Protocol summary

Summary
This study will done with aim to investigate the effectiveness of the nasal cannula with high pressure and continuous positive airway pressure through the nose for the treatment of premature infants with respiratory distress syndrome. This study is not-blinded clinical trial. The study population will included all premature infants with less than 37 weeks gestational age with respiratory distress syndrome, hospitalized in Imam Reza Hospital in Kermanshah city that require surfactant injection in Insure way, that the number of 200 subjects are selected and randomly are assigned to experimental and control groups. In the first group after the injection of the surfactant and Extube, Placed under respiratory support with nasal (CPAP) and in the second group respiratory support is established using the oxygen hot and humid high flow through nasal cannula (HFNC). In the first group initiation of treatment is with 4 ml of water and Fio2 40% and in the second group Blender and nasal cannula devices with an inner diameter of 2 mm is used for administering oxygen . Then in both groups, the duration of treatment with nasal or nasal cannula, need for mechanical ventilation, need to prescribe another dose of surfactant, damage to the nasal septum, intracerebral bleeding, compared with each other during and end of the study. Inclusion criteria: premature infants under 37 weeks and over 24 weeks; respiratory distress syndrome; written informed consent of the parents Exclusion criteria: Apgar score of fifth minute less than 5; there are syndromes or major congenital anomalies; congenital heart disease, mother Radiography and chorioamnionitis

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015100814333N41
Registration date: 2015-10-19, 1394/07/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-10-19, 1394/07/27
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2015-07-06, 1394/04/15
Expected recruitment end date
2016-01-05, 1394/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of effectiveness and ineffectiveness of the nasal cannula with high pressure and continuous positive airway pressure through the nose for the treatment of premature infants with respiratory distress syndrome
Public title
Comparison of the effects of High flow nasal cannula versus nasal continuous positive Air way pressure in treatment of respiratory distress syndrome in premature newborns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: premature infants under 37 weeks and over 24 weeks; respiratory distress syndrome; written informed consent of the parents Exclusion criteria: Apgar score of fifth minute less than 5; there are syndromes or major congenital anomalies; congenital heart disease, mother Radiography and chorioamnionitis
Age
From 6 months old to 9 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random method according to the random number table

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2015-08-18, 1394/05/27
Ethics committee reference number
kums.rec.1394.90

Health conditions studied

1

Description of health condition studied
Respiratory distress syndrome
ICD-10 code
P22
ICD-10 code description
Respiratory distress syndrome of newborn

Primary outcomes

1

Description
Cerebral hemorrhage
Timepoint
During study
Method of measurement
By cerebral ultrasound

2

Description
Necrotizing enterocolitis
Timepoint
During study
Method of measurement
Based on the clinical symptoms and a doctor observation and an abdominal radiograph

3

Description
Amount of nasal septum injury
Timepoint
During study
Method of measurement
Based on the doctor examination

4

Description
Air leak syndrome
Timepoint
During study
Method of measurement
Based on the clinical symptoms and doctor observation and chest radiography

5

Description
Broncho-pulmonary dysplasia
Timepoint
During study
Method of measurement
Based on the clinical symptoms, doctor observation, x-ray and laboratory

6

Description
The need for re-intubating
Timepoint
During study
Method of measurement
Based on laboratory and doctor clinical examination

Secondary outcomes

empty

Intervention groups

1

Description
In the first group after the injection of the surfactant and Extube, Placed under respiratory support with nasal (CPAP) and initiation of treatment is with 4 ml of water and Fio2 40%. Then the duration of treatment with nasal or nasal cannula, need for mechanical ventilation, need to prescribe another dose of surfactant, damage to the nasal septum, intracerebral bleeding, during and end of the study is investigated
Category
Treatment - Drugs

2

Description
In the second group respiratory support is established using the oxygen hot and humid high flow through nasal cannula (HFNC). Blender and nasal cannula devices with an inner diameter of 2 mm is used for administering oxygen. Then the duration of treatment with nasal or nasal cannula, need for mechanical ventilation, need to prescribe another dose of surfactant, damage to the nasal septum, intracerebral bleeding, during and end of the study is investigated
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr. Mansour Ahoon
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Proportion provided by this source
100
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Homa Babaei
Position
Infants Specialist
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6300
Fax
Email
HOMA_BABAEI@KUMS.AC.IR
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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