Clinical trial NCT06473350: Effect of Three Different Post-Feeding Positions on Vital Signs and Comfort Levels in Preterm Infants
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature
Keywords: preterm infants
vital signs
comfort
position
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 48
Sex: ALL
Minimum age (years): 28
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Experimental study in a single group with three positions applied sequentially
Primary purpose: SUPPORTIVE_CARE

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."

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The effect of the right lateral position on heart rate
timeFrame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
measure: The effect of the right lateral position on oxygen saturation
timeFrame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
measure: The effect of the right lateral position on respiratory rate
timeFrame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
measure: The effect of the right lateral position on pain level
timeFrame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
measure: The effect of the right lateral position on comfort level
timeFrame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
measure: The effect of the supine position on heart rate
timeFrame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
measure: The effect of the supine position on oxygen saturation
timeFrame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
measure: The effect of the supine position on respiratory rate
timeFrame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
measure: The effect of the supine position on pain level
timeFrame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
measure: The effect of the supine position on comfort level
timeFrame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
measure: The effect of the prone position on heart rate
timeFrame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
measure: The effect of the prone position on respiratory rate
timeFrame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
measure: The effect of the prone position on pain level
timeFrame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
measure: The effect of the prone position on comfort level
timeFrame: immediately after the post-feeding, first hour post-feeding, third hour post-feeding
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Health Science University
Study officials:
affiliation: Health Science University
name: CANAN AYASLİ UNAL
role: PRINCIPAL_INVESTIGATOR
affiliation: Health Science University
name: Dilek YILDIZ, Prof.
role: PRINCIPAL_INVESTIGATOR
References: