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

Phase 3

Terminated

• Conditions: Acute Respiratory Distress Syndrome
• Interventions: Procedure: Surfactant instillation; Procedure: nCPAP

• Registration Number: NCT01306240
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2011-02-28
• Study First Submitted QC: 2011-02-28
• Study Start: 2011-03
• Study First Posted: 2011-03-01
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early strategy	Surfactant instillation	Intratracheal poractant alpha (Curosurf®) after tracheal intubation
Delayed strategy	nCPAP	Nasal Continous Positive Airways Pressure. Intratracheal poractant alpha as a rescue treatment if FiO2 \> 60%

Primary Outcome Measures

Name	Time	Method
Succes of the procedure	72 hours of life	survival without any oxygen treatment

Secondary Outcome Measures

Name	Time	Method
Morbidity associated to the management of a newborn with RDS in a neonatal intensive care unit	Every 8 hours of life between birth and 72 hours of life. Then every day until neonatal intensive care unit discharge.	* 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

Trial Locations

Locations (1)

Amiens University Hospital; 🇫🇷 Amiens, Picardie, France