Protocol summary

Study aim
comparison of the efficacy of CPAP and HFNC methods in the treatment of Iranian premature infants with RDS
Design
Clinical trial with control group, with parallel groups, one blind, randomized
Settings and conduct
This randomized control trail study was conducted among 60 infants suffering from RDS in Imam Khomeini Hospital Complex, Valiasr Hospital, in Tehran city, during 2018. Infantsin the neonatal intensive care unit (NICU) of Valiasr Hospital participated in the study.
Participants/Inclusion and exclusion criteria
Only the infant’s with mild to moderate RDS, birth weight less than 2000 grams, gestational age less than 34 weeks, respiratory severity between 4 to 7 score, and requires oxygen 60% or less were eligible to participate in this study. As well as, infants who had heart, digestive and respiratory anomalies, intraventricular hemorrhage (IVH) at birth, persistent air leak, sepsis positive at hospitalization in NICU, and Apgar score of less than 5 at 5 minutes were considered to exclusion criteria in this study.
Intervention groups
CPAP treatment was 4 to 6 cm water and FIO2 equivalent to 30% to improve respiratory distress and to reduce the need for oxygen for newborns. The positive pressure created by the device for the infants was measured by a manometer at the beginning of the respiratory tube expiratory arm. It should be noted that treatment was carried out on infants in supine position. Infants in another group were treated with HFNC methods, and this method continued to improve respiratory distress and eliminate the need for oxygen. Oxygen was heated with a blender unit with a temperature of 32 to 35 °C, and the infant’s mouthwaskeptopen during the use of the upper flow. Regulation flow was calculated based on the following formula: flow rate (liters per minute) = weight (kilograms) & 0.86 + 0.92
Main outcome variables
treatment of infants with RDS

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190623043988N1
Registration date: 2019-07-05, 1398/04/14
Registration timing: retrospective

Last update: 2019-07-05, 1398/04/14
Update count: 0
Registration date
2019-07-05, 1398/04/14
Registrant information
Name
Seyyed Nasrollah Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8804 7711
Email address
hosseiniseyyednasrollah@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-01-03, 1395/10/14
Expected recruitment end date
2018-06-19, 1397/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Continuous Positive Airway Pressure or High Flow Nasal Cannula for Respiratory Distress Syndrome: a Randomized Control Trail among Premature Infants
Public title
Continuous Positive Airway Pressure or High Flow Nasal Cannula for Respiratory Distress Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
birth weight less than 2000 grams, gestational age less than 34 weeks respiratory severity between 4 to 7 score requires oxygen 60% or less
Exclusion criteria:
Age
From 1 day old to 29 days old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Individual Randomization Permuted (block randomization) one infant in CPAP group and one infant in HFNC group
Blinding (investigator's opinion)
Single blinded
Blinding description
Single-way: patients In our study, only patients were blind Researchers and data analyst knew the treatment groups
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
This study was approved by the Institutional Ethics Committee of the Tehran University of Medical Sc
Street address
Ghods Town, Iran's Broadcasting Street, between Falamak and Zarafshan, Headquarters of the Ministry of Health and Medical Education
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2017-01-19, 1395/10/30
Ethics committee reference number
IR.TUMS.IKHC.REC.1395.1477

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
evaluate Continuous Positive Airway Pressure (CPAP) and High Flow Nasal Cannula (HFNC) intervention effectiveness among premature infants with RDS
Timepoint
Until the end of the breathtaking Rage
Method of measurement
evaluate Continuous Positive Airway Pressure (CPAP) and High Flow Nasal Cannula (HFNC) intervention effectiveness among premature infants with RDS

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Overall, 60 preterm infants with RDS at Valiasr Hospital, Tehran, during 2018 in this randomized control trail participated as CPAP and HFNC groups’ treatment. CPAP group received the nose with a peep of 4-6 centimeters from birth and continued to improve respiratory distress and the need for oxygen (O2). HFNC group received hot and humid flowing 2 to 5 liters/min in nose cannula, until respiratory distress and O2 needing to be resolved
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital, Tehran
Full name of responsible person
Seyyed Nasrollah Hosseini
Street address
بیمارستان امام خمینی تهران
City
Tehran
Province
Tehran
Postal code
1467664961
Phone
+98 21 8804 7711
Email
hosseiniseyyednasrollah@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyyed Nasrollah Hosseini
Street address
Tehran, Ghods Town, Iran's Simay Ave., Between Falamak and Zarafshan, Headquarters of the Ministry of Health and Medical Education
City
Tehran
Province
Tehran
Postal code
1467664961
Phone
+98 21 8804 7711
Email
hosseiniseyyednasrollah@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyyed Nasrollah Hosseini
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Tehran, Ghods Town, Iran's Simay Ave., Between Falamak and Zarafshan, Headquarters of the Ministry of Health and Medical Education
City
Tehran
Province
Tehran
Postal code
1467664961
Phone
+98 21 8804 7711
Email
hosseiniseyyednasrollah@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyyed Nasrollah Hosseini
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Tehran, Ghods Town, Iran's Simay Ave., Between Falamak and Zarafshan, Headquarters of the Ministry of Health and Medical Education
City
Tehran
Province
Tehran
Postal code
1467664961
Phone
+98 21 8804 7711
Email
hosseiniseyyednasrollah@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyyed Nasrollah Hosseini
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Tehran, Ghods Town, Iran's Simay Ave., Between Falamak and Zarafshan, Headquarters of the Ministry of Health and Medical Education
City
Tehran
Province
Tehran
Postal code
1467664961
Phone
+98 21 8804 7711
Email
hosseiniseyyednasrollah@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
.
When the data will become available and for how long
Start the access period 6 months after publish the results
To whom data/document is available
Health professionals
Under which criteria data/document could be used
Please contact the corresponding author for data requests.
From where data/document is obtainable
Please contact the corresponding author for data requests.
What processes are involved for a request to access data/document
Please contact the corresponding author for data requests.
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