Objective: Evaluate the effect of clustered care with different number of procedures (stressor scores) on physiological and behavioral responses of preterm infants. Design: Randomized; three periodic three groups crossover design. Setting and conduct: At any time, after devoting 30 minutes to relax, breathing score will be calculated for infants, one of clustered cares will be done, two cameras, one focused on the infant's face and body and other focuses on monitor screen, will take filming two minutes before the clustered care, during clustered care and by two minutes after it. Then will be evaluated behavioral responses and physiological measures (heart rate, respiratory rate, blood oxygen saturation) from recorded films. Intervention: clustered cares with three, four and five procedures. Inclusion criteria: Infants' age between 30-32 weeks at birth and 32 weeks during the study; having a minimum weight of 1000 g at the time of study; consent form is signed by parents; absence of congenital anomalies; written order of a physician for gavage; without prohibited changing position; respiratory score lower than or equal to five; no status of asphyxia. Exclusion criteria: Infants with IVH grade 3 and 4; periventricular leukomalacia; need for mechanical ventilation; steady decline in HR and O2 sat and respiratory rate of normal range; septicemia or be transferred to the neonatal unit refrain from further testing. Main outcome measures (variables): Behavioral and physiological responses of infant during clustered care and by two minutes after it.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201302058315N5
Registration date:2013-05-13, 1392/02/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-05-13, 1392/02/23
Registrant information
Name
Leila Valizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
valizadehl@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-05-15, 1392/02/25
Expected recruitment end date
2013-06-21, 1392/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of clustered care on physiological and behavioral responses in preterm infants: Randomised cross-over clinical trial
Public title
The effect of clustered care on physiological and behavioral responses in preterm infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Being admitted to the NICU; infants' age between 30-32 weeks at birth and 32 weeks during the study; having a minimum weight of 1000 g at the time of study; consent form is signed by parents; absence of congenital anomalies; written order of a physician for gavage; without prohibited changing position; respiratory score lower than or equal to five; no status of asphyxia
Exclusion criteria: Infants with IVH grade 3 and 4; periventricular leukomalacia; need for mechanical ventilation; steady decline in HR and O2 sat and respiratory rate of normal range; septicemia or be transferred to the neonatal unit refrain from further testing.
Age
From 30 years old to 32 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
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
Tabriz University of Medical Sciences Ethics Committee
Street address
Golgasht Street, Tabriz
City
Tabriz
Postal code
Approval date
2013-05-06, 1392/02/16
Ethics committee reference number
9220
Health conditions studied
1
Description of health condition studied
Other preterm infants
ICD-10 code
P07.3
ICD-10 code description
28 completed weeks or more but less than 37 completed weeks (196 completed days but less than 259 completed days) of gestation.
Primary outcomes
1
Description
Behavioral responses
Timepoint
Two minutes before the start of clustered care, during the clustered care and by two minutes after it
Method of measurement
The camera is already installed
2
Description
Physiological responses
Timepoint
Two minutes before the start of clustered care, during clustered care and by two minutes after it
Method of measurement
The camera is already installed
Secondary outcomes
empty
Intervention groups
1
Description
Clustered care including four invasive procedures (stressor score ten) consists of measuring axillary temperature (2 points), change location of pulse oximeter probe (2 points), gavage (3 points) and changing position (3 points)
Category
Other
2
Description
Clustered care including three invasive procedures (stressor score seven) consists of measuring axillary temperature (2 points), change location of pulse oximeter probe (2 points) and changing position (3 points)
Category
Other
3
Description
Clustered care including five invasive procedures (stressor score thirteen) consists of measuring axillary temperature (2 points), change location of pulse oximeter probe (2 points), weighing (3 points), gavage (3 points) and changing position (3 points)
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational and Therapeutic Center Al-Zahra
Full name of responsible person
Poor Ashoori- Sheryzad
Street address
Artesh Street, Baghshmal Crossroads, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Rashidi
Street address
Golgasht Street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz 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
Tabriz School of Nursing and Midwifery
Full name of responsible person
Marziyeh Avazeh
Position
Student of Master degree in Neonatal Intensive Care Nursing
Other areas of specialty/work
Street address
Shariati South Street, Tabriz
City
Tabriz
Postal code
Phone
00984262232793, 00989141284596
Fax
Email
m.avazeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz School of Nursing and Midwifery
Full name of responsible person
Dr Leila Valizadeh
Position
Associate Professor
Other areas of specialty/work
Street address
Shariati South Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
Valizadehl@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz School of Nursing and Midwifery
Full name of responsible person
Marziyeh Avazeh
Position
Student of Master degree in Neonatal Intensive Care Nursing
Other areas of specialty/work
Street address
Shariati South Street, Tabriz
City
Tabriz
Postal code
Phone
Fax
Email
m.avazeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)