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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01306240

Acronym

ASPEN

Enrollment

Registered

2011-03-01

Start date

2011-03-31

Completion date

2012-10-31

Last updated

2016-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome

Keywords

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

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.

Interventions

PROCEDURESurfactant instillation

Intra-tracheal poractant alpha instillation after tracheal intubation

PROCEDUREnCPAP

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%.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

No minimum to 1 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Succes of the procedure	72 hours of life	survival without any oxygen treatment

Secondary

Measure	Time frame	Description
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.	* 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026