determine the impact of the nesting technique on preterm neonates` physiological indicators: temperature, heart rate, respiratory rate, and oxygen saturation.
Comparison between neonates' groups (intervene and control).
Design
A quasi-experimental design; four parallel groups (including a control group); non-randomized, non-blinding total sample size of 60.
Settings and conduct
60 preterm neonates were admitted at the NICU of Al-Batool Teaching Hospital for Women and Children in Diyala governorate. the purposive A sampling technique used with the available sample.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Preterm neonate born with gestational age 28–37 weeks.
Parents of admitted NICU babies willing to give consent.
Subjects from both genders,
Neonates admitted to NICU with spontaneous breathing without the need for assistive devices.
exclusion criteria: premature neonates who were on the ventilator, CPAP, Oxygen, asphyxia, Apnea, septicemia, seriously ill, congenital anomalies.
other serious illnesses medical or surgical.
Intervention groups
When a preterm neonate in intervene group within the included criteria, nesting is applied for six hours, pretest is performed to check physiological parameters (temperature, heart rate, respiratory rate, oxygen saturation) by a pulse oximeter, axillary thermometer, and manual respiratory check, and then apply nesting for two hours (first trial or Session ) then free position for half hours, then regain to the same position for two hours (second trial or session ), posttest performs at first and second hours for each session for three days consecutively. while preterm neonates in the control group, were not applied in nesting position, and their physiological parameters were checked every 2 hours for 3 days.
Main outcome variables
Temperature, heart rate, respiratory rate, and oxygen saturation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231120060117N3
Registration date:2023-12-17, 1402/09/26
Registration timing:prospective
Last update:2023-12-17, 1402/09/26
Update count:1
Registration date
2023-12-17, 1402/09/26
Registrant information
Name
Adraa Shawq
Name of organization / entity
University of Baghdad
Country
Iraq
Phone
+964 770 263 8811
Email address
adraa.hussein@conursing.uobaghdad.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-01, 1402/11/12
Expected recruitment end date
2024-05-01, 1403/02/12
Actual recruitment start date
2024-02-01, 1402/11/12
Actual recruitment end date
2024-05-01, 1403/02/12
Trial completion date
2024-05-01, 1403/02/12
Scientific title
Effect of Nesting Technique Intervention on Preterms Physiological Indicators
Public title
Effect of Nesting Technique on Preterm Physiological Indicators
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Neonates admitted to NICU with spontaneous breathing without the need for assistive devices.
Parents of admitted NICU babies willing to give consent.
preterm without obvious congenital anomalies.
the responsible physician was agreed.
Exclusion criteria:
a preterm neonate who was on the ventilator, CPAP, Oxygen, septicemia, seriously ill, and congenital anomalies.
serious illnesses medical or surgical.
Age
From 1 day old to 14 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Actual sample size reached:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethical Approval Committee, at the College of Nursing
Street address
Bab AL-Muadum
City
Baghdad
Postal code
10001
Approval date
2023-10-01, 1402/07/09
Ethics committee reference number
2399
Health conditions studied
1
Description of health condition studied
Preterm neonate gestational age between 28 – 37 weeks without congenital anomalies and assertive devices.
ICD-10 code
O60
ICD-10 code description
Preterm labor
Primary outcomes
1
Description
more stability physiological parameter (temperature) of preterm neonates.
Timepoint
neonates who applied the nesting technique will measure temperature grade pre-test and post-test for two hours for three days consecutively.
Method of measurement
direct observational record by using a hospital electronic thermometer.
2
Description
more stability physiological parameter (heart rate) of preterm neonates.
Timepoint
neonates who applied the nesting technique will measure heart rate pre-test and post-test for two hours for three days consecutively.
Method of measurement
direct observational record by manual counting thorough a pediatric stethoscope.
3
Description
more stability physiological parameter (respiratory rate) of preterm neonates.
Timepoint
neonates who applied the nesting technique will measure respiratory rate pre-test and post-test for two hours for three days consecutively.
Method of measurement
direct observational record by manual counting of abdominal movement.
4
Description
more stability physiological parameter (oxygen saturation) of preterm neonates.
Timepoint
neonates who applied the nesting technique will monitor oxygen saturation pre-test and post-test for two hours for three days consecutively.
Method of measurement
direct observational record by monitoring oxygen saturation through a hospital pulse oximeter.
Secondary outcomes
empty
Intervention groups
1
Description
intervention group A: the preterm neonates within the included criteria, will be placed in nesting technique (prone position). for six hours, and check their physiological parameters (temperature, heart rate, respiratory rate) every 2 hours.
Category
Other
2
Description
Intervention group B: the preterm neonates within the included criteria, will be placed in nesting technique (supine position). for six hours, and check their physiological parameters (temperature, heart rate, respiratory rate) every 2 hours.
Category
N/A
3
Description
Intervention group C: the preterm neonates within the included criteria, will be placed in nesting technique (lateral position). for six hours, and check their physiological parameters (temperature, heart rate, respiratory rate) every 2 hours.
Category
N/A
4
Description
Control group: the preterm neonates within the included criteria, were not placed in the nesting technique, and their physiological parameters (temperature, heart rate, respiratory rate) will be checked every 2 hours.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Batool Teaching Hospital for Maternal and Children in Diyala governorate..
Full name of responsible person
Adraa Hussein Shawq
Street address
Bab AL-Muadum
City
Baghdad
Postal code
10001
Phone
+964 770 263 8810
Email
adraa.hussein@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
College of Nursing, University of Baghdad
Full name of responsible person
Professor Wissam Jabar Qasim, PhD. Dean
Street address
Bab AL-Muadum campus
City
Baghdad
Postal code
10001
Phone
+964 770 263 8810
Email
adraa.hussein@conursing.uobaghdad.edu.iq
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The author of the trial is the funding source.
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
College of Nursing, University of Baghdad
Full name of responsible person
Adraa Hussein Shawq
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Bab AL-Muadum
City
Baghdad
Province
Baghdad
Postal code
10001
Phone
+964 770 263 8810
Email
adraa.hussein@conursing.uobaghdad.edu.iq
Person responsible for scientific inquiries
Contact
Name of organization / entity
College of Nursing, University of Baghdad
Full name of responsible person
Adraa Hussein Shawq
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Bab AL-Muadum
City
Baghdad
Province
Baghdad
Postal code
10001
Phone
+964 770 263 8810
Email
adraa.hussein@conursing.uobaghdad.edu.iq
Person responsible for updating data
Contact
Name of organization / entity
College of Nursing, University of Baghdad
Full name of responsible person
Adraa Hussein Shawq
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
nursing
Street address
Baghdad, Haifa street
City
Baghdad
Province
Baghdad
Postal code
10001
Phone
+964 770 263 8810
Email
adraa.hussein@conursing.uobaghdad.edu.iq
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The researcher is acknowledging the scientific community to have verifiable findings of the study. sharing plan includes making all the related data available through publishing the study report in peer-reviewed reputable journals.
When the data will become available and for how long
God willing, once the process of data collection, analysis, and successful publishing of the manuscript, all the related files will become available for 6 months after publication.
To whom data/document is available
All the related files will be shared with any scientific interested parties.
Under which criteria data/document could be used
It may be used after seeking the author's permission and acknowledging his contribution.
From where data/document is obtainable
The author's professional e-mail that will be available with the published manuscript can be used to contact the author. e-Mail: adraa.hussein@conursing.uobaghdad.edu.iq
What processes are involved for a request to access data/document
N/A
Comments
Profound appreciation is due to the IRCT members for their genuine efforts in helping researchers fulfill their academic endeavors.