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

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

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.

Study Overview

• Status: Terminated
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Procedure: Surfactant instillation; Procedure: nCPAP

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • Amiens University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early strategy; Intratracheal poractant alpha (Curosurf®) after tracheal intubation	Procedure: Surfactant instillation; Intra-tracheal poractant alpha instillation after tracheal intubation
Active Comparator: Delayed strategy; Nasal Continous Positive Airways Pressure. Intratracheal poractant alpha as a rescue treatment if FiO2 > 60%	Procedure: nCPAP; 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%.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: February 28, 2011
• First Submitted That Met QC Criteria: February 28, 2011
• First Posted (Estimate): March 1, 2011

Study Record Updates

• Last Update Posted (Estimate): May 12, 2016
• Last Update Submitted That Met QC Criteria: May 11, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Acute respiratory distress syndrome; surfactant; Infant newborn; Infant preterm; Hyaline Membrane disease; Newborn acute respiratory distress syndrome (ARDS)
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Respiratory System Agents; Pulmonary Surfactants
• Other Study ID Numbers: PHRCIR09-DR-TOURNEUX