Does The Surfactant Administration by Aerosolization Effective?

Respiratory Distress Syndrome Clinical Trial

Official title: Does The Surfactant Administration by Aerosolization of Respiratory Distress Syndrome Effective in Spontaneously Breathing Premature Infants ?

Status Active, not recruiting

Clinical Trial Summary

The present study was designed to evaluate, in premature babies with RDS breathing spontaneously, the efficacy of combined treatment with nasal continuous positive airway pressure (CPAP) and aerosolized surfactant. The first objective of investigators is to assess the safety of surfactant nebulization in this clinical situation, and to find out whether treatment with aerosolized surfactant would reduce the need for mechanical ventilation. And other aim suggest that aerosolized dates compared with dates of INSURE (intubation-surfactant-extubation) and minimally invasive surfactant therapy (MIST) method.

Clinical Trial Description

Does The Surfactant Administration by Aerosolization of Respiratory Distress Syndrome effective in Spontaneously Breathing Premature Infants ? Endotracheal bolus application of natural surfactant has been shown to be an effective treatment for idiopathic respiratory distress syndrome (RDS), especially in premature neonates with weeks of pregnancy > 27 week. However, patients are intubated nasotracheal or orotracheal for this form of treatment. This intubation carries potential risks of injuries to the dental lamina, the larynx, and the trachea, bronchopulmonary infections, and fluctuations in cerebral blood flow, intra- and periventricular haemorrhage (1). In addition, many babies with RDS who initially respond to surfactant therapy later develop chronic lung disease (CLD) (2). With this in mind, the investigators attempt to administer surfactant in a more gentle way, i.e. by nebulization. Administration by aerosol during spontaneous respiration is less traumatic and avoids intubation with the accompanying mechanical and infectious risks and pathophysiological effects.

The present study was designed to evaluate, in premature babies with RDS breathing spontaneously, the efficacy of combined treatment with nasal continuous positive airway pressure (CPAP) and aerosolized surfactant. The first objective of investigators is to assess the safety of surfactant nebulization in this clinical situation, and to find out whether treatment with aerosolized surfactant would reduce the need for mechanical ventilation. And other aim suggest that aerosolized dates compared with dates of INSURE (intubation-surfactant-extubation) and minimally invasive surfactant therapy (MIST) method.

Seventy-five newborn babies from neonatal intensive care unit (NICU) of Yuzuncu Yil University Medical Scholl (Van, Turkey) will be randomized to treatment with nebulized surfactant (Curosurf®, Chiesi Pharmaceutics, Parma, Italy) or to two control groups receiving INSURE and MIST method. The study will be conducted with 75 infants, 25 in each group. Randomization will be central and performed using sealed envelopes kept at the neonatal ward of Yuzuncu Yil University Medical Centre Hospital. Informed consent was obtained from all parents before randomization. Inclusion criteria are corrected gestational age >26 week or <34 week, age 2-36 h, clinically and radiologically diagnosed progressive RDS, FiO2 needed to maintain SaO2 85-95%; >0.4, and no evident lung or cardiovascular malformation.

The surfactant aerosol will generate with a ultrasonic nebulizer (Aeroneb Pro; Aerogen, Inc., Sunnyvale, CA) and administer via the nasal continuous positive airway pressure (NCPAP) equipment into the Laryngeal Mask Airway (LMA). Surfactant will be diluted to 40 mg/ml with saline before nebulization. These modifications will be introduced to enhance the delivery of nebulized material to the lungs (3). In the control groups, the babies will be supported with the same type of NCPAP equipment, after given surfactant via endotracheal bolus application and MIST method. Parameters will be documented at three different times, namely before application of surfactant (200 mg/kg BW), and 2 h, 6 h after completion of nebulization or application of others.

The infants will be stabilised on NCPAP (Neopuff; Fisher and Paykel, Auckland, New Zealand) in the delivery room and during transport to the NICU. NCPAP or NIPPV will be started within 30 min of birth immediately after randomisation. Both NCPAP and NIPPV will be delivered by a neonatal ventilator (Engström Carestation; GE Healthcare, Madison, USA) via short, binasal Cannula (RAM Cannula; Neotech, Valencia, CA). NCPAP pressure will be set at 5-6 cm H2O, and NIPPV will be set in a non-synchronised mode at 20-30 bpm, with positive end-expiratory pressure of 5-6 cm H2O and peak inspiratory pressure of 15-20 cm H2O. FiO2 will be titrated at 0.21-0.50 to maintain an oxygen saturation level of 90%-95%, as measured via pulse oximeter. Under non-invasive ventilation, the surfactant will be administered as a rescue therapy if the infant required ≥0.40 FiO2 to maintain the target saturation level of 90%-95%.

Findings in chest radiograms before inclusion and head ultrasound images taken as soon as possible according to the clinical situation will be evaluated and graded according to criteria defined by Papile et al. (4) and Kero et al.(5) CLD will be defined as need for supplemental oxygen at 36 wk gestational age.

Statistical evaluation Data will be analyzed using the 20 Windows Version of Statistical Package for the Social Sciences (SPSS) Program (Chicago, IL, USA).

Data were compared using unpaired t-test and Chi-square test, and p-values below <0.05 were considered statistically significant.

Ethical approval The study was approved by the regional ethics committee at the Yuzuncu Yil University Institute, Van, Turkey.

The regional ethics committee No: 05.05.2015/09 ;

Study Design

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

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Surfactant Administration by Aerosolization
• Syndrome

• NCT number: NCT02825953
• Study type: Interventional
• Source: Yuzuncu Yil University
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2016
• Completion date: January 2017