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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Centre Hospitalier Universitaire, Amiens.
Recruitment status was  Recruiting
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

February 28, 2011
September 26, 2011
March 2011
January 2012   (final data collection date for primary outcome measure)
Succes of the procedure [ Time Frame: 72 hours of life ] [ Designated as safety issue: Yes ]
survival without any oxygen treatment
Same as current
Complete list of historical versions of study NCT01306240 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Surfactant Versus Nasal Continuous Positive Airway Pressure (nCPAP) for Respiratory Distress Syndrome in the Newborn ≥ 35 Weeks of Gestation
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Acute Respiratory Distress Syndrome
  • Procedure: Surfactant instillation
    Intra-tracheal poractant alpha instillation after tracheal intubation
  • 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%.
  • Experimental: Early strategy
    Intratracheal poractant alpha (Curosurf®) after tracheal intubation
    Intervention: Procedure: Surfactant instillation
  • Active Comparator: Delayed strategy
    Nasal Continous Positive Airways Pressure. Intratracheal poractant alpha as a rescue treatment if FiO2 > 60%
    Intervention: Procedure: nCPAP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
152
November 2013
January 2012   (final data collection date for primary outcome measure)

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
Both
up to 1 Month
No
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
France
 
NCT01306240
PHRC IR09 - Dr TOURNEUX
Yes
Centre Hospitalier Universitaire, Amiens
Centre Hospitalier Universitaire, Amiens
Not Provided
Not Provided
Centre Hospitalier Universitaire, Amiens
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP