Back to resultsSurfactant Versus Nasal Continuous Positive Airway Pressure (nCPAP) for Respiratory Distress Syndrome in the Newborn ≥ 35 Weeks of Gestation (ASPEN)
Primary Purpose
Acute Respiratory Distress Syndrome
Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Surfactant instillation
nCPAP
Sponsored by
About this trial
This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring Infant newborn, Infant preterm, Acute respiratory distress syndrome, surfactant, Hyaline Membrane disease, Newborn acute respiratory distress syndrome (ARDS)
Eligibility Criteria
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
Sites / Locations
- Amiens University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early strategy
Delayed strategy
Arm Description
Intratracheal poractant alpha (Curosurf®) after tracheal intubation
Nasal Continous Positive Airways Pressure. Intratracheal poractant alpha as a rescue treatment if FiO2 > 60%
Outcomes
Primary Outcome Measures
Succes of the procedure
survival without any oxygen treatment
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01306240
First Posted
February 28, 2011
Last Updated
May 11, 2016
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT01306240
Brief Title
Surfactant Versus Nasal Continuous Positive Airway Pressure (nCPAP) for Respiratory Distress Syndrome in the Newborn ≥ 35 Weeks of Gestation
Acronym
ASPEN
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Why Stopped
recruiting problems
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
Infant newborn, Infant preterm, Acute respiratory distress syndrome, surfactant, Hyaline Membrane disease, Newborn acute respiratory distress syndrome (ARDS)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early strategy
Arm Type
Experimental
Arm Description
Intratracheal poractant alpha (Curosurf®) after tracheal intubation
Arm Title
Delayed strategy
Arm Type
Active Comparator
Arm Description
Nasal Continous Positive Airways Pressure. Intratracheal poractant alpha as a rescue treatment if FiO2 > 60%
Intervention Type
Procedure
Intervention Name(s)
Surfactant instillation
Intervention Description
Intra-tracheal poractant alpha instillation after tracheal intubation
Intervention Type
Procedure
Intervention Name(s)
nCPAP
Intervention Description
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%.
Primary Outcome Measure Information:
Title
Succes of the procedure
Description
survival without any oxygen treatment
Time Frame
72 hours of life
Secondary Outcome Measure Information:
Title
Morbidity associated to the management of a newborn with RDS in a neonatal intensive care unit
Description
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
Time Frame
Every 8 hours of life between birth and 72 hours of life. Then every day until neonatal intensive care unit discharge.
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Amiens University Hospital
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
12. IPD Sharing Statement
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Surfactant Versus Nasal Continuous Positive Airway Pressure (nCPAP) for Respiratory Distress Syndrome in the Newborn ≥ 35 Weeks of Gestation
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