NCT07428408

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

The Effect of the Side Kangaroo Position on Comfort and Physiological Parameters in Newborns Undergoing Noninvasive Mechanical Ventilation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Tarsus University · Academic / Other
• Sex: All
• Age: 1 Day – 1 Month
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-25
• Primary completion: 2026-07-01
• Completion: 2026-09-01
• First posted: 2026-02-23
• Last updated: 2026-02-23

Locations

1 site across 1 country: Turkey (Türkiye)