TerminatedPhase 2

A Study To InvestigateThe Safety, Tolerability And Efficacy Of Nebulised Curosurf® In Preterm Neonates With Respiratory Distress Syndrome (RDS)

Stopped: Change in the benefit-risk balance

Italy166 participantsStarted 2017-08-28

Plain-language summary

The present study will mainly aim at investigating the safety, tolerability and efficacy of different escalating single doses administration of nebulised Curosurf®, in preterm neonates with RDS (Respiratory Distress Syndrome) during nCPAP.

Who can participate

Age range28 Weeks – 32 Weeks

SexALL

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Inclusion criteria

✓. Written informed consent obtained by parents/legal representative (according to local regulation) prior to or after birth
✓. Inborn neonates from 28+0 to 32+6 weeks of gestational age (GA), spontaneously breathing and stabilised on nCPAP
✓. Clinical course consistent with RDS.
✓. Receiving CPAP pressure 5-8 centimeter of water (cm H2O) and fraction of inspired oxygen (FiO2) between 0.25 and 0.40 to maintain saturation of peripheral oxygen (SpO2) between 88% and 95% for at least 30 minutes. Randomization should occur between 60 minutes and 12 hours after birth.

Exclusion criteria

✕. Early need for endotracheal intubation for cardiopulmonary resuscitation in delivery room or within 1 hour from birth because of severe RDS
✕. Respiratory Distress not secondary to surfactant deficiency
✕. Use of surfactant prior to study entry and need for endotracheal administration of any other treatment.
✕. Major congenital anomalies.
✕. Evidence of severe birth asphyxia
✕. Mothers with prolonged rupture of the membranes
✕. Presence of air leaks.
✕. Presence of IVH (intraventricular hemorrhage ) ≥ III.

What they're measuring

Percentage of neonates with respiratory failure

Timeframe: in the first 72 hours of life

Adverse Events

Timeframe: discharge or 36 weeks post menstrual age (PMA), whichever comes first

Adverse Drug Reactions

Timeframe: discharge or 36 weeks post menstrual age (PMA), whichever comes first

Trial details

NCT IDNCT03235986

SponsorChiesi Farmaceutici S.p.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-05-05

View on ClinicalTrials.gov More Neonatal Respiratory Distress Syndrome trials