NCT02825953

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

1 year

First QC Date

June 16, 2016

Last Update Submit

July 6, 2016

Conditions

Respiratory Distress SyndromeSurfactant Administration by Aerosolization

Outcome Measures

Primary Outcomes (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.

    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%.

    within the first 72 hour of life

Secondary Outcomes (5)

  • Chronic Lung Disease (CLD)

    up to 36 weeks of post gestational age

  • Patent ductus arteriosus

    In 5 days of life

  • Intraventricular haemorrhage

    Within 1 month of life

  • Necrotising enterocolitis

    Within 3 months of life

  • Retinopathy of prematurity (ROP)

    Up to 3 months of life

Study Arms (3)

Nebulized surfactant

ACTIVE COMPARATOR

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: surfactantDevice: nasal continuous positive airway pressureDevice: non-invasive intermittent positive-pressure ventilationDevice: NeopuffDevice: neonatal ventilator

Endotracheal bolus application

ACTIVE COMPARATOR

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: surfactantDevice: nasal continuous positive airway pressureDevice: non-invasive intermittent positive-pressure ventilationDevice: NeopuffDevice: neonatal ventilator

Minimally invasive surfactant therapy

ACTIVE COMPARATOR

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: surfactantDevice: nasal continuous positive airway pressureDevice: non-invasive intermittent positive-pressure ventilationDevice: NeopuffDevice: neonatal ventilator

Interventions

surfactantDRUG

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

Also known as: Curosurf
Endotracheal bolus applicationMinimally invasive surfactant therapyNebulized surfactant
nasal continuous positive airway pressureDEVICE

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).

Also known as: NCPAP
Endotracheal bolus applicationMinimally invasive surfactant therapyNebulized surfactant
non-invasive intermittent positive-pressure ventilationDEVICE

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).

Also known as: NIPPV
Endotracheal bolus applicationMinimally invasive surfactant therapyNebulized surfactant
NeopuffDEVICE

Fisher and Paykel, Auckland, New Zealand

Endotracheal bolus applicationMinimally invasive surfactant therapyNebulized surfactant
neonatal ventilatorDEVICE

GE Healthcare, Madison, USA

Also known as: Engström Carestation
Endotracheal bolus applicationMinimally invasive surfactant therapyNebulized surfactant

Eligibility Criteria

Age26 Weeks - 34 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Corrected gestational age \<26 week or \>34 week,
  • Age \>36 h
  • Premature babies with RDS but no breathing spontaneously
  • Evident lung or cardiovascular malformation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Cowan F, Whitelaw A, Wertheim D, Silverman M. Cerebral blood flow velocity changes after rapid administration of surfactant. Arch Dis Child. 1991 Oct;66(10 Spec No):1105-9. doi: 10.1136/adc.66.10_spec_no.1105.

    PMID: 1750756RESULT

  • Mercier CE, Soll RF. Clinical trials of natural surfactant extract in respiratory distress syndrome. Clin Perinatol. 1993 Dec;20(4):711-35.

    PMID: 8131364RESULT

  • Berggren E, Liljedahl M, Winbladh B, Andreasson B, Curstedt T, Robertson B, Schollin J. Pilot study of nebulized surfactant therapy for neonatal respiratory distress syndrome. Acta Paediatr. 2000 Apr;89(4):460-4. doi: 10.1080/080352500750028195.

    PMID: 10830460RESULT

  • Papile LA, Burstein J, Burstein R, Koffler H. Incidence and evolution of subependymal and intraventricular hemorrhage: a study of infants with birth weights less than 1,500 gm. J Pediatr. 1978 Apr;92(4):529-34. doi: 10.1016/s0022-3476(78)80282-0.

    PMID: 305471RESULT

  • Kero PO, Makinen EO. Comparison between clinical and radiological classification of infants with the respiratory distress syndrome (RDS). Eur J Pediatr. 1979 Apr 3;130(4):271-8. doi: 10.1007/BF00441363.

    PMID: 436851RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Surface-Active Agentsporactant alfaContinuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Specialty Uses of ChemicalsChemical Actions and UsesPositive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 16, 2016

First Posted

July 7, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

July 11, 2016

Record last verified: 2016-07