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Extremely Low Gestatonal Age Infants' Paracetamol Study (Paras)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03641209
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : January 10, 2019
Information provided by (Responsible Party):
Outi Aikio, University of Oulu

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.

Condition or disease Intervention/treatment Phase
Prematurity; Extreme Low Birthweight, Extremely (999 Grams or Less) Drug: Paracetamol 10mg/mL infusion solution Other: Placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Official Title: Extremely Low Gestational Age Infants' Paracetamol Study: a Randomized Trial
Actual Study Start Date : September 3, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight

Arm Intervention/treatment
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
Drug: Paracetamol 10mg/mL infusion solution
Intravenous paracetamol solution for infusion
Other Names:
  • acetaminophen
  • Paracetamol Fresenius Kabi 10 mg/mL infusion solution

Placebo Comparator: Placebo
0.45% sodium chloride (NaCl) solution, equal amounts in mL as would have been given the experimental drug
Other: Placebo
Half physiological saline solution as the non-active placebo solution
Other Name: Natriumklorid Braun 4,5mg/mL solution for infusion

Primary Outcome Measures :
  1. Ductal closure [ Time Frame: Neonatal intensive care unit (NICU) treatment period up to 13 weeks ]
    Postnatal age of the observed closure of ductus arteriosus

Secondary Outcome Measures :
  1. Near-infrared spectroscopy values [ Time Frame: Study drug period up to 10 days ]
    Near-infrared spectroscopy values

  2. Paracetamol serum levels [ Time Frame: Study drug period up to 10 days ]
    Paracetamol serum levels

  3. Paracetamol side effects [ Time Frame: Neonatal intensive care unit (NICU) treatment period up to 13 weeks ]
    Any observed or detected paracetamol side effects

  4. PDA [ Time Frame: Neonatal intensive care unit (NICU) treatment period up to 13 weeks ]
    Open ductus arteriosus without any traditional PDA therapies

  5. PDA, treated [ Time Frame: Neonatal intensive care unit (NICU) treatment period up to 13 weeks ]
    The need for PDA therapies (ibuprofen, paracetamol, ligation)

  6. Ventilatory assist [ Time Frame: Neonatal intensive care unit (NICU) treatment period up to 13 weeks ]
    The duration of any ventilation assist, days

  7. 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)

  8. Long term morbidity [ Time Frame: The first hospitalization period up to 19 weeks ]
    Other long-term morbidity

  9. Mortality [ Time Frame: The first hospitalization period up to 19 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 96 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.)

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 identifier (NCT number): NCT03641209

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Contact: Outi Aikio, MD, PhD +35883155810
Contact: Aliisa Laitala, MD +35883155823

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Department of Pediatrics, Oulu University Hospital Recruiting
Oulu, Finland, 90014
Contact: Outi Aikio, MD, PhD    +358 8 3155810   
Principal Investigator: Outi Aikio, MD, PhD         
Principal Investigator: Antti Harma, MD         
Principal Investigator: Timo Saarela, MD, PhD         
Principal Investigator: Mikko Hallman, MD, PhD         
Principal Investigator: Aliisa Laitala, MD         
Sponsors and Collaborators
Outi Aikio
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Principal Investigator: Outi Aikio, MD, PhD Oulu University Hospital
  Study Documents (Full-Text)

Documents provided by Outi Aikio, University of Oulu:

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Responsible Party: Outi Aikio, MD, PhD, specialist in pediatrics and neonatology, University of Oulu Identifier: NCT03641209     History of Changes
Other Study ID Numbers: 39/2018
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Outi Aikio, University of Oulu:
ductus arteriosus
Additional relevant MeSH terms:
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Birth Weight
Body Weight
Signs and Symptoms
Pharmaceutical Solutions
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs