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

NCT04596202 | Completed

• 1 other identifier: CanakkaleOMU
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Comfort; Newborn, Infant, Disease; Position; Residual

Keywords

Newborn; Comfort Score; Residual Volume; infant positioning

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Heart Rate (min): "change" will be assessed

  It will be evaluated at 30 to 120 minutes after positioning.

• Oxygen Saturation (%SpO2): "change" will be assessed

  It will be evaluated at 30 to 120 minutes after positioning.

• Respiration Rate (min): "change" will be assessed

  It will be evaluated at 30 to 120 minutes after positioning.

Study Arms (3)

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.

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.

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.

Behavioral: Lateral position

Interventions

Supine position BEHAVIORAL

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.

Supine Position

Prone position BEHAVIORAL

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.

Prone Position

Lateral position BEHAVIORAL

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.

Lateral position

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Çanakkale Onsekiz Mart University: lead

Study Sites (1)

Fatma Yılmaz Kurt

Çanakkale, Çanakkale, 17100, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 30016174 BACKGROUND

• Khatony 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.

  PMID: 30621733 RESULT

• Ozdel 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.

  PMID: 31642602 RESULT

• Kaur 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.

  PMID: 30129537 RESULT

• Chen 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.

  PMID: 23537895 RESULT

MeSH Terms

Conditions

Disease

Interventions

Supine Position; Prone Position

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• fatma yılmaz kurt

  Çanakkale Onsekiz Mart University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asist Prof Dr

Model Details: Randomized Controlled Crossover Design Model

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 22, 2020
• Study Start: December 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: February 7, 2023
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)