Preterm Infants Physiological Parameters and Sleep-Wakefulness Status

NCT05673213 | Completed DMC

• 1 other identifier: HRU-BOZDAG-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This research was carried out between December 2021 and May 2022 as a randomized controlled experimental design. In the study, between 28-35 weeks of gestation preterm infants were divided into two groups as the experimental group (n=30) and the control group (n=30). The block randomization method was used to ensure that the infants were similar in terms of both weeks and weight due to the large interval between the weeks and to ensure the balance between the groups. Infants in the control group were followed in the routine prone position of the neonatal intensive care unit, while infants in the experimental group were followed in the prone position with three-stair positioning pillows.

Conditions

Sleep

Outcome Measures

Primary Outcomes (5)

• Sleep Status/minute

  Between 09:00-12:00

  3 hours

• Wakefulness Status/minute

  Measurements were made with an actigraphy device between 09:00 and 12:00.

  3 hours

• Physiological Parameters (oxygen saturation /%)

  Measurements were made with an actigraphy device between 09:00 and 12:00.

  3 hours

• Physiological Parameters (heart rate/minute )

  Between 09:00-12:00

  3 hours

• Physiological Parameters (respiratory rate/minute )

  Between 09:00-12:00

  3 hours

Study Arms (2)

Routine 15º head raised prone position (control group)

NO INTERVENTION

The infant was cared for, fed and treated by the primary nurse responsible for the infant between 08:30 and 08:55. No intervention was made to the preterm infant between 09:00-12:00 and the infant was allowed to rest. Preterm infants were followed for 3 hours (09:00-12:00) with routine 15º head raised prone position. Between these hours, the oxygen saturation and heart rate of the preterm infants in were counted by the researcher with a pulse oximeter device and recorded 18 times in 10 minutes. Sleep-wakefulness status was recorded by taking 15-second recordings with the Actigraphy measuring device.

Three-stair positioning pillows group

EXPERIMENTAL

The infant was cared for, fed and treated by the primary nurse responsible for the infant between 08:30 and 08:55. No intervention was made to the preterm infant between 09:00-12:00 and the infant was allowed to rest. Preterm infants were followed for 3 hours (09:00-12:00) with three-stair positioning pillows. Between these hours, the oxygen saturation and heart rate of the preterm infants in were counted by the researcher with a pulse oximeter device and recorded 18 times in 10 minutes. Sleep-wakefulness status was recorded by taking 15-second recordings with the Actigraphy measuring device.

Other: Three-stair positioning pillows group

Interventions

Three-stair positioning pillows group OTHER

The infant was cared for, fed and treated by the primary nurse responsible for the infant between 08:30 and 08:55. No intervention was made to the preterm infant between 09:00-12:00 and the infant was allowed to rest. Preterm infants were followed for 3 hours (09:00-12:00) with three-stair positioning pillows. Between these hours, the oxygen saturation and heart rate of the preterm infants in were counted by the researcher with a pulse oximeter device and recorded 18 times in 10 minutes. Sleep-wakefulness status was recorded by taking 15-second recordings with the Actigraphy measuring device.

Three-stair positioning pillows group

Eligibility Criteria

• Age: 28 Weeks - 35 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Only being diagnosed as preterm as a result of the examination performed by the physician,
• Parent's willingness to participate in the research,
• The infant is between 28-35 weeks of gestation,
• Being in appropriate weight according to the week of gestation,
• Having a history of intubation and being extubated.

You may not qualify if:

• Surgical procedure has been applied,
• Diagnosed with sepsis,
• Congenital anomaly,
• Taking analgesics 4 hours before, which may affect sleep,
• Having hyperbilirubinemia,
• Having hypoglycemia,
• Presence of intracranial bleeding,
• Receiving any oxygen support (nasal O2, incubator O2, etc.),
• Intubated infants were not included in the study.

Sponsors & Collaborators

• Harran University: lead

Study Sites (1)

Harran University

Şanliurfa, Turkey (Türkiye)

Location

Study Officials

• Fatma BOZDAĞ, Lecturer

  Harran University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer Doctor

Study Record Dates

• First Submitted: January 1, 2023
• First Posted: January 6, 2023
• Study Start: December 1, 2021
• Primary Completion: March 15, 2022
• Study Completion: May 28, 2022
• Last Updated: January 9, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)