Skip to main content
OpenTrials
Completed

NCT Number: NCT06473350

Effect of Three Different Post-Feeding Positions on Vital Signs 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."

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

28 week–36 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Science University

Ankara, 06010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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

  9. 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.

  10. 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.

  11. 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

  12. 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

  13. 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.

  14. 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.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 25, 2024
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.