The Effect of the Side Kangaroo Position in Newborns Undergoing Noninvasive Mechanical Ventilation

February 16, 2026 updated by: Duygu Sonmez Duzkaya, Tarsus University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Elif Kahraman

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Gestational age between 32 and 36 weeks
  • No congenital anomalies
  • No issues preventing positioning
  • No infection

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Side kangaroo position group
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.
Other: Side kangaroo position group
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.
No Intervention: Control Group
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 day
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
1 day
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tarsus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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
  • 6. Hess, D. R. (2005). The evidence for noninvasive positive-pressure ventilation in the care of patients in acute respiratory failure: A systematic review. Respiratory Care, 50(7), 924-929.
  • 5. 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026/02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Newborn Care

Clinical Trials on Side kangaroo position group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings