Protocol summary

Summary
In this randomized clinical trial, two groups of preterm infants (each group contains 44 infants, gestational age 28-37 weeks) with respiratory distress syndrome (RDS) in NICU of Al-Zahra or Shahid-Beheshti hospitals who are on the Nasal Continuous Positive Airway Pressure (NCPAP) with P=5 CmHg and Fio2≤30% at least for 6 hours, in stable state (respiratory rate<60, without pulmonary resuscitation, having no apnea and bagging, having less than 6 apnea episodes) will be studied. Written informed consent will be obtained from parents. Then we randomly allocate infants into two groups; HHFNC group (Humidified High Flow Nasal Cannula) who dissent from NCPAP at Fio2≤30% and receive 2 Lit/min O2 via cannula nasal, control group who are continued to the NCPAP till Fio2=21% to achieve a stable condition for 24 hours. In HHFNC group, O2 is adjusted according to infant need to maintain the O2 arterial pressure between 87 and 92%. The O2 flow is not changed till Fio2=21%, then its flow will decrease each 6 hours to achieve 0.5 L/min and at this time infant will be disparted. To maximize the efficacy, prong size will be appropriate to infant’s nose. Successful weaning is considered when infant could be stable for 72 hours in the room temperature. Statistical analysis will be conducted using SPSS version 20 , independent t-test, and chi-square test will be used to test significant differences between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014012716376N1
Registration date: 2014-02-08, 1392/11/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-02-08, 1392/11/19
Registrant information
Name
Alireza Eshghi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1625 5555
Email address
ali_phd203@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2014-02-19, 1392/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing two methods of cannula nasal with high flow and conventional Fio2 for successful weaning of preterm infants with respiratory distress from Nasal CPAP in Alzahra and Shahidbeheshti hospitals, Isfahan
Public title
Comparing two methods of cannula nasal with high flow and conventional Fio2 for successful weaning of preterm infants with respiratory distress from Nasal CPAP in Alzahra and Shahidbeheshti hospitals, Isfahan
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: preterm infants with respiratory distress syndrome (RDS) and gestational age (28-37 weeks) who require NCPAP; being stable on NCPAP at Fio2≤30% for 6 hours; no clinical sign of RDS such as tachypnea, sever apnea, intercostals retraction and nasal flaring. Exclusion criteria: infants with genetic anomalies; congenital cyanotic heart disease; genetic anomalies in airways or chest; pulmonary hypoplasy; genetic neurologic disease; neuro-mascular disease; inter ventricular hemorrhages (grade 3-4) and hydrocephaly.
Age
From 28 years old to 37 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib St., Isfahan
City
Isfahan
Postal code
73461-8174
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
390620

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
Apnea
Timepoint
From the time on the Nasal Continuous Positive Airway Pressure (NCPAP) till disparting from O2
Method of measurement
Observation

2

Description
Duration of need for respiratory support
Timepoint
From the time on the Nasal Continuous Positive Airway Pressure (NCPAP) till disparting from O2
Method of measurement
Observation

3

Description
Duration of O2 treatment
Timepoint
From the time on the Nasal Continuous Positive Airway Pressure (NCPAP) till disparting from O2
Method of measurement
Observation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group (Humidified High Flow Nasal Cannula group) who dissent from NCPAP at Fio2≤30% and receive 2 Lit/min O2 via cannula nasal
Category
Treatment - Other

2

Description
Control group: who are connected to the NCPAP at Fio2=21% to achieve a stable condition for 24 hours.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Dr. Alireza Eshghi
Street address
Sofeh st., Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Peyman Adibi
Street address
Isfahan University of Medical Sciences, Hezar Jarib St., Isfahan
City
Isfahan
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, Isfahan 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
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Alireza Eshghi
Position
MD, Resident of pediatrics
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.
City
Isfahan
Postal code
73461-8174
Phone
+98 31 1625 5555
Fax
Email
ali_phd203@ yahoo.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. Zohre Badiei
Position
Specialist in pediatrics
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.
City
Isfahan
Postal code
73461-8174
Phone
+98 31 1625 5555
Fax
Email
badiei@ 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. Alireza Eshghi
Position
MD, Resident of pediatrics
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.
City
Isfahan
Postal code
73461-8174
Phone
+98 31 1625 5555
Fax
Email
ali_phd203@ yahoo.com
Web page address

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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