BathsNCT06242340
The Effect of Newborn's First Bath Time on Physiological Variables
A study testing Preterm group bathing 24 hours after birth., Preterm group bathing 48 hours after birth. and Early term group bathing 24 hours after birth. in people with Baths, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 32 to 38 weeksHealthy volunteers can take part
- Conditions the study is for
- Baths
- What is being tested?
- Preterm group bathing 24 hours after birth., Preterm group bathing 48 hours after birth. and Early term group bathing 24 hours after birth.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Oct 2022to 20 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 38 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical University Health Application and Research Center Farabi Hospital
Trabzon, 61080
About this study
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.
- H₁: There is a difference in the effect of bathing preterm newborns after 24 hours or 48 hours on the peak heart rate.
- H2: There is a difference in the effect of bathing early term newborns after 24 hours or 48 hours on the peak heart rate.
- H3: There is a difference in the effect of bathing preterm newborns after 24 hours or 48 hours on their respiratory rate.
- H4: There is a difference in the effect of bathing early term newborns after 24 hours or 48 hours on their respiratory rate.
- H5: There is a difference in the effect of baths given to preterm newborns after 24 hours or 48 hours on body temperature.
- 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.
- H7: There is a difference in the effect of baths given to preterm newborns after 24 hours or 48 hours on oxygen saturation.
- 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.
Read the 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).
- Conditions
- Baths
- Being tested
- Preterm group bathing 24 hours after birth., Preterm group bathing 48 hours after birth., Early term group bathing 24 hours after birth., Early term group bathing 48 hours after birth.
- Keywords
- infant, intensive care unit, baths, touch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preterm group bathing 24 hours after birth.Other
Preterm (between 32 0/7 and 36 6/7 weeks) babies (n=30) were bathed in the form of a shower 24 hours after birth. Before the bath, after the bath, 10 minutes after the bath and 60 minutes after the bath, heart rate, body temperature, respiratory rate, oxygen saturation value, and skin color were evaluated.
Preterm group bathing 48 hours after birth.Other
Preterm (between 32 0/7 and 36 6/7 weeks) babies (n=30) were bathed in the form of a shower 48 hours after birth. Before the bath, after the bath, 10 minutes after the bath and 60 minutes after the bath, heart rate, body temperature, respiratory rate, oxygen saturation value, and skin color were evaluated.
Early term group bathing 24 hours after birth.Other
Early term (between 37 0/7 and 38 6/7 weeks) babies (n=30) were bathed in the form of a shower 24 hours after birth. Before the bath, after the bath, 10 minutes after the bath and 60 minutes after the bath, heart rate, body temperature, respiratory rate, oxygen saturation value, and skin color were evaluated.
Early term group bathing 48 hours after birth.Other
Early term (between 37 0/7 and 38 6/7 weeks) babies (n=30) were bathed in the form of a shower 48 hours after birth. Before the bath, after the bath, 10 minutes after the bath and 60 minutes after the bath, heart rate, body temperature, respiratory rate, oxygen saturation value, and skin color were evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Preterm (between 32 0/7 and 36 6/7 weeks) Receives: Other: Preterm group bathing 24 hours after birth. |
| Group 2 | Experimental | Preterm (between 32 0/7 and 36 6/7 weeks) Receives: Other: Preterm group bathing 48 hours after birth. |
| Group 3 | Experimental | Early term (between 37 0/7 and 38 6/7 weeks) Receives: Other: Early term group bathing 24 hours after birth. |
| Group 4 | Experimental | Early term (between 37 0/7 and 38 6/7 weeks) Receives: Other: Early term group bathing 48 hours after birth. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body temperature
Body temperature will be recorded and evaluated in degrees Celsius.
Measured: It was evaluated at 1 minute before bath, after bath, 10 minutes after bath and 60 minutes after bath.
Respiratory rate
Respiration will be recorded and evaluated in numbers by counting for 1 minute by the researcher.
Measured: It was evaluated at 1 minute before bath, after bath, 10 minutes after bath and 60 minutes after bath.
Heart rate
Heart rate will be recorded and evaluated in numbers by measuring with a monitor,
Measured: It was evaluated at 1 minute before bath, after bath, 10 minutes after bath and 60 minutes after bath.
Oxygen saturation value
Oxygen saturation value will be recorded and evaluated in numbers by the monitor.
Measured: It was evaluated at 1 minute before bath, after bath, 10 minutes after bath and 60 minutes after bath.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start18 Oct 2022
- Primary completion20 Nov 2023
- Study completion20 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BathsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlknur KAHRİMAN, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242340
- Sponsor's protocol ID
- KARADENIZTEKNIK
- Status last verified
- Feb 2024
- First submitted
- 25 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Newborn's First Bath Time on Physiological Variables
- ClinicalTrials.gov ID
- NCT06242340
- Acronym / sponsor ID
- KARADENIZTEKNIK
- Conditions
- Baths
- Keywords
- infant, intensive care unit, baths, touch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 20 Jan 2024 (actual)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- H₁: There is a difference in the effect of bathing preterm newborns after 24 hours or 48 hours on the peak heart rate.
- H2: There is a difference in the effect of bathing early term newborns after 24 hours or 48 hours on the peak heart rate.
- H3: There is a difference in the effect of bathing preterm newborns after 24 hours or 48 hours on their respiratory rate.
- H4: There is a difference in the effect of bathing early term newborns after 24 hours or 48 hours on their respiratory rate.
- H5: There is a difference in the effect of baths given to preterm newborns after 24 hours or 48 hours on body temperature.
- 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.
- H7: There is a difference in the effect of baths given to preterm newborns after 24 hours or 48 hours on oxygen saturation.
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Preterm group bathing 24 hours after birth.Preterm (between 32 0/7 and 36 6/7 weeks) |
| Group 2 | Experimental | Other: Preterm group bathing 48 hours after birth.Preterm (between 32 0/7 and 36 6/7 weeks) |
| Group 3 | Experimental | Other: Early term group bathing 24 hours after birth.Early term (between 37 0/7 and 38 6/7 weeks) |
| Group 4 | Experimental | Other: Early term group bathing 48 hours after birth.Early term (between 37 0/7 and 38 6/7 weeks) |
Who may qualify
- Ages
- 32 to 38 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- Less than 32 0/7 weeks.
- 39 0/7 weeks over.
- Being connected to a mechanical ventilator.
- Lacking epidermal integrity.
- Having an infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preterm group bathing 24 hours after birth.Preterm (between 32 0/7 and 36 6/7 weeks) babies (n=30) were bathed in the form of a shower 24 hours after birth. Before the bath, after the bath, 10 minutes after the bath and 60 minutes after the bath, heart rate, body temperature, respiratory rate, oxygen saturation value, and skin color were evaluated. | Other | Group 1 |
| Preterm group bathing 48 hours after birth.Preterm (between 32 0/7 and 36 6/7 weeks) babies (n=30) were bathed in the form of a shower 48 hours after birth. Before the bath, after the bath, 10 minutes after the bath and 60 minutes after the bath, heart rate, body temperature, respiratory rate, oxygen saturation value, and skin color were evaluated. | Other | Group 2 |
| Early term group bathing 24 hours after birth.Early term (between 37 0/7 and 38 6/7 weeks) babies (n=30) were bathed in the form of a shower 24 hours after birth. Before the bath, after the bath, 10 minutes after the bath and 60 minutes after the bath, heart rate, body temperature, respiratory rate, oxygen saturation value, and skin color were evaluated. | Other | Group 3 |
| Early term group bathing 48 hours after birth.Early term (between 37 0/7 and 38 6/7 weeks) babies (n=30) were bathed in the form of a shower 48 hours after birth. Before the bath, after the bath, 10 minutes after the bath and 60 minutes after the bath, heart rate, body temperature, respiratory rate, oxygen saturation value, and skin color were evaluated. | Other | Group 4 |
Primary outcome
Body temperature
Time frame: It was evaluated at 1 minute before bath, after bath, 10 minutes after bath and 60 minutes after bath.
Body temperature will be recorded and evaluated in degrees Celsius.
Respiratory rate
Time frame: It was evaluated at 1 minute before bath, after bath, 10 minutes after bath and 60 minutes after bath.
Respiration will be recorded and evaluated in numbers by counting for 1 minute by the researcher.
Heart rate
Time frame: It was evaluated at 1 minute before bath, after bath, 10 minutes after bath and 60 minutes after bath.
Heart rate will be recorded and evaluated in numbers by measuring with a monitor,
Oxygen saturation value
Time frame: It was evaluated at 1 minute before bath, after bath, 10 minutes after bath and 60 minutes after bath.
Oxygen saturation value will be recorded and evaluated in numbers by the monitor.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preterm group bathing 24 hours after birth., Preterm group bathing 48 hours after birth. and Early term group bathing 24 hours after birth. in people with Baths, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body temperature (time frame: It was evaluated at 1 minute before bath, after bath, 10 minutes after bath and 60 minutes after bath.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.