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The Preterm Infants' Paracetamol Study (PreParaS)

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ClinicalTrials.gov Identifier: NCT01938261
Recruitment Status : Recruiting
First Posted : September 10, 2013
Last Update Posted : May 25, 2022
Sponsor:
Information provided by (Responsible Party):
Outi Aikio, University of Oulu

Brief Summary:

Present randomized, controlled, double-blind trial investigates the efficacy and safety of early (<24 h) intravenous paracetamol therapy for pain medication in very small premature infants. This phase 2 drug study focuses on the efficacy and safety of short-term use. The pharmacokinetics and pharmacodynamics of paracetamol, as well as the long-term effects, are studied.

This study recruits preterm infants born less than 32 weeks gestational age and treated at the neonatal intensive care unit of Oulu University Hospital. The informed consent is asked from all parents. The first drug dose is given before 24 hours of age. Masked study drug is paracetamol infusion solution 10 mg/mL or placebo, 0.45% saline solution. The loading dose is 20 mg/kg, and the maintenance dose 7.5 mg/kg every 6 hours for 4 days. The exact date of the closure of ductus is studied by repeated echocardiographic examinations. The symptoms of pain are screened by a pain scale of preterm infants (NIAPAS). Patients are monitored for signs of possible side effects. After discharge from hospital, patients are examined at follow-up clinic for the first year every 3 months and at 2 years of age.


Condition or disease Intervention/treatment Phase
Persistent Ductus Arteriosus Complication of Prematurity Pain or Discomfort in Intensive Care of Preterm Infants Drug: paracetamol Drug: 0.45 % saline solution Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Preterm Infants' Paracetamol Study
Actual Study Start Date : August 2013
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Paracetamol effect on ductus
The first drug dose is given before 24 hours of age. Masked study drug is paracetamol infusion solution 10 mg/mL (PERFALGAN ®) or placebo, 0.45% saline solution. The loading dose is 20 mg/kg and the maintenance dose 7.5 mg kg every 6 hours for 4 days.
Drug: paracetamol
Other Names:
  • Perfalgan 10 mg/ml infusion solution
  • Paracetamol Fresenius Kabi 10mg/ml

Drug: 0.45 % saline solution
Placebo
Other Name: Natriumklorid Braun 4.5mg/ml solution

Experimental: Paracetamol effect on pain
The first drug dose is given before 24 hours of age. Masked study drug is paracetamol infusion solution 10 mg/mL (PERFALGAN ®) or placebo, 0.45% saline solution. The loading dose is 20 mg/kg and the maintenance dose 7.5 mg kg every 6 hours for 4 days.
Drug: paracetamol
Other Names:
  • Perfalgan 10 mg/ml infusion solution
  • Paracetamol Fresenius Kabi 10mg/ml

Drug: 0.45 % saline solution
Placebo
Other Name: Natriumklorid Braun 4.5mg/ml solution




Primary Outcome Measures :
  1. Ductus diameter mm/kg [ Time Frame: at postnatal age of 5 days ]
    Measured by cardiac ultrasound

  2. Cumulative dosage of morphine [ Time Frame: at postnatal age of 5 days ]
    The amount of morphine doses administerd during the study


Secondary Outcome Measures :
  1. Number of patients who received any treatment for persistent ductus arteriosus [ Time Frame: participants will be followed for the duration of NICU stay, an expected average of 12 weeks ]
    Prescribed by an attending clinician

  2. Postnatal age of ductus closure [ Time Frame: participants will be followed for the duration of NICU stay, an expected average of 12 weeks ]
    The date of the cardiac ultrasound examination when ductus was judged closed

  3. Left atrium to aorta ratio [ Time Frame: participants will be followed for the duration of NICU stay, an expected average of 12 weeks ]
    Measured by cardiac ultrasound

  4. Number of apneic periods/day [ Time Frame: up to 5 days postnatal age ]
    Apneas requiring stimulation by nurses

  5. NIAPAS screening scores [ Time Frame: up to 5 days postnatal age ]
    Scale 2-18, according to Polkki et al

  6. Duration of mechanical ventilation [ Time Frame: participants will be followed for the duration of NICU stay, an expected average of 12 weeks ]
    The number of days from intubation to extubation


Other Outcome Measures:
  1. Long-term morbidity diagnoses [ Time Frame: participants will be followed until 40 weeks gestational age, an expected average of 16 weeks ]
    BPD; ROP; ICH; NEC

  2. Mortality [ Time Frame: participants will be followed until 40 weeks gestational age, an expected average of 16 weeks ]
    Death cases

  3. Paracetamol side effects [ Time Frame: participants will be followed until 40 weeks gestational age, an expected average of 16 weeks ]
    Adverse reactions linked to IMP

  4. Paracetamol serum concentrations [ Time Frame: up to 5 days postanatal age ]
    Measured paracetamol serum levels



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • preterm infants born < 32 weeks gestational age

Exclusion Criteria:

  • congenital malformation
  • lethal disease
  • chromosomal abnormality
  • persistent pulmonary hypertension of a newborn

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): NCT01938261


Contacts
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Contact: Outi Aikio, M.D., Ph.D. +358 8 3155810 outi.aikio@ppshp.fi
Contact: Pia Harkin, M.D. +358 8 3155846 pia.harkin@ppshp.fi

Locations
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Finland
Department of Pediatrics, Oulu Univeristy Hospital Recruiting
Oulu, Finland
Contact: Outi Aikio, M.D., Ph.D.    +358 8 3155810    outi.aikio@ppshp.fi   
Contact: Pia Harkin, M.D.    +358 8 3155486    pia.harkin@ppshp.fi   
Principal Investigator: Outi Aikio, M.D, Ph.D.         
Principal Investigator: Pia Harkin, M.D.         
Principal Investigator: Antti Harma, M.D.         
Principal Investigator: Markku Leskinen, M.D., Ph.D.         
Principal Investigator: Timo Saarela, M.D., Ph.,D.         
Principal Investigator: Mikko Hallman, M.D.,Ph. D.         
Sponsors and Collaborators
University of Oulu
Investigators
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Principal Investigator: Antti Harma, M.D. Oulu University Hospital
Principal Investigator: Markku Leskinen, M.D., Ph.D. Oulu University Hospital
Principal Investigator: Timo Saarela, M.D., Ph. D. Oulu University Hospital
Study Chair: Mikko Hallman, M.D., Ph.D. University of Oulu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Outi Aikio, Specialist in Pediatrics and Neonatology, M.D., Ph.D., University of Oulu
ClinicalTrials.gov Identifier: NCT01938261    
Other Study ID Numbers: 100-2013
2013-001842-33 ( EudraCT Number )
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: May 25, 2022
Last Verified: May 2022
Additional relevant MeSH terms:
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Premature Birth
Ductus Arteriosus, Patent
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Acetaminophen
Pharmaceutical Solutions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics