Premature InfantsNCT05807191
The Effect of Using Clinical Guidelines on Kangaroo Care on Newborn and Maternal Outcomes
A study testing Kangaroo care based on kangaroo care guide in people with Premature Infants, run by Selcuk University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the effect of the use of clinical guidelines in kangaroo care (KB) practice on neonatal and maternal outcomes in premature infants. The study was a single-blind, parallel group (experimental-control), randomized controlled experimental design with pretest-posttest design. Read more about this study
- Who is it for?
- Ages 26 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Premature Infants
- What is being tested?
- Kangaroo care based on kangaroo care guide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 4 Jul 2022to 13 Dec 2022
- 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 26 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- For premature infants;
- The baby is born before 36+6 weeks of gestation
- Stability of vital parameters at the time of application,
- Stable health status (cardiorespiratory stability, no congenital or chromosomal abnormalities, no history of intraventricular hemorrhage, no history of periventricular leukomalacia and NEC, no systemic and metabolic disorders),
- For mothers;
- Willingness to participate in the research
- Being able to read and write Turkish
Who cannot join
- For premature infants;
- Being connected to a mechanical ventilator
- Congenital or chromosomal abnormality
- Being with deprivation syndrome
- Having a history of intraventricular hemorrhage
- For mothers; Not being willing to care for kangaroos
- Having a physical disability to care for kangaroos
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Selcuk University
Konya, Selcuklu, 42060
Selcuk University
Konya
About this study
Official title: The Effect of Using Clinical Guidelines on Kangaroo Care in Premature Infants on Newborn and Maternal Outcomes: A Randomized Controlled Trial
The aim of this study was to determine the effect of the use of clinical guidelines in kangaroo care (KB) practice on neonatal and maternal outcomes in premature infants.
The study was a single-blind, parallel group (experimental-control), randomized controlled experimental design with pretest-posttest design.
It was carried out in the neonatal intensive care unit of Selçuk University Faculty of Medicine Hospital in Konya province. Study data were collected from 40 premature newborns between September 2022 and November 2022. Premature infants in the intervention (n = 20) and control groups (n = 20) were determined by randomization method.
Read the detailed description
Kangaroo care was applied to the intervention group with the Kangaroo Care Guide created by reviewing the current literature, and kangaroo care was applied to the control group with the standard kangaroo care method of the clinic. Data were collected using the Descriptive Information Form, Physiological Parameters Form, Neonatal Comfort Behavior Scale, Nurse-Parent Support Scale, Parental Satisfaction Scale and Kangaroo Care Guide/Checklist for Infants Without Respiratory Support.
Premature infants were followed up with skin-to-skin contact with their mothers in kangaroo care for 65 minutes. In the study, physiological parameters and Neonatal Comfort Behavior Scale scores of premature infants and Nurse-Parent Support Scale and Parental Satisfaction Scale scores of mothers were evaluated. Pearson Chi-Square Test, Yates Correction and Fisher's Exact Test were used to compare categorical data according to groups. Two Independent Sample t Test was used to compare normally distributed variables and Mann Whitney U Test was used to compare non-normally distributed variables. Statistical significance level was accepted as p˂0.05.
- Conditions
- Premature Infants
- Being tested
- Kangaroo care based on kangaroo care guide
- Keywords
- Kangaroo care, Evidence-based guideline, Prematurity, NICU
- 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 care based on kangaroo care guideOther
Under the supervision of the researcher, a kangaroo care practice was applied to premature babies by their mothers based on the kangaroo care guide. This practice took 65 minutes. In addition, before the application, the kangaroo application information was explained to the mothers through a brochure.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Kangaroo care was applied for 65 minutes to premature infants by their mothers based on the kangaroo care guide. Receives: Other: Kangaroo care based on kangaroo care guide |
| Control Group | No intervention | Kangaroo care was routinely administered by the nurse for 65 minutes without using a kangaroo care guide. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological parameters of the premature infant:respiration rate
The infant's is respiratory rate per minute.
Measured: Change from baseline and 70 min
Physiological parameters of the premature infant:peak heart rate
The infant's is heart rate per minute. Philips IntelliVue MP40 device was used to monitor heart rete.
Measured: Change from baseline and 70 min
Physiological parameters of the premature infant: oxygen saturation
Oxygen saturation measures the percentage of oxyhemoglobin (oxygen-bound hemoglobin) in the blood, and it is represented as arterial oxygen saturation (SaO2) and venous oxygen saturation (SvO2). Philips IntelliVue MP40 device was used to monitor %SpO2.
Measured: Change from baseline and 70 min
Physiological parameters of the premature infant: body temperature
Shows body temperature.
Measured: Change from baseline and 70 min
Comfort Behavior scale scores of the premature infant
Comfort Behavior scale was used. The Neonatal Comfort Behavior Scale (NEAS) is a Likert-type scale consisting of six parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tone. Each item in the scale is scored from 1 to 5. It is evaluated over the total score. The lowest score that can be obtained from the Newborn Comfort Behavior Scale (NEAS) is 6, and the highest score is 30.
Measured: Change from baseline and 70 min
Secondary outcomes (2)
Parent Satisfaction points
Parental Satisfaction scale was used. This scale was developed to assess parents' satisfaction in NICU. EMPATHIC-30 scale, 1= definitely not; 6 = absolutely yes and consists of five sub-dimensions; information (5 items), care and treatment (8 items), organization (5 items), parent involvement (6 items) and the professional attitude of the staff (6 items). One point represents the lowest satisfaction, while 6 points represents the highest satisfaction.
Measured: baseline and 70 min
Nurse Parent Support score
Nurse Parent Support scale was used. The scale consists of 21 items and four scales in five-point Likert type (1) "almost never", (2) "sometimes", (3) "sometimes", (4) "often" and (5) "always". consists of sub-scales; "Information and Communication Support" (9 items), "Emotional Support" (3 items), "Respect Support" (4 items), "Quality Care Giving" (5 items) (See Appendix E). The lowest score that can be obtained from the scale is 21, while the highest score is 105. A high score indicates that the support given by the nurse to the parent is high.
Measured: 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 posted11 Apr 2023
- Study start4 Jul 2022
- Primary completion24 Oct 2022
- Study completion13 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantsStudies 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
- parallel group (experimental-control)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Taş Arslan, Selcuk University
- Investigators
- Rabia Ayça Özkan, Principal investigator, Konya Beyhekim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807191
- Sponsor's protocol ID
- SelcukU-12-2022
- Status last verified
- Apr 2023
- First submitted
- 20 Dec 2022
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Clinical Guidelines on Kangaroo Care in Premature Infants on Newborn and Maternal Outcomes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05807191
- Acronym / sponsor ID
- SelcukU-12-2022
- Conditions
- Premature Infants
- Keywords
- Kangaroo care, Evidence-based guideline, Prematurity, NICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 13 Dec 2022 (actual)
- First posted
- 11 Apr 2023 (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 aim of this study was to determine the effect of the use of clinical guidelines in kangaroo care (KB) practice on neonatal and maternal outcomes in premature infants.
The study was a single-blind, parallel group (experimental-control), randomized controlled experimental design with pretest-posttest design.
It was carried out in the neonatal intensive care unit of Selçuk University Faculty of Medicine Hospital in Konya province. Study data were collected from 40 premature newborns between September 2022 and November 2022. Premature infants in the intervention (n = 20) and control groups (n = 20) were determined by randomization method.
Detailed description
Kangaroo care was applied to the intervention group with the Kangaroo Care Guide created by reviewing the current literature, and kangaroo care was applied to the control group with the standard kangaroo care method of the clinic. Data were collected using the Descriptive Information Form, Physiological Parameters Form, Neonatal Comfort Behavior Scale, Nurse-Parent Support Scale, Parental Satisfaction Scale and Kangaroo Care Guide/Checklist for Infants Without Respiratory Support.
Premature infants were followed up with skin-to-skin contact with their mothers in kangaroo care for 65 minutes. In the study, physiological parameters and Neonatal Comfort Behavior Scale scores of premature infants and Nurse-Parent Support Scale and Parental Satisfaction Scale scores of mothers were evaluated. Pearson Chi-Square Test, Yates Correction and Fisher's Exact Test were used to compare categorical data according to groups. Two Independent Sample t Test was used to compare normally distributed variables and Mann Whitney U Test was used to compare non-normally distributed variables. Statistical significance level was accepted as p˂0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- parallel group (experimental-control)
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Kangaroo care based on kangaroo care guideKangaroo care was applied for 65 minutes to premature infants by their mothers based on the kangaroo care guide. |
| Control Group | No intervention | –Kangaroo care was routinely administered by the nurse for 65 minutes without using a kangaroo care guide. |
Who may qualify
- Ages
- 26 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- For premature infants;
- The baby is born before 36+6 weeks of gestation
- Stability of vital parameters at the time of application,
- Stable health status (cardiorespiratory stability, no congenital or chromosomal abnormalities, no history of intraventricular hemorrhage, no history of periventricular leukomalacia and NEC, no systemic and metabolic disorders),
- For mothers;
Key exclusion criteria (7 listed)
- For premature infants;
- Being connected to a mechanical ventilator
- Congenital or chromosomal abnormality
- Being with deprivation syndrome
- Having a history of intraventricular hemorrhage
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 care based on kangaroo care guideUnder the supervision of the researcher, a kangaroo care practice was applied to premature babies by their mothers based on the kangaroo care guide. This practice took 65 minutes. In addition, before the application, the kangaroo application information was explained to the mothers through a brochure. | Other | Intervention Group |
Primary outcome
Physiological parameters of the premature infant:respiration rate
Time frame: Change from baseline and 70 min
The infant's is respiratory rate per minute.
Physiological parameters of the premature infant:peak heart rate
Time frame: Change from baseline and 70 min
The infant's is heart rate per minute. Philips IntelliVue MP40 device was used to monitor heart rete.
Physiological parameters of the premature infant: oxygen saturation
Time frame: Change from baseline and 70 min
Oxygen saturation measures the percentage of oxyhemoglobin (oxygen-bound hemoglobin) in the blood, and it is represented as arterial oxygen saturation (SaO2) and venous oxygen saturation (SvO2). Philips IntelliVue MP40 device was used to monitor %SpO2.
Physiological parameters of the premature infant: body temperature
Time frame: Change from baseline and 70 min
Shows body temperature.
Comfort Behavior scale scores of the premature infant
Time frame: Change from baseline and 70 min
Comfort Behavior scale was used. The Neonatal Comfort Behavior Scale (NEAS) is a Likert-type scale consisting of six parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tone. Each item in the scale is scored from 1 to 5. It is evaluated over the total score. The lowest score that can be obtained from the Newborn Comfort Behavior Scale (NEAS) is 6, and the highest score is 30.
2 secondary outcomes
Parent Satisfaction points
Time frame: baseline and 70 min
Nurse Parent Support score
Time frame: 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 11 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Rabia Ayça Özkan principal investigator
Konya Beyhekim Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kangaroo care based on kangaroo care guide in people with Premature Infants, run by Selcuk University at 2 sites 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 7 inclusion and 7 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 11 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 2 sites 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?
Physiological parameters of the premature infant:respiration rate (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?
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 11 Apr 2023.