Surfactant Application During Spontaneous Breathing With Continuous Positive Airway Pressure (CPAP) in Premature Infants < 27 Weeks

Study Overview
=================
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.

Official Title
-----------------
Surfactant Application During Spontaneous Breathing With CPAP or During Mechanical Ventilation in the Therapy of IRDS in Premature Infants < 27 Weeks

Conditions
-----------------
Respiratory Distress Syndrome, Newborn

Intervention / Treatment
-----------------
* Drug: Curosurf
* Drug: Curosurf


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 23 Weeks
Maximum Age: 26 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>Conventional therapy with intubation, initiation of mechanical ventilation and surfactant application | Drug: Curosurf<br>* Conventional therapy with intubation, initiation of mechanical ventilation and surfactant application<br>|
| Experimental: 1<br>Surfactant application via a thin endotracheal catheter during spontaneous breathing with CPAP, followed by respiratory support with CPAP | Drug: Curosurf<br>* Surfactant application via a thin endotracheal catheter during spontaneous breathing with CPAP, followed by respiratory support with CPAP<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival until term without CLD |  | 13-17 weeks after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival until term without CLD, IVH>II°, cystic PVL, ROP with need for surgery |  | 13-17 weeks after birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Continuous positive airway pressure (CPAP), extremely preterm infant, Idiopathic respiratory distress syndrome (IRDS), Surfactant