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Evaluation of Cerebral Oxygenation Results in Premature Infant

Primary Purpose

Cerebral Oxygenation, Premature, Kangaroo Care

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kangaroo care
Facilitated Tucking Position
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cerebral Oxygenation focused on measuring cerebral oxygenation, premature, kangaroo care, facilitated tucking

Eligibility Criteria

24 Weeks - 37 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Selcuk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Kangaroo care

Facilitated tucking position

Arm Description

No Intervention: Standard care The control group will be followed by infants using nesting in the incubator. It will be followed for 60 minutes without any action or application. Experimental: Kangaroo care The mother kangaroo will care for at least 60 minutes.

No Intervention: Standard care In the Control Group, the heel stick procedure will be performed in the infants own bed as in the clinical routine. 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.

Outcomes

Primary Outcome Measures

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%.
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).
The first sub-purpose Outcome: physiological parameters of the premature infant- SpO2 level
Defines the change of SpO2 level.
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.
The first sub-purpose Outcome: physiological parameters of the premature infant-respiratory rate (min)
Defines the change of respiratory rate (min) level.

Secondary Outcome Measures

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.)
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.
The second sub-purpose Outcome: physiological parameters of the premature infant- respiratory rate
Defines the change of respiratory rate (min) level.
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).
The second sub-purpose Outcome: physiological parameters of the premature infant- oxygen saturation (%SpO2)
Defines the change of SpO2 level.
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%.

Full Information

First Posted
January 15, 2021
Last Updated
April 11, 2023
Sponsor
Selcuk University
Collaborators
The Scientific and Technological Research Council of Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT04725435
Brief Title
Evaluation of Cerebral Oxygenation Results in Premature Infant
Official Title
Evaluation of Cerebral Oxygenation Results in Premature Infants: Kangaroo Care and Facilitated Tucking Example
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 20, 2020 (Actual)
Primary Completion Date
October 20, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University
Collaborators
The Scientific and Technological Research Council of Turkey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Oxygenation, Premature, Kangaroo Care, Facilitated Tucking
Keywords
cerebral oxygenation, premature, kangaroo care, facilitated tucking

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
First sub purpose was designed as a single blind, parallel group, randomized controlled pre-test post-test order. Second sub purpose was designed as a single blind, parallel group, two intervention groups in pre-test and post-test order, and a randomized controlled control group.
Masking
Participant
Masking Description
Single (Participant, Outcomes Assessor)
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kangaroo care
Arm Type
Experimental
Arm Description
No Intervention: Standard care The control group will be followed by infants using nesting in the incubator. It will be followed for 60 minutes without any action or application. Experimental: Kangaroo care The mother kangaroo will care for at least 60 minutes.
Arm Title
Facilitated tucking position
Arm Type
Experimental
Arm Description
No Intervention: Standard care In the Control Group, the heel stick procedure will be performed in the infants own bed as in the clinical routine. 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.
Intervention Type
Behavioral
Intervention Name(s)
Kangaroo care
Intervention Description
Experimental: Kangaroo care The mother kangaroo will care for at least 60 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Facilitated Tucking Position
Intervention Description
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.
Primary Outcome Measure Information:
Title
The first sub-purpose Outcome: rSO2 level
Description
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%.
Time Frame
Change from baseline and 70 min
Title
The first sub-purpose Outcome: physiological parameters of the premature infant- heart rate (min).
Description
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).
Time Frame
Change from baseline and 70 min
Title
The first sub-purpose Outcome: physiological parameters of the premature infant- SpO2 level
Description
Defines the change of SpO2 level.
Time Frame
Change from baseline and 70 min
Title
The first sub-purpose Outcome: Neonates COMFORTneo scale
Description
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.
Time Frame
Change from baseline and 70 min
Title
The first sub-purpose Outcome: physiological parameters of the premature infant-respiratory rate (min)
Description
Defines the change of respiratory rate (min) level.
Time Frame
Change from baseline and 70 min
Secondary Outcome Measure Information:
Title
The second sub-purpose Outcome: Premature Infant Pain Profile Scale-Revised (PIPP-R)
Description
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.)
Time Frame
Change from baseline and 70 min
Title
The second sub-purpose Outcome:Neonates The COMFORTneo Scale
Description
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.
Time Frame
Change from baseline and 70 min
Title
The second sub-purpose Outcome: physiological parameters of the premature infant- respiratory rate
Description
Defines the change of respiratory rate (min) level.
Time Frame
Change from baseline and 70 min
Title
The second sub-purpose Outcome: physiological parameters of the premature infant- heart rate (min)
Description
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).
Time Frame
Change from baseline and 70 min
Title
The second sub-purpose Outcome: physiological parameters of the premature infant- oxygen saturation (%SpO2)
Description
Defines the change of SpO2 level.
Time Frame
Change from baseline and 70 min
Title
The second sub-purpose Outcome: rSO2 level
Description
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%.
Time Frame
Change from baseline and 70 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma Tas Arslan, Prof
Organizational Affiliation
Selcuk University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sibel Kucukoglu, assoc. prof.
Organizational Affiliation
Selcuk University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Deniz Kocoglu-Tanyer, assoc. prof.
Organizational Affiliation
Selcuk University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hanifi Soylu, Prof
Organizational Affiliation
Selcuk University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Murat Konak, assoc. prof.
Organizational Affiliation
Selcuk University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sevinc Akkoyun, Msc
Organizational Affiliation
Konya Ereğli State Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Selcuk University
City
Konya
State/Province
Selcuklu
ZIP/Postal Code
42060
Country
Turkey

12. IPD Sharing Statement

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Evaluation of Cerebral Oxygenation Results in Premature Infant

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