The Effect of Position on Gastric Residual Volume and Comfort Level in Newborns

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Position in Post-op Newborns Hospitalized in Pediatric Cardio Vascular Surgery Intensive Care Unit on Gastric Residual Volume and Comfort Level

Conditions
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Comfort, Newborn, Infant, Disease, Position, Residual

Intervention / Treatment
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* Behavioral: Supine position
* Behavioral: Prone position
* Behavioral: Lateral position


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • 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, 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. Exclusion Criteria: • 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.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized Controlled Crossover Design Model
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supine Position<br>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. | Behavioral: Supine position<br>* 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.<br>|
| Experimental: Prone Position<br>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. | Behavioral: Prone position<br>* 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.<br>|
| Experimental: Lateral position<br>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. | Behavioral: Lateral position<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | It will be evaluated at 30 to 120 minutes after positioning. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | It will be evaluated at 30 to 120 minutes after positioning. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Newborn, Comfort Score, Residual Volume, infant positioning