Determining the duration of sleep of premature infants after feeding in the supine position in the baby's nest in the control group
Determining the duration of sleep of an premature infant after feeding in the supine position similar to the mother's arms in the intervention group
Comparison of sleep duration of premature infants after feeding in the control group and the intervention group
Design
Crossover
Settings and conduct
NICU, Ommol Banin hospital, Mashhad University of Medical Sciences
Participants/Inclusion and exclusion criteria
Pregnancy age 31 to 34 weeks
• Birth weight 1500 to 2000 kg
• Feed the baby every 2 hours
Intervention groups
Assess sleep in premature newborn
Main outcome variables
situation of sleep in newborn
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140610018046N4
Registration date:2020-09-16, 1399/06/26
Registration timing:retrospective
Last update:2020-09-16, 1399/06/26
Update count:0
Registration date
2020-09-16, 1399/06/26
Registrant information
Name
Sedighe Khanjari
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8867 1613
Email address
khanjari.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-04, 1399/03/15
Expected recruitment end date
2020-07-21, 1399/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mother’s bosom like position on the duration of sleep in premature neonates.
Public title
Sleep in premature neonates
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnancy age 31 to 34 weeks; Birth weight 1500 to 2000 kg; Feed the baby every 2 hours; No restriction on position change; Self-breathing without the need for respiratory support; Lack of congenital disease or brain defects such as intraventricular hemorrhage; Do not use sedatives 24 hours before the study; Failure to perform painful invasive interventions such as vessel sampling or sampling 12 hours before the start of the study; Do not use phototherapy; Failure to use tobacco by the mother or substance abuse during pregnancy; Normal blood sugar
Exclusion criteria:
Need immediate medical attention while studying
Blood infection
Seizures
Age
From 1 day old to 15 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling in this study was performed by continuous sampling . Eligible infants were randomly assigned to quadruple blockade in two intervention and control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
A crossover design selected to reduce the effect of interfering factors
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
14665-354
Approval date
2019-10-28, 1398/08/06
Ethics committee reference number
IR.IUMS.REC.1397.721
Health conditions studied
1
Description of health condition studied
sleep in premature neonates.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
situation of sleep in immature neonate
Timepoint
The first week
Method of measurement
Amplitude-integrated Electroencephalography
Secondary outcomes
1
Description
Mother’s bosom like position on the duration of sleep in premature neonates
Timepoint
Immediately after feeding for two hours in the supine position on the baby's nest
Method of measurement
Sleep status was evaluated by aEEG
Intervention groups
1
Description
Intervention group: After feeding and connecting the electrodes, the baby was first placed in a nest appropriate for his size in the same position as the mother's arms, and his brain tape was recorded for 2 hours using an aEEG device. To prevent the effect of the intervention in the control group, the infant was placed in the wash out stage for 2 hours, and the electrodes were reconnected to his head and placed in his nest lying on his stomach while his head was turned to one side. Similarly, his brain tape was recorded by the aEEG device within 2 hours. Due to the fact that the research environment was low traffic between 14:00 and 20:00 and the number of medical procedures and nursing care was minimal, the study was conducted during this period.
Category
N/A
2
Description
Control group:In the control group, immediately after feeding, three electrodes of the aEEG device were attached to the infant's head and the infant was lying on its stomach for 2 hours with the head turned to one side and in the normal and routine position in the nest in proportion to the body. His brain tape was recorded during these 2 hours
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad University of Medical Sciences، Omolbanin hospital,
Full name of responsible person
Sedigheh Khanjari
Street address
Nursing Care Research center, Building of Nursing and Midwifery in front of Khatam Al-Nabia Hospital, Rashid Yasemi Ave. Above Vanak Sq, Valiasr Ave.,Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 8867 1613
Fax
+98 21 8862 2692
Email
khanjari.s@iums.ac.ir
Web page address
http://Ncrc.iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Motevalian
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Fax
+98 21 8862 2692
Email
adminsite@iums.ac.ir
Web page address
http://www.iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Sedigheh khanjari
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing Care Research center, Building of Nursing and Midwifery in front of Khatam Al-Nabia Hospital, Rashid Yasemi Ave. Above Vanak Sq, Valiasr Ave.,Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 8867 1613
Fax
+98 21 8867 1613
Email
khanjari.s@iums.ac.ir
Web page address
http://Ncrc.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sedigheh khanjari
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing Care Research center, Building of Nursing and Midwifery in front of Khatam Al-Nabia Hospital, Rashid Yasemi Ave. Above Vanak Sq, Valiasr Ave.,Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 8867 1613
Fax
+98 21 8867 1613
Email
khanjari.s@iums.ac.ir
Web page address
http://Ncrc.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Toktam Gharaee
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing Care Research center, Building of Nursing and Midwifery in front of Khatam Al-Nabia Hospital, Rashid Yasemi Ave. Above Vanak Sq, Valiasr Ave.,Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Fax
+98 21 8867 1613
Email
toktamgharaei@yahoo.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
-Will be done upon request
When the data will become available and for how long
August 2020
To whom data/document is available
Research team
Under which criteria data/document could be used
Better care than premature baby
From where data/document is obtainable
Nursing Care Research Center
What processes are involved for a request to access data/document
Send a request to the head of the Nursing Care Research Center