Clinical trial NCT00751959: Surfactant Application During Spontaneous Breathing With Continuous Positive Airway Pressure (CPAP) in Premature Infants < 27 Weeks
Official title: Surfactant Application During Spontaneous Breathing With CPAP or During Mechanical Ventilation in the Therapy of IRDS in Premature Infants < 27 Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome, Newborn
Keywords: Continuous positive airway pressure (CPAP)
extremely preterm infant
Idiopathic respiratory distress syndrome (IRDS)
Surfactant
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: University Hospital Schleswig-Holstein
name: Altona Children's Hospital
name: Ruhr University of Bochum
name: Vestische Kinder- und Jugendklinik Datteln
name: Hospital of Leverkusen
name: Kliniken der Stadt Koeln, Kinderkrankenhaus Riehl
name: Heinrich-Heine University, Duesseldorf
name: Klinikum Aschaffenburg-Alzenau
name: Asklepios Kliniken Hamburg GmbH
name: Klinikum Stuttgart
name: DRK Kinderklinik Siegen
name: University Hospital, Bonn
name: Charite University, Berlin, Germany
name: The Clinical Trials Centre Cologne
name: German Federal Ministry of Education and Research
First posted: 2008-09-12
Enrollment: 213
Sex: ALL
Minimum age (years): 23
Maximum age (years): 26
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the efficacy of surfactant application during spontaneous breathing with CPAP in avoiding death and chronic lung disease (CLD) in very immature infants with a gestational age of less than 27 weeks.

Detailed description: 80 % of extremely preterm infants with a gestational age of less than 27 completed weeks suffer from severe idiopathic respiratory distress syndrome (IRDS). They are still at high risk of mortality and long term morbidity especially of the lung and the brain. At least death and chronic lung disease (CLD) are related to the need and the duration of mechanical ventilation. Continuous positive airway pressure (CPAP) has been shown to be effective to avoid mechanical ventilation in the treatment of IRDS but it often fails in the most immature infants. Early or prophylactic surfactant application is effective in the treatment of IRDS and is the only causal therapy, but it is usually related to intubation and mechanical ventilation that should be avoided.Therefore to overcome the dilemma between need for mechanical ventilation with surfactant administration on the one hand and surfactant withholding with the use of CPAP on the other hand, a strategy was developed to administer surfactant during spontaneous breathing with CPAP (1). In the proposed prospective randomised controlled trial this strategy shall be compared with the recent gold standard in the therapy of extremely preterm infants with IRDS, that is intubation, mechanical ventilation and surfactant administration. Based on the results of a feasibility (1) study and some clinical observations it is hypothesised that the new approach is superior in avoidance of death and chronic lung disease compared to the recent gold standard.

Eligibility criteria: Inclusion Criteria:

* IRDS with Silverman-Score ≥ 5 and / or FiO2 ≥ 0,3
* Postnatal age of more than 10 min. and less than 2 hours
* Gestational age ≥ 23+0 and \< 27+0

Exclusion Criteria:

* Primary cardio- pulmonary resuscitation
* Prenatally diagnosed severe malformation
* No parental consent
* Participation in another interventional trial

Primary outcomes:
measure: Survival until term without CLD
timeFrame: 13-17 weeks after birth
Secondary outcomes:
measure: Survival until term without CLD, IVH>II°, cystic PVL, ROP with need for surgery
timeFrame: 13-17 weeks after birth
Other outcomes:
Locations:
city: Aschaffenburg
country: Germany
facility: Klinikum Aschaffenburg, Klinik für Kinder- und Jugendmedizin
city: Berlin
country: Germany
facility: Charité
city: Bochum
country: Germany
facility: Ruhr University of Bochum, Children's Hospital St. Josef Spital
city: Bonn
country: Germany
facility: University Hospital, Dept. of Neonatology
city: Cologne
country: Germany
facility: Kliniken der Stadt Koeln, Kinderkrankenhaus Riehl
city: Cologne
country: Germany
facility: University of Cologne, Clinic for Paediatrics
city: Datteln
country: Germany
facility: Vestische Kinder- und Jugendklinik
city: Duesseldorf
country: Germany
facility: University Hospital, Clinic for Paediatrics
city: Hamburg
country: Germany
facility: Asklepios Klinik Barmbek
city: Leverkusen
country: Germany
facility: Hospital of Leverkusen, Dept. of Children's Medicine
city: Lübeck
country: Germany
facility: University Hospital of Schleswig-Holstein, Campus Lübeck, Dept. of Children's Medicine
city: Siegen
country: Germany
facility: DRK Kinderklinik
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart, Olgahospital
Study officials:
affiliation: University of Cologne, Clinic for Paediatrics
name: Angela Kribs, MD
role: PRINCIPAL_INVESTIGATOR
References: