Determination and Evaluation of the Effect of Artificial Night and Facilitated tucking position on Physiological Parameters in Premature Infants
Design
Patients are numbered according to the order of referral. Using a random number table provided by the software, 60 qualified eligible babies are divided into 3 groups. In addition, the investigator himself does not have a randomized list
Settings and conduct
Neonatal Intensive Care Unit of Yazd Social Security Hospital
The researcher did not know at the beginning of the sampling the list of samples and their placement in the investigated groups, and the information analyst had no information about them either.
Participants/Inclusion and exclusion criteria
inclusion criteria:Gestational age between 36-32 weeks, respiratory score less than 5, fifth minute apgar scores 7 and more, breastfeeding by gavage method.
excluded criteria: Infants of addicted mothers, equal or more than 5 respiratory score, restless babies, fifth minute Apgar scores less than 7, neonates requiring phototherapy, prematurely with other illnesses such as cardiac abnormalities, congenital anomalies, metabolic disease, needy Surgery
Intervention groups
infants in group 1 receive artificial night with facilitated tucking position and in group 2, infants will be placed in artificial night and newborns in group 3 (control group) are in routine care only .
Main outcome variables
Physiological parameters
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171226038086N1
Registration date:2018-09-04, 1397/06/13
Registration timing:retrospective
Last update:2018-09-04, 1397/06/13
Update count:0
Registration date
2018-09-04, 1397/06/13
Registrant information
Name
Akram Raie ezabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3821 8420
Email address
a.raei@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-07-01, 1396/04/10
Expected recruitment end date
2018-04-09, 1397/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of artificial night and facilitated tucking position on the physiological parameters in premature infants.
Public title
The effect of artificial night and facilitated tucking position in premature infants.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
GA:32-36W
respiratory score<5
apgar score in min 5 >7
breast feeding with gavage
Exclusion criteria:
Respiratory score>5
addict infant mothers
restless infants
apgar score in min 5 <5
infants needed phototherapy
others disease for example congenital heart disease and malformations,metabolic disease, surgical cases
Age
From 1 day old to 4 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are numbered according to the order of referral. Using a random number table provided by the software, 60 qualified eligible babies are divided into 3 groups. In addition, the investigator himself does not have a randomized list.
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
yazd shahid sadoughi university of medical sciences
Street address
shahid bahonar square-central university building
City
yazd
Province
Yazd
Postal code
8916978477
Approval date
2017-03-18, 1395/12/28
Ethics committee reference number
ir.ssu.rec.1395.225
Health conditions studied
1
Description of health condition studied
physiological parameters
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
heart rate
Timepoint
before and during intervention
Method of measurement
pulse oximeter
2
Description
respiratory rate
Timepoint
before and during intervention
Method of measurement
pulse oximeter
3
Description
arterial oxygen saturation percent
Timepoint
before and during intervention
Method of measurement
pulse oximeter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group(1): Infants who are placed under artificial night and facilitated tucking position. To create an artificial night in the dark period of 19 pm to 7am, a black duplex lining from the four sides placed on incubators, and during the light period, from 7 to 19, the coating is removed on the incubator. To create and maintain facilitated tucking in different positions( prone or siding ) is used in soft, medium-soft towels, and the baby is placed while the hands and feet are glued to the body and placed near the face and mouth.
Category
Other
2
Description
Intervention group(2): infants who are under normal position in artificial night conditions
Category
Other
3
Description
Control group: infants who were routinely treated (normal position without artificial night intervention)
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Social Security Hospital
Full name of responsible person
Department responsible for science
Street address
Yazd Social Security Hospital
City
yazd
Province
Yazd
Postal code
8944167699
Phone
+98 35 3182 2000
Fax
+98 35 3825 0007
Email
hospital.kargar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
دکتر مسعود میرزایی
Street address
Shahid Bahonar Square - Central University Building
City
yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0151
Fax
+98 35 3725 8413
Email
info@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Khadije Dehghani
Position
Master's Degree - Academic
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Yazd - Bouali Ave. - Faculty of Nursing and Midwifery
City
yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3824 1752
Email
shadehghani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Khadije Dehghani
Position
Master's Degree - Academic
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Yazd - Bouali Ave. - Faculty of Nursing and Midwifery
City
yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3824 1752
Email
shadehghani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Khadije Dehghani
Position
Academic member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Yazd - Bouali Ave. - Faculty of Nursing and Midwifery
City
yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3824 1752
Email
shadehghani@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