The Preterm Infants’ Paracetamol Study

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Brief Title

The Preterm Infants' Paracetamol Study

Official Title

The Preterm Infants' Paracetamol Study

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

ductus diameter mm/kg

Secondary Outcome

 number of patients who received any treatment for persistent ductus arteriosus prescribed by an attending clinician

Condition

Persistent Ductus Arteriosus

Intervention

paracetamol

Study Arms / Comparison Groups

 Paracetamol effect on ductus
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

48

Start Date

August 2013

Completion Date

March 2015

Primary Completion Date

January 2015

Eligibility Criteria

        Inclusion Criteria:

          -  preterm infants born < 32 weeks gestational age

        Exclusion Criteria:

          -  congenital malformation

          -  lethal disease

          -  chromosomal abnormality

          -  persistent pulmonary hypertension of a newborn
      

Gender

All

Ages

N/A - 24 Hours

Accepts Healthy Volunteers

No

Contacts

Antti Harma, M.D., , 

Location Countries

Finland

Location Countries

Finland

Administrative Informations


NCT ID

NCT01938261

Organization ID

100-2013

Secondary IDs

2013-001842-33

Responsible Party

Principal Investigator

Study Sponsor

University of Oulu


Study Sponsor

Antti Harma, M.D., Principal Investigator, Oulu University Hospital


Verification Date

May 2015