Comparative study of non-invasive respiratory support CCD-01534CA1-01

• Research type

  Research Study

• Full title

  A RANDOMIZED, OPEN, MULTINATIONAL, MULTICENTRE, 2-PART STUDY IN SPONTANEOUSLY BREATHING PRETERM NEONATES WITH MILD TO MODERATE RESPIRATORY DISTRESS SYNDROME TO INVESTIGATE THE SAFETY, TOLERABILITY AND EFFICACY OF INHALED NEBULISED PORACTANT ALFA (PORCINE SURFACTANT, CUROSURF®) IN COMPARISON WITH nCPAP ALONE

• IRAS ID

  221773

• Contact name

  Benjamin Stenson

• Contact email

  ben.stenson@luht.scot.nhs.uk

• Sponsor organisation

  Chiesi Farmaceutici

• Eudract number

  2016-004547-36

• Duration of Study in the UK

  4 years, 11 months, 19 days

• Research summary

  The aim of the study is to check whether the administration of Poractant Alfa (Curosurf®, Chiesi Farmaceutici S.p.A.) using a specific nebuliser, is safe and effective in treating premature babies with Respiratory Distress Syndrome (RDS) compared to the nCPAP alone which is a ventilator support to help opening the lungs without administration of any drug.
  The nebuliser used to administer Curosurf® is a medical device already on the market but specifically modified for its use in the neonatal population.
  Data about the efficacy of this method for drug administration and possible side effects will be collected in the hours after each baby has been given the medicine, in the following 7 days, and at additional follow up time points of 28 days postnatal age (time elapsed after birth), 36 weeks postmenstrual age (PMA) (the number of weeks the mother was pregnant plus the number of days since the baby was born), discharge home and when the baby is about 24 months old. These data will be monitored carefully and reviewed by the researchers who are part of the clinical care team. Independent medical doctors and health care professionals will also look at the data.

  It is expected that approximately 300 premature babies will participate in the study. The study is being done in 40 investigational sites all over Europe.
  The participation will last until the baby is discharged home or if the baby is discharged home prior to 36-week PMA. His/her participation will last until a clinical assessment at 36-week PMA (on-site visit or phone call). Then, a further medical visit in the hospital will occur when the baby is 24 months old.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  17/EM/0121

• Date of REC Opinion

  12 May 2017

• REC opinion

  Further Information Favourable Opinion