Respiratory Distress SyndromeNCT06428916
Facilitated Tucking Position During Endotracheal Suctioning
A study testing tucking position during endotracheal suctioning in people with Respiratory Distress Syndrome, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Aim of the present study The present study will aimed to determine the effect of facilitated tucking position during endotracheal suctioning on physiological criteria and behavioural responses of the preterm neonates. Research Hypotheses 1. Read more about this study
- Who is it for?
- Ages 32 to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- tucking position during endotracheal suctioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 36 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age between 32 and 36 weeks, weight 1200 grams or greater.
- Postnatal age: two days after delivery to allow for resolution of analgesia or anesthesia received by their mothers during labor.
- Have endotracheal intubation.
Who cannot join
- Preterm neonates who have congenital anomalies or neurological malformations, intracranial hemorrhage, seizures.
- Preterm neonates who received sedatives within four hours before the intervention
- Preterm neonates who exposed to any uncomfortable procedure for at least 30 minutes prior to the intervention.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kafrelsheikh University
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33516
About this study
Official title: The Effect of Facilitated Tucking Position During Endotracheal Suctioning on Physiological Measurement and Behavioral Responses of the Preterm Neonates
Aim of the present study The present study will aimed to determine the effect of facilitated tucking position during endotracheal suctioning on physiological criteria and behavioural responses of the preterm neonates.
Research Hypotheses
- Preterm neonates who receive facilitated tucking position during endotracheal suctioning exhibit more stable physiological criteria than those who do not.
- Preterm neonates who receive facilitated tucking position during endotracheal suctioning exhibit more stable behavioral responses than those who do not.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- tucking position during endotracheal suctioning
- Keywords
- Physiological measurement, Behavioral Responses of the Preterm Neonates, Facilitated Tucking Position, Endotracheal Suctioning
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tucking position during endotracheal suctioningProcedure or surgery
, the staff nurse will perform the endotracheal suctioning while the researcher will carried out the intervention
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Consisted of 20 neonates who will receive tucking position during endotracheal suctioning Receives: Procedure: tucking position during endotracheal suctioning |
| Control group | No intervention | Consisted of 20 neonates who will receive routine care during Endotracheal suctioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of heart rate of preterm neonates on Neonates' Physiological Assessment Tool during and immediately following the endotracheal suction procedure
Neonates' Physiological Assessment Tool was developed by researchers after a review of relevant literature to assess Physiological Parameters of preterm neonates as Heart Rate (HR)
Measured: during procedural and immediately after procedure
Change from baseline of Respiratory Rate of preterm neonates on Neonates' Physiological Assessment Tool during and immediately following the endotracheal suction procedure
Neonates' Physiological Assessment Tool was developed by researchers after a review of relevant literature to assess Physiological Parameters of preterm neonates as Respiratory Rate (RR)
Measured: during procedural and immediately after procedure
Change from baseline of oxygen saturation in blood of preterm neonates on Neonates' Physiological Assessment Tool during and immediately following the endotracheal suction procedure
Neonates' Physiological Assessment Tool was developed by researchers after a review of relevant literature to assess Physiological Parameters of preterm neonates as oxygen saturation in blood(SPO2)
Measured: during procedural and immediately after procedure
Secondary outcomes (1)
change of baseline of Neonates' behavioral states on Anderson Behavioral State Scale during and immediately following the endotracheal suction procedure
This scale was adopted from Anderson et al.(1990) to assess the behavioral organization of preterm neonates. Neonates' behavioral states are assessed by observing their respiratory regularity, opening or closing of the eyes, limb and trunk activity, and the intensity of crying. Based on the observations, the scale will differentiate 12 behavioral states, including; regular quiet sleep (1), irregular quiet sleep (2), active sleep (3), very active sleep (4), drowsy (5), alert inactivity (6), quite awake (7), active awake (8), very active awake (9), fussing (10), crying (11) and hard crying (12). Scores from 1 to 5 indicate that the neonate is sleeping. Scores from 6 to 8 indicate that the neonate is awake and calm. Scores from 9 to 12 indicate that the neonate is in a state of restless activity or fussiness, which takes substantial energy
Measured: during procedural and immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Dec 2022
- Primary completion1 May 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Wardany Abdelaal Mohamed, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428916
- Sponsor's protocol ID
- KafrelsheikhU2
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 24 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Facilitated Tucking Position During Endotracheal Suctioning on Physiological Measurement and Behavioral Responses of the Preterm Neonates
- ClinicalTrials.gov ID
- NCT06428916
- Acronym / sponsor ID
- KafrelsheikhU2
- Conditions
- Respiratory Distress Syndrome
- Keywords
- Physiological measurement, Behavioral Responses of the Preterm Neonates, Facilitated Tucking Position, Endotracheal Suctioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the present study The present study will aimed to determine the effect of facilitated tucking position during endotracheal suctioning on physiological criteria and behavioural responses of the preterm neonates.
Research Hypotheses
- Preterm neonates who receive facilitated tucking position during endotracheal suctioning exhibit more stable physiological criteria than those who do not.
- Preterm neonates who receive facilitated tucking position during endotracheal suctioning exhibit more stable behavioral responses than those who do not.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Procedure: tucking position during endotracheal suctioningConsisted of 20 neonates who will receive tucking position during endotracheal suctioning |
| Control group | No intervention | –Consisted of 20 neonates who will receive routine care during Endotracheal suctioning |
Who may qualify
- Ages
- 32 to 36 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Gestational age between 32 and 36 weeks, weight 1200 grams or greater.
- Postnatal age: two days after delivery to allow for resolution of analgesia or anesthesia received by their mothers during labor.
- Have endotracheal intubation.
Key exclusion criteria (3 listed)
- Preterm neonates who have congenital anomalies or neurological malformations, intracranial hemorrhage, seizures.
- Preterm neonates who received sedatives within four hours before the intervention
- Preterm neonates who exposed to any uncomfortable procedure for at least 30 minutes prior to the intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tucking position during endotracheal suctioning, the staff nurse will perform the endotracheal suctioning while the researcher will carried out the intervention | Procedure or surgery | Study Group |
Primary outcome
Change from baseline of heart rate of preterm neonates on Neonates' Physiological Assessment Tool during and immediately following the endotracheal suction procedure
Time frame: during procedural and immediately after procedure
Neonates' Physiological Assessment Tool was developed by researchers after a review of relevant literature to assess Physiological Parameters of preterm neonates as Heart Rate (HR)
Change from baseline of Respiratory Rate of preterm neonates on Neonates' Physiological Assessment Tool during and immediately following the endotracheal suction procedure
Time frame: during procedural and immediately after procedure
Neonates' Physiological Assessment Tool was developed by researchers after a review of relevant literature to assess Physiological Parameters of preterm neonates as Respiratory Rate (RR)
Change from baseline of oxygen saturation in blood of preterm neonates on Neonates' Physiological Assessment Tool during and immediately following the endotracheal suction procedure
Time frame: during procedural and immediately after procedure
Neonates' Physiological Assessment Tool was developed by researchers after a review of relevant literature to assess Physiological Parameters of preterm neonates as oxygen saturation in blood(SPO2)
1 secondary outcome
change of baseline of Neonates' behavioral states on Anderson Behavioral State Scale during and immediately following the endotracheal suction procedure
Time frame: during procedural and immediately after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tucking position during endotracheal suctioning in people with Respiratory Distress Syndrome, run by Kafrelsheikh University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of heart rate of preterm neonates on Neonates' Physiological Assessment Tool during and immediately following the endotracheal suction procedure (time frame: during procedural and immediately after procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.