Therapeutic effect of heated, humidified, high-flow nasal cannula (HHHFNC) and Nasal intermittent mandatory ventilation (NIMV) as initial therapy of respiratory distress syndrome (RDS) in very Low Birth Weight (VLBW) Infants
Premature babies (especially VLBW) respiratory distress syndrome (RDS) may require respiratory support .Now is general agreement that the use of mechanical ventilation due to high to minimize side effects. For this reason; various methods of non-invasive ventilation (NRS) to reduce the use of mechanical ventilation is evolving and developing. The main advantage of this novel therapeutic approaches to reduce the rate of neonatal endotracheal tube intubation is. Infants were excluded if there was any of the following cases :Major congenital anomalies ;asphyxia and congenital cyanotic heart disease .In this study very low brith weight (BW<1500gr) with respiratory distress were considered eligible .Thirty-five infants were randomly assigned early NIMV and thirty-five comparable infants to early HHHFNC .Surfactant were given; when Fio2 requirement was of more than 30% .Shown that the application of continuous positive airway pressure to the airway through the nose (NCPAP) is one of the treatment options RDS in premature newborns that as an effective method to reduce the use of mechanical ventilation in a fairly large number of newborns preterm RDS is. Another method of treatment NRS nasal intermittent mechanical ventilation (NIMV) that the use of NIMV and HHHFNC post extubation and apea of prematurity are more effective than NCPAP. NIMV in the treatment of premature infants with RDS used. But do NIMV use as an initial treatment for RDS is controversial. In this way; despite the use of endotracheal intubation ventilation device can not be used and from nasal pronge.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052510026N7
Registration date:2017-07-08, 1396/04/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-08, 1396/04/17
Registrant information
Name
Amir mohammad Armanian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1235 5059
Email address
armanian@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2017-01-09, 1395/10/20
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effect of heated, humidified, high-flow nasal cannula (HHHFNC) and Nasal intermittent mandatory ventilation (NIMV) as initial therapy of respiratory distress syndrome (RDS) in very Low Birth Weight (VLBW) Infants
Public title
Therapeutic effect of heated, humidified, high-flow nasal cannula (HHHFNC) in respiratory distress syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: premature infants, weighing less than 1500 g and RDS symptoms requires treatment. Exclusion criteria: are major congenital anomalies; respiratory anomalies; orofacial malformations and cyanotic heart diseases.
Age
To 1 month old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjerib st.
City
Isfahan
Postal code
8184757851
Approval date
2016-07-20, 1395/04/30
Ethics committee reference number
IR.MUI.REC.1395.3.415
Health conditions studied
1
Description of health condition studied
Respiratory distress syndrome
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
The duration of non-invasive respiratory support
Timepoint
at the 3th and 7th days of life
Method of measurement
Daily recorded sheets
Secondary outcomes
1
Description
Time to full enteral feeds
Timepoint
at the 3th, 7th and 15th days of life
Method of measurement
Daily recorded sheets
Intervention groups
1
Description
For infants in early-NIMV group (non-synchronized mode), NIMV will set at peak inspiratory pressure (PIP) of 16 -20
cmH2O (according to infant’s birth weight and chest wall expansion), positive end expiratory pressure (PEEP) of 5 to 6
cmH2O, rate of 40- 50 breaths/min (according to PaCO2), inspiratory time (Ti) of 0.4 seconds and flow rate of 8 to 10 L/minute.
Setting was adjusted according to arterial blood gases (ABG), clinical parameters and to maintain SPO2between 91% - 95%. Surfactant [(100 mg/kg per dose, Curosurf (Chiesa pharmaceuticals, Parma, Italy) or Survanta (Abbott laboratories, Illinois, USA)] was administered if studied neonates needed a fraction of inspired oxygen (FIO2) of >30% to keep the SPO2of > 91%. INSURE approach, only as rescue therapy, was used in both groups
Category
Treatment - Devices
2
Description
For infants in HHHFNC group, high flow was initiated with a flow of 2.5-3 L/minute by a short bi-nasal prongs. Setting was adjusted according to arterial blood gases (ABG), clinical parameters and to maintain SPO2between 91% - 95%. Surfactant [(100 mg/kg per dose, Curosurf (Chiesa pharmaceuticals, Parma, Italy) or Survanta (Abbott laboratories, Illinois, USA)] was administered if studied neonates needed a fraction of inspired oxygen (FIO2) of >30% to keep the SPO2of > 91%. INSURE approach, only as rescue therapy, was used in both groups
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU at Alzahra and Shahid Beheshti hospitals in Isfahan IRAN
Full name of responsible person
Dr. Amir Mohammad Armanian
Street address
Number 133, Shahid ansari alley, Saeb street, Isfahan,Iran Isfahan
City
Isfahan
2
Recruitment center
Name of recruitment center
NICU at Alzahra and Shahid Beheshti hospitals in Isfahan IRAN
Full name of responsible person
Dr. Amir Mohammad Armanian
Street address
Number 133, Shahid ansari alley, Saeb street, Isfahan,Iran Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr.nasri
Street address
Isfahan University of Medical Sciences, Hezarjerib st.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr.nasri
Street address
Isfahan University of Medical Sciences, Hezarjerib st.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mahdi Parvaneh
Position
Neonatal feloshib
Other areas of specialty/work
Street address
Department of Pediatrics, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Postal code
8184757851
Phone
+98 31 3337 8059
Fax
+98 31 3235 5059
Email
Drmparvaneh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr.Amir Mohammad Armanian
Position
Associate professor of neonatology
Other areas of specialty/work
Street address
Number 133, Shahid ansari Alley, Saeb Street, Isfahan
City
Isfahan
Postal code
8184757851
Phone
+98 31 3235 5059
Fax
+98 31 3235 5059
Email
armanian@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr.Amir Mohammad Armanian
Position
Associate professor of neonatology
Other areas of specialty/work
Street address
Number 133, Shahid ansari Alley, Saeb Street, Isfahan,
City
Isfahan
Postal code
8184757851
Phone
+31 32355059
Fax
+98 31 3235 5059
Email
armanian@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)