Effect of Three Different Post-Feeding Positions on Vital Signs and Comfort Levels in Preterm Infants

NCT06473350 | Completed

• 1 other identifier: SBU-SBE-CAU-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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."

Conditions

Premature

Keywords

preterm infants; vital signs; comfort; position

Outcome Measures

Primary Outcomes (14)

• 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

  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

  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

  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.

  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.

  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

  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

  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

  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.

  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.

  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

  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

  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.

  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.

  immediately after the post-feeding, first hour post-feeding, third hour post-feeding

Study Arms (1)

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.

Other: The application of right lateral, supine, and prone positions to preterm infants after feeding

Interventions

The application of right lateral, supine, and prone positions to preterm infants after feeding OTHER

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.

Right lateral, supine, and prone position

Eligibility Criteria

• Age: 28 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Health Science University

Ankara, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Supine Position

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• CANAN AYASLİ UNAL

  Health Science University

  PRINCIPAL INVESTIGATOR

• Dilek YILDIZ, Prof.

  Health Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: To examine the effect of the predetermined right lateral, supine, and prone positions on preterm infants, all infants comprising the sample group were sequentially subjected to all positions. Therefore, blinding was not performed. In this study, preterm infants who met the inclusion criteria for the sample group were selected. The composition of the sample group solely with infants naturally resulted in blinding, as the infants were not aware of the positions being applied.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Nurse, Principal Investigator

Model Details: Experimental study in a single group with three positions applied sequentially

Study Record Dates

• First Submitted: June 8, 2024
• First Posted: June 25, 2024
• Study Start: January 1, 2022
• Primary Completion: September 20, 2022
• Study Completion: September 30, 2022
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)