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Does The Surfactant Administration by Aerosolization Effective?

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ClinicalTrials.gov Identifier: NCT02825953
Recruitment Status : Unknown
Verified July 2016 by nihat demir, Yuzuncu Yıl University.
Recruitment status was:  Active, not recruiting
First Posted : July 7, 2016
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
nihat demir, Yuzuncu Yıl University

Brief 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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome Surfactant Administration by Aerosolization Drug: surfactant Device: nasal continuous positive airway pressure Device: non-invasive intermittent positive-pressure ventilation Device: Neopuff Device: neonatal ventilator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Does The Surfactant Administration by Aerosolization of Respiratory Distress Syndrome Effective in Spontaneously Breathing Premature Infants ?
Study Start Date : January 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017


Arm Intervention/treatment
Active Comparator: Nebulized surfactant
For randomisatio, each infant will be randomly assigned to nasal continuous positive airway pressure (NCPAP) or non-invasive intermittent positive-pressure ventilation (NIPPV), and than premature babies with RDS breathing spontaneously will be administered surfactant by nebulizer.
Drug: surfactant
the investigators attempt to administer surfactant in a more gentle way, i.e. by nebulization, by minimally invasive surfactant therapy, and endotracheal bolus application of natural surfactant
Other Name: Curosurf

Device: nasal continuous positive airway pressure
each infant will be randomly assigned to nasal continuous positive airway pressure (NCPAP) or non-invasive intermittent positive-pressure ventilation (NIPPV). 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).
Other Name: NCPAP

Device: non-invasive intermittent positive-pressure ventilation
each infant will be randomly assigned to nasal continuous positive airway pressure (NCPAP) or non-invasive intermittent positive-pressure ventilation (NIPPV). 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).
Other Name: NIPPV

Device: Neopuff
Fisher and Paykel, Auckland, New Zealand

Device: neonatal ventilator
GE Healthcare, Madison, USA
Other Name: Engström Carestation

Active Comparator: Endotracheal bolus application
For randomisatio, each infant will be randomly assigned to nasal continuous positive airway pressure (NCPAP) or non-invasive intermittent positive-pressure ventilation (NIPPV). The investigators will administer surfactant via fundamental method.
Drug: surfactant
the investigators attempt to administer surfactant in a more gentle way, i.e. by nebulization, by minimally invasive surfactant therapy, and endotracheal bolus application of natural surfactant
Other Name: Curosurf

Device: nasal continuous positive airway pressure
each infant will be randomly assigned to nasal continuous positive airway pressure (NCPAP) or non-invasive intermittent positive-pressure ventilation (NIPPV). 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).
Other Name: NCPAP

Device: non-invasive intermittent positive-pressure ventilation
each infant will be randomly assigned to nasal continuous positive airway pressure (NCPAP) or non-invasive intermittent positive-pressure ventilation (NIPPV). 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).
Other Name: NIPPV

Device: Neopuff
Fisher and Paykel, Auckland, New Zealand

Device: neonatal ventilator
GE Healthcare, Madison, USA
Other Name: Engström Carestation

Active Comparator: Minimally invasive surfactant therapy
For randomisatio, each infant will be randomly assigned to nasal continuous positive airway pressure (NCPAP) or non-invasive intermittent positive-pressure ventilation (NIPPV). After randomisation, the investigators will administer surfactant via minimally invasive surfactant therapy (MIST) method which is recently very popular method
Drug: surfactant
the investigators attempt to administer surfactant in a more gentle way, i.e. by nebulization, by minimally invasive surfactant therapy, and endotracheal bolus application of natural surfactant
Other Name: Curosurf

Device: nasal continuous positive airway pressure
each infant will be randomly assigned to nasal continuous positive airway pressure (NCPAP) or non-invasive intermittent positive-pressure ventilation (NIPPV). 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).
Other Name: NCPAP

Device: non-invasive intermittent positive-pressure ventilation
each infant will be randomly assigned to nasal continuous positive airway pressure (NCPAP) or non-invasive intermittent positive-pressure ventilation (NIPPV). 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).
Other Name: NIPPV

Device: Neopuff
Fisher and Paykel, Auckland, New Zealand

Device: neonatal ventilator
GE Healthcare, Madison, USA
Other Name: Engström Carestation




Primary Outcome Measures :
  1. 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. [ Time Frame: within the first 72 hour of life ]
    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%.


Secondary Outcome Measures :
  1. Chronic Lung Disease (CLD) [ Time Frame: up to 36 weeks of post gestational age ]
    Chronic Lung Disease (CLD) will be defined according to National Institutes of Health criteria.

  2. Patent ductus arteriosus [ Time Frame: In 5 days of life ]
    Echocardiography will be performed routinely for patent ductus arteriosus at a postnatal age of 48-96 h.

  3. Intraventricular haemorrhage [ Time Frame: Within 1 month of life ]
    We will assess for intraventricular haemorrhage higher than grade II using the Papile classification system

  4. Necrotising enterocolitis [ Time Frame: Within 3 months of life ]
    Necrotising enterocolitis with the modified Bell's classification system

  5. Retinopathy of prematurity (ROP) [ Time Frame: Up to 3 months of life ]
    Retinopathy of prematurity (ROP) requiring laser treatment based on the criteria of the American Academy of Pediatrics, American Academy of Ophthalmology and American Association for Pediatric Ophthalmology and Strabismus.



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Ages Eligible for Study:   26 Weeks to 34 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • No evident lung or cardiovascular malformation.

Exclusion Criteria:

  • Corrected gestational age <26 week or >34 week,
  • Age >36 h
  • Premature babies with RDS but no breathing spontaneously
  • Evident lung or cardiovascular malformation.
Publications of Results:
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Responsible Party: nihat demir, Principal Investigator, Yuzuncu Yıl University
ClinicalTrials.gov Identifier: NCT02825953    
Other Study ID Numbers: YYU-09
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pulmonary Surfactants
Respiratory System Agents