICU) treatment period up to 13 weeks ]
Postnatal age of the observed closure of ductus arteriosus
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03641209 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2018)
  • Near-infrared spectroscopy values [ Time Frame: Study drug period up to 10 days ]
    Near-infrared spectroscopy values
  • Paracetamol serum levels [ Time Frame: Study drug period up to 10 days ]
    Paracetamol serum levels
  • Paracetamol side effects [ Time Frame: Neonatal intensive care unit (NICU) treatment period up to 13 weeks ]
    Any observed or detected paracetamol side effects
  • PDA [ Time Frame: Neonatal intensive care unit (NICU) treatment period up to 13 weeks ]
    Open ductus arteriosus without any traditional PDA therapies
  • PDA, treated [ Time Frame: Neonatal intensive care unit (NICU) treatment period up to 13 weeks ]
    The need for PDA therapies (ibuprofen, paracetamol, ligation)
  • Ventilatory assist [ Time Frame: Neonatal intensive care unit (NICU) treatment period up to 13 weeks ]
    The duration of any ventilation assist, days
  • Complications of prematurity [ Time Frame: The first hospitalization period up to 19 weeks ]
    The long term complications of prematurity (moderate-to-severe bronchopulmonary dysplasia (BPD), intraventricular hemorrhage gr 2-4, moderate to severe necrotizing enterocolitis, retinopathy of prematurity (ROP) needing therapy)
  • Long term morbidity [ Time Frame: The first hospitalization period up to 19 weeks ]
    Other long-term morbidity
  • Mortality [ Time Frame: The first hospitalization period up to 19 weeks ]
    Mortality
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extremely Low Gestatonal Age Infants' Paracetamol Study
Official Title  ICMJE Extremely Low Gestational Age Infants' Paracetamol Study: a Randomized Trial
Brief Summary In the present trial, early, intravenous paracetamol is compared to placebo in extremely premature or low birth weight infants in order to evaluate the effect on ductal closure.
Detailed Description

The purpose of this randomized, placebo-controlled, double-blind, phase 2, one center clinical trial is to study the efficacy and safety of early (< 96 h) intravenous paracetamol in prophylactic closure of ductus arteriosus in extremely premature (gestational age <28+0 wk, ELGA) or low birth weight (<1000 g, ELBW) infants. The infants born extremely preterm or low birth weight are a focus of the study, since a small phase 2 study on paracetamol failed to demonstrate contraction of ductus arteriosus.

In the investigator's previous cohort of ELGA/ELBW infants, the numbers of patients who needed any therapies for patent ductus arteriosus (PDA) were 29 (23%) in the paracetamol exposed group, and 90 (54%) in the control group. As demonstrated in a phase 2 study, the early paracetamol treatment induced the closure of ductus arteriosus: the mean (SD) ductal closure age was 177 (338) h in the whole paracetamol group. However, in the subgroup of ELGA infants born before 28 gestation weeks (n=14), the mean (SD) ductal closure ages in the paracetamol and placebo groups were 491 (504) h and 858 (719) h, respectively.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, controlled, one center trial
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Placebo, 0.45 % saline, is similar to paracetamol, both being clear liquids, so the staff will remain unaware which drug the patient receives. The study drug will be kept and prepared away from the NICU, at the separate ward 55 office, in a locked cabinet. The study drug will be prepared by the research nurse, the pharmacist of the ward, or during nighttime, by a nurse who does not participate in the study patients' treatment in any way.
Primary Purpose: Prevention
Condition  ICMJE
  • Prematurity; Extreme
  • Low Birthweight, Extremely (999 Grams or Less)
Intervention  ICMJE
  • Drug: Paracetamol 10mg/mL infusion solution
    Intravenous paracetamol solution for infusion
    Other Names:
    • acetaminophen
    • Paracetamol Fresenius Kabi 10 mg/mL infusion solution
  • Other: Placebo
    Half physiological saline solution as the non-active placebo solution
    Other Name: Natriumklorid Braun 4,5mg/mL solution for infusion
Study Arms  ICMJE
  • Experimental: Paracetamol
    Paracetamol 10 mg/mL infusion solution, intravenous loading dose 20 mg/kg, followed by maintenance dose 7.5 mg/kg every 6 h up to 9 days
    Intervention: Drug: Paracetamol 10mg/mL infusion solution
  • Placebo Comparator: Placebo
    0.45% sodium chloride (NaCl) solution, equal amounts in mL as would have been given the experimental drug
    Intervention: Other: Placebo
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 20, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2021
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Premature infants born before 28+0 gestation weeks and/or birth weight less than 1000g

Exclusion Criteria:

  • Severe malformation or suspected chromosomal defect or other very severe life-threatening disease (e.g. very severe birth asphyxia or persistent pulmonary hypertension, etc.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 96 Hours   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Outi Aikio, MD, PhD +35883155810 outi.aikio@ppshp.fi
Contact: Aliisa Laitala, MD +35883155823 aliisa.laitala@ppshp.fi
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03641209
Other Study ID Numbers  ICMJE 39/2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Outi Aikio, University of Oulu
Study Sponsor  ICMJE Outi Aikio
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Outi Aikio, MD, PhD Oulu University Hospital
PRS Account University of Oulu
Verification Date January 2019

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