Effect of fetal position on sleep-wake cycle in premature infants
Design
To determine the sample size, the pilot study will be with ten infants. The sample includes neonates hospitalized in the Hospital who had the initial criteria of the study and were chosen using a convenience sampling technique. The randomly-assignment of the infants to the two groups of fetal position and supine position will follow this procedure: On two cards with the same size and shape the letters A and B will be written and a colleague—who does not know about the card information with regard to the position— will be asked to choose a card which represents the position. If the chosen card is A, the infant will be placed under the fetal position and if it is B, the infant will be placed under the supine position.
Settings and conduct
This study will be conducted in the Ali ibn Abi Talib Hospital in Zahedan using a crossover and randomized design.The chosen infants will be randomly assigned into the control and test groups and will be examined. Before applying the intervention, the infants will be fed and all the medical procedures, if needed, will be carried out. After three hours, the infant’s position will be changed by a well-trained nurse.
Participants/Inclusion and exclusion criteria
Inclusion criteria:The pregnancy week between 33-36؛ The second day after the birth؛ The birth weight between 1200-2000 gr.
Exclusion criteria:Infant death
Intervention groups
The infants will be randomly assigned into two groups. Before applying the intervention, the infants will be assessed and will be fed. In the supine position group(Control), they will be put loosely and with their hands free sleeping in the incubator. Infants’ sleep-wake cycle under the investigation will be observed for 20 minutes using the method of Als. If required, the infants will be fed after three hours and the required medical interventions will be applied. The infants will be moved gently to a fetal positing by a well-trained nurse. In this group, a nest will be placed around the infant and their hands will have flexibility in a way that the arms and legs of the curved baby are placed in the middle of the line and the hands are placed in front of their face so that the infants can put his hands to his mouth. The sleep-wake cycle will be assessed for twenty minutes using the method of Als.
Main outcome variables
The Development of sleep-wake cycle in Premature infants
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171007036599N3
Registration date:2018-02-22, 1396/12/03
Registration timing:retrospective
Last update:2018-02-22, 1396/12/03
Update count:0
Registration date
2018-02-22, 1396/12/03
Registrant information
Name
freshte ghaljaei
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 33442481
Email address
ghaljaei-f@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ex: Personnel costs
4200000 Rials
B: Total costs of testing and specialized services
C: Collecting equipment and supplies
20200000 Rials
D: Total Travel Costs
2800000
E: Total fees
3060000 Rials
Total cost (Rials): 2604000
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of fetal position on sleep-wake cycle in premature infants
Public title
Effect of fetal Position on sleep-wake cycles in premature infant
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The pregnancy week between 33-36
The second day after the birth
The birth weight between 1200-2000 gr.
Absence of congenital anomalies in the baby
The lack of the need to use mechanical ventilation
Contraindications for change Position
Lack of growth defects within the uterus
No consumption of aminophylline or caffeine in the neonate
Lack of substance abuse in the mother
Exclusion criteria:
Infant death
The presence of neurological disorders such as seizure and intraventricular hemorrhage of the grades 3 and 4
Congenital infections in the baby
The presence of severe conditions requiring the use of therapies such as sedation
The unwillingness of the mother to continue with in the study
The need for surgery
Age
From 2 days old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
10
After conducting a pilot study to be determined
Randomization (investigator's opinion)
Randomized
Randomization description
The randomly-assignment of the infants to the two groups of fetal position and supine position will follow this procedure: On two cards with the same size and shape the letters A and B will be written and a colleague—who does not know about information on the card with regard to the position— will be asked to choose a card which represents the position. If the chosen card is A, the infant will be placed under the fetal position and if it is B, the infant will be placed under the supine position.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Khalij Fars Blvd., Dr. Hesabi SquareCampus, Research & Technology Dept. of Zahedan University of Medical Sciences,
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Approval date
2017-09-24, 1396/07/02
Ethics committee reference number
153.IR.ZAUMS.REC.1396
Health conditions studied
1
Description of health condition studied
Premature infants
ICD-10 code
p07.1 - p0
ICD-10 code description
Disorders related to short gestation and low birth weight, not elsewhere classifiedOther low birth weight
Primary outcomes
1
Description
sleep-wake cycle in 5 hours
Timepoint
for 20 minutes on each postion
Method of measurement
Sleep Diagram scale Doctor Elas
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group: In the intervention group (fetal position), the infants will be moved to a fetal position by a well-trained nurse. In this group, a nest will be placed around the infant and their hands will have flexibility in a way that the arms and legs of the curved baby are placed in the middle of the line and the hands are placed in front of their face so that the infant can put his hands to his mouth. The sleep-wake cycle will be assessed for twenty minutes using the method of Als.
Category
N/A
2
Description
The control group: After three hours since the intervention, the infants will be moved to a supine position by a well-trained nurse. In this group, they will be put loosely and with their hands free sleeping in the incubator. Infants’ sleep-wake cycle under the investigation will be observed for 20 minutes using the method of Als.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ibn Abi Talib Hospital
Full name of responsible person
Freshte ghaljaei
Street address
Dr Hasabi Square, Ali ibn Abi Talib Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
ameri13539879@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The Zahedan University of Medical Sciences
Full name of responsible person
Nor Mohammad Bakhshani
Street address
Dr Hesabi Square, Assistant Professor of Research and Technology,
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Fax
+98 54 3329 5796
Email
bakhshani@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Zahedan 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
2
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Nor Mohammad Bakhshani
Street address
Dr Hesabi Square, Assistant Professor of Research and Technology,
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Fax
+98 54 3329 5796
Email
bakhshani@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
zahra ameri
Position
Senior Child Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Pediatrics
Street address
Dr. Hassabi Square,Assistant Professor of Research and Technology
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 913 196 9879
Fax
Email
ameri13539879@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
freshteh ghaljaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pediatrics
Street address
Dr. Hassabi Square,Assistant Professor of Research and Technology
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
ghaljaei-f@zaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
zahra ameri
Position
Senior Child Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Pediatrics
Street address
Dr. Hassabi Square,Assistant Professor of Research and Technology
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
ameri13539879@gmail.com
Web page address
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