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

This study is currently recruiting participants.
Verified September 2011 by Centre Hospitalier Universitaire, Amiens
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT01306240
First received: February 28, 2011
Last updated: September 26, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Respiratory Distress Syndrome
 Procedure: Surfactant instillation
Procedure: nCPAP
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire, Amiens:

Primary Outcome Measures:
  • Succes of the procedure [ Time Frame: 72 hours of life ] [ Designated as safety issue: Yes ]
    survival without any oxygen treatment


Secondary Outcome Measures:
  • Morbidity associated to the management of a newborn with RDS in a neonatal intensive care unit [ Time Frame: Every 8 hours of life between birth and 72 hours of life. Then every day until neonatal intensive care unit discharge. ] [ Designated as safety issue: Yes ]
    • 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


Estimated Enrollment: 152
Study Start Date: March 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%.

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.

  Eligibility

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306240

Contacts
Contact: Pierre Tourneux, MD +33 3 22 66 82 86 tourneux.pierre@chu-amiens.fr
Contact: Bertrand Labattu +33 3 22 66 80 63 labattu.bertrand@chu-amiens.fr

Locations
France
Amiens University Hospital Recruiting
Amiens, Picardie, France, 80054
Contact: Pierre Tourneux, MD     +33 3 22 66 82 86     tourneux.pierre@chu-amiens.fr    
Contact: Bertrand Labattu     +33 3 22 66 80 63     labattu.bertrand@chu-amiens.fr    
Sub-Investigator: Cecile Fontaine, MD            
Sub-Investigator: Marie Bissuel, MD            
Sub-Investigator: Ghida Ramadan-Ghostine, MD            
Sub-Investigator: Guy Kongolo, MD            
Sub-Investigator: Laurent Ghyselen, MD            
Principal Investigator: Pierre Tourneux, MD            
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01306240     History of Changes
Other Study ID Numbers: PHRC IR09 - Dr TOURNEUX
Study First Received: February 28, 2011
Last Updated: September 26, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire, Amiens:
Infant newborn
Infant preterm
Acute respiratory distress syndrome
 surfactant
Hyaline Membrane disease
Newborn acute respiratory distress syndrome (ARDS)

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
 Infant, Newborn, Diseases
Lung Injury
Pulmonary Surfactants
Poractant alfa
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013