Clinical trial NCT01306240: Surfactant Versus Nasal Continuous Positive Airway Pressure (nCPAP) for Respiratory Distress Syndrome in the Newborn ≥ 35 Weeks of Gestation
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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acute Respiratory Distress Syndrome
Keywords: Infant newborn
Infant preterm
Acute respiratory distress syndrome
surfactant
Hyaline Membrane disease
Newborn acute respiratory distress syndrome (ARDS)
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2011-03-01
Enrollment: 19
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Succes of the procedure
timeFrame: 72 hours of life
Secondary outcomes:
measure: Morbidity associated to the management of a newborn with RDS in a neonatal intensive care unit
timeFrame: Every 8 hours of life between birth and 72 hours of life. Then every day until neonatal intensive care unit discharge.
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens University Hospital
state: Picardie
Study officials:
References: