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The Preterm Infants' Paracetamol Study (PreParaS)

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ClinicalTrials.gov Identifier: NCT01938261
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : May 28, 2015
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 both the early closure of the ductus and 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 (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. The exact date of the closure of ductus is studied by repeated echocardiographic examinations. The symptoms of pain are screened by a locally used 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)
Actual Enrollment : 48 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
Study Start Date : August 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: 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 Name: Perfalgan 10 mg/ml infusion solution

Drug: 0.45 % saline solution
Placebo

Placebo Comparator: 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 Name: Perfalgan 10 mg/ml infusion solution

Drug: 0.45 % saline solution
Placebo




Primary Outcome Measures :
  1. ductus diameter mm/kg [ Time Frame: at postnatal age of 5 days ]
  2. cumulative dosage of morphine [ Time Frame: at postnatal age of 5 days ]

Secondary Outcome Measures :
  1. number of patients who received any treatment for persistent ductus arteriosus prescribed by an attending clinician [ Time Frame: participants will be followed for the duration of NICU stay, an expected average of 12 weeks ]
  2. postnatal age of ductus closure [ Time Frame: participants will be followed for the duration of NICU stay, an expected average of 12 weeks ]
  3. left atrium to aorta ratio [ Time Frame: participants will be followed for the duration of NICU stay, an expected average of 12 weeks ]
  4. number of apneic periods/day [ Time Frame: up to 5 days postnatal age ]
  5. cumulative NIAPAS screening score/day [ Time Frame: up to 5 days postnatal age ]
  6. duration of mechanical ventilation [ Time Frame: participants will be followed for the duration of NICU stay, an expected average of 12 weeks ]

Other Outcome Measures:
  1. number of patients with long-term morbidity diagnoses [ Time Frame: participants will be followed until 40 weeks gestational age, an expected average of 16 weeks ]
  2. number of patients who died [ Time Frame: participants will be followed until 40 weeks gestational age, an expected average of 16 weeks ]
  3. number of patients with paracetamol side effects [ Time Frame: participants will be followed until 40 weeks gestational age, an expected average of 16 weeks ]
  4. paracetamol serum concentrations [ Time Frame: up to 5 days postanatal age ]


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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


Locations
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Finland
Department of Pediatrics, Oulu Univeristy Hospital
Oulu, Finland
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     History of Changes
Other Study ID Numbers: 100-2013
2013-001842-33 ( EudraCT Number )
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

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