Determination of the effect of head positioning on the tissue oxygenation of brain in preterm infants.
Design
A clinical trial with a control group, crossover, single blind,
Randomized by generating random numbers by SPSS software with sample size 30.
Settings and conduct
In the NICU ward of Umm al-Banin Hospital, 30 infants are treated within the first 48 hours after birth who meet the inclusion criteria.
During the intervention, tissue oxygenation of the brain is recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Infant age less than or equal to 32 weeks; Infant weight less than 1500 grams; Infant stable condition (non Invasive mechanical ventilation and hemodynamic status stable neonate)Have; Apgar score of first minute exceeds 5 and fifth minute greater than 7;A hemoglobin level greater than or equal to 12 g / dl. mean arterial blood pressure(MAP) were within normal range.Exclusion criteria: Congenital and chromosomal abnormalities; Intrauterine growth restriction (IUGR) ; known intracranial hemorrhage; recipient of dense red blood cell product.
Intervention groups
In the intervention group, infants are placed in supine position and every 2 hours the head is switched to one of 6 modes [1 midline head and 0° bed head .2 The head rotates 60-45 ° from the midline to the left and the bed head 0°. 3 The head rotates 60-45 ° from the midline to the right and the bed head 0°.4 midline head position with the bed head 15- 30°, 5 The head rotates 60-45 ° from the midline to the left and the bed head 15- 30°. 6 The head rotates 60-45 ° from the midline to the right and the bed head 15- 30° ].During each head positioning,tissue oxygenation of brain is recorded by the NIRS device .infants under intervention are also used as their control group.To this end, the data are compared before and after their intervention.
Main outcome variables
tissue oxygenation of brain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190826044623N1
Registration date:2019-10-17, 1398/07/25
Registration timing:registered_while_recruiting
Last update:2019-10-17, 1398/07/25
Update count:0
Registration date
2019-10-17, 1398/07/25
Registrant information
Name
Zeinab Rabbani Mohammadie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3868 9372
Email address
rabbanimz961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-06, 1398/06/15
Expected recruitment end date
2020-03-05, 1398/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of head positioning on the tissue oxygenation of brain in preterm infants
Public title
The effect of head positioning on the tissue oxygenation of brain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The age of the infant on a Ballard basis is less than or equal to 32 weeks at the time of study.
infant weight under 1500 grams.
neonate stable condition (non Invasive mechanical ventilation and hemodynamic status stable neonate)Have.
Apgar score of first minute exceeds 5 and fifth minute greater than 7.
A hemoglobin level greater than or equal to 12 g / dl.
Mean arterial blood pressure (MAP) is within normal range.
Exclusion criteria:
The infant will have have congenital and chromosomal abnormalities.
The infant have intrauterine growth restriction (IUGR) .
The infant receiving the red blood cell product is dense.
The infant with known intracranial hemorrhage.
Age
To 8 months old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
All possible sequence combinations are coded for 6 study positions in SPSS software, 720 modes. We assign a unique number to each position. In the study sample number, random numbers are generated by SPSS software. Hence the random modes of the research units are obtained.Write each of the modes in a separate card and put all the cards in a package. For each research unit, we remove and use one of the cards from the envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
The analyst will be unaware of the intervention and control groups.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of School of Nursing and Midwifery - Mashhad University of Medical Sciences
Street address
Unit 1, Floor 1,No. 154, Vilaye 7
City
Mashhad
Province
Razavi Khorasan
Postal code
9171618995
Approval date
2019-07-21, 1398/04/30
Ethics committee reference number
IR.MUMS.NURSE.REC.1398.040
Health conditions studied
1
Description of health condition studied
The effect of head positioning on the tissue oxygenation of brain in preterm infants
ICD-10 code
P52.3
ICD-10 code description
Unspecified intraventricular (nontraumatic) hemorrhage of newborn
Primary outcomes
1
Description
tissue oxygenation of brain
Timepoint
After every two hours of head positioning, tissue oxygenation of brain is recorded by the NIRS device.It should be noted that before the intervention, the tissue oxygenation of brain of each infant is measured and recorded within ten minutes to obtain the baseline value for each infant and compare with subsequent values.
Method of measurement
NIRS device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, infants are placed in supine position and every 2 hours the head is switched to one of 6 modes [1 midline head and 0° bed head .2 The head rotates 60-45 ° from the midline to the left and the bed head 0°. 3 The head rotates 60-45 ° from the midline to the right and the bed head 0°.4 midline head position with the bed head 15- 30°, 5 The head rotates 60-45 ° from the midline to the left and the bed head 15- 30°. 6 The head rotates 60-45 ° from the midline to the right and the bed head 15- 30° ].During each head positioning, tissue oxygenation of brain is recorded by the NIRS device. The infants under intervention are also used as their control group. And according to the routine inpatient treatment center, they receive their medical care before the intervention, and brain tissue oxygenation data are collected and compared with post-intervention data.And they are also used as witnesses for this purpose.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
UmmOl-Banin Hospital
Full name of responsible person
Monir Ramezani
Street address
UmmOl-Banin Hospitalon, Corner of Ayatollah Behjat 16, Zarineh Intersection
City
Mashhad
Province
Razavi Khorasan
Postal code
9171618995
Phone
+98 51 3223 1061
Fax
+98 51 3223 1444
Email
ramezanimn@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Robab Latifnejad Rodsari
Street address
School of Nursing and Midwifery, Ibn Sina Street, Doctora crossroads, Danshgah street,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
latifnejadr@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Zeinab Rabbani Mohammadie
Position
Master of student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 1, Floor 1, No. 154, Villaye 7
City
Mashhad
Province
Razavi Khorasan
Postal code
9171618995
Phone
+98 51 3868 9372
Fax
Email
Rabbanimz961@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zeinab Rabbani Mohammadie
Position
Master of student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 1, Floor 1, No. 154, Villaye 7
City
Mashhad
Province
Razavi Khorasan
Postal code
9171618995
Phone
+98 51 3868 9372
Fax
Email
Rabbanimz961@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zeinab Rabbani Mohammadie
Position
Master of student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 1, Floor 1, No. 154, Villaye 7
City
Mashhad
Province
Razavi Khorasan
Postal code
9171618995
Phone
+98 51 3868 9372
Fax
Email
Rabbanimz961@mums.ac.ir
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 potential data can be shared after unidentifiable people.
When the data will become available and for how long
The access period starts 2 months after the results are published.
To whom data/document is available
The data are made available to researchers working in academic and scientific institutions, and to those involved in the industry as well as to the Ministry.
Under which criteria data/document could be used
If positive, this study could lead to a caring approach for the premature infant within the first 72 hours after birth, which improves brain oxygenation and hemodynamics and reduces the chance of occurrence and severity of intraventricular hemorrhage in the premature infant.
From where data/document is obtainable
Zeinab Rabbani Mohammadie:rabbanimz961@mumc.ac.ir,Phone Call:00989910435332
Dr Monir Ramezani:ramezanimn@mums.ac.ir,Phone Call:00989124186326
What processes are involved for a request to access data/document
The applicant should contact through the given contact number and e-mail.