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The effect of neonatal massage on increasing the salivary secretory IgA level in premature infants with RDS diagnosis

Protocol summary

Study aim
The effect of neonatal massage on increasing the salivary secretory IgA level in premature infants with RDS diagnosis
Design
All preterm infants weighing between 1,500and2,000 grams who are suffering from RDS problems in Asalian, ShahidMadani and ShahidRahimi hospitals in 1396 and are deprived of breast milk for any reason and use dry milk. Sampling:The infants were available and assigned to the study groups using stratified random blocks method (in order to identify gender probability). 75 neonates in each intervention and control group received 2-4 days after birth after acute RDS symptoms were resolved and when sIgA was prepared from saliva when used for milk preparation. The next sample will be received on the 14th birthday and will be recorded. During this period, the infants of the intervention group will be treated thoroughly 3 times a day, each time for 15 minutes by the trained expert.
Settings and conduct
This study is done in hospitals in Khorramabad,when have section has infants.Sampling:The infants were available and assigned to the study groups using stratified random blocks method (in order to identify gender probability).Blinding is not done.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Preterm infants weighing between 1,500 and 2,000 grams admitted to the NICU of Asalian, Shahid Madani and Shahid Rahimi hospitals with RDS problems who are deprived of breast milk for any reason. Exit criteria:These infants are in need of treatment in case of sepsis (positive blood culture or other blood-positive parameters), need for IPPV, seizure, symptomatic PDA, history of weakened immune system in the family, infants with any malformations, minor or major, and babies with jaundice requiring blood replacement. Abnormalities are minor and major, and babies with jaundice requiring blood replacement
Intervention groups
Massage by child care clinicians
Main outcome variables
Increased secretion IgA level (SIGA) in preterm infants with RDS

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171225038056N1
Registration date: 2018-01-22, 1396/11/02
Registration timing: registered_while_recruiting

Last update: 2018-01-22, 1396/11/02
Update count: 0
Registration date
2018-01-22, 1396/11/02
Registrant information
Name
Majid Firouzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3322 3004
Email address
firouzi.m@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-04-17, 1395/01/29
Expected recruitment end date
2017-12-20, 1396/09/29
Actual recruitment start date
2017-12-20, 1396/09/29
Actual recruitment end date
2018-03-11, 1396/12/20
Trial completion date
empty
Scientific title
The effect of neonatal massage on increasing the salivary secretory IgA level in premature infants with RDS diagnosis
Public title
"The effect of neonatal massage on increasing the salivary secretory IgA level"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Preterm infants weighing between 1,500 and 2,000 grams admitted to NICU at Asalian, ShahidMadani and ShahidRahimi Hospitals with RDS problems Babies who are deprived of milk for any reason and use dry milk
Exclusion criteria:
Sepsis (positive blood culture or other positive blood parameters) Requires IPPV Seizure PDAs Symptoms require treatment A history of weakened immune systems in the family infants who have any malformations, both minor and major and babies with jaundice requiring blood replacement
Age
From 2 days old to 14 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
Actual sample size reached: 150
Randomization (investigator's opinion)
Randomized
Randomization description
accident cases were classified as simple random blocks due to elimination of the probability of sex in two groups of control and intervention
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 Lorestan University of Medical Sciences
Street address
Research and Technology Dept,Campus University Complex,Lorestan University of Medical Sciences,Koolimeter 5 Khorramabad Road, Tehran
City
khorramabad
Province
Lorestan
Postal code
858575
Approval date
2017-04-24, 1396/02/04
Ethics committee reference number
IR LUMS.REC.1396.232

Health conditions studied

1

Description of health condition studied
Infants with Respiratory distress syndrom
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn

Primary outcomes

1

Description
Saliva level of secretion IgA
Timepoint
3 times a day every 15 minutes to 14 days
Method of measurement
Saliva sampling (sIgA)

Secondary outcomes

1

Description
Normal breathing
Timepoint
14 days
Method of measurement
Ventilator

2

Description
Added weight in newborns
Timepoint
14 days
Method of measurement
Scales

Intervention groups

1

Description
Intervention group: Babies massage therapy 2-4 days with respiratory distress daily 3 times
Category
Treatment - Other

2

Description
Control group: Infants with respiratory distress 2-4 days after birth
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Asli Charity Hospital
Full name of responsible person
Dr.masoumeh ghafarzadeh
Street address
Asli Charity Hospital,Corner of the street,Twelfth Street,Cui Palestine
City
Khorramabad
Province
Lorestan
Postal code
68559878
Phone
+98 66 3322 3030
Email
asali.hospital@lums.ac.ir

2

Recruitment center
Name of recruitment center
Shahid Rahimi Hospital
Full name of responsible person
Dr majidabdolahian
Street address
Shahid Rahimi Hospital, Azadi Avenue, Khorramabad, Iran
City
Khorramabad
Province
Lorestan
Postal code
858570
Phone
+98 66 3333 6138
Email
pr@lums.ac.ir

3

Recruitment center
Name of recruitment center
Shahid Madani Hospital
Full name of responsible person
Dr.majid firouzi
Street address
Shaheed Madani Hospital, Kheyrabad Ave., Khorramabad, Iran
City
khorramabad
Province
Lorestan
Postal code
858795
Phone
+98 66 3343 7164
Email
dr.firouzai@lums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
dr.morovat taheri kalani
Street address
Deputy of research and technology,Campus complex,Lorestan University of Medical Sciences,5 km Khorram Abad-Boroujerd
City
khorramabad
Province
Lorestan
Postal code
381251698
Phone
+98 66 3312 0172
Email
research@lums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Dr.majid firouzi
Position
Infants Specialty
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Neonatal group, Shaheed Madani Hospital, Kheirabad
City
Khorramabad
Province
Lorestan
Postal code
858795
Phone
+98 66 3343 7164
Email
firouzi.m@lums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Dr.majid firouzi
Position
Infants Specialty
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Neonatal group, Shaheed Madani Hospital, Kheirabad
City
Khorramabad
Province
Lorestan
Postal code
858795
Phone
+98 66 3343 7164
Email
firouzi.m@lums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Elham Shikhey
Position
Research expert
Latest degree
Bachelor
Other areas of specialty/work
Library and Medical Information
Street address
Clinical Research Unit, Department of Clinical, Shohada Hospital
City
khorramabad
Province
Lorestan
Postal code
8858588685
Phone
+98 66333323004
Email
nedaesh1@yahooo.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
Yes - There is a plan to make this available
Title and more details about the data/document
All data after Unidentifiable Can be Publication
When the data will become available and for how long
Start the access period 12 months after printing the results
To whom data/document is available
Data will only be available for doctors, nurses and midwives
Under which criteria data/document could be used
The analyzes concerning the outcomes of the plan are for the benefit of doctors, nurses and midwives of their positive outcomes
From where data/document is obtainable
00989163979788-email: nedaesh1@yahoo.com Elham Shikhey
What processes are involved for a request to access data/document
Send email To responsive person
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