Comparsion of two methods nest and handpillow on physiologic variables premature infants hospitalized in neonatal intensive care unit of Hazrat Zeinab hospital,Shiraz
The main objective of the study the determine the avoidable cause physiological disorders in premature infants hospitalized in neonatal intensive care unit intervention and control groups. Informed consent was signed by the parents that the baby is placed in one of two study groups and parents do not know their child groups. So this study is a single blind study. Inclusion criteria for the study included premature infants weighing less than 2500 grams and with gestational age 24-36 weeks, premature infants birth to age 2 to3 days, the first and fifth minutes APGAR between 7-10, infants with doctor confirmed the status register, parental consent for children to participate in the study, no history of addiction and/or taking sedative drugs and hypnotics in infants during the intervention. Exclusion criteria: unwillingness of parents to continue cooperation during the study, creating any problem. 70 infants by creating random numbers with the method of block permutation divided into two groups, control and intervention. In intervention group we use handpillow for infants and we use nest for control group. In this study the main outcome variable, physiological variables contains heart rate, respiratory rate and O2 saturation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062628636N1
Registration date:2017-05-20, 1396/02/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-20, 1396/02/30
Registrant information
Name
Atila Erami
Name of organization / entity
Shiraz university
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 5410
Email address
eramia@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparsion of two methods nest and handpillow on physiologic variables premature infants hospitalized in neonatal intensive care unit of Hazrat Zeinab hospital,Shiraz
Public title
Pillows effect on infant development
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1-preterm infants weighing less than 1500 grams and gestetional age 24-36 weeks.
2-preterm infants with posnatal age 2-3 days.
3-the first and fifth minute apgar 7-10.
4- infants with physician stability
5-parental consent to participate in the study.
6-no history of drug abuse and use of tranquilizers and sleeping mom.
7-do not use hypnotic and sedative drugs to the infant during intervention.
Exclusion criteria:
1-unwillingness of parents to continue working during study.
2-report any problems during the study.
Age
To 29 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz,zand street,across the street palestinian-building of the central University of Medical Scinces,Shiraz
City
shiraz
Postal code
7134814336
Approval date
2016-10-09, 1395/07/18
Ethics committee reference number
95-01-08-11735
Health conditions studied
1
Description of health condition studied
Developmental care
ICD-10 code
P07.3
ICD-10 code description
Other preterm infants
Primary outcomes
1
Description
Respiratory Rate in intervention group
Timepoint
Intervention time
Method of measurement
Pulse oximetry
2
Description
Heart Rate in intervention group
Timepoint
before and in intenvention time
Method of measurement
Pulse oximetry
3
Description
O2 Saturationin intervention group
Timepoint
Intervention time
Method of measurement
Pulse oximetry
4
Description
Respiratory Rate in control group
Timepoint
before and in intenvention time
Method of measurement
pulse oximetery
5
Description
Heart Rate in control group
Timepoint
before and in intenvention time
Method of measurement
pulse oximetery
6
Description
O2 Saturationin control group
Timepoint
before and in intenvention time
Method of measurement
pulse oximetery
Secondary outcomes
1
Description
Regulate Body Temperature in control group
Timepoint
intervention time
Method of measurement
termometer
2
Description
Regulate Body Temperature in intrrvention group
Timepoint
Intervention time
Method of measurement
Termometer
Intervention groups
1
Description
Hand pillow an optimal intervention group is a means to position the babies particularly premature infants who can not maintain their status and also to increase the stability of relationship and attachment between mother and babies and stability of physiological parameter
Category
Prevention
2
Description
Nest in control group is a means to stabilize the situation they approached the baby curved shoulders ,wrist movements to facilitate the mid line and motor and postural rigidity suspention arms and legs to reduce and prevent newborns from sudden moves and uncomfortable
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Zeinab hospital
Full name of responsible person
Atila Erami
Street address
Hazrat Zeinab hospital, Defa Moghadas square
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Shiraz University of Medical Sciences, Zand Ave.
City
Shiraz
Grant name
95-01-08-11735
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz university of Medical Sciences
Full name of responsible person
Mitra Edraki
Position
Master of nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Namazi Square
City
Shiraz
Postal code
7193613119
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
mitraedraki@yahoo.com
Web page address
nurs-midwif.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Atila Erami
Position
BA in Nursing
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Postal code
7134814336
Phone
+98 71 3230 5410
Fax
+98 71 3233 1549
Email
eramia@sums.ac.ir
Web page address
darmanof@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Atila Erami
Position
Nursing/Supervisor babies
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Postal code
7134814336
Phone
+98 71 3230 5410
Fax
+98 71 3233 1549
Email
eramia@sums.ac.ir
Web page address
darmanof@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)