Observational Study on the Prophylactic Use of Curosurf in Neonatal Respiratory Distress Syndrome (RDS)

Chiesi

Status: Completed

Conditions: Respiratory Distress Syndrome, Newborn

Study type: Observational

Funder types: Industry

Identifiers

NCT01102543

CUR7101

Details and patient eligibility

About

The aim of Alizé is to describe a population of premature babies (gestational age (GA) < 32 weeks) in real life situation and the management of RDS.

Full description

Description includes gestational age, birth clinical characteristics in particular the respiratory function, evaluation of the mother prenatal corticosteroids treatment in prophylaxis of RDS, mother medical and obstetric history, premature babies care in the delivery room with a special focus on the Curosurf use: prophylactic or curative use / other surfactant / no surfactant. A special focus is on the Prophylactic use.

Enrollment: 972 patients

Sex: All

Ages: 1 minute to 12 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• during the study, each neonatologist will have to include all the babies born with a gestational age < 32 GA

Exclusion criteria

• gestational age > 32 GA
• No consent to the data collection by one of the parents

Trial design

972 participants in 2 patient groups

Premature babies < 28 GA

Premature babies > 28 & < 32 weeks GA