Surfactant Versus Nasal Continuous Positive Airway Pressure (nCPAP) for Respiratory Distress Syndrome in the Newborn ≥ 35 Weeks of Gestation

Study Overview
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Brief Summary
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Term and near term newborns can present acute respiratory distress syndrome (RDS). Surfactant treatment has been shown effective in reducing mechanical ventilation and oxygen treatment durations in the preterm newborn. Whether surfactant treatment is beneficial for term and near term newborns is unknown. The purpose of this study is to compare surfactant treatment vs. nasal continuous positive airways pressure in the newborn between 35 and 41 weeks of gestation with RDS within the first 24 hours of life. The study's primary endpoint is survival with no oxygen treatment at 72 hours of life. The secondary endpoints are: death, surfactant treatment, pneumothorax, secondary infections, pulmonary hypertension, inhaled nitric oxide treatment, fluid loading treatment, vasopressive amines treatment, mechanical ventilation duration, nCPAP treatment duration, Oxygen treatment duration, Oxygen treatment at 28 days of life, hospitalization duration and treatment strategy cost.

Detailed Description
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Newborn between 35 and 41 weeks of gestation with RDS within the first 24 hours of life, treated with nCPAP and a FiO2 ≥ 30% are eligible. Randomisation is stratified by centre and 2 age groups (35-36 weeks of gestation and 37-41 weeks ogf gestation). One arm will receive surfactant treatment after tracheal intubation. The second arm will continue nCPAP. A rescue treatment is used in the second arm if FiO2 > 60%. In each arm the newborn is weaned from mechanical ventilation and oxygen treatment as soon as possible. The primary outcome of the study is the success of the procedure defined as survival without any oxygen treatment at 72 hours of life.

Official Title
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Surfactant Treatment Compared to Nasal Continuous Positive Airway Pressure for the Management of Respiratory Distress Syndrome in the Newborn Between 35 and 41 Weeks of Gestation

Conditions
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Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Procedure: Surfactant instillation
* Procedure: nCPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age between 35 and 41 weeks of gestation < 24 hours of life Nasal Continuous Positive Airways Pressure (nCPAP) for more than 1 hour FiO2 ≥ 30% with nCPAP and a target post-ductus arteriosus SpO2 >92% Written consent of the parents Exclusion Criteria: FiO2 > 60% with nCPAP, ou FiO2 > 40% for 3 consecutives hours whatever the respiratory support Life threatening congenital pathology Congenital cardiopathy (except patent ductus arteriosus) Shock defined as systemic hypotension (mean blood pressure <10th percentile of the normal range for birth weight and postnatal age) with at least 3 of the following criteria for decrease perfusion: 1) tachycardia (heart rate > 160 beats/min); 2) abnormal peripheral pulses; 3) modified extremities coloration; 4) prolonged capillary refill time > 3 seconds; 5) urine output < 1 ml/kg/h Blood gas pH < 7.19 and / or PCO2 > 65 mmHg Apgar score ≤ 3 at 5 minutes of life

Ages Eligible for Study
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Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early strategy<br>Intratracheal poractant alpha (Curosurf®) after tracheal intubation | Procedure: Surfactant instillation<br>* Intra-tracheal poractant alpha instillation after tracheal intubation<br>|
| Active Comparator: Delayed strategy<br>Nasal Continous Positive Airways Pressure. Intratracheal poractant alpha as a rescue treatment if FiO2 > 60% | Procedure: nCPAP<br>* Nasal Continous Positive Airways Pressure (nCPAP). Positive End Expiratory Pressure (PEEP) is set between 4 to 6 cm H2O. FiO2 is adjusted for a target post-ductus arteriosus SpO2 between 92% and 96%.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Succes of the procedure | survival without any oxygen treatment | 72 hours of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity associated to the management of a newborn with RDS in a neonatal intensive care unit | Death Surfactant treatment, Pneumothorax, Secondary infections, Pulmonary hypertension, Inhaled nitric oxide treatment, Fluid loading treatment, Vasopressive amines treatment, Mechanical ventilation duration, nCPAP treatment duration, Oxygen treatment duration, Oxygen treatment at 28 days of life Hospitalization duration Treatment strategy cost | Every 8 hours of life between birth and 72 hours of life. Then every day until neonatal intensive care unit discharge. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant newborn, Infant preterm, Acute respiratory distress syndrome, surfactant, Hyaline Membrane disease, Newborn acute respiratory distress syndrome (ARDS)