Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants

Study Overview
=================
Brief Summary
-----------------
Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. This multi-center, randomized trial tested whether early surfactant therapy and nasal continuous positive airway pressure (CPAP) in infants 1,250-2,000g with RDS reduced mechanical ventilation usage without added complications. Infants with mild to moderate respiratory distress syndrome were enrolled in the trial and given either early administration of surfactant followed by extubation within 30 minutes and the use of CPAP, or standard practice (surfactant according to current center practice, only after initiation of mechanical ventilation), to see whether the experimental method would reduce the need for subsequent mechanical ventilation.

Detailed Description
-----------------
Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. The role of surfactant therapy in the management of larger infants with respiratory distress syndrome (RDS) was unclear. In many neonatal intensive care units, these infants were routinely managed with continuous positive airway pressure (CPAP) alone. This trial tested whether early use of surfactant combined with CPAP would ameliorate the course of RDS without an increased risk of death. Primary study outcomes were measures of use of mechanical ventilation, and thereby likely reduction in risk of ventilator-associated morbidity. Eligible infants were randomized before the infant is 12 hours of age to receive either: early surfactant followed by extubation within 30 minutes and application of CPAP (intervention group); or surfactant according to current center practice, only after initiation of mechanical ventilation (control group). The trial was stopped after 7 months for lack of recruitment.

Official Title
-----------------
Early Surfactant Followed by Nasal CPAP to Reduce the Use of Mechanical Ventilation Without Additional Morbidity in Infants 1250- 2000 Grams With RDS

Conditions
-----------------
Infant, Newborn, Respiratory Distress Syndrome, Respiratory Insufficiency

Intervention / Treatment
-----------------
* Drug: Early surfactant
* Drug: Standard practice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants born at 1,250-2g000 grams birth weight <12 hours of age Clinical and radiographic diagnosis of respiratory distress syndrome (RDS) Receiving supplemental oxygen with head-hood Fi02 of 0.35 to 0.50 or CPAP Fi02 of 0.25 to 0.50 to maintain oxygen saturation less than 90 percent and more than 96 percent Exclusion Criteria: Receiving mechanical ventilation Air leak Pulmonary hemorrhage Major congenital anomaly Congenital non-bacterial infection Parental refusal of consent Refusal of attending neonatologist

Ages Eligible for Study
-----------------
Maximum Age: 12 Hours

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early surfactant group<br> | Drug: Early surfactant<br>* Early surfactant followed by extubation within 30 minutes and application of continuous positive airway pressure (CPAP)<br>* Other names: Survanta;|
| Active Comparator: Standard Practice group<br> | Drug: Standard practice<br>* Surfactant according to current center practice, only after initiation of mechanical ventilation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for mechanical ventilation following randomization |  | Until hospital discharge or 120 days of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean duration of mechanical ventilation |  | Until hospital discharge or 120 days of life | 
| Risk morbidities associated with mechanical ventilation and/or early surfactant administration |  | Until hospital discharge or 120 days of life | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NICHD Neonatal Research Network, Pulmonary ventilation, Respiratory distress syndrome, Respiratory insufficiency, Surfactant, pulmonary, Mechanical Ventilation, Survanta