Newborn CareNCT07428408
The Effect of the Side Kangaroo Position in Newborns Undergoing Noninvasive Mechanical Ventilation
A study testing Side kangaroo position group in people with Newborn Care, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial summary
Aim:The study was designed as a randomized controlled trial to determine the effect of the side kangaroo position on comfort and physiological parameters in newborns receiving noninvasive mechanical ventilation. Read more about this study
- Who is it for?
- Ages 1 day to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Newborn Care
- What is being tested?
- Side kangaroo position group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2026to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 day to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age between 32 and 36 weeks
- No congenital anomalies
- No issues preventing positioning
- No infection
Who cannot join
- Gestational age greater than 37 weeks
- With neurological problems
- With immune system problems
- Receiving sedative medication
- With signs of meconium aspiration syndrome
- With low Apgar scores (1-minute Apgar score: 0-3)
- Newborns requiring intubation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elif Kahraman contact
Turkey (Türkiye)1 site
Tarsus University
Mersin, 33400
Duygu SÖNMEZ DÜZKAYA, PhD, ++903246000033 ext. 2200, duygusduzkaya@tarsus.edu.tr
About this study
Official title: The Effect of the Side Kangaroo Position on Comfort and Physiological Parameters in Newborns Undergoing Noninvasive Mechanical Ventilation
Aim:The study was designed as a randomized controlled trial to determine the effect of the side kangaroo position on comfort and physiological parameters in newborns receiving noninvasive mechanical ventilation. Method: The study will be conducted between February 2026 and July 2026 at Mersin University Faculty of Medicine Hospital, Neonatal Intensive Care Unit, with infants receiving nCPAP. Newborns scheduled to receive nCPAP will be divided into two groups (Side Kangaroo Position Group: 48, Control Group: 48), comprising a total of 92 newborns. Prior to the procedure, infants will be placed in the side kangaroo position on their mothers' chests; the control group will receive routine clinical care. Infants will be assessed using an "information form" and the "Newborn Comfort Behavior Scale." Vital signs will also be recorded before and after the procedure.
Read the detailed description
The research will be conducted between July 2025 and April 2026 at the Neonatal Intensive Care Unit of Mersin University Faculty of Medicine Hospital. The Neonatal Intensive Care Unit has a capacity of 27 beds, including 15 beds in Level 4A and 12 beds in Level 3. The unit has two isolation rooms and one mother-baby bonding room. There are 25 nurses working in the unit, with 6 nurses during the day and 6 nurses at night. The unit provides care and treatment services to 22 babies. In addition, there are 3 pediatricians and 19 assistant physicians working in the unit. The unit mainly admits patients who are premature, have respiratory distress, RDS, TTN, congenital malformations, hypoxic ischemic encephalopathy, sepsis, and those undergoing phototherapy treatment. The neonatal intensive care unit provides continuous care and treatment services 24 hours a day, 7 days a week.
Research variables Dependent variables: newborn comfort level, oxygen saturation, heart rate, respiratory rate Dependent variables: side kangaroo position, nesting position Control variables: environmental factors (heat, light, sound), socio-demographic characteristics
Data Collection The study will include infants who are in the neonatal intensive care unit, are receiving nCPAP, are greater than 32 weeks gestation, and meet the sample selection criteria. Newborns who do not meet the criteria will be excluded from the study. The feeding status of newborns will be assessed before nCPAP application. Care will be taken to ensure that they have been fed at least one hour prior. Care will be taken to ensure that the newborn's diaper is clean; if necessary, the diaper will be changed. The temperature, light, and noise levels of the environment will be assessed. The ambient temperature will be maintained between 22-24°C in accordance with the World Health Organization's recommendation (WHO, 2003). The average sound level for the newborn will be kept between 45 dB(A) and 65 dB(A) for maximum instantaneous sounds. The light level in the environment will be kept below 200 lux to prevent excessive lighting. Babies will be left naked with diapers on, and a pulse oximeter probe will be attached to their hands.
nCPAP Application Materials appropriate for the weight of the newborns scheduled to receive nCPAP are prepared. Materials (nasal tube, nasal mask/binazalprog, headgear, necessary bands, skin protective cover, oxygen source, appropriate covers) are brought to the newborn. The newborn is positioned appropriately and the OGS is attached. The nCPAP cannula is prepared and checked. Before application, secretions in the newborn's mouth and nose are aspirated appropriately. Protective covers are placed on pressure points to reduce skin irritation. The recommended ventilator parameters are set. The headgear is put on, the CPAP is attached to the newborn, and the sponges that come with the product are placed on the pressure areas, and the application is started.
Sample The study, planned as a randomized controlled experimental research, will include preterm newborns admitted to the Neonatal Intensive Care Unit at Mersin University Hospital, born between 32 and 36 weeks, meeting the sample criteria, and requiring nCPAP.
When determining the sample size of the study, the scientific study titled "The Effect of Fetal Position and White Noise on Cerebral Oxygenation in Neonates on Nasal CPAP" by Kaplan Laço (2024), based on literature reviews, was used to determine the sample size for the effect size. According to the Power analysis (G*Power 3.1.9.2) performed based on the Kaplan Laço (2024) study, it was calculated that with an effect size = 0.778, a 95% confidence interval, and 95% power, a total of 88 children, at least 44 in each group, should be included. Considering the possibility of dropouts and confounding variables during the research process, the number in each group was increased by 10%. The sample size for the study was determined to be 92 newborns in total, with 48 newborns in each group.
STATISTICAL ANALYSIS The data obtained in the study were analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 25.0 program. Descriptive statistical methods (number, percentage, min-max values, mean, and standard deviation) will be used when evaluating the data. The normality of the data used will be checked using skewness and kurtosis values. For data with a normal distribution, an independent t-test will be used to compare quantitative data between two independent groups, and analysis of variance will be used for repeated measurements when comparing more than two dependent groups. If a difference is found, Bonferroni will be used to find the group causing the difference. For non-normally distributed data, the Mann Whitney U test will be applied to compare quantitative data between two independent groups, and the Friedman test will be applied when comparing more than two dependent groups. If a difference is found, the adjusted Bonferroni test will be used to identify the group causing the difference. Chi-square analysis will be applied to test the relationship between categorical variables. The findings will be evaluated at a 95% confidence interval and a 5% significance level. Cohen's Kappa test will be applied in the inter-observer agreement analysis.
- Conditions
- Newborn Care
- Being tested
- Side kangaroo position group
- Keywords
- nCPAP, kangaroo care, newborn, nurse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Side kangaroo position groupOther
An appropriate environment will be provided for the application to ensure the privacy of the mothers in this group. It will be placed diagonally on the newborn mother's bare chest. The baby's head will be positioned sideways between the mother's chest and collarbone. Before, during, and 30 minutes after the procedure, the babies' comfort level, oxygen saturation, heart rate, and respiratory rate will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Side kangaroo position group | Experimental | An appropriate environment will be provided for the application to ensure the privacy of the mothers in this group. It will be placed diagonally on the newborn mother's bare chest. The baby's head will be positioned sideways between the mother's chest and collarbone. Before, during, and 30 minutes after the procedure, the babies' comfort level, oxygen saturation, heart rate, and respiratory rate will be recorded. Receives: Other: Side kangaroo position group |
| Control Group | No intervention | The infant is placed in a supine, lateral, or prone (face-down) position. The head and extremities are held slightly flexed. The arms are placed close to the body, and the legs are positioned in a slightly flexed, frog-like position. The head is kept in the midline and symmetrical. Soft rolls, preferably covered with flannel, are placed around the head, on the sides, under the feet, and, if necessary, behind the head. The mothers of infants in this group will be present during the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Information Form
The information form was prepared by reviewing the relevant literature (Kaplan Laço, 2024; Göktürk, 2024) and consists of 11 questions regarding the newborn's gestational age, gender, diagnosis, height, weight, and mode of delivery.
Measured: 1 day
Newborn Comfort Behavior Scale
The comfort scale developed by Ambuel and colleagues in 1992 was adapted by Van Dijk and colleagues in 2009 as the COMFORTneo scale for patients receiving mechanical ventilator support in the pediatric intensive care unit, and reliability and validity studies were conducted. This scale aims to measure only behavioral parameters without considering the physiological indicators of newborns. The Turkish validity and reliability analysis of the COMFORTneo scale, designed to determine the distress levels of pediatric patients, was conducted by Kahraman and colleagues in 2014. This scale is a Likert-type scale developed to assess the comfort levels and pain and distress estimates of infants monitored in the neonatal intensive care unit. The scale includes a total of seven parameters: muscle tone, alertness, facial tension, calmness or agitation, body movements, respiratory response, and crying. The measurement results in a minimum score of 6 and a maximum sco
Measured: 1 day
Vital Signs Monitoring Form
A patient-side monitor, routinely used in neonatal intensive care settings, will be employed to measure physiological parameters such as pulse, respiration, and oxygen saturation before, during, and after the procedure for newborns participating in the study. The device consists of a monitor, power cord, skin temperature probe, ECG cable, blood pressure cuff (4 different sizes), and oxygen saturation probe. The data obtained is displayed on the device's LCD screen, and measurements can be recorded. Before application, during application, and 30 minutes after application, the babies' oxygen saturation, heart rate, and respiratory rate will be recorded.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start25 Aug 2026 (estimated)
- Primary completion10 Sep 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Newborn CareStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Sonmez Duzkaya, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428408
- Sponsor's protocol ID
- 2026/02
- Status last verified
- Aug 2026
- First submitted
- 16 Feb 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
17. Uslu, S., Tanriverdi, H. A., & Balat, A. (2015). The role of nasal CPAP in mild and moderate meconium aspiration syndrome. Journal of Clinical Neonatology, 4(2), 85-95. https://doi.org/10.4103/2249-4847.153045 18. Weet, J. (2022). Neonatal respiratory disorders
16. Sharma, D., Murki, S., & Kumar, P. (2020). Nasal mask versus nasal prong interface for CPAP in preterm neonates. Archives of Disease in Childhood - Fetal and Neonatal Edition, 105(2), F163-F167. https://doi.org/10.1136
13. Ramaswamy, V. V., Bandyopadhyay, T., & Jain, A. (2020). Non-invasive respiratory support in neonates: A review of current evidence and practices. Indian Journal of Pediatrics, 87(4), 2940-2963. https://doi.org/10.1007/s12098-019-03160-3
12. Prakash, G. K., Srivastava, S., & Shetty, S. (2022). Comparison of nasal mask versus nasal prongs in preterm infants receiving nCPAP. Journal of Neonatal-Perinatal Medicine, 15(1), 22-29. https://doi.org/10.3233
10. Özkan, H. (2014). Respiratuvar distres sendromu ve surfaktan tedavisi. Türkiye Klinikleri Pediatri Dergisi, 23(1), 45-54.
9. Meyer, M. P., Hou, D., & North, K. N. (2015). Hypothermia in neonates from inadequate humidification during respiratory support. Journal of Paediatrics and Child Health, 51(6), 621-625. https://doi.org/10.1111/jpc.12820
8. Mariam, A. (2020). Developmentally supportive care practices in neonatal intensive care units: Importance and implementation. Pediatrics & Neonatology, 61(3), 256-261. https://doi.org/10.1016/j.pedneo.2019.08.004
Ludington-Hoe, S. M., Morgan, K., & Abouelfettoh, A. (2005). A clinical guideline for implementation of kangaroo care with premature infants of 30 or more weeks' postmenstrual age. Advances in Neonatal Care, 5(5), 265-277. https://doi.org/10.1016/j.adnc.2005.06.007
Hess DR. The evidence for noninvasive positive-pressure ventilation in the care of patients in acute respiratory failure: a systematic review of the literature. Respir Care. 2004 Jul;49(7):810-29.
PubMed 152229125. Güner Başar, D., Yıldırım, G., & Kaya, M. (2024). Noninvaziv solunum desteği verilen yenidoğanlarda cihaz ve ekipman yönetimi. Yenidoğan Yoğun Bakım Hemşireliği Dergisi, 8(1), 123-133.
4. Erkal İlhan, Ş. (2023). Biyoritmik bakım: Yenidoğanlarda biyolojik ritimlerin korunması ve desteklenmesi. Sağlık Bilimleri Dergisi, 13(1), 1-9. https://doi.org/10.31086
3. Çelik, A., & Avşar, G. (2021). Kangaroo care in preterm infants receiving noninvasive ventilation: Effects on comfort and physiological parameters. Journal of Pediatric Nursing, 60, e51-e58. https://doi.org/10.1016/j.pedn.2021.04.011
2. Anne, R. S., & Murki, S. (2021). Impact of nurse training on incidence of nasal trauma in neonates on non-invasive ventilation. Indian Pediatrics, 58(7), 670-678. https://doi.org/10.1007/s13312-021
1. Abu-Eleneen, R., Metwally, F., & Abd El Hady, H. (2022). Effect of nesting position on physiological and behavioral responses among preterm infants. International Journal of Nursing Didactics, 12(02), 1-8. https://doi.org/10.6007
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Side Kangaroo Position on Comfort and Physiological Parameters in Newborns Undergoing Noninvasive Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT07428408
- Acronym / sponsor ID
- 2026/02
- Conditions
- Newborn Care
- Keywords
- nCPAP, kangaroo care, newborn, nurse
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 25 Aug 2026 (estimated)
- Primary completion
- 10 Sep 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 23 Feb 2026 (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.
Aim:The study was designed as a randomized controlled trial to determine the effect of the side kangaroo position on comfort and physiological parameters in newborns receiving noninvasive mechanical ventilation. Method: The study will be conducted between February 2026 and July 2026 at Mersin University Faculty of Medicine Hospital, Neonatal Intensive Care Unit, with infants receiving nCPAP. Newborns scheduled to receive nCPAP will be divided into two groups (Side Kangaroo Position Group: 48, Control Group: 48), comprising a total of 92 newborns. Prior to the procedure, infants will be placed in the side kangaroo position on their mothers' chests; the control group will receive routine clinical care. Infants will be assessed using an "information form" and the "Newborn Comfort Behavior Scale." Vital signs will also be recorded before and after the procedure.
Detailed description
The research will be conducted between July 2025 and April 2026 at the Neonatal Intensive Care Unit of Mersin University Faculty of Medicine Hospital. The Neonatal Intensive Care Unit has a capacity of 27 beds, including 15 beds in Level 4A and 12 beds in Level 3. The unit has two isolation rooms and one mother-baby bonding room. There are 25 nurses working in the unit, with 6 nurses during the day and 6 nurses at night. The unit provides care and treatment services to 22 babies. In addition, there are 3 pediatricians and 19 assistant physicians working in the unit. The unit mainly admits patients who are premature, have respiratory distress, RDS, TTN, congenital malformations, hypoxic ischemic encephalopathy, sepsis, and those undergoing phototherapy treatment. The neonatal intensive care unit provides continuous care and treatment services 24 hours a day, 7 days a week.
Research variables Dependent variables: newborn comfort level, oxygen saturation, heart rate, respiratory rate Dependent variables: side kangaroo position, nesting position Control variables: environmental factors (heat, light, sound), socio-demographic characteristics
Data Collection The study will include infants who are in the neonatal intensive care unit, are receiving nCPAP, are greater than 32 weeks gestation, and meet the sample selection criteria. Newborns who do not meet the criteria will be excluded from the study. The feeding status of newborns will be assessed before nCPAP application. Care will be taken to ensure that they have been fed at least one hour prior. Care will be taken to ensure that the newborn's diaper is clean; if necessary, the diaper will be changed. The temperature, light, and noise levels of the environment will be assessed. The ambient temperature will be maintained between 22-24°C in accordance with the World Health Organization's recommendation (WHO, 2003). The average sound level for the newborn will be kept between 45 dB(A) and 65 dB(A) for maximum instantaneous sounds. The light level in the environment will be kept below 200 lux to prevent excessive lighting. Babies will be left naked with diapers on, and a pulse oximeter probe will be attached to their hands.
nCPAP Application Materials appropriate for the weight of the newborns scheduled to receive nCPAP are prepared. Materials (nasal tube, nasal mask/binazalprog, headgear, necessary bands, skin protective cover, oxygen source, appropriate covers) are brought to the newborn. The newborn is positioned appropriately and the OGS is attached. The nCPAP cannula is prepared and checked. Before application, secretions in the newborn's mouth and nose are aspirated appropriately. Protective covers are placed on pressure points to reduce skin irritation. The recommended ventilator parameters are set. The headgear is put on, the CPAP is attached to the newborn, and the sponges that come with the product are placed on the pressure areas, and the application is started.
Sample The study, planned as a randomized controlled experimental research, will include preterm newborns admitted to the Neonatal Intensive Care Unit at Mersin University Hospital, born between 32 and 36 weeks, meeting the sample criteria, and requiring nCPAP.
When determining the sample size of the study, the scientific study titled "The Effect of Fetal Position and White Noise on Cerebral Oxygenation in Neonates on Nasal CPAP" by Kaplan Laço (2024), based on literature reviews, was used to determine the sample size for the effect size. According to the Power analysis (G*Power 3.1.9.2) performed based on the Kaplan Laço (2024) study, it was calculated that with an effect size = 0.778, a 95% confidence interval, and 95% power, a total of 88 children, at least 44 in each group, should be included. Considering the possibility of dropouts and confounding variables during the research process, the number in each group was increased by 10%. The sample size for the study was determined to be 92 newborns in total, with 48 newborns in each group.
STATISTICAL ANALYSIS The data obtained in the study were analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 25.0 program. Descriptive statistical methods (number, percentage, min-max values, mean, and standard deviation) will be used when evaluating the data. The normality of the data used will be checked using skewness and kurtosis values. For data with a normal distribution, an independent t-test will be used to compare quantitative data between two independent groups, and analysis of variance will be used for repeated measurements when comparing more than two dependent groups. If a difference is found, Bonferroni will be used to find the group causing the difference. For non-normally distributed data, the Mann Whitney U test will be applied to compare quantitative data between two independent groups, and the Friedman test will be applied when comparing more than two dependent groups. If a difference is found, the adjusted Bonferroni test will be used to identify the group causing the difference. Chi-square analysis will be applied to test the relationship between categorical variables. The findings will be evaluated at a 95% confidence interval and a 5% significance level. Cohen's Kappa test will be applied in the inter-observer agreement analysis.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Side kangaroo position group | Experimental | Other: Side kangaroo position groupAn appropriate environment will be provided for the application to ensure the privacy of the mothers in this group. It will be placed diagonally on the newborn mother's bare chest. The baby's head will be positioned sideways between the mother's chest and collarbone. Before, during, and 30 minutes after the procedure, the babies' comfort level, oxygen saturation, heart rate, and respiratory rate will be recorded. |
| Control Group | No intervention | –The infant is placed in a supine, lateral, or prone (face-down) position. The head and extremities are held slightly flexed. The arms are placed close to the body, and the legs are positioned in a slightly flexed, frog-like position. The head is kept in the midline and symmetrical. Soft rolls, preferably covered with flannel, are placed around the head, on the sides, under the feet, and, if necessary, behind the head. The mothers of infants in this group will be present during the procedure. |
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gestational age between 32 and 36 weeks
- No congenital anomalies
- No issues preventing positioning
- No infection
Key exclusion criteria (7 listed)
- Gestational age greater than 37 weeks
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 |
|---|---|---|
| Side kangaroo position groupAn appropriate environment will be provided for the application to ensure the privacy of the mothers in this group. It will be placed diagonally on the newborn mother's bare chest. The baby's head will be positioned sideways between the mother's chest and collarbone. Before, during, and 30 minutes after the procedure, the babies' comfort level, oxygen saturation, heart rate, and respiratory rate will be recorded. | Other | Side kangaroo position group |
Primary outcome
Information Form
Time frame: 1 day
The information form was prepared by reviewing the relevant literature (Kaplan Laço, 2024; Göktürk, 2024) and consists of 11 questions regarding the newborn's gestational age, gender, diagnosis, height, weight, and mode of delivery.
Newborn Comfort Behavior Scale
Time frame: 1 day
The comfort scale developed by Ambuel and colleagues in 1992 was adapted by Van Dijk and colleagues in 2009 as the COMFORTneo scale for patients receiving mechanical ventilator support in the pediatric intensive care unit, and reliability and validity studies were conducted. This scale aims to measure only behavioral parameters without considering the physiological indicators of newborns. The Turkish validity and reliability analysis of the COMFORTneo scale, designed to determine the distress levels of pediatric patients, was conducted by Kahraman and colleagues in 2014. This scale is a Likert-type scale developed to assess the comfort levels and pain and distress estimates of infants monitored in the neonatal intensive care unit. The scale includes a total of seven parameters: muscle tone, alertness, facial tension, calmness or agitation, body movements, respiratory response, and crying. The measurement results in a minimum score of 6 and a maximum sco
Vital Signs Monitoring Form
Time frame: 1 day
A patient-side monitor, routinely used in neonatal intensive care settings, will be employed to measure physiological parameters such as pulse, respiration, and oxygen saturation before, during, and after the procedure for newborns participating in the study. The device consists of a monitor, power cord, skin temperature probe, ECG cable, blood pressure cuff (4 different sizes), and oxygen saturation probe. The data obtained is displayed on the device's LCD screen, and measurements can be recorded. Before application, during application, and 30 minutes after application, the babies' oxygen saturation, heart rate, and respiratory rate will be recorded.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Background17. Uslu, S., Tanriverdi, H. A., & Balat, A. (2015). The role of nasal CPAP in mild and moderate meconium aspiration syndrome. Journal of Clinical Neonatology, 4(2), 85-95. https://doi.org/10.4103/2249-4847.153045 18. Weet, J. (2022). Neonatal respiratory disorders
- Results publication16. Sharma, D., Murki, S., & Kumar, P. (2020). Nasal mask versus nasal prong interface for CPAP in preterm neonates. Archives of Disease in Childhood - Fetal and Neonatal Edition, 105(2), F163-F167. https://doi.org/10.1136
- Results publication13. Ramaswamy, V. V., Bandyopadhyay, T., & Jain, A. (2020). Non-invasive respiratory support in neonates: A review of current evidence and practices. Indian Journal of Pediatrics, 87(4), 2940-2963. https://doi.org/10.1007/s12098-019-03160-3
- Results publication12. Prakash, G. K., Srivastava, S., & Shetty, S. (2022). Comparison of nasal mask versus nasal prongs in preterm infants receiving nCPAP. Journal of Neonatal-Perinatal Medicine, 15(1), 22-29. https://doi.org/10.3233
- Results publication10. Özkan, H. (2014). Respiratuvar distres sendromu ve surfaktan tedavisi. Türkiye Klinikleri Pediatri Dergisi, 23(1), 45-54.
- Results publication9. Meyer, M. P., Hou, D., & North, K. N. (2015). Hypothermia in neonates from inadequate humidification during respiratory support. Journal of Paediatrics and Child Health, 51(6), 621-625. https://doi.org/10.1111/jpc.12820
- Results publication8. Mariam, A. (2020). Developmentally supportive care practices in neonatal intensive care units: Importance and implementation. Pediatrics & Neonatology, 61(3), 256-261. https://doi.org/10.1016/j.pedneo.2019.08.004
- Results publicationLudington-Hoe, S. M., Morgan, K., & Abouelfettoh, A. (2005). A clinical guideline for implementation of kangaroo care with premature infants of 30 or more weeks' postmenstrual age. Advances in Neonatal Care, 5(5), 265-277. https://doi.org/10.1016/j.adnc.2005.06.007
- Results publication: PubMed 15222912Hess DR. The evidence for noninvasive positive-pressure ventilation in the care of patients in acute respiratory failure: a systematic review of the literature. Respir Care. 2004 Jul;49(7):810-29.
- Results publication5. Güner Başar, D., Yıldırım, G., & Kaya, M. (2024). Noninvaziv solunum desteği verilen yenidoğanlarda cihaz ve ekipman yönetimi. Yenidoğan Yoğun Bakım Hemşireliği Dergisi, 8(1), 123-133.
- Results publication4. Erkal İlhan, Ş. (2023). Biyoritmik bakım: Yenidoğanlarda biyolojik ritimlerin korunması ve desteklenmesi. Sağlık Bilimleri Dergisi, 13(1), 1-9. https://doi.org/10.31086
- Results publication3. Çelik, A., & Avşar, G. (2021). Kangaroo care in preterm infants receiving noninvasive ventilation: Effects on comfort and physiological parameters. Journal of Pediatric Nursing, 60, e51-e58. https://doi.org/10.1016/j.pedn.2021.04.011
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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.
Elif Kahraman contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Side kangaroo position group in people with Newborn Care, run by Tarsus 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 4 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: opening soon, as of the sponsor's last update on 11 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Duygu SÖNMEZ DÜZKAYA, PhD (++903246000033 ext. 2200, duygusduzkaya@tarsus.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Information Form (time frame: 1 day). The study lists 3 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 NCT07428408, which also lists 14 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 11 Aug 2026.