The aim of this study is to determine the impact of bath on clinical outcomes in preterm infants. It is a single blinded study, so that the researchers were not blinded, only to be blinded by the executive nurse. In this study, cases will be randomly divided into two groups; intervention and control group. Infants in the control group will receive only the routine skin care which is common in that unit and in Intervention group in addition to routine care, every three days, each time for 5 minutes; infants will be bathed in the bathtub by two helping researchers. In total during the study infants in the intervention group will experience this type of bath just three times. During the entire study period, physiological parameters (body temperature, oxygen saturation and pulse rate) in intervention days; '10 minutes before and 10 minutes after bathing intervention' and desired outcome (weight) daily will be measured and recorded in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306164617N7
Registration date:2013-06-28, 1392/04/07
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-06-28, 1392/04/07
Registrant information
Name
Mahnaz Jabraeili
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
jabraeilim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-09-01, 1392/06/10
Expected recruitment end date
2013-12-01, 1392/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of bath on clinical outcomes in preterm infants: a randomized controlled trial
Public title
Effect of bath on clinical outcomes in preterm infants: a randomized controlled trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age of infants 34-37 weeks of gestation; infant's age at study entry should be 72 hours after birth; no chromosomal abnormalities and congenital anomaly; 5-minute Apgar score of 7; Physiologic stability and no need to oxygen; not having any discharge or bleeding at the site of the umbilical cord; exclusive breast feeding; lack of feeding for at least half an hour before bath; not receiving drugs that affect the level of consciousness, like: phenobarbital; not having a brain hemorrhage, asphyxia, kernicterus, and diseases leading to loss of consciousness; having a baseline baby's body temperature that should be at 36.5 ° C and parent consent for participating of infant in the study.
Exclusion criteria: occurrence of symptoms such as apnea and cyanosis, or have any ill during bathing; baby bathe in the intervention and control groups by staff without notice; washing any parts of baby's body in the intervention and control groups for any reason (including changing diapers, etc.); at least one hour before intervention; tendency of control infant's mother to bath her baby; the baby's mother's unwillingness to continue the study in the intervention group (giving the baby a bath); low frequency of infants' bathing in the intervention group during the study (less than two).
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences Ethics Committee
Street address
Deputy of Research, Tabriz University of Medical Sciences ,Golgasht street , Tabriz, East Azarbaijan
City
tabriz
Postal code
Approval date
2013-07-22, 1392/04/31
Ethics committee reference number
9248
Health conditions studied
1
Description of health condition studied
Bath outcome in preterm infants
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Changes of body temperature of preterm infants
Timepoint
On intervention days in 10 minutes before and 10 minutes after the bath
Method of measurement
Using a mercury thermometer
Secondary outcomes
1
Description
O2 saturation of preterm infants
Timepoint
On intervention days in 10 minutes before and 10 minutes after the bath
Method of measurement
Using a novametrix pulse oximeter
2
Description
Heart rates of preterm infants
Timepoint
On intervention days in 10 minutes before and 10 minutes after the bath
Method of measurement
Using a novametrix pulse oximeter
3
Description
Weight gain preterm infant
Timepoint
Throughout the study period; daily
Method of measurement
Using a Seca Scale
Intervention groups
1
Description
Intervention infants, every three days, each time for 5 minutes, will be bathed in the bathtub by two helping researchers. In total during the study these infants will experience this type of bath just three times.
Category
Other
2
Description
Infants in the control group will receive only the routine skin care which is common in that unit
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Educational Center Affiliated Medical Sciences of Tabriz;Iran
Full name of responsible person
Ameneh Safaei
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research, Tabriz University of Medical Sciences
Full name of responsible person
Dr Ostad Rahimi
Street address
Research Department, Central Building , Golgasht , Tabriz Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of 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 University of Medical Sciences
Full name of responsible person
Ameneh Safaei
Position
Nursing Master of Science Student
Other areas of specialty/work
Street address
Shariety South St. Faculty of Nursing & Midwifery, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 1380 3738
Fax
Email
b.a.safaee1365@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz Jabraeili
Position
MS, Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shariati South Street , Tabriz , Iran Tabriz
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
jabraeilim@tbzmed.ac.ir; jebreilim@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ameneh Safaei
Position
Nursing Master of Science Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shariati South Street , Tabriz, Iran Tabriz
City
Tabriz
Postal code
Phone
+98 41 1380 3738
Fax
Email
b.a.safaee1365@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)