Healthy NewbornsNCT07445139
THE EFFECT OF BATHING METHODS APPLIED TO NEWBORNS ON VITAL SIGNS
A study testing sponge bath of newborns, immersion bath of newborns and swaddle bath of newborns in people with Healthy Newborns, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The neonatal mortality rate is a global issue and an important indicator reflecting the quality and accessibility of a country's healthcare system. The main causes of death in newborns include premature birth, birth complications (birth asphyxia/trauma), and neonatal infections. Read more about this study
- Who is it for?
- Ages 0 to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy Newborns
- What is being tested?
- sponge bath of newborns, immersion bath of newborns and swaddle bath of newborns
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Hospitalized in the Level I Neonatal Intensive Care Unit of Sultangazi Haseki Training and Research Hospital
- Aged between 0-28 days
- 5-minute APGAR score ≥ 7
- Born at term (37-42 weeks of gestation)
- Birth weight ≥ 2500 grams
- No life-threatening condition
Show all 9Show fewer
- No history of surgical procedures
- Stable vital signs within the last 24 hours
- Written informed consent obtained from the mother
Who cannot join
- Presence of congenital anomalies
- Presence of impaired skin integrity or open wounds
- Receiving mechanical ventilation or intubated
- Withdrawal of consent by the mother
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Sultangazi Haseki Training and Research Hospital
Istanbul, Sultangazi, 34265
Dilara Erdoğan, BSc, +905448054615, erdogandilara03@gmail.com
About this study
Official title: THE EFFECT OF BATHING METHODS APPLIED TO NEWBORNS ON VITAL SIGNS: A RANDOMIZED CONTROLLED TRIAL
The neonatal mortality rate is a global issue and an important indicator reflecting the quality and accessibility of a country's healthcare system.
The main causes of death in newborns include premature birth, birth complications (birth asphyxia/trauma), and neonatal infections. Neonatal hypothermia is also associated with increased neonatal mortality. Therefore, the World Health Organization (WHO) has recommended a comprehensive neonatal care protocol to improve health outcomes for newborns. This protocol includes management steps such as emergency care at birth (delayed cord clamping, thorough drying, respiratory assessment, skin-to-skin contact, early initiation of breastfeeding), infection prevention, and thermal care (prevention of hypothermia).
Read more
Hypothermia is a condition in newborns where a drop in body temperature can lead to serious health problems such as metabolic acidosis, hypoglycemia, respiratory distress, hypoxia, bradycardia, hypotension, and infection. It is known that bathing newborns early on is therefore a significant risk factor for hypothermia in newborns.
Bathing newborns stimulates skin circulation, providing relaxation and a sense of well-being. It also contributes to the regulation of respiration and circulation, improvement of cell metabolism and capillary permeability, reduction of pain, increase in intestinal peristalsis, and decrease in bilirubin levels.
On the other hand, during bathing, light, noise, changes in ambient temperature, stress, and increased crying may cause thermal and cardiorespiratory changes in the newborn, such as heart rate, body temperature, respiratory rate, and oxygen saturation.
Delaying the first bath for at least 24 hours in newborns has been associated with reducing hypothermia and excessive crying, as well as benefiting from the vernix caseosa on the skin. Therefore, bathing under appropriate conditions and at the right time is critically important for newborn health.
Another important issue is the methods used for bathing newborns. There are various methods, such as tub bathing, sponge bathing, swaddling bathing, cradle bathing, bathing under running water, and oil bathing.
However, there was a need for more high-level evidence regarding the effect of different bathing methods used in term newborns on newborn health outcomes, and it was decided to conduct this study.
This study will provide important data for basing newborn care protocols on scientific evidence and improving clinical practices.
This randomized controlled study will compare immersion bathing (control group), swaddled bathing, and sponge bathing in term newborns to evaluate their effects on vital signs such as body temperature, heart rate, respiratory rate, and oxygen saturation.
- Conditions
- Healthy Newborns
- Being tested
- sponge bath of newborns, immersion bath of newborns, swaddle bath of newborns
- Keywords
- Term Newborn, Midwifery, Newborn Bathing, Neonatal Vital Signs, Neonatal Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sponge bath of newbornsProcedure or surgery
Newborns bathed using a sponge bath among the types of baths
immersion bath of newbornsProcedure or surgery
Newborns bathed using a immersion bath among the types of baths
swaddle bath of newbornsProcedure or surgery
Newborns bathed using a swaddle bath among the types of baths
| Study group | Role | What they receive |
|---|---|---|
| immersion bath of newborns | Experimental | Newborns bathed using a immersion bath among the types of baths Receives: Procedure: immersion bath of newborns |
| swaddle bath of newborns | Experimental | Newborns bathed using a swaddle bath among the types of baths Receives: Procedure: swaddle bath of newborns |
| sponge bath of newborns | Experimental | Newborns bathed using a sponge bath among the types of baths Receives: Procedure: sponge bath of newborns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal body temperature
Forehead body temperature measured using non-contact infrared thermometer
Measured: Baseline (before bathing), immediately after bathing, and at 5, 10, 30 and 60 minutes after bathing
Secondary outcomes (3)
Heart rate
heart rate measured using standard neonatal monitoring equipment
Measured: Baseline (before bathing), immediately after bathing, and at 5, 10, 30 and 60 minutes after bathing
respiratory rate
respiratory rate measured through clinical observation
Measured: Baseline (before bathing), immediately after bathing, and at 5, 10, 30 and 60 minutes after bathing
oxygen saturation
peripheral oxygen saturation measured using pulse oximetry
Measured: Baseline (before bathing), immediately after bathing, and at 5, 10, 30 and 60 minutes after bathing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy NewbornsStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilara Erdoğan, Marmara University
- Investigators
- Döndü Kurnaz, PhD, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445139
- Sponsor's protocol ID
- 546724004
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF BATHING METHODS APPLIED TO NEWBORNS ON VITAL SIGNS: A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT07445139
- Acronym / sponsor ID
- 546724004
- Conditions
- Healthy Newborns
- Keywords
- Term Newborn, Midwifery, Newborn Bathing, Neonatal Vital Signs, Neonatal Care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 107 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 3 Mar 2026 (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 neonatal mortality rate is a global issue and an important indicator reflecting the quality and accessibility of a country's healthcare system.
The main causes of death in newborns include premature birth, birth complications (birth asphyxia/trauma), and neonatal infections. Neonatal hypothermia is also associated with increased neonatal mortality. Therefore, the World Health Organization (WHO) has recommended a comprehensive neonatal care protocol to improve health outcomes for newborns. This protocol includes management steps such as emergency care at birth (delayed cord clamping, thorough drying, respiratory assessment, skin-to-skin contact, early initiation of breastfeeding), infection prevention, and thermal care (prevention of hypothermia).
Hypothermia is a condition in newborns where a drop in body temperature can lead to serious health problems such as metabolic acidosis, hypoglycemia, respiratory distress, hypoxia, bradycardia, hypotension, and infection. It is known that bathing newborns early on is therefore a significant risk factor for hypothermia in newborns.
Bathing newborns stimulates skin circulation, providing relaxation and a sense of well-being. It also contributes to the regulation of respiration and circulation, improvement of cell metabolism and capillary permeability, reduction of pain, increase in intestinal peristalsis, and decrease in bilirubin levels.
On the other hand, during bathing, light, noise, changes in ambient temperature, stress, and increased crying may cause thermal and cardiorespiratory changes in the newborn, such as heart rate, body temperature, respiratory rate, and oxygen saturation.
Delaying the first bath for at least 24 hours in newborns has been associated with reducing hypothermia and excessive crying, as well as benefiting from the vernix caseosa on the skin. Therefore, bathing under appropriate conditions and at the right time is critically important for newborn health.
Another important issue is the methods used for bathing newborns. There are various methods, such as tub bathing, sponge bathing, swaddling bathing, cradle bathing, bathing under running water, and oil bathing.
However, there was a need for more high-level evidence regarding the effect of different bathing methods used in term newborns on newborn health outcomes, and it was decided to conduct this study.
This study will provide important data for basing newborn care protocols on scientific evidence and improving clinical practices.
This randomized controlled study will compare immersion bathing (control group), swaddled bathing, and sponge bathing in term newborns to evaluate their effects on vital signs such as body temperature, heart rate, respiratory rate, and oxygen saturation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| immersion bath of newborns | Experimental | Procedure: immersion bath of newbornsNewborns bathed using a immersion bath among the types of baths |
| swaddle bath of newborns | Experimental | Procedure: swaddle bath of newbornsNewborns bathed using a swaddle bath among the types of baths |
| sponge bath of newborns | Experimental | Procedure: sponge bath of newbornsNewborns bathed using a sponge bath among the types of baths |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Hospitalized in the Level I Neonatal Intensive Care Unit of Sultangazi Haseki Training and Research Hospital
- Aged between 0-28 days
- 5-minute APGAR score ≥ 7
- Born at term (37-42 weeks of gestation)
- Birth weight ≥ 2500 grams
Key exclusion criteria (4 listed)
- Presence of congenital anomalies
- Presence of impaired skin integrity or open wounds
- Receiving mechanical ventilation or intubated
- Withdrawal of consent by the mother
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 |
|---|---|---|
| sponge bath of newbornsNewborns bathed using a sponge bath among the types of baths | Procedure or surgery | sponge bath of newborns |
| immersion bath of newbornsNewborns bathed using a immersion bath among the types of baths | Procedure or surgery | immersion bath of newborns |
| swaddle bath of newbornsNewborns bathed using a swaddle bath among the types of baths | Procedure or surgery | swaddle bath of newborns |
Primary outcome
Neonatal body temperature
Time frame: Baseline (before bathing), immediately after bathing, and at 5, 10, 30 and 60 minutes after bathing
Forehead body temperature measured using non-contact infrared thermometer
3 secondary outcomes
Heart rate
Time frame: Baseline (before bathing), immediately after bathing, and at 5, 10, 30 and 60 minutes after bathing
respiratory rate
Time frame: Baseline (before bathing), immediately after bathing, and at 5, 10, 30 and 60 minutes after bathing
oxygen saturation
Time frame: Baseline (before bathing), immediately after bathing, and at 5, 10, 30 and 60 minutes after bathing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy Newborns
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Active, not recruitingPhase 1
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Netherton Syndrome
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
RecruitingObservational study
Studies of Skin Microbes in Healthy People and in People With Skin Conditions
Eczema, Atopic Dermatitis
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.
Döndü Kurnaz, PhD principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sponge bath of newborns, immersion bath of newborns and swaddle bath of newborns in people with Healthy Newborns, run by Marmara 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 9 inclusion and 4 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: opening soon, as of the sponsor's last update on 3 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dilara Erdoğan, BSc (+905448054615, erdogandilara03@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal body temperature (time frame: Baseline (before bathing), immediately after bathing, and at 5, 10, 30 and 60 minutes after bathing). 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 3 Mar 2026.