Newborn; VitalityNCT06589349
Effects of Kangaroo Care on Circadian Rhythm, Growth and Physiological Effects
A study testing Kangaroo Care in people with Newborn; Vitality and Sleep, run by Sibel Küçükoğlu at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to investigate the effect of premature babies receiving regular kangaroo care in the NICU on circadian rhythm, growth and physiological parameters, and breast milk cortisol levels Read more about this study
- Who is it for?
- Ages 28 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Newborn; Vitality, Sleep, Preterm Labor
- What is being tested?
- Kangaroo Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2024to 15 Apr 2025
- 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 28 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being between 28+0-37 weeks of pregnancy,
- Birth weight >1000 g,
- APGAR score >7 at the 5th minute after birth,
- Ability to feed every 2-3 hours
Who cannot join
- Getting mechanical ventilation support
- Undergoing surgery
- Having diseases and disorders such as congenital brain malformations, meningitis, seizures, encephalopathy, congenital abnormalities, history of intraventricular bleeding, herpes, sepsis and heart or metabolic diseases.
- Taking medication that affects sleep patterns, such as theophylline, phenobarbital, midazolam, caffeine, fentalnil
- Having developed intraventricular hemorrhage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Kangaroo Care on Circadian Rhythm, Growth and Physiological Effects of Newborns Effect of Parameters on Breast Milk Cortisol Levels: Randomized Controlled Study
This study was planned to investigate the effect of premature babies receiving regular kangaroo care in the NICU on circadian rhythm, growth and physiological parameters, and breast milk cortisol levels
Read the detailed description
Kangaroo Care (KC) may have positive effects on biological phase markers of immature circadian rhythms in newborns. KC provides circadian rhythm development by reducing the stress of newborns. Skin-to- skin contact intervention, which is similar to kangaroo care, affects the ẞ-endorphin concentration, which reduces pain in premature babies, and is known to reduce cortisol levels. KC, which supports exclusive breastfeeding and breastfeeding, can affect the circadian rhythm in newborns by providing information about the time of day to newborns through the increase in breastfeeding rates and the hormones and immune elements contained in breast milk. Although there are a limited number of studies in the literature examining the circadian rhythm or sleep-wake cycle of babies in the neonatal intensive care unit, no study has been found examining the circadian rhythm of babies receiving regular kangaroo care using brain imaging methods. In this respect, the study has unique value. In addition, within the scope of the study, regular kangaroo care for three days had a positive effect on the growth and physiological parameters of babies any studies examining the effect of breast milk on cortisol levels No study was found.
- Conditions
- Newborn; Vitality, Sleep, Preterm Labor, Care Pattern, Maternal
- Being tested
- Kangaroo Care
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo CareBehavioural
Physiological parameters will be measured in the Day (10:00) - Night (22:00) cycle for 3 days, just before being taken into kangaroo care in the experimental group, and when the kangaroo care is terminated, the baby will be measured in the mother's arms. Then, the mother and baby will be placed in kangaroo care for a minimum of 70 minutes
| Study group | Role | What they receive |
|---|---|---|
| kangaroo care group | Experimental | Kangaroo care will be performed twice a day, in the morning and evening, for three days, between 10:00 in the morning and 22:00 in the evening, 1 hour after the treatment and care practices applied to the baby. To measure breast milk cortisol levels, breast milk samples will be collected by the researcher by expressing breast milk at 12.00 on the 1st, 2nd and 3rd days of the experimental and control groups. Receives: Behavioral: Kangaroo Care |
| Control Group | No intervention | Babies in the control group will be followed routinely in an incubator/cotton. It will be monitored for 70 minutes without any procedure or application, and as in the experimental group, stimuli that will disturb the baby during this period will be tried to be controlled. If mothers in this group want to do kangaroo care, they will be encouraged, not prevented. However, mothers in this group who start giving kangaroo care at least twice a day for three days will be excluded from the study. To measure breast milk cortisol levels, samples of mothers in the control group will be collected by expressing breast milk at 12:00 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newborn Circadian Rhythm Tracking Chart
To measure circadian rhythms, BIS spectrometry will be attached to the baby's forehead area, as specified in the user manual, after the babies in the experimental and control groups are given group care in the morning and evening
The device provides a different application to babies as it records the duration of being in "awake, REM, N-REM/ STAGE I, N-REM/ STAGE II, N-REM/ STAGE III, N-REM/ STAGE IV" measured in 5-minute periods. It will not be done. The sensor will be removed from the baby's forehead at the next care hour. At the end of 3 days, records will be taken from the BIS monitor and recorded in the "Newborn Circadian Rhythm Tracking Chart
Measured: First Day, (10:00-12:00 AM) - First Night (22:00- 24:00 PM)
Breast milk cortisol levels Tracking Chart
To measure breast milk cortisol levels, breast milk samples will be collected by the researcher by expressing breast milk at 12.00 on the 1st, 2nd and 3rd days of the experimental and control groups. This period was determined by considering the possibility of terminating kangaroo care in the experimental group as it coincided with the babies' care and feeding hours at 12:00, and the times when the mother would want to receive kangaroo care for more than 70 minutes, and the maximum kangaroo care would last 120 minutes
Measured: First Day (12:00AM) - first Night (24:00 PM)
Growth Tracking Chart
The chart was created by the researcher in such a way that body weight (g) from growth parameters would be recorded daily for 3 days.
Measured: First Day (10:00 AM)
Physiological Parameter Follow-up Form- body temperature (°C)
Body temperature (°C) found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the first day.
Measured: First Day (10:00 AM) and First Night (22:00 PM)
Physiological Parameter Follow-up Form-oxygen saturation (mmHg)
Oxygen saturation found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the first day.
Measured: First Day (10:00 AM) and First Night (22:00 PM)
Physiological Parameter Follow-up Form-heart rate (min)
Heart rate found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the first day.
Measured: First Day (10:00AM) and First Night (22:00 PM)
Physiological Parameter Follow-up Form-respiratory rate (min)
Respiratory rate found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the first day.
Measured: First Day (10:00 AM) and First Night (22:00 PM)
Secondary outcomes (14)
Newborn Circadian Rhythm Tracking Chart
To measure circadian rhythms, BIS spectrometry will be attached to the baby's forehead area, as specified in the user manual, after the babies in the experimental and control groups are given group care in the morning and evening
The device provides a different application to babies as it records the duration of being in "awake, REM, N-REM/ STAGE I, N-REM/ STAGE II, N-REM/ STAGE III, N-REM/ STAGE IV" measured in 5-minute periods. It will not be done. The sensor will be removed from the baby's forehead at the next care hour. At the end of 3 days, records will be taken from the BIS monitor and recorded in the "Newborn Circadian Rhythm Tracking Chart
Measured: Second Day (10:00-12:00 AM) - Second Night (22:00-24:00 PM)
Newborn Circadian Rhythm Tracking Chart
To measure circadian rhythms, BIS spectrometry will be attached to the baby's forehead area, as specified in the user manual, after the babies in the experimental and control groups are given group care in the morning and evening
The device provides a different application to babies as it records the duration of being in "awake, REM, N-REM/ STAGE I, N-REM/ STAGE II, N-REM/ STAGE III, N-REM/ STAGE IV" measured in 5-minute periods. It will not be done. The sensor will be removed from the baby's forehead at the next care hour. At the end of 3 days, records will be taken from the BIS monitor and recorded in the "Newborn Circadian Rhythm Tracking Chart
Measured: Third Day (10:00-12:00 AM) - Third Night (22:00-24:00 PM)
Breast milk cortisol levels Tracking Chart
To measure breast milk cortisol levels, breast milk samples will be collected by the researcher by expressing breast milk at 12.00 on the 1st, 2nd and 3rd days of the experimental and control groups. This period was determined by considering the possibility of terminating kangaroo care in the experimental group as it coincided with the babies' care and feeding hours at 12:00, and the times when the mother would want to receive kangaroo care for more than 70 minutes, and the maximum kangaroo care would last 120 minutes
Measured: Second Day (12:00 AM) - Second Night (24:00 PM)
Breast milk cortisol levels Tracking Chart
To measure breast milk cortisol levels, breast milk samples will be collected by the researcher by expressing breast milk at 12.00 on the 1st, 2nd and 3rd days of the experimental and control groups. This period was determined by considering the possibility of terminating kangaroo care in the experimental group as it coincided with the babies' care and feeding hours at 12:00, and the times when the mother would want to receive kangaroo care for more than 70 minutes, and the maximum kangaroo care would last 120 minutes
Measured: Third Day (12:00 AM) - Third Night (24:00 PM)
Growth Tracking Chart
The chart was created by the researcher in such a way that body weight (g) from growth parameters would be recorded daily for 3 days.
Measured: Second Day (10:00)
Growth Tracking Chart
The chart was created by the researcher in such a way that body weight (g) from growth parameters would be recorded daily for 3 days.
Measured: Third Day (10:00 AM)
Physiological Parameter Follow-up Form- body temperature (°C)
Body temperature (°C) found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the second day.
Measured: Second Day (10:00 AM) - Second Night (22:00 PM)
Physiological Parameter Follow-up Form-oxygen saturation (mmHg)
Oxygen saturation found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the second day.
Measured: Second Day (10:00 AM) - Second Night (22:00 PM)
Physiological Parameter Follow-up Form-heart rate (min)
Heart rate found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the second day.
Measured: Second Day (10:00 AM) - Second Night (22:00 PM)
Physiological Parameter Follow-up Form-respiratory rate (min)
Respiratory rate found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the second day.
Measured: Second Day (10:00 AM) - Second Night (22:00 PM)
Physiological Parameter Follow-up Form- body temperature (°C)
Body temperature (°C) found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the third day.
Measured: Third Day (10:00 AM) - Third Night (22:00 PM)
Physiological Parameter Follow-up Form-oxygen saturation (mmHg)
Oxygen saturation found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the third day.
Measured: Third Day (10:00 AM) - Third Night (22:00 PM)
Physiological Parameter Follow-up Form-heart rate (min)
Heart rate found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the third day.
Measured: Third Day (10:00 AM) - Third Night (22:00 PM)
Physiological Parameter Follow-up Form-respiratory rate (min)
Respiratory rate found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the third day.
Measured: Third Day (10:00 AM) - Third Night (22:00 PM)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Sep 2024 (estimated)
- Primary completion15 Apr 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Newborn; VitalityStudies of the same condition, open and under way.
- 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
- In the study, randomization will be done by stratifying according to type of nutrition (breast milk-formula milk) and week of gestation (28-31+6 32-37), as it may affect sleep. After the blocks are created, the groups included in the study will be randomly assigned to the layers with the letters A and B, using the random numbers table obtained in the computer environment (www.random.org). Which group the children included in the study will be included in will be determined by an independent statistician and will be given to the researcher in a sealed envelope
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sibel Küçükoğlu
- Sponsor type
- University, hospital or other
- Collaborators
- Health Institutes of Turkey
- Responsible party
- Sponsor-investigator, Sibel Küçükoğlu, Selcuk University
- Investigators
- Sibel Kucukoglu, Prof, Study director, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589349
- Sponsor's protocol ID
- SelcukUni2535
- Status last verified
- Sep 2024
- First submitted
- 19 Apr 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be shared after the article is published
Publications
Kucukoglu S, Yilmaz Kurt F, Aytekin Ozdemir A, Ozcan Z. The Effect of Kangaroo Care on Breastfeeding and Development in Preterm Neonates. J Pediatr Nurs. 2021 Sep-Oct;60:e31-e38. doi: 10.1016/j.pedn.2021.02.019. Epub 2021 Mar 6.
PubMed 33750645Lan HY, Yin T, Chen JL, Chang YC, Liaw JJ. Factors Associated With Preterm Infants' Circadian Sleep/Wake Patterns at the Hospital. Clin Nurs Res. 2019 May;28(4):456-472. doi: 10.1177/1054773817724960. Epub 2017 Aug 9.
PubMed 28793784Martin-Montero A, Gutierrez-Tobal GC, Gozal D, Barroso-Garcia V, Alvarez D, Del Campo F, Kheirandish-Gozal L, Hornero R. Bispectral Analysis of Heart Rate Variability to Characterize and Help Diagnose Pediatric Sleep Apnea. Entropy (Basel). 2021 Aug 6;23(8):1016. doi: 10.3390/e23081016.
PubMed 34441156Gebuza G, Kazmierczak M, Lenska K. The effects of kangaroo mother care and music listening on physiological parameters, oxygen saturation, crying, awake state and sleep in infants in NICU. J Matern Fetal Neonatal Med. 2022 Oct;35(19):3659-3669. doi: 10.1080/14767058.2020.1836619. Epub 2020 Oct 20.
PubMed 33081550Erturk F, Kucukoglu S. Impact of kangaroo care on circadian rhythm, growth, physiological stability in premature infants, and cortisol and melatonin levels in maternal breast milk: A randomized controlled trial. Midwifery. 2026 Jul 13;162:104926. doi: 10.1016/j.midw.2026.104926. Online ahead of print.
PubMed 42574938
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Kangaroo Care on Circadian Rhythm, Growth and Physiological Effects of Newborns Effect of Parameters on Breast Milk Cortisol Levels: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06589349
- Acronym / sponsor ID
- SelcukUni2535
- Conditions
- Newborn; Vitality, Sleep, Preterm Labor, Care Pattern, Maternal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Sibel KüçükoğluUniversity, hospital or other
- Collaborators
- Health Institutes of Turkey
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
This study was planned to investigate the effect of premature babies receiving regular kangaroo care in the NICU on circadian rhythm, growth and physiological parameters, and breast milk cortisol levels
Detailed description
Kangaroo Care (KC) may have positive effects on biological phase markers of immature circadian rhythms in newborns. KC provides circadian rhythm development by reducing the stress of newborns. Skin-to- skin contact intervention, which is similar to kangaroo care, affects the ẞ-endorphin concentration, which reduces pain in premature babies, and is known to reduce cortisol levels. KC, which supports exclusive breastfeeding and breastfeeding, can affect the circadian rhythm in newborns by providing information about the time of day to newborns through the increase in breastfeeding rates and the hormones and immune elements contained in breast milk. Although there are a limited number of studies in the literature examining the circadian rhythm or sleep-wake cycle of babies in the neonatal intensive care unit, no study has been found examining the circadian rhythm of babies receiving regular kangaroo care using brain imaging methods. In this respect, the study has unique value. In addition, within the scope of the study, regular kangaroo care for three days had a positive effect on the growth and physiological parameters of babies any studies examining the effect of breast milk on cortisol levels No study was found.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- In the study, randomization will be done by stratifying according to type of nutrition (breast milk-formula milk) and week of gestation (28-31+6 32-37), as it may affect sleep. After the blocks are created, the groups included in the study will be randomly assigned to the layers with the letters A and B, using the random numbers table obtained in the computer environment (www.random.org). Which group the children included in the study will be included in will be determined by an independent statistician and will be given to the researcher in a sealed envelope
| Arm | Type | Receives |
|---|---|---|
| kangaroo care group | Experimental | Behavioral: Kangaroo CareKangaroo care will be performed twice a day, in the morning and evening, for three days, between 10:00 in the morning and 22:00 in the evening, 1 hour after the treatment and care practices applied to the baby. To measure breast milk cortisol levels, breast milk samples will be collected by the researcher by expressing breast milk at 12.00 on the 1st, 2nd and 3rd days of the experimental and control groups. |
| Control Group | No intervention | –Babies in the control group will be followed routinely in an incubator/cotton. It will be monitored for 70 minutes without any procedure or application, and as in the experimental group, stimuli that will disturb the baby during this period will be tried to be controlled. If mothers in this group want to do kangaroo care, they will be encouraged, not prevented. However, mothers in this group who start giving kangaroo care at least twice a day for three days will be excluded from the study. To measure breast milk cortisol levels, samples of mothers in the control group will be collected by expressing breast milk at 12:00 |
Who may qualify
- Ages
- 28 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Being between 28+0-37 weeks of pregnancy,
- Birth weight >1000 g,
- APGAR score >7 at the 5th minute after birth,
- Ability to feed every 2-3 hours
Key exclusion criteria (5 listed)
- Getting mechanical ventilation support
- Undergoing surgery
- Having diseases and disorders such as congenital brain malformations, meningitis, seizures, encephalopathy, congenital abnormalities, history of intraventricular bleeding, herpes, sepsis and heart or metabolic diseases.
- Taking medication that affects sleep patterns, such as theophylline, phenobarbital, midazolam, caffeine, fentalnil
- Having developed 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 CarePhysiological parameters will be measured in the Day (10:00) - Night (22:00) cycle for 3 days, just before being taken into kangaroo care in the experimental group, and when the kangaroo care is terminated, the baby will be measured in the mother's arms. Then, the mother and baby will be placed in kangaroo care for a minimum of 70 minutes | Behavioural | kangaroo care group |
Primary outcome
Newborn Circadian Rhythm Tracking Chart
Time frame: First Day, (10:00-12:00 AM) - First Night (22:00- 24:00 PM)
To measure circadian rhythms, BIS spectrometry will be attached to the baby's forehead area, as specified in the user manual, after the babies in the experimental and control groups are given group care in the morning and evening The device provides a different application to babies as it records the duration of being in "awake, REM, N-REM/ STAGE I, N-REM/ STAGE II, N-REM/ STAGE III, N-REM/ STAGE IV" measured in 5-minute periods. It will not be done. The sensor will be removed from the baby's forehead at the next care hour. At the end of 3 days, records will be taken from the BIS monitor and recorded in the "Newborn Circadian Rhythm Tracking Chart
Breast milk cortisol levels Tracking Chart
Time frame: First Day (12:00AM) - first Night (24:00 PM)
To measure breast milk cortisol levels, breast milk samples will be collected by the researcher by expressing breast milk at 12.00 on the 1st, 2nd and 3rd days of the experimental and control groups. This period was determined by considering the possibility of terminating kangaroo care in the experimental group as it coincided with the babies' care and feeding hours at 12:00, and the times when the mother would want to receive kangaroo care for more than 70 minutes, and the maximum kangaroo care would last 120 minutes
Growth Tracking Chart
Time frame: First Day (10:00 AM)
The chart was created by the researcher in such a way that body weight (g) from growth parameters would be recorded daily for 3 days.
Physiological Parameter Follow-up Form- body temperature (°C)
Time frame: First Day (10:00 AM) and First Night (22:00 PM)
Body temperature (°C) found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the first day.
Physiological Parameter Follow-up Form-oxygen saturation (mmHg)
Time frame: First Day (10:00 AM) and First Night (22:00 PM)
Oxygen saturation found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the first day.
Physiological Parameter Follow-up Form-heart rate (min)
Time frame: First Day (10:00AM) and First Night (22:00 PM)
Heart rate found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the first day.
Physiological Parameter Follow-up Form-respiratory rate (min)
Time frame: First Day (10:00 AM) and First Night (22:00 PM)
Respiratory rate found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the first day.
14 secondary outcomes
Newborn Circadian Rhythm Tracking Chart
Time frame: Second Day (10:00-12:00 AM) - Second Night (22:00-24:00 PM)
Newborn Circadian Rhythm Tracking Chart
Time frame: Third Day (10:00-12:00 AM) - Third Night (22:00-24:00 PM)
Breast milk cortisol levels Tracking Chart
Time frame: Second Day (12:00 AM) - Second Night (24:00 PM)
Breast milk cortisol levels Tracking Chart
Time frame: Third Day (12:00 AM) - Third Night (24:00 PM)
Growth Tracking Chart
Time frame: Second Day (10:00)
Growth Tracking Chart
Time frame: Third Day (10:00 AM)
Physiological Parameter Follow-up Form- body temperature (°C)
Time frame: Second Day (10:00 AM) - Second Night (22:00 PM)
Physiological Parameter Follow-up Form-oxygen saturation (mmHg)
Time frame: Second Day (10:00 AM) - Second Night (22:00 PM)
Physiological Parameter Follow-up Form-heart rate (min)
Time frame: Second Day (10:00 AM) - Second Night (22:00 PM)
Physiological Parameter Follow-up Form-respiratory rate (min)
Time frame: Second Day (10:00 AM) - Second Night (22:00 PM)
Physiological Parameter Follow-up Form- body temperature (°C)
Time frame: Third Day (10:00 AM) - Third Night (22:00 PM)
Physiological Parameter Follow-up Form-oxygen saturation (mmHg)
Time frame: Third Day (10:00 AM) - Third Night (22:00 PM)
Physiological Parameter Follow-up Form-heart rate (min)
Time frame: Third Day (10:00 AM) - Third Night (22:00 PM)
Physiological Parameter Follow-up Form-respiratory rate (min)
Time frame: Third Day (10:00 AM) - Third Night (22:00 PM)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 33750645Kucukoglu S, Yilmaz Kurt F, Aytekin Ozdemir A, Ozcan Z. The Effect of Kangaroo Care on Breastfeeding and Development in Preterm Neonates. J Pediatr Nurs. 2021 Sep-Oct;60:e31-e38. doi: 10.1016/j.pedn.2021.02.019. Epub 2021 Mar 6.
- Background: PubMed 28793784Lan HY, Yin T, Chen JL, Chang YC, Liaw JJ. Factors Associated With Preterm Infants' Circadian Sleep/Wake Patterns at the Hospital. Clin Nurs Res. 2019 May;28(4):456-472. doi: 10.1177/1054773817724960. Epub 2017 Aug 9.
- Background: PubMed 34441156Martin-Montero A, Gutierrez-Tobal GC, Gozal D, Barroso-Garcia V, Alvarez D, Del Campo F, Kheirandish-Gozal L, Hornero R. Bispectral Analysis of Heart Rate Variability to Characterize and Help Diagnose Pediatric Sleep Apnea. Entropy (Basel). 2021 Aug 6;23(8):1016. doi: 10.3390/e23081016.
- Results publication: PubMed 33081550Gebuza G, Kazmierczak M, Lenska K. The effects of kangaroo mother care and music listening on physiological parameters, oxygen saturation, crying, awake state and sleep in infants in NICU. J Matern Fetal Neonatal Med. 2022 Oct;35(19):3659-3669. doi: 10.1080/14767058.2020.1836619. Epub 2020 Oct 20.
- Derived from this study: PubMed 42574938Erturk F, Kucukoglu S. Impact of kangaroo care on circadian rhythm, growth, physiological stability in premature infants, and cortisol and melatonin levels in maternal breast milk: A randomized controlled trial. Midwifery. 2026 Jul 13;162:104926. doi: 10.1016/j.midw.2026.104926. Online ahead of print.
- Individual participant dataSharing planned: No. It will be shared after the article is published
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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.
Sibel Kucukoglu, Prof study director
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 in people with Newborn; Vitality and Sleep, run by Sibel Küçükoğlu 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 4 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sibel Kucukoglu, Prof (+903322230789 ext. 31623, s_nadaroglu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Newborn Circadian Rhythm Tracking Chart (time frame: First Day, (10:00-12:00 AM) - First Night (22:00- 24:00 PM)). The study lists 7 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 NCT06589349, which also lists 5 linked publications.
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 19 Sep 2024.