The effect of Swaddling bathing on oxygen needs and physiologic parameters (body temperature, HR and RR) among premature neonates with chronic lung disease (CLD): a randomized clinical trial
The main objective:
The effect of Swaddling bathing on oxygen needs and physiologic parameters (body temperature, HR and RR) among premature neonates with chronic lung disease (CLD): a randomized clinical trial
Design
The study is a clinical trial (pre-test-post-test) with control group. The sample size (available) is 50 newborns admitted to Al-Zahra Hospital, which are randomly assigned to 25-person intervention and control groups using a table of random numbers. Meanwhile the study is single blind (analyzer) and Phase 2.
Settings and conduct
This study will be performed at NICU in Al-Zahra Hospital in Tabriz. To reduce possible bias, this study will be single blind in which the analyzer will be unaware of the allocation of participants to study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Preterm infants with CLD hospitalized in the NICU;
Has received oxygen;
At least one parent is present during the bath;
Physiological stability at the start of the study;
Bathing instructions by a neonatal specialist;
The venous line is cut off.
Non-inclusion criteria:
Having a congenital anomaly;
The presence of any kind of wound in the body
Intervention groups
In the intervention group, infants are bathed in the bath at a set time and three times a day, using the protocol of bathing in a bathtub. There is no intervention in the control group, but the need for oxygen and physiological indicators are measured as the intervention group.
Main outcome variables
Oxygen requirements; body temperature; heart rate (HR); respiratory rate (RR).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190326043115N1
Registration date:2020-07-06, 1399/04/16
Registration timing:registered_while_recruiting
Last update:2020-07-06, 1399/04/16
Update count:0
Registration date
2020-07-06, 1399/04/16
Registrant information
Name
zahra zadmahmoud
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3762 1302
Email address
zadmahmood61@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-30, 1399/04/10
Expected recruitment end date
2020-10-01, 1399/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Swaddling bathing on oxygen needs and physiologic parameters (body temperature, HR and RR) among premature neonates with chronic lung disease (CLD): a randomized clinical trial
Public title
The effect of Swaddling bathing on Oxygen needs in premature neonates with chronic lung disease (CLD)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Preterm infants with CLD hospitalized in the NICU (infants in need of oxygen for more than 28 days and reaching a calendar age of 32 to 36 weeks (Postconceptional Age))
Has received oxygen
At least one parent is present during the bath
Physiological stability at the start of the study (in the last 24 hours there is no decreased saturation, hypothermia, decreased or increased heart rate)
Bathing instructions by a neonatal subspecialist
The venous line is cut off
Exclusion criteria:
Having a congenital anomaly
Any type of wound, including surgical wounds on the skin
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Random numbers table will be used to randomly assign people to study groups. Each participant is assigned a code, and then, by selecting a one-digit refinement on the random number table and moving to a specific side on the number table, the required number of people in each group is determined. The even numbers will be allocated to the intervention group and the odds numbers to the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study is planned in such a way that the data analyzer does not know which study group is control or experimental groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences
Street address
School of Nursing and Midwifery; South Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947-977
Approval date
2020-04-20, 1399/02/01
Ethics committee reference number
IR.TBZMED.REC.1399.034
Health conditions studied
1
Description of health condition studied
The need for oxygen in infants with chronic lung disease (CLD).
ICD-10 code
J06
ICD-10 code description
Acute upper respiratory infections of multiple and unspecified sites
Primary outcomes
1
Description
Oxygen needs
Timepoint
It will be measured three times at certain times of the day, every other day, 10 minutes before and 10 minutes and 1 hour after bathing.
Method of measurement
In measuring the need for oxygen, the concentration of saturated oxygen using a blender and the duration of oxygen therapy per day will be measured using a finger oxygen meter that is fixed to the baby's foot.
2
Description
Body temperature
Timepoint
It will be measured three times at certain times of the day, every other day, 10 minutes before and 10 minutes and 1 hour after bathing.
Method of measurement
Using a digital armpit thermometer
3
Description
Heart rate
Timepoint
It will be measured three times at certain times of the day, every other day, 10 minutes before and 10 minutes and 1 hour after bathing.
Method of measurement
Using a finger probe connected to the monitor
4
Description
Respiratory Rate
Timepoint
It will be measured three times at certain times of the day, every other day, 10 minutes before and 10 minutes and 1 hour after bathing.
Method of measurement
By observing and counting chest movements
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, infants are bathed three times, once a day, at a certain time of the day, according to the Swaddle Bathing protocol in the bathtub. Oxygen requirements, body temperature, respiration rate and heart rate will be measured 10 minutes before, 10 minutes and 1 hour after bathing. Room temperature is 26-27 degrees Celsius and water temperature is 38 to 40 degrees Celsius. The bath time is between 6-8 minutes before the baby's feeding time and with the presence, support and participation of at least one parent. The baby's body temperature is fully monitored during the bath to avoid hypothermia and to control stressful symptoms. Bathing will be done using a bathtub, shampoo and other special equipment and in full compliance with the baby's bath protocol as well as hygienic instructions. After bathing, we prepare the baby for nourishment and skin-to-skin contact with the mother.
Category
Treatment - Devices
2
Description
Control group: There is no intervention in the control group, but the amount of oxygen required, body temperature, number of breaths and heart rate 10 minutes before and 10 minutes and 1 hour after bathing as the intervention group (three times, one day in Intermediate will be measured at a set time of day.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational and Medical Center; Al-Zahra Hospital; Tabriz University of Medical Sciences
Full name of responsible person
Zahra Zad Mahmoud
Street address
Baghshamal Crossroads; South Artesh street
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3553 9161
Fax
+98 41 3556 6449
Email
info@alzahrahosp.tbzmed.ac.ir
Web page address
https://alzahrahosp.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Hossein Soomi
Street address
Central building of Tabriz University of Medical Sciences; Golgasht street; Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3335 5921
Fax
+98 41 3335 9680
Email
research-vice@tbzmed.ac.ir
Web page address
https://www.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Zad Mahmoud
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 112; 2 closed alley; 11 alley; Koie Janbazan
City
Ajabshir
Province
East Azarbaijan
Postal code
5541635631
Phone
+98 41 3762 1302
Email
zadmahmood61@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Arshadi
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tabriz School of Nursing and Midwifery; South Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947-977
Phone
+98 41 3479 6770
Email
arshadi9429@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Zad Mahmoud
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 112; 2 closed alley; 11 alley; Koie Janbazan
City
Ajabshir
Province
East Azarbaijan
Postal code
5541635631
Phone
+98 41 3762 1302
Email
zadmahmood61@gmail.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
Information about age, sex, weight, height, multiple children, smoking mother and mother demographic profile.
When the data will become available and for how long
Since 1399
To whom data/document is available
Researchers, doctors and nurses and medical centers
Under which criteria data/document could be used
Research development and improvement in treatment routine
From where data/document is obtainable
Tabriz University of Medical Sciences, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences
What processes are involved for a request to access data/document
Written request from Tabriz University of Medical Sciences, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences. Visit the center in person