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

NCT07428408 | Not Yet Recruiting

• 1 other identifier: 2026/02
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Newborn Care

Keywords

nCPAP, kangaroo care, newborn, nurse

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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.

  1 day

Study Arms (2)

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.

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.

Interventions

Side kangaroo position group OTHER

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.

Side kangaroo position group

Eligibility Criteria

• Age: 1 Day - 1 Month
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tarsus University: lead

Study Sites (1)

Tarsus University

Mersin, 33400, Turkey (Türkiye)

Location

Related Publications (14)

• 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

  BACKGROUND

• 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

  RESULT

• 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

  RESULT

• 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

  RESULT

• 10. Özkan, H. (2014). Respiratuvar distres sendromu ve surfaktan tedavisi. Türkiye Klinikleri Pediatri Dergisi, 23(1), 45-54.

  RESULT

• 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

  RESULT

• 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

  RESULT

• 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

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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

  RESULT

• 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

  RESULT

• 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

  RESULT

• 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

  RESULT

Central Study Contacts

Duygu SÖNMEZ DÜZKAYA, PhD

CONTACT

++903246000033; duygusduzkaya@tarsus.edu.tr

Elif Kahraman

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 23, 2026
• Study Start: February 25, 2026
• Primary Completion: July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

TU (1)