ComfortNCT04596202
The Effect of Position on Gastric Residual Volume and Comfort Level in Newborns
A study testing Supine position, Prone position and Lateral position in people with Comfort and Newborn, Infant, Disease, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this randomized controlled trial is to determine the effect of different positions (supine, prone, right lateral and left lateral) in post-op term newborns staying in Pediatric Cardio Vascular Surgery (PCVS) Intensive Care Unit on gastric residual volume and comfort level. Read more about this study
- Who is it for?
- Ages 1 day to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Comfort, Newborn, Infant, Disease, Position
- What is being tested?
- Supine position, Prone position and Lateral position
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 7 Feb 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 1 day to 30 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- • Having a gestational week of 37 and above,
- Undergoing heart surgery,
- Being separated from the mechanical ventilator,
- Starting to be fed with nasogastric or orogastric tube,
- Not showing any signs of infection,
- Not using narcotic drugs in post-op period,
Show all 9Show fewer
- Having no factors that can interfere with feeding (vomiting, distention, necrotizing enterocolitis, etc.)
- Having no condition that can prevent positioning,
- Receiving Informed Consent Form from their families.
Who cannot join
- • Having a gestational week of less than 36+6 days,
- Have not been separated from the mechanical ventilator,
- Showing any signs of infection,
- Using narcotic drugs in the post-op period,
- Having factors that may prevent feeding (vomiting, distention, necrotizing enterocolitis, etc.)
- Having a condition that can prevent positioning,
- Receiving no consent from their mother or father.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Position in Post-op Newborns Hospitalized in Pediatric Cardio Vascular Surgery Intensive Care Unit on Gastric Residual Volume and Comfort Level
The purpose of this randomized controlled trial is to determine the effect of different positions (supine, prone, right lateral and left lateral) in post-op term newborns staying in Pediatric Cardio Vascular Surgery (PCVS) Intensive Care Unit on gastric residual volume and comfort level.
Read the detailed description
In the study, crossover design from experimental designs was preferred. Crossover design is an experimental design type in which two or more interventions are applied in a sequence to each case in the study group. In these studies, each group is its own control group. In this design type, all different interventions in the study are applied to the same case; thus, differences that may arise due to individual differences are prevented. Additionally, less number of cases is sufficient in order to obtain the same number of observation data compared to the other design examples. Due to these properties, randomized crossover design model was used in this study. The study will be conducted in PCVS Intensive Care Unit of a University Hospital in Turkey between October 2020 and August 2021.
In this study, sample size was calculated at the confidence interval of 95% using "G. Power-3.1.9.4" program. In a study the effect size used for determining the sample size in the study was found to be 0.54 based on the mean and standard deviation values of the study. By using this effect size, minimum sample size was found as 38 children in order for the gastric residue amount difference between positions to express statistically significance (p<0.05) with theoretical power of 0.95. By considering that there might be losses in the study, it is planned to include a total of 44 children in the study.
The order of the 4 positions to be given to the infants in the study group (A:Prone Position, B:Right lateral Position, C:Left lateral Position, D:Supine Position) was determined by lot method. 4 different orders were chosen randomly from all possible orders of 4 positions to be given to the infants in the study group (24 different orders). Each different order of the positions was expressed as a group. 4 orders randomly selected from 24 different orders were as follows:
The order in the first group is A, C, D, and B; The order in the second group is D, A, B, and C; The order in the third group is C, B, A, and D; The order in the fourth group is B, D, C, and A.
Groups and position orders according to the result of the draw:
- st GROUP ORDER; Prone (A), Left lateral (C), Supine (D), and Right lateral (B)
- nd GROUP ORDER; Supine (D), Prone (A), Right lateral (B), and Left lateral (C)
- rd GROUP ORDER; Left lateral (C), Right lateral (B), Prone (A), and Supine (D)
- th GROUP ORDER; Right lateral (B), Supine (D), Left lateral (C), and Prone (A)
Assigning the infants to 4 groups was made in Microsoft Excel program using "RANDBETWEEN" command. All positions will be applied once to each infant. The newborns to be assigned to the groups according to this result are stated in the below table.
Groups Newborns
- st group A, C, D, B 1, 5, 10, 11, 12, 20, 21, 30, 36, 38, 44
- nd group D, A, B, C 19, 22, 23, 24, 25, 27, 28, 31, 32, 33, 42
- rd group C, B, A, D 3, 4, 6, 7, 9, 13, 15, 29, 34, 37, 43
- th group B, D, C, A 2, 8, 14, 16, 17, 18, 26, 35, 39, 40, 41
Data Collection tools:
In the data collection, "Information Form" prepared by the researcher to record the descriptive information of the newborn, "Newborn Comfort Behavior Scale" to evaluate the comfort level and "Residue Follow-up Form" to record the residual amount and the "Vital Signs Follow-up Form" to record the vital signs will be used.
Information Form: It is a form prepared by the researcher in line with the literature to record the natal and postnatal information of the newborn. The information in this form will be filled out by the researcher.
Newborn Comfort Behavior Scale: It is a Likert-type scale developed to be used to assess sedation and comfort needs, pain, and distress of newborns followed-up in the intensive care. The Newborn Comfort Behavior Scale will be evaluated at the 30th, 60th and 120th minutes after the position. The comfort level scale scoring will be evaluated and filled by the researcher and a second observer working in the Intensive Care Unit for 5 years.
Residue Follow-up Form: The form prepared to follow up the residue includes the position given, amount of nutrition, the way of feeding, feeding type, and residue amount control. The researcher will evaluate and fill out the form at the 30th, 60th and 120th minutes after feeding.
Vital Signs Follow-up Form: This form prepared by the researcher in line with the literature was composed of the parameters of heart rate (min), respiratory rate (min) and oxygen saturation value (%SpO2) of the newborn. The researcher will evaluate and fill out the form at the 30th, 60th and 120th minutes after positioning.
- Conditions
- Comfort, Newborn, Infant, Disease, Position, Residual
- Being tested
- Supine position, Prone position, Lateral position
- Keywords
- Newborn, Comfort Score, Residual Volume, infant positioning
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supine positionBehavioural
After the infants are treated and fed, they will be given the supine position. After positioning, the residue control will be performed in accordance with the procedure steps guideline at the 30th, 60th and 120th minutes and it will be recorded on residue follow-up form. In addition, the comfort level, heart rate, respiratory rate, and oxygen saturation levels of the infant will be evaluated and recorded at the specified times. At the end of two hours, until the next feeding hour (between 121st-180th minutes), the routine position (supine position) applied in the clinic will be given to the infant and waited in order for physiological parameters and comfort levels to return the period without intervention. The aim here is to ensure for the case to get over the effect of the previous position. No data will be collected within this period.
Prone positionBehavioural
After the infants are treated and fed, they will be given the prone position. After positioning, the residue control will be performed in accordance with the procedure steps guideline at the 30th, 60th and 120th minutes and it will be recorded on residue follow-up form. In addition, the comfort level, heart rate, respiratory rate, and oxygen saturation levels of the infant will be evaluated and recorded at the specified times. At the end of two hours, until the next feeding hour (between 121st-180th minutes), the routine position (supine position) applied in the clinic will be given to the infant and waited in order for physiological parameters and comfort levels to return the period without intervention. The aim here is to ensure for the case to get over the effect of the previous position. No data will be collected within this period.
Lateral positionBehavioural
After the infants are treated and fed, they will be given the left or right position. After positioning, the residue control will be performed in accordance with the procedure steps guideline at the 30th, 60th and 120th minutes and it will be recorded on residue follow-up form. In addition, the comfort level, heart rate, respiratory rate, and oxygen saturation levels of the infant will be evaluated and recorded at the specified times. At the end of two hours, until the next feeding hour (between 121st-180th minutes), the routine position (supine position) applied in the clinic will be given to the infant and waited in order for physiological parameters and comfort levels to return the period without intervention. The aim here is to ensure for the case to get over the effect of the previous position. No data will be collected within this period. These processes will continue until the 4 positions are completed. Infants will stay in each position for 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| Supine Position | Experimental | It is the supine position. The body parts of the patient stand as if the patient is standing upright. The head, neck and shoulders should be supported with a pillow placed under the head. Arms are aside and body muscles are relaxed. The upper arms should lie on both sides of the body, should slightly be moved away from the body and should be supported by a pillow. Receives: Behavioral: Supine position |
| Prone Position | Experimental | It is the position where the patient lies face down with his/her head turned to the side. Arms are stretched to both sides of the head. The prone position (prone lying) is a relaxing and resting position. Receives: Behavioral: Prone position |
| Lateral position | Experimental | Lateral position is the left or right lateral lying position. The lateral position is given to the patient to provide proper anatomical lying and to reduce lateral flexion of the back and the strain of the large back muscles. This position prevents pressure on the bones in the back. Receives: Behavioral: Lateral position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Comfort Behavior Scale (COMFORTneo):"change" will be assessed
This scale is a Likert type scale developed to be used in the evaluation of sedation and comfort needs, pain and distress of newborns followed-up in intensive care. COMFORTneo is composed of six parameters including alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tone. Each item in the scale is scored from 1 to 5. It is evaluated over the total score. The lowest score of COMFORTneo is 6 and the highest score is 30. If total score of the scale is between 9-13 points, it refers that the infant is "comfortable". If it is between 14-30 points, it is emphasized that the infant has "pain or distress", is uncomfortable and requires interventions that will provide comfort.
Measured: The Newborn Comfort Behavior Scale will be evaluated at the 30 to 120 minutes after the position.
Residue Follow-up Form: "change" will be assessed
The form prepared to follow up the residue includes the position given, amount of nutrition, the way of feeding, feeding type, and residue amount control.
Measured: It will be checked at 30 to 120 minutes after feeding.
Vital Signs Follow-up Form: "change" will be assessed
This form prepared by the researcher in line with the literature was composed of the parameters of heart rate (min), respiratory rate (min) and oxygen saturation value (%SpO2) of the newborn.
Measured: It will be evaluated at 30 to 120 minutes after positioning.
Secondary outcomes (3)
Heart Rate (min): "change" will be assessed
The heart rate per minute will be obtained using a pulse oximeter device. A separate pulse oximeter probe will be placed on each of the infants.
Measured: It will be evaluated at 30 to 120 minutes after positioning.
Oxygen Saturation (%SpO2): "change" will be assessed
Oxygen saturation (SpO2) will be obtained using a pulse oximeter device. A separate pulse oximeter probe will be placed on each of the infants. Pulse oximeter is a noninvasive, painless, and reliable method used to measure oxygen saturation (SpO2) in arterial blood. The rate of hemoglobin carrying oxygen in arterial blood is measured and the qualifying result is defined as functional oxygen saturation.
Measured: It will be evaluated at 30 to 120 minutes after positioning.
Respiration Rate (min): "change" will be assessed
The respiration rate is the number of inspirations per minute. It is counted by chest movements or auscultation.
Measured: It will be evaluated at 30 to 120 minutes after positioning.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Dec 2021
- Primary completion1 Jan 2023
- Study completion7 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ComfortStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- Randomized Controlled Crossover Design Model
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Yılmaz Kurt, Çanakkale Onsekiz Mart University
- Investigators
- fatma yılmaz kurt, Principal investigator, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596202
- Sponsor's protocol ID
- CanakkaleOMU
- Status last verified
- Feb 2023
- First submitted
- 9 Oct 2020
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be shared after the article is published.
Publications
Yayan EH, Kucukoglu S, Dag YS, Karsavuran Boyraz N. Does the Post-Feeding Position Affect Gastric Residue in Preterm Infants? Breastfeed Med. 2018 Jul/Aug;13(6):438-443. doi: 10.1089/bfm.2018.0028.
PubMed 30016174Khatony A, Abdi A, Karimi B, Aghaei A, Brojeni HS. The effects of position on gastric residual volume of premature infants in NICU. Ital J Pediatr. 2019 Jan 8;45(1):6. doi: 10.1186/s13052-018-0591-9.
PubMed 30621733Ozdel D, Sari HY. Effects of the prone position and kangaroo care on gastric residual volume, vital signs and comfort in preterm infants. Jpn J Nurs Sci. 2020 Jan;17(1):e12287. doi: 10.1111/jjns.12287. Epub 2019 Oct 23.
PubMed 31642602Kaur V, Kaur R, Saini SS. Comparison of Three Nursing Positions for Reducing Gastric Residuals in Preterm Neonates: A Randomized Crossover Trial. Indian Pediatr. 2018 Jul 15;55(7):568-572.
PubMed 30129537Chen SS, Tzeng YL, Gau BS, Kuo PC, Chen JY. Effects of prone and supine positioning on gastric residuals in preterm infants: a time series with cross-over study. Int J Nurs Stud. 2013 Nov;50(11):1459-67. doi: 10.1016/j.ijnurstu.2013.02.009. Epub 2013 Mar 26.
PubMed 23537895
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Position in Post-op Newborns Hospitalized in Pediatric Cardio Vascular Surgery Intensive Care Unit on Gastric Residual Volume and Comfort Level
- ClinicalTrials.gov ID
- NCT04596202
- Acronym / sponsor ID
- CanakkaleOMU
- Conditions
- Comfort, Newborn, Infant, Disease, Position, Residual
- Keywords
- Newborn, Comfort Score, Residual Volume, infant positioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 7 Feb 2023 (actual)
- First posted
- 22 Oct 2020 (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.
The purpose of this randomized controlled trial is to determine the effect of different positions (supine, prone, right lateral and left lateral) in post-op term newborns staying in Pediatric Cardio Vascular Surgery (PCVS) Intensive Care Unit on gastric residual volume and comfort level.
Detailed description
In the study, crossover design from experimental designs was preferred. Crossover design is an experimental design type in which two or more interventions are applied in a sequence to each case in the study group. In these studies, each group is its own control group. In this design type, all different interventions in the study are applied to the same case; thus, differences that may arise due to individual differences are prevented. Additionally, less number of cases is sufficient in order to obtain the same number of observation data compared to the other design examples. Due to these properties, randomized crossover design model was used in this study. The study will be conducted in PCVS Intensive Care Unit of a University Hospital in Turkey between October 2020 and August 2021.
In this study, sample size was calculated at the confidence interval of 95% using "G. Power-3.1.9.4" program. In a study the effect size used for determining the sample size in the study was found to be 0.54 based on the mean and standard deviation values of the study. By using this effect size, minimum sample size was found as 38 children in order for the gastric residue amount difference between positions to express statistically significance (p<0.05) with theoretical power of 0.95. By considering that there might be losses in the study, it is planned to include a total of 44 children in the study.
The order of the 4 positions to be given to the infants in the study group (A:Prone Position, B:Right lateral Position, C:Left lateral Position, D:Supine Position) was determined by lot method. 4 different orders were chosen randomly from all possible orders of 4 positions to be given to the infants in the study group (24 different orders). Each different order of the positions was expressed as a group. 4 orders randomly selected from 24 different orders were as follows:
The order in the first group is A, C, D, and B; The order in the second group is D, A, B, and C; The order in the third group is C, B, A, and D; The order in the fourth group is B, D, C, and A.
Groups and position orders according to the result of the draw:
- st GROUP ORDER; Prone (A), Left lateral (C), Supine (D), and Right lateral (B)
- nd GROUP ORDER; Supine (D), Prone (A), Right lateral (B), and Left lateral (C)
- rd GROUP ORDER; Left lateral (C), Right lateral (B), Prone (A), and Supine (D)
- th GROUP ORDER; Right lateral (B), Supine (D), Left lateral (C), and Prone (A)
Assigning the infants to 4 groups was made in Microsoft Excel program using "RANDBETWEEN" command. All positions will be applied once to each infant. The newborns to be assigned to the groups according to this result are stated in the below table.
Groups Newborns
- st group A, C, D, B 1, 5, 10, 11, 12, 20, 21, 30, 36, 38, 44
- nd group D, A, B, C 19, 22, 23, 24, 25, 27, 28, 31, 32, 33, 42
- rd group C, B, A, D 3, 4, 6, 7, 9, 13, 15, 29, 34, 37, 43
- th group B, D, C, A 2, 8, 14, 16, 17, 18, 26, 35, 39, 40, 41
Data Collection tools:
In the data collection, "Information Form" prepared by the researcher to record the descriptive information of the newborn, "Newborn Comfort Behavior Scale" to evaluate the comfort level and "Residue Follow-up Form" to record the residual amount and the "Vital Signs Follow-up Form" to record the vital signs will be used.
Information Form: It is a form prepared by the researcher in line with the literature to record the natal and postnatal information of the newborn. The information in this form will be filled out by the researcher.
Newborn Comfort Behavior Scale: It is a Likert-type scale developed to be used to assess sedation and comfort needs, pain, and distress of newborns followed-up in the intensive care. The Newborn Comfort Behavior Scale will be evaluated at the 30th, 60th and 120th minutes after the position. The comfort level scale scoring will be evaluated and filled by the researcher and a second observer working in the Intensive Care Unit for 5 years.
Residue Follow-up Form: The form prepared to follow up the residue includes the position given, amount of nutrition, the way of feeding, feeding type, and residue amount control. The researcher will evaluate and fill out the form at the 30th, 60th and 120th minutes after feeding.
Vital Signs Follow-up Form: This form prepared by the researcher in line with the literature was composed of the parameters of heart rate (min), respiratory rate (min) and oxygen saturation value (%SpO2) of the newborn. The researcher will evaluate and fill out the form at the 30th, 60th and 120th minutes after positioning.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Randomized Controlled Crossover Design Model
| Arm | Type | Receives |
|---|---|---|
| Supine Position | Experimental | Behavioral: Supine positionIt is the supine position. The body parts of the patient stand as if the patient is standing upright. The head, neck and shoulders should be supported with a pillow placed under the head. Arms are aside and body muscles are relaxed. The upper arms should lie on both sides of the body, should slightly be moved away from the body and should be supported by a pillow. |
| Prone Position | Experimental | Behavioral: Prone positionIt is the position where the patient lies face down with his/her head turned to the side. Arms are stretched to both sides of the head. The prone position (prone lying) is a relaxing and resting position. |
| Lateral position | Experimental | Behavioral: Lateral positionLateral position is the left or right lateral lying position. The lateral position is given to the patient to provide proper anatomical lying and to reduce lateral flexion of the back and the strain of the large back muscles. This position prevents pressure on the bones in the back. |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- • Having a gestational week of 37 and above,
Key exclusion criteria (7 listed)
- • Having a gestational week of less than 36+6 days,
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 |
|---|---|---|
| Supine positionAfter the infants are treated and fed, they will be given the supine position. After positioning, the residue control will be performed in accordance with the procedure steps guideline at the 30th, 60th and 120th minutes and it will be recorded on residue follow-up form. In addition, the comfort level, heart rate, respiratory rate, and oxygen saturation levels of the infant will be evaluated and recorded at the specified times. At the end of two hours, until the next feeding hour (between 121st-180th minutes), the routine position (supine position) applied in the clinic will be given to the infant and waited in order for physiological parameters and comfort levels to return the period without intervention. The aim here is to ensure for the case to get over the effect of the previous position. No data will be collected within this period. | Behavioural | Supine Position |
| Prone positionAfter the infants are treated and fed, they will be given the prone position. After positioning, the residue control will be performed in accordance with the procedure steps guideline at the 30th, 60th and 120th minutes and it will be recorded on residue follow-up form. In addition, the comfort level, heart rate, respiratory rate, and oxygen saturation levels of the infant will be evaluated and recorded at the specified times. At the end of two hours, until the next feeding hour (between 121st-180th minutes), the routine position (supine position) applied in the clinic will be given to the infant and waited in order for physiological parameters and comfort levels to return the period without intervention. The aim here is to ensure for the case to get over the effect of the previous position. No data will be collected within this period. | Behavioural | Prone Position |
| Lateral positionAfter the infants are treated and fed, they will be given the left or right position. After positioning, the residue control will be performed in accordance with the procedure steps guideline at the 30th, 60th and 120th minutes and it will be recorded on residue follow-up form. In addition, the comfort level, heart rate, respiratory rate, and oxygen saturation levels of the infant will be evaluated and recorded at the specified times. At the end of two hours, until the next feeding hour (between 121st-180th minutes), the routine position (supine position) applied in the clinic will be given to the infant and waited in order for physiological parameters and comfort levels to return the period without intervention. The aim here is to ensure for the case to get over the effect of the previous position. No data will be collected within this period. These processes will continue until the 4 positions are completed. Infants will stay in each position for 2 hours. | Behavioural | Lateral position |
Primary outcome
Neonatal Comfort Behavior Scale (COMFORTneo):"change" will be assessed
Time frame: The Newborn Comfort Behavior Scale will be evaluated at the 30 to 120 minutes after the position.
This scale is a Likert type scale developed to be used in the evaluation of sedation and comfort needs, pain and distress of newborns followed-up in intensive care. COMFORTneo is composed of six parameters including alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tone. Each item in the scale is scored from 1 to 5. It is evaluated over the total score. The lowest score of COMFORTneo is 6 and the highest score is 30. If total score of the scale is between 9-13 points, it refers that the infant is "comfortable". If it is between 14-30 points, it is emphasized that the infant has "pain or distress", is uncomfortable and requires interventions that will provide comfort.
Residue Follow-up Form: "change" will be assessed
Time frame: It will be checked at 30 to 120 minutes after feeding.
The form prepared to follow up the residue includes the position given, amount of nutrition, the way of feeding, feeding type, and residue amount control.
Vital Signs Follow-up Form: "change" will be assessed
Time frame: It will be evaluated at 30 to 120 minutes after positioning.
This form prepared by the researcher in line with the literature was composed of the parameters of heart rate (min), respiratory rate (min) and oxygen saturation value (%SpO2) of the newborn.
3 secondary outcomes
Heart Rate (min): "change" will be assessed
Time frame: It will be evaluated at 30 to 120 minutes after positioning.
Oxygen Saturation (%SpO2): "change" will be assessed
Time frame: It will be evaluated at 30 to 120 minutes after positioning.
Respiration Rate (min): "change" will be assessed
Time frame: It will be evaluated at 30 to 120 minutes after positioning.
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 10 Feb 2023.
- Background: PubMed 30016174Yayan EH, Kucukoglu S, Dag YS, Karsavuran Boyraz N. Does the Post-Feeding Position Affect Gastric Residue in Preterm Infants? Breastfeed Med. 2018 Jul/Aug;13(6):438-443. doi: 10.1089/bfm.2018.0028.
- Results publication: PubMed 30621733Khatony A, Abdi A, Karimi B, Aghaei A, Brojeni HS. The effects of position on gastric residual volume of premature infants in NICU. Ital J Pediatr. 2019 Jan 8;45(1):6. doi: 10.1186/s13052-018-0591-9.
- Results publication: PubMed 31642602Ozdel D, Sari HY. Effects of the prone position and kangaroo care on gastric residual volume, vital signs and comfort in preterm infants. Jpn J Nurs Sci. 2020 Jan;17(1):e12287. doi: 10.1111/jjns.12287. Epub 2019 Oct 23.
- Results publication: PubMed 30129537Kaur V, Kaur R, Saini SS. Comparison of Three Nursing Positions for Reducing Gastric Residuals in Preterm Neonates: A Randomized Crossover Trial. Indian Pediatr. 2018 Jul 15;55(7):568-572.
- Results publication: PubMed 23537895Chen SS, Tzeng YL, Gau BS, Kuo PC, Chen JY. Effects of prone and supine positioning on gastric residuals in preterm infants: a time series with cross-over study. Int J Nurs Stud. 2013 Nov;50(11):1459-67. doi: 10.1016/j.ijnurstu.2013.02.009. Epub 2013 Mar 26.
- Individual participant dataSharing planned: No. It will be shared after the article is published.
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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.
fatma yılmaz kurt principal investigator
Çanakkale Onsekiz Mart 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 Supine position, Prone position and Lateral position in people with Comfort and Newborn, Infant, Disease, run by Çanakkale Onsekiz Mart University 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 9 inclusion and 7 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 10 Feb 2023. 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?
Neonatal Comfort Behavior Scale (COMFORTneo):"change" will be assessed (time frame: The Newborn Comfort Behavior Scale will be evaluated at the 30 to 120 minutes after the position.). 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?
On the ClinicalTrials.gov record for NCT04596202, which also lists 5 linked publications.
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 10 Feb 2023.