Clinical trial NCT06242340: The Effect of Newborn's First Bath Time on Physiological Variables
Official title: The Effect of Newborn's First Bath Time on Physiological Variables
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Baths
Keywords: infant, intensive care unit, baths, touch
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 120
Sex: ALL
Minimum age (years): 32
Maximum age (years): 38
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: Inclusion Criteria:

* Newborns should be between 32 0/7 and 38 6/7 weeks.
* Birth weight must be over 2000 grams.
* He should not be connected to a mechanical ventilator.
* The parent must agree to work.

Exclusion Criteria:

* Less than 32 0/7 weeks.
* 39 0/7 weeks over.
* Being connected to a mechanical ventilator.
* Lacking epidermal integrity.
* Having an infection.
* Babies with anomalies and syndromes.
* Whose mother has an infection (hepatitis B, hepatitis C, HIV).
* Having phototherapy treatment.
* Having a body temperature below 36.5 °C.
* Having a body temperature above 37.5 ºC.
* Feeding within an hour before bathing.
* A painful procedure is performed within thirty minutes before bathing.
* Taking sedative medication.
* Those whose parents do not allow them to work.

Primary outcomes:
measure: Body temperature
timeFrame: It was evaluated at 1 minute before bath, after bath, 10 minutes after bath and 60 minutes after bath.
measure: Respiratory rate
timeFrame: It was evaluated at 1 minute before bath, after bath, 10 minutes after bath and 60 minutes after bath.
measure: Heart rate
timeFrame: It was evaluated at 1 minute before bath, after bath, 10 minutes after bath and 60 minutes after bath.
measure: Oxygen saturation value
timeFrame: It was evaluated at 1 minute before bath, after bath, 10 minutes after bath and 60 minutes after bath.
Secondary outcomes:
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University Health Application and Research Center Farabi Hospital
Study officials:
References: