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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01306240
Recruitment Status : Terminated (recruiting problems)
First Posted : March 1, 2011
Last Update Posted : May 12, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Procedure: Surfactant instillation Procedure: nCPAP Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : March 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

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%.

Primary Outcome Measures :
  1. Succes of the procedure [ Time Frame: 72 hours of life ]
    survival without any oxygen treatment

Secondary Outcome Measures :
  1. 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. ]
    • 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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01306240

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Amiens University Hospital
Amiens, Picardie, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
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Responsible Party: Centre Hospitalier Universitaire, Amiens Identifier: NCT01306240    
Other Study ID Numbers: PHRCIR09-DR-TOURNEUX
First Posted: March 1, 2011    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Keywords provided by Centre Hospitalier Universitaire, Amiens:
Infant newborn
Infant preterm
Acute respiratory distress syndrome
Hyaline Membrane disease
Newborn acute respiratory distress syndrome (ARDS)
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Pulmonary Surfactants
Respiratory System Agents