A comparative study on the effect of using nasal protector (Neo-Guard)on the incidence rate and severity of nasal injury in preterm infants treated with Nasal-Continuous Positive Airway Pressure
A comparative study on the effect of using nasal protector (Neo-Guard)on the incidence rateand severity of nasal injuryin preterm infants treated withNasal-Continuous Positive Airway Pressure
Design
A randomized controlled clinical trial with parallel groups, single blind, randomized blocking method in two 40-person groups
Settings and conduct
This study will be performed in the NICU section of Alzahra and Shahid Beheshti Hospital in Isfahan. At first we receive written informed consent from the parents of the newborns. After convenience sampling, random allocation will be done using blocking method (https://www.sealedenvelope.com/simple-randomiser/v1/lists). Considering the sample size, there will be 40 neonate in each group. A list of letters A and B will be drawn at random from the four blocks using the software. Neonates in group (A) will receive Neo-Guard and infants in group (B) will receive routine care. Neonates in both groups will be monitored and evaluated every 12 hours to 72 hours after treatment with N-CPAP.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1-Premature infants 32 weeks or less or premature infants weighing 1500 g or less who require N-CPAP
2-Parents of infants consent to study for infants
Exclusion criteria
1-Premature infants who are >32 weeks of postmenstrual age (PMA) or Premature infants(<37 weeks(PMA)) at a weight <1500 g
2-The infant was intubated before receiving N-CPAP and received invasive ventilation
3-Preterm infants who had facial features that might preclude treatment with binasal CPAP (eg, cleft lip, Pierre Robin sequence,choanal atresia
Intervention groups
The intervention group will be treated with Neo-Guard and the control group will receive routine care.
Main outcome variables
The scale of incidence of nasal injury;Severity of nasal injuries;N-CPAP failure rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191217045769N1
Registration date:2020-03-15, 1398/12/25
Registration timing:registered_while_recruiting
Last update:2020-03-15, 1398/12/25
Update count:0
Registration date
2020-03-15, 1398/12/25
Registrant information
Name
Soheila Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3670 0196
Email address
jafari.soheila@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-31, 1398/10/10
Expected recruitment end date
2020-04-29, 1399/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effect of using nasal protector (Neo-Guard)on the incidence rate and severity of nasal injury in preterm infants treated with Nasal-Continuous Positive Airway Pressure
Public title
Effect of neogard protection to reduce nasal injury in preterm infants receiving N-CPAP
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Premature infants 32 weeks or less or premature infants weighing 1500 g or less who require N-CPAP
Parents are satisfied with the baby's entry into the study.
Exclusion criteria:
Premature infants who are >32 weeks of postmenstrual age (PMA) or Premature infants(<37 weeks(PMA)) at a weight <1500 g
The infant was intubated before receiving N-CPAP and received invasive ventilation
Preterm infants who had facial features that might preclude treatment with binasal CPAP (eg, cleft lip, Pierre Robin sequence,choanal atresia)
Age
To 8 months old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
We first identify each group with a letter such as Group A (Intervention Group), Group B (Control Group) and thus two groups will be named A and B.Each research unit is assigned a number, and depending on the sample size, a list of 80 neonates will be obtained, each grouping 40 neonates. with using the software and considering the four blocks a list of letters A and B will be randomly generated . Then they will be assigned to one of the groups by list and arrival arrange
Blinding (investigator's opinion)
Single blinded
Blinding description
Because the participants are newborns
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy of research and technology-Isfahan University of Medical Sciences
Street address
Hezar Jarib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2019-11-05, 1398/08/14
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.415
Health conditions studied
1
Description of health condition studied
Nasal injury associated with N-CPAP in preterm infants
ICD-10 code
P07.3
ICD-10 code description
Preterm [premature] newborn [other]
Primary outcomes
1
Description
Incidence and severity of nasal injury
Timepoint
Every 12 hours to 72 hours
Method of measurement
Check list
Secondary outcomes
1
Description
N-CPAP failure or success rate
Timepoint
Time of removing neonatal from N-CPAP
Method of measurement
Check list
Intervention groups
1
Description
Intervention group will use neoguard nasal protector to prevent nasal injury
Category
Prevention
2
Description
Control group will receive routine care.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra and Shahid Beheshti Hospital of Isfahan
Full name of responsible person
Soheila Jafari-Mianaei
Street address
Hezar jarib street,isfahan,iran
City
Isfahan
Province
Isfehan
Postal code
8174643446
Phone
+98 31 3792 7595
Email
m_jafari@nm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Soheila jafari mianaei
Street address
Hezar jarib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 9595
Email
m_jafari@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Soheila Jafari-Mianaei
Position
Assistant Professor of Pediatric and neonatal Department, School of Nursing and Midwifery
Latest degree
Ph.D.
Other areas of specialty/work
Pediatrics
Street address
Hezar jarib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174643446
Phone
+98 31 3792 7595
Email
m_jafari@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Soheila Jafari-Mianaei
Position
Assistant Professor of Pediatric and Neonatal Department, School of Nursing and Midwifery
Latest degree
Ph.D.
Other areas of specialty/work
Pediatrics
Street address
Isfahan Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174643446
Phone
+98 31 3792 7595
Email
m_jafari@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Soheila Jafari-Mianaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pediatrics
Street address
Sofeh Blvd,School of Nursing and Midwifery, Isfahan University of Medical Sciences,group infant
City
Isfahan
Province
Isfehan
Postal code
8174643446
Phone
+98 31 3670 0196
Fax
Email
jafari.soheila@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available