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Clinical Trial Summary

The aim of this study is to examine the effect of the first bath timing after birth on the physiological variables of the newborn and to determine the correct bath time. 1. H₁: There is a difference in the effect of bathing preterm newborns after 24 hours or 48 hours on the peak heart rate. 2. H2: There is a difference in the effect of bathing early term newborns after 24 hours or 48 hours on the peak heart rate. 3. H3: There is a difference in the effect of bathing preterm newborns after 24 hours or 48 hours on their respiratory rate. 4. H4: There is a difference in the effect of bathing early term newborns after 24 hours or 48 hours on their respiratory rate. 5. H5: There is a difference in the effect of baths given to preterm newborns after 24 hours or 48 hours on body temperature. 6. H6: There is a difference in the effect of baths given to early term newborns after 24 hours or after 48 hours on body temperature. 7. H7: There is a difference in the effect of baths given to preterm newborns after 24 hours or 48 hours on oxygen saturation. 8. H8: There is a difference in the effect of baths given to early term newborns after 24 hours or after 48 hours on oxygen saturation.


Clinical Trial Description

The aim of this study is to examine the effect of the first bath timing after birth on the physiological variables of the newborn and to determine the correct bath time. The research is a single-center, prospective parallel group randomized controlled experimental design study. The research was conducted with a total of 120 babies, 60 preterm babies and 60 early term babies, who received inpatient care and treatment in the neonatal intensive care unit between October 2022 and November 2023. Depending on randomization, newborns were bathed within 24 hours or 48 hours after birth. Physiological measurements of newborns were evaluated before application. Measurements were repeated after application, 10 minutes after application and 60 minutes after application. In the study, it was collected with the Baby Information Form and Physiological Variables Monitoring Form. Data were analyzed using chi-square, mean, percentage distributions, dependent groups t-test for comparison of intra-group measurements, repeated measures anova test, and independent groups t-test for comparison of quantitative continuous data. In the preterm group, the pre-bath respiration, body temperature and oxygen saturation values of newborns bathed within 48 hours were found to be significantly lower than those of newborns bathed within 24 hours in post-bath measurements (p<0.05). In the early term group, it was found that the pre-bath heart rate peak values of newborns bathed within 48 hours were significantly lower than those of newborns bathed within 24 hours in post-bath measurements (p<0.05). ;


Study Design


NCT number NCT06242340
Study type Interventional
Source Karadeniz Technical University
Contact
Status Completed
Phase N/A
Start date October 18, 2022
Completion date January 20, 2024