The effect of four- handed endotracheal suctioning on physiological and behavioral responses of premature neonate hospitalized in Neonatal Intensive Care Unit
Comparison the neonatal physiological responses in study groups; comparison the neonatal behavioral responses in study groups; comparison the behavioral responses in study groups.
Design
The present study is a clinical trial. The study population consisted of all preterm infants admitted to Shariati Hospital. The number of samples was 40
Settings and conduct
During the study, the baby will be subjected to suction with a routine (dual) method by the responsible nurse and the cameraman will begin. The newborn behaviors will be observed using the ALPS-Neo checklist as well as physiological responses monitored by the researcher. In the intervention group, they begin care of the quadruple, and the researcher's support will provide care. And the neonatal behavior status is observed using the ALPS-Neo tool .
Participants/Inclusion and exclusion criteria
Infants aged 29 to 37 weeks of gestation and ectopic age less than one week; birth weight of 1000 grams or more; having a tracheal tube; mechanical ventilation. Exit criteria: having chest tube; grade 2 or more intracranial hemorrhage; receiving opiate and logo sections 4 hours before suction.
Intervention groups
During the study, the baby will be subjected to suction in a routine (dual) method by the responsible nurse and the cameraman will begin and the newborn behaviors will be observed using the ALPS-Neo checklist as well as physiological responses will be monitored and recorded. In the intervention group, they begin care of the four. And the neonatal behavior status is observed and recorded using the ALPS-Neo tool. The physiological condition will also be observed and recorded. Then the filming of the baby begins 2 minutes before the intervention by the researcher.
Main outcome variables
Improvement of physiological and behavioral responses of infants
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180121038461N1
Registration date:2018-06-03, 1397/03/13
Registration timing:registered_while_recruiting
Last update:2018-06-03, 1397/03/13
Update count:0
Registration date
2018-06-03, 1397/03/13
Registrant information
Name
Somayeh Sadeghi niaraki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6609 0524
Email address
tt_8958@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of four- handed endotracheal suctioning on physiological and behavioral responses of premature neonate hospitalized in Neonatal Intensive Care Unit
Public title
The effect of four-handed endotracheal suctioning on physiological and behavioral respons of premature neonate hospitalized in Neonatal Intensive Care Unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Infants aged 29 to 37 weeks of gestation and uterine age less than one week
Birth weight 1000 grams or more,
Having an endotracheal tube
The need for mechanical ventilation,
The absence of congenital anomalies
Exclusion criteria:
Having a chest tube
Intracranial hemorrhage grade 2 or higher,
Receive opiate and logo parts 4 hours before suction,
Having any damages to the baby's head or organs such as hematoma pottery and capillary succinate
Age
From 1 day old to 7 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
The specimens were randomly selected using a two-handed suction method, followed by suction with a four-handed or first-suction method, quadriceps, and then suction, in a dual fashion, so that each baby is controlled as He will be considered
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 Tehran University of Medical Sciences
Street address
tohid sq
City
tehran
Province
Tehran
Postal code
1419733171
Approval date
2018-04-12, 1397/01/23
Ethics committee reference number
IR.TUMS.FNM.REC.1397.4949
Health conditions studied
1
Description of health condition studied
suction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Neonatal suction in infants in intensive care unit
Timepoint
Before intervention, in a double-blind manner. And once after the intervention, the quadruple method
Method of measurement
questionnaire
Secondary outcomes
1
Description
Evaluation of behavioral responses and physiological criteria of neonates
Timepoint
Once before the intervention. During the intervention and after the intervention
Method of measurement
APLS-NEO
Intervention groups
1
Description
Intervention group: first, the researcher's help with a washed and warmed hands and with the help of the nurses responsible for the newborn begins care of the four, and the researcher's help provides support. (If the baby is restrained by a gentle touch, it will make a better position with his hands or help the baby to be calm, and in addition to the needs of the nursing carer during the suction, and if necessary, help him throughout the process And staying with the baby). From 2 minutes before doing any action, the observation begins for 30 seconds and the results are recorded. With the onset of support, the baby will be re-examined for 30 seconds. During suction and after suction, observation is performed as well as control time 5 times every 2 minutes for 30 seconds, and the neonatal behavior status is observed and recorded using the ALPS-Neo tool. The physiological status will be observed and recorded.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Somayeh Sadeghi Niaraki
Street address
Shariati Hospital, North Kargar St.
City
Tehran
Province
Tehran
Postal code
1349673979
Phone
+98 21 6609 0524
Email
tt_8958@yahoo.com
2
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Somayeh Sadeghi Niaraki
Street address
Shariati Hospital, North Kargar St.
City
Tehran
Province
Tehran
Postal code
1349673979
Phone
+98 21 84901
Email
tt_8958@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Maryam Modarres
Street address
School of Nursing and Midwifery, Tohid sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4560
Email
modarres@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Somayeh Sadeghi Niaraki
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Tohid Sq.
City
Tehran
Province
Tehran
Postal code
1349673979
Phone
+98 216690524
Email
tt_8958@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Batool Pouraboli
Position
Assisstant proffesor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Tohid sq.
City
Tehran
Province
Tehran
Postal code
1349673979
Phone
+98 61054411
Email
b.pouraoli@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Somayeh Sadeghi Niaraki
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Nursery
Street address
Tehran University of Medical Sciences, Qhods St., Keshvarz Blvd.
City
Tehran
Province
Tehran
Postal code
1349673979
Phone
+98 66 90524
Email
tt_8958@yahoo.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