Cerebral OxygenationNCT04725435
Evaluation of Cerebral Oxygenation Results in Premature Infant
A study testing Kangaroo care and Facilitated Tucking Position in people with Cerebral Oxygenation and Premature, run by Selcuk University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 24 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Cerebral Oxygenation, Premature, Kangaroo Care
- What is being tested?
- Kangaroo care and Facilitated Tucking Position
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adjusted gestational age of 28-36(+6) weeks at time of registration
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Cerebral Oxygenation Results in Premature Infants: Kangaroo Care and Facilitated Tucking Example
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.
Read the 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.
- Conditions
- Cerebral Oxygenation, Premature, Kangaroo Care, Facilitated Tucking
- Being tested
- Kangaroo care, Facilitated Tucking Position
- Keywords
- cerebral oxygenation, premature, kangaroo care, facilitated tucking
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo careBehavioural
Experimental: Kangaroo care The mother kangaroo will care for at least 60 minutes.
Facilitated Tucking PositionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Kangaroo care | Experimental | 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. Receives: Behavioral: Kangaroo care |
| Facilitated tucking position | Experimental | 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. Receives: Behavioral: Facilitated Tucking Position |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Change from baseline and 70 min
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).
Measured: Change from baseline and 70 min
The first sub-purpose Outcome: physiological parameters of the premature infant- SpO2 level
Defines the change of SpO2 level.
Measured: Change from baseline and 70 min
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.
Measured: Change from baseline and 70 min
The first sub-purpose Outcome: physiological parameters of the premature infant-respiratory rate (min)
Defines the change of respiratory rate (min) level.
Measured: Change from baseline and 70 min
Secondary outcomes (6)
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.)
Measured: Change from baseline and 70 min
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.
Measured: Change from baseline and 70 min
The second sub-purpose Outcome: physiological parameters of the premature infant- respiratory rate
Defines the change of respiratory rate (min) level.
Measured: Change from baseline and 70 min
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).
Measured: Change from baseline and 70 min
The second sub-purpose Outcome: physiological parameters of the premature infant- oxygen saturation (%SpO2)
Defines the change of SpO2 level.
Measured: Change from baseline and 70 min
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%.
Measured: Change from baseline and 70 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start20 Dec 2020
- Primary completion20 Oct 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral OxygenationStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Fatma Taş Arslan, Selcuk University
- Investigators
- Fatma Tas Arslan, Prof, Study director, Selcuk UniversitySibel Kucukoglu, assoc. prof., Study director, Selcuk UniversityDeniz Kocoglu-Tanyer, assoc. prof., Study chair, Selcuk UniversityHanifi Soylu, Prof, Study chair, Selcuk UniversityMurat Konak, assoc. prof., Study director, Selcuk UniversitySevinc Akkoyun, Msc, Study director, Konya Ereğli State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725435
- Sponsor's protocol ID
- 2021/42
- Status last verified
- Apr 2023
- First submitted
- 15 Jan 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tas Arslan F, Akkoyun S, Kucukoglu S, Kocoglu-Tanyer D, Konak M, Soylu H. Effect of kangaroo mother care on cerebral oxygenation, physiological parameters, and comfort levels in late-premature infants: A randomized controlled trial. Midwifery. 2024 Oct;137:104096. doi: 10.1016/j.midw.2024.104096. Epub 2024 Jul 7.
PubMed 39024964
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cerebral Oxygenation Results in Premature Infants: Kangaroo Care and Facilitated Tucking Example
- ClinicalTrials.gov ID
- NCT04725435
- Acronym / sponsor ID
- 2021/42
- Conditions
- Cerebral Oxygenation, Premature, Kangaroo Care, Facilitated Tucking
- Keywords
- cerebral oxygenation, premature, kangaroo care, facilitated tucking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 20 Dec 2020 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Kangaroo care | Experimental | Behavioral: Kangaroo careNo 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. |
| Facilitated tucking position | Experimental | Behavioral: Facilitated Tucking PositionNo 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. |
Who may qualify
- Ages
- 24 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Adjusted gestational age of 28-36(+6) weeks at time of registration
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kangaroo careExperimental: Kangaroo care The mother kangaroo will care for at least 60 minutes. | Behavioural | Kangaroo care |
| Facilitated Tucking PositionExperimental 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. | Behavioural | Facilitated tucking position |
Primary outcome
The first sub-purpose Outcome: rSO2 level
Time frame: Change from baseline and 70 min
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).
Time frame: Change from baseline and 70 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
Time frame: Change from baseline and 70 min
Defines the change of SpO2 level.
The first sub-purpose Outcome: Neonates COMFORTneo scale
Time frame: Change from baseline and 70 min
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)
Time frame: Change from baseline and 70 min
Defines the change of respiratory rate (min) level.
6 secondary outcomes
The second sub-purpose Outcome: Premature Infant Pain Profile Scale-Revised (PIPP-R)
Time frame: Change from baseline and 70 min
The second sub-purpose Outcome:Neonates The COMFORTneo Scale
Time frame: Change from baseline and 70 min
The second sub-purpose Outcome: physiological parameters of the premature infant- respiratory rate
Time frame: Change from baseline and 70 min
The second sub-purpose Outcome: physiological parameters of the premature infant- heart rate (min)
Time frame: Change from baseline and 70 min
The second sub-purpose Outcome: physiological parameters of the premature infant- oxygen saturation (%SpO2)
Time frame: Change from baseline and 70 min
The second sub-purpose Outcome: rSO2 level
Time frame: Change from baseline and 70 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 39024964Tas Arslan F, Akkoyun S, Kucukoglu S, Kocoglu-Tanyer D, Konak M, Soylu H. Effect of kangaroo mother care on cerebral oxygenation, physiological parameters, and comfort levels in late-premature infants: A randomized controlled trial. Midwifery. 2024 Oct;137:104096. doi: 10.1016/j.midw.2024.104096. Epub 2024 Jul 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma Tas Arslan, Prof study director
Selcuk University
Sibel Kucukoglu, assoc. prof. study director
Selcuk University
Deniz Kocoglu-Tanyer, assoc. prof. study chair
Selcuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kangaroo care and Facilitated Tucking Position in people with Cerebral Oxygenation and Premature, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The first sub-purpose Outcome: rSO2 level (time frame: Change from baseline and 70 min). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04725435, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.