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

NCT01306240 | Terminated Phase 3 DMC

• 1 other identifier: PHRCIR09-DR-TOURNEUX
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

Infant newborn; Infant preterm; Acute respiratory distress syndrome; surfactant; Hyaline Membrane disease; Newborn acute respiratory distress syndrome (ARDS)

Outcome Measures

Primary Outcomes (1)

• Succes of the procedure

  survival without any oxygen treatment

  72 hours of life

Secondary Outcomes (1)

• Morbidity associated to the management of a newborn with RDS in a neonatal intensive care unit

  Every 8 hours of life between birth and 72 hours of life. Then every day until neonatal intensive care unit discharge.

Study Arms (2)

Early strategy

EXPERIMENTAL

Intratracheal poractant alpha (Curosurf®) after tracheal intubation

Procedure: Surfactant instillation

Delayed strategy

ACTIVE COMPARATOR

Nasal Continous Positive Airways Pressure. Intratracheal poractant alpha as a rescue treatment if FiO2 \> 60%

Procedure: nCPAP

Interventions

Surfactant instillation PROCEDURE

Intra-tracheal poractant alpha instillation after tracheal intubation

Early strategy

nCPAP PROCEDURE

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%.

Delayed strategy

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

Amiens University Hospital

Amiens, Picardie, 80054, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Hyaline Membrane Disease

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Distress Syndrome, Newborn; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2011
• First Posted: March 1, 2011
• Study Start: March 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

FR (1)