Prematurity, Mechanical VentilationNCT07681934
The Effect of Breast Milk Odor and Swaddling on Physiological Parameters and Stress Levels in Premature Infants Receiving Ventilator Support
A study testing Breast Milk Smell and Arson in people with Prematurity, Mechanical Ventilation, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
It will be done to shorten the hospital stay of the newborn and increase the quality of care by proving the positive effect of the safe wrapping method and the smell of breast milk on the physiological parameters and stress level of the newborn in premature newborns receiving mechanical ventilator support. 1. Read more about this study
- Who is it for?
- Ages 34 to 36 weeks
- Conditions the study is for
- Prematurity, Mechanical Ventilation
- What is being tested?
- Breast Milk Smell and Arson
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jun 2024to 30 Aug 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 34 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns with gestational weeks between 340/7-366/7,
- In the first 28 days of life,
- High-flow nasal cannula applied,
- Birth weight 1500 gr and above,
- Breastfeeding mothers,
- No health problems that would prevent positioning,
Who cannot join
- Those who have had a painful procedure within the last hour,
- Those who have taken analgesic/sedative drugs within the last 6 hours,
- Those who have undergone any surgical intervention,
- Those with other diagnoses (hyperbilirubinemia, hypoglycemia, etc.),
- Those with cerebral hypoxia/ischemia,
- Those with intraventricular hemorrhage,
- Newborns with congenital anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Safe Swaddling Method and the Scent of Breast Milk on Physiological Parameters, Stress, and Comfort Levels in Premature Newborns Receiving Mechanical Ventilator Support: A Randomized Controlled Study
It will be done to shorten the hospital stay of the newborn and increase the quality of care by proving the positive effect of the safe wrapping method and the smell of breast milk on the physiological parameters and stress level of the newborn in premature newborns receiving mechanical ventilator support.
- Safe wrapping method positively affects physiological parameters in premature newborns receiving mechanical ventilation support.
- Safe wrapping method reduces stress in premature newborns receiving mechanical ventilation support.
- Safe wrapping method increases comfort in premature newborns receiving mechanical ventilation support.
- The smell of breast milk positively affects physiological parameters in premature newborns receiving mechanical ventilation support.
- The smell of breast milk reduces stress in premature newborns receiving mechanical ventilation support.
- The smell of breast milk increases comfort in premature newborns receiving mechanical ventilation support.
This study aims to answer the hypotheses
Read the detailed description
The universe of the study will consist of premature newborns receiving ventilator support in the neonatal intensive care clinic of Selçuk University Medical Faculty Hospital. Three groups will be included in the study: the wrapping group (24), the breastfeeding group (24), and a control group (24). The study data will be collected using the Introductory Information Form, Preterm Infant Physiological Measurement Form, Premature Infant Comfort Scale, and the Neonatal Stress Scale. Before randomization, general information about the study will be given to the parents of newborns who meet the inclusion criteria, the mothers' consent will be obtained, and pre-test data will be collected. Premature newborns receiving ventilator support, whose pre-test data have been collected, will be assigned to the intervention and control groups using the simple randomization method. The intervention will be applied one hour after the 18:00 care, 10 minutes before the procedure, considering the calmest and most stable hours of the research unit, and will be evaluated at the fifth and twentieth minutes after the procedure.
- Conditions
- Prematurity, Mechanical Ventilation
- Being tested
- Breast Milk Smell, Arson, Control
- Keywords
- Breast Milk Scent, Swaddling, Premature Infant, Mechanical Ventilation, Physiological Parameters, Neonatal Stress, Neonatal Comfort, Respiratory Distress
- Medical subject headings
- Premature Birth, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Milk SmellOther
During the application, pre-test data and physiological measurement values, stress scale, and comfort scale levels are recorded three times, at the 5th and 20th minutes.
ArsonOther
In order to prevent the possibility of the wrapping increasing the body temperature, the incubator temperature, which is kept at a standard level, will be reduced by 1oC during the intervention. Pre-test data and physiological measurement values, stress scale and comfort scale levels will be recorded three times during the application, at the 5th and 20th minutes.
ControlOther
No intervention other than routine care will be applied to the control group of the study.
| Study group | Role | What they receive |
|---|---|---|
| Breast Milk Smell Group | Experimental | The premature newborn's own mother's milk will be dripped 10 drops onto a sterile gauze in a container one millimeter away from the newborn's nose, and the breast milk in the container will be placed in the incubator where the new baby is to be milked. Receives: Other: Breast Milk Smell |
| Arson Group | Experimental | A 90 cm² square muslin blanket will be used for wrapping. During the application, care will be taken to leave a certain space between the blanket and the newborn in order not to restrict the newborn's movements and to leave a suitable area where the newborn's feet can be comfortable when folding the bottom of the blanket. Receives: Other: Arson |
| Control Group | Experimental | The control group of the study will not receive any intervention other than routine care. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premature Baby Comfort Scale
The scale was first developed by Ambuel et al. (1992) to assess the pain and stress levels of children aged 0-18 years hospitalized in a pediatric intensive care unit to determine the comfort levels of premature infants. It was later adapted by Caljouw et al. (2007) for premature infants aged 28-37 weeks. The scale is a 5-point Likert-type scale with seven subscales and 35 items. The subscales are defined as alertness, calmness/agitation, respiratory status or crying, physical movement, muscle tone, facial movements, and mean heart rate. The scale is a multidimensional measure that holistically assesses behavioral and physiological indicators of comfort in premature infants. As the total score on the scale increases, the infant's comfort level decreases; a score of 7 indicates the highest level of comfort, and a score of 35 indicates the lowest.
Measured: 9 Months
Secondary outcomes (1)
Newborn Stress Scale
Developed by Ceylan and Bolışık (2017) to assess stress levels in premature infants, the scale consists of 24 items and 8 subscales: facial expression, body color, respiration, activity level, comfortability, muscle tone, extremities, and posture. Each item is scored on a 3-point Likert-type scale from 0 to 2. The total score ranges from 0 to 16, with higher scores indicating higher stress levels.
Measured: 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start28 Jun 2024
- Primary completion30 Aug 2025
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prematurity, Mechanical VentilationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hediye Karakoç, KTO Karatay University
- Investigators
- Hediye Karakoç, Principal investigator, KTO Karatay Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681934
- Sponsor's protocol ID
- KARATAYU-SBF-ES-01
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Security
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Safe Swaddling Method and the Scent of Breast Milk on Physiological Parameters, Stress, and Comfort Levels in Premature Newborns Receiving Mechanical Ventilator Support: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07681934
- Acronym / sponsor ID
- KARATAYU-SBF-ES-01
- Conditions
- Prematurity, Mechanical Ventilation
- Keywords
- Breast Milk Scent, Swaddling, Premature Infant, Mechanical Ventilation, Physiological Parameters, Neonatal Stress, Neonatal Comfort, Respiratory Distress
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 2 Jul 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.
It will be done to shorten the hospital stay of the newborn and increase the quality of care by proving the positive effect of the safe wrapping method and the smell of breast milk on the physiological parameters and stress level of the newborn in premature newborns receiving mechanical ventilator support.
- Safe wrapping method positively affects physiological parameters in premature newborns receiving mechanical ventilation support.
- Safe wrapping method reduces stress in premature newborns receiving mechanical ventilation support.
- Safe wrapping method increases comfort in premature newborns receiving mechanical ventilation support.
- The smell of breast milk positively affects physiological parameters in premature newborns receiving mechanical ventilation support.
- The smell of breast milk reduces stress in premature newborns receiving mechanical ventilation support.
- The smell of breast milk increases comfort in premature newborns receiving mechanical ventilation support.
This study aims to answer the hypotheses
Detailed description
The universe of the study will consist of premature newborns receiving ventilator support in the neonatal intensive care clinic of Selçuk University Medical Faculty Hospital. Three groups will be included in the study: the wrapping group (24), the breastfeeding group (24), and a control group (24). The study data will be collected using the Introductory Information Form, Preterm Infant Physiological Measurement Form, Premature Infant Comfort Scale, and the Neonatal Stress Scale. Before randomization, general information about the study will be given to the parents of newborns who meet the inclusion criteria, the mothers' consent will be obtained, and pre-test data will be collected. Premature newborns receiving ventilator support, whose pre-test data have been collected, will be assigned to the intervention and control groups using the simple randomization method. The intervention will be applied one hour after the 18:00 care, 10 minutes before the procedure, considering the calmest and most stable hours of the research unit, and will be evaluated at the fifth and twentieth minutes after the procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breast Milk Smell Group | Experimental | Other: Breast Milk SmellThe premature newborn's own mother's milk will be dripped 10 drops onto a sterile gauze in a container one millimeter away from the newborn's nose, and the breast milk in the container will be placed in the incubator where the new baby is to be milked. |
| Arson Group | Experimental | Other: ArsonA 90 cm² square muslin blanket will be used for wrapping. During the application, care will be taken to leave a certain space between the blanket and the newborn in order not to restrict the newborn's movements and to leave a suitable area where the newborn's feet can be comfortable when folding the bottom of the blanket. |
| Control Group | Experimental | Other: ControlThe control group of the study will not receive any intervention other than routine care. |
Who may qualify
- Ages
- 34 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Newborns with gestational weeks between 340/7-366/7,
- In the first 28 days of life,
- High-flow nasal cannula applied,
- Birth weight 1500 gr and above,
- Breastfeeding mothers,
Key exclusion criteria (7 listed)
- Those who have had a painful procedure within the last hour,
- Those who have taken analgesic/sedative drugs within the last 6 hours,
- Those who have undergone any surgical intervention,
- Those with other diagnoses (hyperbilirubinemia, hypoglycemia, etc.),
- Those with cerebral hypoxia/ischemia,
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 |
|---|---|---|
| Breast Milk SmellDuring the application, pre-test data and physiological measurement values, stress scale, and comfort scale levels are recorded three times, at the 5th and 20th minutes. | Other | Breast Milk Smell Group |
| ArsonIn order to prevent the possibility of the wrapping increasing the body temperature, the incubator temperature, which is kept at a standard level, will be reduced by 1oC during the intervention. Pre-test data and physiological measurement values, stress scale and comfort scale levels will be recorded three times during the application, at the 5th and 20th minutes. | Other | Arson Group |
| ControlNo intervention other than routine care will be applied to the control group of the study. | Other | Control Group |
Primary outcome
Premature Baby Comfort Scale
Time frame: 9 Months
The scale was first developed by Ambuel et al. (1992) to assess the pain and stress levels of children aged 0-18 years hospitalized in a pediatric intensive care unit to determine the comfort levels of premature infants. It was later adapted by Caljouw et al. (2007) for premature infants aged 28-37 weeks. The scale is a 5-point Likert-type scale with seven subscales and 35 items. The subscales are defined as alertness, calmness/agitation, respiratory status or crying, physical movement, muscle tone, facial movements, and mean heart rate. The scale is a multidimensional measure that holistically assesses behavioral and physiological indicators of comfort in premature infants. As the total score on the scale increases, the infant's comfort level decreases; a score of 7 indicates the highest level of comfort, and a score of 35 indicates the lowest.
1 secondary outcome
Newborn Stress Scale
Time frame: 9 Months
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 2 Jul 2026.
- Individual participant dataSharing planned: No. Security
Related trials for Prematurity, Mechanical Ventilation
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The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
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Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
Neonatal Resuscitation, Apnea Neonatal
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Noninvasive High Frequency Oscillatory Ventilation Versus Nasal Intermittent Mandatory Ventilation for Respiratory Distress Syndrome in Preterm Neonates
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Predictors of Prolonged Mechanical Ventilation in Preterm Infants
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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.
Hediye Karakoç principal investigator
KTO Karatay Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast Milk Smell and Arson in people with Prematurity, Mechanical Ventilation, run by KTO Karatay 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 6 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 2 Jul 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?
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?
Premature Baby Comfort Scale (time frame: 9 Months). 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 2 Jul 2026.