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Protocol summary
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Study aim
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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).
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Design
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A quasi-experimental design; four parallel groups (including a control group); non-randomized, non-blinding total sample size of 60.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Temperature, heart rate, respiratory rate, and oxygen saturation.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20231120060117N3
Registration date:
2023-12-17, 1402/09/26
Registration timing:
prospective
Last update:
2024-12-08, 1403/09/18
Update count:
1
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Registration date
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2023-12-17, 1402/09/26
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-02-01, 1402/11/12
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Expected recruitment end date
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2024-05-01, 1403/02/12
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Actual recruitment start date
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2024-02-01, 1402/11/12
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Actual recruitment end date
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2024-05-01, 1403/02/12
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Trial completion date
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2024-05-01, 1403/02/12
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Scientific title
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Effect of Nesting Technique Intervention on Preterms Physiological Indicators
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Public title
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Effect of Nesting Technique on Preterm Physiological Indicators
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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.
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Age
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From 1 day old to 14 days old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
150
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-10-01, 1402/07/09
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Ethics committee reference number
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2399
Health conditions studied
1
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Description of health condition studied
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Preterm neonate gestational age between 28 – 37 weeks without congenital anomalies and assertive devices.
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ICD-10 code
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O60
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ICD-10 code description
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Preterm labor
Primary outcomes
1
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Description
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more stability physiological parameter (temperature) of preterm neonates.
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Timepoint
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neonates who applied the nesting technique will measure temperature grade pre-test and post-test for two hours for three days consecutively.
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Method of measurement
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direct observational record by using a hospital electronic thermometer.
2
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Description
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more stability physiological parameter (heart rate) of preterm neonates.
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Timepoint
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neonates who applied the nesting technique will measure heart rate pre-test and post-test for two hours for three days consecutively.
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Method of measurement
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direct observational record by manual counting thorough a pediatric stethoscope.
3
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Description
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more stability physiological parameter (respiratory rate) of preterm neonates.
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Timepoint
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neonates who applied the nesting technique will measure respiratory rate pre-test and post-test for two hours for three days consecutively.
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Method of measurement
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direct observational record by manual counting of abdominal movement.
4
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Description
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more stability physiological parameter (oxygen saturation) of preterm neonates.
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Timepoint
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neonates who applied the nesting technique will monitor oxygen saturation pre-test and post-test for two hours for three days consecutively.
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Method of measurement
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direct observational record by monitoring oxygen saturation through a hospital pulse oximeter.
Intervention groups
1
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Description
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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.
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Category
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Other
2
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Description
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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.
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Category
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N/A
3
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Description
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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.
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Category
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N/A
4
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Description
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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.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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The author of the trial is the funding source.
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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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.
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To whom data/document is available
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All the related files will be shared with any scientific interested parties.
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Under which criteria data/document could be used
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It may be used after seeking the author's permission and acknowledging his contribution.
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From where data/document is obtainable
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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
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What processes are involved for a request to access data/document
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N/A
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Comments
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Profound appreciation is due to the IRCT members for their genuine efforts in helping researchers fulfill their academic endeavors.