Evaluation of Cerebral Oxygenation Results in Premature Infant

Premature Clinical Trial

Official title:

Evaluation of Cerebral Oxygenation Results in Premature Infants: Kangaroo Care and Facilitated Tucking Example

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04725435
• Other study ID #: 2021/42
• Status: Completed
• Phase: N/A
• Start date: December 20, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2023
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The general purpose of this project is; Evaluation of cerebral oxygenation results in premature infants.

These results will be evaluated in two different applications. The first practice and the first sub-aim of the study is to determine the effect of kangaroo care on cerebral oxygenation (rSO2) in premature infants.

The second application and purpose is to determine the effect of giving the infant the facilitated tucking position by hand and the nesting bed on the cerebral oxygenation (rSO2) of the infant during the heel blood collection process.

The study will be conducted between December 2020 and December 2021 at Level III NICU at the Medical Faculty Hospital in Konya.

Description:

The general purpose of this project is; To determine the effect of kangaroo care and facilitated tucking position on cerebral oxygenation (rSO2) in premature infants.

In this context, the study has two sub-objectives. First sub purpose; to determine the effect of kangaroo care application given to premature inafants hospitalized in the NICU with the mother on cerebral oxygenation (rSO2), physiological parameters (heart rate, peripheral oxygen saturation (SpO2) and respiratory rate) and comfort / comfort levels.

This study was designed as a single blind, parallel group, pre-test and post-test randomized controlled trial.

First sub purpose; total sample size was determined as 40 preterm babies (20 in each group). Block randomization was used in this study. During the data collection phase, the purpose of the study will be explained to the parents of preterm infants by the researcher, and written consent will be obtained from the parents who agree to participate in the study through the "Informed Consent Form". Introductory Information Form, Physiological Parameter and rSO2 Follow-up Chart and Neonatal Comfort Scale created by the researcher will be used.

Second sub purpose; to determine the effect of facilitated tucking position on the infant's cerebral oxygenation (rSO2), physiological parameters (heart peak beat, SpO2 and respiratory rate), pain and comfort / comfort levels during the heel stick procedure.

This study was designed as a single blind, parallel group, two intervention groups in pre-test and post-test order, and a randomized controlled control group.

Second sub purpose; the total sample size was determined as 66 (22 in each group). Block randomization was used in this study. During the data collection phase, the purpose of the study will be explained to the parents of preterm infants by the researcher, and written consent will be obtained from the parents who agree to participate in the study through the "Informed Consent Form". The Introductory Information Form, Physiological Parameters and rSO2 Tracking Chart, PIPP-R and Neonatal Comfort Scale created by the researcher will be used.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 31, 2021
• Est. primary completion date: October 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Weeks to 37 Weeks

Eligibility

Inclusion Criteria:

• Adjusted gestational age of 28-36(+6) weeks at time of registration

Exclusion Criteria:

• Mechanical ventilation,

• Major congenital abnormalities,

• Surgical or severe medical morbidity (bronchopulmonary dysplasia, NEC, sepsis, or intraventricular bleeding)

• The mother is under 18 years of age

• The mother is not willing to do kangaroo care

Related Conditions & MeSH terms

• Cerebral Oxygenation
• Facilitated Tucking
• Kangaroo Care
• Premature
• Premature Birth

Intervention

Behavioral:
• Kangaroo care
Experimental: Kangaroo care The mother kangaroo will care for at least 60 minutes.
• Facilitated Tucking Position
Experimental 1: Manual Facilitated Tucking Position, infants will be given a manual facilitated tucking position during the heel stick procedure. Experimental 2: Facilitated Tucking Position with the Nesting Bed (Tortoise Neo Bed), the facilitated tucking position will be given by the clinic nurse with the nesting bed during the heel stick collection procedure.

Locations

Country	Name	City	State
Turkey	Selcuk University	Konya	Selcuklu

Sponsors (2)

Lead Sponsor	Collaborator
Selcuk University	The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The first sub-purpose Outcome: rSO2 level	Defines the change of rSO2 level. The NIRS monitor (COVIDEN Operations Manual INVOS® System, Model 5100C) was used to monitor rSO2 levels. The normal range of the rSO2 measured by the device was between 55% and 85%.	Change from baseline and 70 min
Primary	The first sub-purpose Outcome: physiological parameters of the premature infant- heart rate (min).	Defines the change of heart rate (min) level.Philips IntelliVue MP40 device was used to monitor respiratory rate. Philips IntelliVue MP40 device was used to monitor heart rate (min).	Change from baseline and 70 min
Primary	The first sub-purpose Outcome: physiological parameters of the premature infant- SpO2 level	Defines the change of SpO2 level.	Change from baseline and 70 min
Primary	The first sub-purpose Outcome: Neonates COMFORTneo scale	The COMFORTneo scale is a Likert-type scale consisting of seven parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tonus. The items are rated between 0 and 10, and the score that can be obtained from the scale ranges between 6 and 30. A score of 4-6 indicates moderate pain and distress and that of 7-10 indicates severe pain and distress.	Change from baseline and 70 min
Primary	The first sub-purpose Outcome: physiological parameters of the premature infant-respiratory rate (min)	Defines the change of respiratory rate (min) level.	Change from baseline and 70 min
Secondary	The second sub-purpose Outcome: Premature Infant Pain Profile Scale-Revised (PIPP-R)	The PIPP-R scale includes 3 behavioral (frowning, squeezing eyes, nasolobial-groove), 2 physiological (heart rate and oxygen saturation) and 2 contextual (behavioral state and gestational age) items used in the assessment of pain in newborns. The items of the scale are scored as 3, 2, 1, 0 ((0-6 points that the pain is mild, 7-12 points is moderate, and 13-21 points is at a severe level.)	Change from baseline and 70 min
Secondary	The second sub-purpose Outcome:Neonates The COMFORTneo Scale	The scale consists of 7 items: muscle tone, alertness, facial tension, calmness / agitation, body movements, respiratory response, and crying. The lowest possible score from Newborn Comfort Behavior Scale is 6 and the highest score is 30. High scores indicate that the baby is not comfortable.	Change from baseline and 70 min
Secondary	The second sub-purpose Outcome: physiological parameters of the premature infant- respiratory rate	Defines the change of respiratory rate (min) level.	Change from baseline and 70 min
Secondary	The second sub-purpose Outcome: physiological parameters of the premature infant- heart rate (min)	Defines the change of heart rate (min) level.Philips IntelliVue MP40 device was used to monitor respiratory rate. Philips IntelliVue MP40 device was used to monitor heart rate (min).	Change from baseline and 70 min
Secondary	The second sub-purpose Outcome: physiological parameters of the premature infant- oxygen saturation (%SpO2)	Defines the change of SpO2 level.	Change from baseline and 70 min
Secondary	The second sub-purpose Outcome: rSO2 level	Defines the change of rSO2 level. The NIRS monitor (COVIDEN Operations Manual INVOS® System, Model 5100C) was used to monitor rSO2 levels. The normal range of the rSO2 measured by the device was between 55% and 85%.	Change from baseline and 70 min