PrematureNCT06473350
Effect of Three Different Post-Feeding Positions on Vital Signs and Comfort Levels in Preterm Infants
A study testing The application of right lateral, supine, and prone positions to preterm infants after feeding in people with Premature, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study purpose to evaluate the effects of sequentially applying right lateral, supine, and prone positions after feeding on the vital signs and comfort levels of preterm infants between 28 and 36 weeks of gestation." Read more about this study
- Who is it for?
- Ages 28 to 36 weeks
- Conditions the study is for
- Premature
- What is being tested?
- The application of right lateral, supine, and prone positions to preterm infants after feeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 30 Sep 2022
- 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 28 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Postnatal weeks 28-36 of gestation
- Weighing over 1000 grams at the time of the study
- Hospitalized for at least two days
- Fed via orogastric tube
- With enteral feeding accounting for at least 75% of energy intake
- Stable vital signs and spontaneous respiration
Who cannot join
- Mechanically ventilated due to respiratory distress
- Receiving analgesic or sedative medications
- Undergoing treatment with inotropic drugs
- Diagnosed with congenital anomalies
- Undergoing medical or surgical treatment for patent ductus arteriosus
- Requiring drainage or chest tube insertion for pneumothorax
- Diagnosed with necrotizing enterocolitis
- Receiving medical treatment for gastroesophageal reflux or diagnosed with cleft palate-lip anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Post-Feeding Right Lateral, Supine, and Prone Positions on Heart Rate, Oxygen Saturation, Respiratory Rate, Pain Levels, and Comfort Levels in Preterm Infants
This study purpose to evaluate the effects of sequentially applying right lateral, supine, and prone positions after feeding on the vital signs and comfort levels of preterm infants between 28 and 36 weeks of gestation."
Read the detailed description
Improvement in physiological parameters of preterm infants, facilitating and supporting cognitive and neuromotor development, and reducing pain and stress are recommended within the scope of developmental care through the application of therapeutic positions (supine, prone, and lateral positioning). There are discussions among neonatal nurses regarding the therapeutic positions applied to preterm infants after feeding.
This study is an experimental research designed as a single-group trial in which preterm infants meeting the inclusion criteria are subjected to sequentially applied right lateral, supine, and prone positions after feeding.The study included preterm infants between postnatal weeks 28 and 36, fed via orogastric tube, and receiving at least 75% of their energy intake enterally, with stable vital signs. Data collection utilized the Preterm Infant Demographic Information Form, Preterm Infant Vital Signs Observation and Monitoring Form, Neonatal Comfort Behavior Scale (ComfortNeo), and Neonatal Pain/Agitation Sedation Scale (N-PASS). According to the N-PASS, as the score increases, the pain level rises, with scale scores ranging from a minimum of 0 to a maximum of 10 point. According to the ComfortNeo Scale, as the comfort score increases, the baby's comfort level decreases, with scale scores ranging from a minimum of 6 to a maximum of 30.
In this study, preterm infants included in the sample group are fed via an orogastric tube in a semi-elevated supine position during their routine feeding time and then placed in the right lateral position. The infants' heart rate, oxygen saturation, respiratory rate, pain score, and comfort level data are evaluated and recorded immediately after feeding, one hour after feeding, and three hours after feeding while in the right lateral position. During the next routine feeding time, the infants are fed in the supine position and kept in this position, with their heart rate, oxygen saturation, respiratory rate, pain score, and comfort level data evaluated and recorded immediately after feeding, one hour after feeding, and three hours after feeding. During the subsequent routine feeding time, the infants are fed in the supine position and then placed in the prone position. The same parameters are evaluated and recorded immediately after feeding, one hour after feeding, and three hours after feeding while in the prone position. This procedure is repeated for each infant for three days to ensure data accuracy. The positions applied to the infants are standardized and applied in the same order to prevent variability in the data.
- Conditions
- Premature
- Being tested
- The application of right lateral, supine, and prone positions to preterm infants after feeding
- Keywords
- preterm infants, vital signs, comfort, position
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The application of right lateral, supine, and prone positions to preterm infants after feedingOther
Each infant included in the sample group is fed at their routine feeding time (9:00 a.m.), followed by placement in the right lateral position. Immediately after this position is applied, as well as one hour and three hours later, data on heart rate, oxygen saturation, respiratory rate, pain level, and comfort level are recorded. This procedure is repeated after the subsequent feeding time (12:00 p.m.) for the supine position and after the feeding time following that (6:00 p.m.) for the prone position. This procedure is repeated for three consecutive days at the same feeding times and in the same sequence.
| Study group | Role | What they receive |
|---|---|---|
| Right lateral, supine, and prone position | Experimental | In this study, the right lateral, supine, and prone positions were applied to each infant sequentially, consecutively, under identical conditions, and within the same time frame. Each position was maintained for three hours immediately after each infant's routine feeding time. Each position was applied immediately after feeding. Data on heart rate, oxygen saturation, respiratory rate, pain level, and comfort level were recorded immediately after positioning, one hour later, and three hours later. This procedure was repeated in the same manner, sequence, and time frame for three consecutive days. Receives: Other: The application of right lateral, supine, and prone positions to preterm infants after feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of the right lateral position on heart rate
The effect of post-feeding application of the right lateral position on heart rate (beats per minute: 100-180/min) in preterm infants
Measured: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
The effect of the right lateral position on oxygen saturation
The effect of post-feeding application of the right lateral position on oxygen saturation (peripheral oxgyen saturation / SpO2: %95-%100) in preterm infants
Measured: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
The effect of the right lateral position on respiratory rate
The effect of post-feeding application of the right lateral position on respiratory rate (respiratory per minute: 40-60/min) in preterm infants
Measured: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
The effect of the right lateral position on pain level
The effect of post-feeding application of the right lateral position on pain level (Evaluted according to the N-PASS:Neonatal Pain Agitation And Sedation Scale / min point: 0 max point: 10) in preterm infants. Pain level increases as the score rises.
Measured: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
The effect of the right lateral position on comfort level
The effect of the right lateral position applied to preterm infants on the comfort level according to the ''Newborn Comfort Behavior Scale (ComfortNeo)" (min point:6 - max point: 30). As the comfort score increases, the level of comfort decreases.
Measured: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
The effect of the supine position on heart rate
The effect of post-feeding application of the supine position on heart rate (beats per minute) in preterm infants
Measured: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
The effect of the supine position on oxygen saturation
The effect of post-feeding application of the supine position on oxygen saturation (peripheral oxgyen saturation / SpO2) in preterm infants
Measured: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
The effect of the supine position on respiratory rate
The effect of post-feeding application of the supine position on respiratory rate (respiratory per minute) in preterm infants
Measured: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
The effect of the supine position on pain level
The effect of post-feeding application of the supine position on pain level (Evaluted according to the N-PASS:Neonatal Pain Agitation And Sedation Scale / min point: 0 max point: 10) in preterm infants. Pain level increases as the score rises.
Measured: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
The effect of the supine position on comfort level
The effect of the supine position applied to preterm infants on the comfort level according to the ''Newborn Comfort Behavior Scale (ComfortNeo)"(min point:6- max point: 30). As the comfort score increases, the level of comfort decreases.
Measured: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
The effect of the prone position on heart rate
The effect of post-feeding application of the prone position on heart rate (beats per minute) in preterm infants
Measured: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
The effect of the prone position on respiratory rate
The effect of post-feeding application of the prone position on respiratory rate (respiratory per minute) in preterm infants
Measured: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
The effect of the prone position on pain level
The effect of post-feeding application of the prone position on pain level (Evaluted according to the N-PASS:Neonatal Pain Agitation And Sedation Scale / min point: 0 max point: 10) in preterm infants. Pain level increases as the score rises.
Measured: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
The effect of the prone position on comfort level
The effect of the prone position applied to preterm infants on the comfort level according to the ''Newborn Comfort Behavior Scale (ComfortNeo) " (min point:6- max point: 30). As the comfort score increases, the level of comfort decreases.
Measured: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Jan 2022
- Primary completion20 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematureStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Not applicable
- Intervention model
- Sequential
- Model description
- Experimental study in a single group with three positions applied sequentially
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Canan Ayaslı Ünal, Saglik Bilimleri Universitesi
- Investigators
- CANAN AYASLİ UNAL, Principal investigator, Health Science UniversityDilek YILDIZ, Prof., Principal investigator, Health Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473350
- Sponsor's protocol ID
- SBU-SBE-CAU-01
- Status last verified
- Jun 2024
- First submitted
- 8 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- 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 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Post-Feeding Right Lateral, Supine, and Prone Positions on Heart Rate, Oxygen Saturation, Respiratory Rate, Pain Levels, and Comfort Levels in Preterm Infants
- ClinicalTrials.gov ID
- NCT06473350
- Acronym / sponsor ID
- SBU-SBE-CAU-01
- Conditions
- Premature
- Keywords
- preterm infants, vital signs, comfort, position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 25 Jun 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.
This study purpose to evaluate the effects of sequentially applying right lateral, supine, and prone positions after feeding on the vital signs and comfort levels of preterm infants between 28 and 36 weeks of gestation."
Detailed description
Improvement in physiological parameters of preterm infants, facilitating and supporting cognitive and neuromotor development, and reducing pain and stress are recommended within the scope of developmental care through the application of therapeutic positions (supine, prone, and lateral positioning). There are discussions among neonatal nurses regarding the therapeutic positions applied to preterm infants after feeding.
This study is an experimental research designed as a single-group trial in which preterm infants meeting the inclusion criteria are subjected to sequentially applied right lateral, supine, and prone positions after feeding.The study included preterm infants between postnatal weeks 28 and 36, fed via orogastric tube, and receiving at least 75% of their energy intake enterally, with stable vital signs. Data collection utilized the Preterm Infant Demographic Information Form, Preterm Infant Vital Signs Observation and Monitoring Form, Neonatal Comfort Behavior Scale (ComfortNeo), and Neonatal Pain/Agitation Sedation Scale (N-PASS). According to the N-PASS, as the score increases, the pain level rises, with scale scores ranging from a minimum of 0 to a maximum of 10 point. According to the ComfortNeo Scale, as the comfort score increases, the baby's comfort level decreases, with scale scores ranging from a minimum of 6 to a maximum of 30.
In this study, preterm infants included in the sample group are fed via an orogastric tube in a semi-elevated supine position during their routine feeding time and then placed in the right lateral position. The infants' heart rate, oxygen saturation, respiratory rate, pain score, and comfort level data are evaluated and recorded immediately after feeding, one hour after feeding, and three hours after feeding while in the right lateral position. During the next routine feeding time, the infants are fed in the supine position and kept in this position, with their heart rate, oxygen saturation, respiratory rate, pain score, and comfort level data evaluated and recorded immediately after feeding, one hour after feeding, and three hours after feeding. During the subsequent routine feeding time, the infants are fed in the supine position and then placed in the prone position. The same parameters are evaluated and recorded immediately after feeding, one hour after feeding, and three hours after feeding while in the prone position. This procedure is repeated for each infant for three days to ensure data accuracy. The positions applied to the infants are standardized and applied in the same order to prevent variability in the data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Experimental study in a single group with three positions applied sequentially
| Arm | Type | Receives |
|---|---|---|
| Right lateral, supine, and prone position | Experimental | Other: The application of right lateral, supine, and prone positions to preterm infants after feedingIn this study, the right lateral, supine, and prone positions were applied to each infant sequentially, consecutively, under identical conditions, and within the same time frame. Each position was maintained for three hours immediately after each infant's routine feeding time. Each position was applied immediately after feeding. Data on heart rate, oxygen saturation, respiratory rate, pain level, and comfort level were recorded immediately after positioning, one hour later, and three hours later. This procedure was repeated in the same manner, sequence, and time frame for three consecutive days. |
Who may qualify
- Ages
- 28 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Postnatal weeks 28-36 of gestation
- Weighing over 1000 grams at the time of the study
- Hospitalized for at least two days
- Fed via orogastric tube
- With enteral feeding accounting for at least 75% of energy intake
Key exclusion criteria (8 listed)
- Mechanically ventilated due to respiratory distress
- Receiving analgesic or sedative medications
- Undergoing treatment with inotropic drugs
- Diagnosed with congenital anomalies
- Undergoing medical or surgical treatment for patent ductus arteriosus
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 |
|---|---|---|
| The application of right lateral, supine, and prone positions to preterm infants after feedingEach infant included in the sample group is fed at their routine feeding time (9:00 a.m.), followed by placement in the right lateral position. Immediately after this position is applied, as well as one hour and three hours later, data on heart rate, oxygen saturation, respiratory rate, pain level, and comfort level are recorded. This procedure is repeated after the subsequent feeding time (12:00 p.m.) for the supine position and after the feeding time following that (6:00 p.m.) for the prone position. This procedure is repeated for three consecutive days at the same feeding times and in the same sequence. | Other | Right lateral, supine, and prone position |
Primary outcome
The effect of the right lateral position on heart rate
Time frame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
The effect of post-feeding application of the right lateral position on heart rate (beats per minute: 100-180/min) in preterm infants
The effect of the right lateral position on oxygen saturation
Time frame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
The effect of post-feeding application of the right lateral position on oxygen saturation (peripheral oxgyen saturation / SpO2: %95-%100) in preterm infants
The effect of the right lateral position on respiratory rate
Time frame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
The effect of post-feeding application of the right lateral position on respiratory rate (respiratory per minute: 40-60/min) in preterm infants
The effect of the right lateral position on pain level
Time frame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
The effect of post-feeding application of the right lateral position on pain level (Evaluted according to the N-PASS:Neonatal Pain Agitation And Sedation Scale / min point: 0 max point: 10) in preterm infants. Pain level increases as the score rises.
The effect of the right lateral position on comfort level
Time frame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
The effect of the right lateral position applied to preterm infants on the comfort level according to the ''Newborn Comfort Behavior Scale (ComfortNeo)" (min point:6 - max point: 30). As the comfort score increases, the level of comfort decreases.
The effect of the supine position on heart rate
Time frame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
The effect of post-feeding application of the supine position on heart rate (beats per minute) in preterm infants
The effect of the supine position on oxygen saturation
Time frame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
The effect of post-feeding application of the supine position on oxygen saturation (peripheral oxgyen saturation / SpO2) in preterm infants
The effect of the supine position on respiratory rate
Time frame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
The effect of post-feeding application of the supine position on respiratory rate (respiratory per minute) in preterm infants
The effect of the supine position on pain level
Time frame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
The effect of post-feeding application of the supine position on pain level (Evaluted according to the N-PASS:Neonatal Pain Agitation And Sedation Scale / min point: 0 max point: 10) in preterm infants. Pain level increases as the score rises.
The effect of the supine position on comfort level
Time frame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
The effect of the supine position applied to preterm infants on the comfort level according to the ''Newborn Comfort Behavior Scale (ComfortNeo)"(min point:6- max point: 30). As the comfort score increases, the level of comfort decreases.
The effect of the prone position on heart rate
Time frame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
The effect of post-feeding application of the prone position on heart rate (beats per minute) in preterm infants
The effect of the prone position on respiratory rate
Time frame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
The effect of post-feeding application of the prone position on respiratory rate (respiratory per minute) in preterm infants
The effect of the prone position on pain level
Time frame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
The effect of post-feeding application of the prone position on pain level (Evaluted according to the N-PASS:Neonatal Pain Agitation And Sedation Scale / min point: 0 max point: 10) in preterm infants. Pain level increases as the score rises.
The effect of the prone position on comfort level
Time frame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
The effect of the prone position applied to preterm infants on the comfort level according to the ''Newborn Comfort Behavior Scale (ComfortNeo) " (min point:6- max point: 30). As the comfort score increases, the level of comfort decreases.
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 25 Jun 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.
CANAN AYASLİ UNAL principal investigator
Health Science University
Dilek YILDIZ, Prof. principal investigator
Health Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The application of right lateral, supine, and prone positions to preterm infants after feeding in people with Premature, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 6 inclusion and 8 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 25 Jun 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 Turkey (Türkiye). 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?
The effect of the right lateral position on heart rate (time frame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding). The study lists 14 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 25 Jun 2024.