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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).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.

Dilara Erdoğan, BSc contact

+905448054615

erdogandilara03@gmail.com

Turkey (Türkiye)1 site
  • Sultangazi Haseki Training and Research Hospital

    Istanbul, Sultangazi, 34265

    Dilara Erdoğan, BSc, +905448054615, erdogandilara03@gmail.com

Other trials in Turkey (Türkiye)

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.

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 groups in NCT07445139
Study groupRoleWhat they receive
immersion bath of newbornsExperimentalNewborns bathed using a immersion bath among the types of baths
Receives: Procedure: immersion bath of newborns
swaddle bath of newbornsExperimentalNewborns bathed using a swaddle bath among the types of baths
Receives: Procedure: swaddle bath of newborns
sponge bath of newbornsExperimentalNewborns 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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted3 Mar 2026
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion15 May 2026 (estimated)
  4. Study completion31 May 2026 (estimated)

Resources

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)
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

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; AzTrials last refreshed its copy on 6 Nov 2026.

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