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

Acute Respiratory Distress Syndrome Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01306240
• Other study ID #: PHRCIR09-DR-TOURNEUX
• Status: Terminated
• Phase: Phase 3
• First received: February 28, 2011
• Last updated: May 11, 2016
• Start date: March 2011
• Est. completion date: October 2012

Study information

• Verified date: May 2016
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Month

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Procedure:
• Surfactant instillation
Intra-tracheal poractant alpha instillation after tracheal intubation
• 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%.

Locations

Country	Name	City	State
France	Amiens University Hospital	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Succes of the procedure	survival without any oxygen treatment	72 hours of life	Yes
Secondary	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.	Yes