Preterm Birth ComplicationNCT05607706
Effect of Maternal Odor and Kangaroo Care on Serum Cortisol and Comfort Levels in Preterm Infants: a Randomised Trial
A study testing Exposure to maternal odor in people with Preterm Birth Complication and Stress Related Disorder, run by Istanbul Nisantasi University at 1 site in Turkey (Türkiye).
Trial summary
Aims and objectives: Studies on stress are generally aimed at young children and infants. However, in the neonatal period, "especially in preterm babies", this issue was not given enough attention and was almost completely ignored. Background: They are exposed to different stressors. Read more about this study
- Who is it for?
- Ages 1 minute to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth Complication, Stress Related Disorder, Cortisol Overproduction
- What is being tested?
- Exposure to maternal odor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 30 Nov 2021
- 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 1 minute to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm infants hospitalized in the NICU for at least 15 days (babies born less than 37 weeks of gestation, greater than 28 weeks of gestation and between 1000-2500 g), babies with a first-minute Apgar score of 7 and above, and with no feeding problems, and who do not have brain-pituitary-adrenal axis problems, babies without congenital defects, and without respiratory problems (endotracheal intubation, mechanical ventilation support or nasal continuous positive airway pressure application), and with no cardiological problems, and who have not undergone surgery, and who have been given kangaroo care by a neonatal specialist, and with no suspected or no sepsis diagnosis, who are not treated with analgesics, sedatives, muscle relaxants because it may affect/pressure the stress situation, and whose mothers do not have a mental and physical problem/condition/health problem that prevents them from giving kangaroo care
Who cannot join
- constitute the research population, were determined as follows. Babies who had a health problem during the study and had a hospitalization period of less than 15 days in the NICU were excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Aims and objectives: Studies on stress are generally aimed at young children and infants. However, in the neonatal period, "especially in preterm babies", this issue was not given enough attention and was almost completely ignored.
Background: They are exposed to different stressors. Too much stress will increase their problems in their future lives.
Read more
Design: This study was planned as a randomized study to determine the effects of Kangaroo Care and mother scent application on toxic stress in preterm infants in the Neonatal Intensive Care Unit environment and to create evidence-based recommendations regarding these applications.
Methods: Research data were collected from a total of 92 preterm babies born. Babies were divided into 3 groups, those who never met their mothers, only mother scent group and KC group. The mother's undershirt was used as the maternal odor. Vital signs, blood cortisol levels and Preterm Infant Comfort Scale scores were determined and recorded each group.The data were evaluated by statistical analysis. The CONSORT checklist for reporting qualitative research was used.
Results: In the group that never encountered mother and mother odor, Preterm Infant Comfort Scale, blood cortisol level and vital signs showed severe stress. It was found that maternal odor is effective in reducing this stress, but kangaroo care is much more effective in preventing stress.
Conclusion: if premature babies are deprived of their mother, the stress may be exposed to reaches toxic levels. It was determined that kangaroo care application during the treatment of these babies is a more effective method in reducing stress than the maternal odor application method.
Relevance to clinical practice: The results of this study will contribute to nurses' use of kangaroo care and maternal odor in the care of preterm babies to prevent stress and related complications.Therefore, it will improve the quality of care of preterm babies in the NICU.
Read the detailed description
About 15 million babies are born preterm every year around the world(Blencowe et al., 2013). This corresponds to more than one in every 10 babies born alive(Lincetto \& Banerjee, 2020). This situation, which is a serious problem all over the world, causes approximately 1 million children to die from complications related to preterm birth before the age of 5 years(Walani, 2020). Many of the living preterm babies also develop psychological and physical problems that require follow-up in adolescence, adulthood or lifelong (Kajantie et al., 2021; Manninen et al., 2022). Compared to term babies, preterm babies continue their lives with lower motor and neurological abilities in the later periods of their lives(Wolke et al., 2019). In addition, unlike full-term babies, hospitalization in the neonatal intensive care unit (NICU) after birth causes them to be exposed to many stress-inducing factors such as noise, nursing intervention and light (Larkin et al., 2019).
Stress is a term used to describe th eresponse of a person to both positive and negative events that he encounters daily throughout his life. Stressors can be physical, emotional, environmental or theoretical. Stressors can all affect the body's stress response equally. Stress response, also known as "fight or flight" response or general adaptation syndrome, includes physiological changes that ocur with an individual's encounter with or perceived stress. This stres response is a result of stimulation of the sympathetic nervous system resulting in a cascade of neuro-endocrine-immune responses, with reproducible physiologic effects that include an increase in respirations, heart rate, blood pressure, and overall oxygen consumption (Franke, 2014). Physiological consequences of stress, hypothalamus-pituitary-adrenal cortisol are regulated. In response to a stressor, there is an increase in the secretion of glucocorticoids, especially cortisol(Gunnar et al., 1991).There are three different types of stress. Positive stress; this type of stress is a normal part of life, a positive and normal stress response, and is essential for a child's growth and development. Positive stress responses are infrequent, short-lived, and mild. Tolerable stress; the stress that can be tolerated is more severe, frequent, or persistent. The body responds to a greater degree, and these biochemical responses have the potential to negatively affect brain architecture. Toxic stress; toxic stress leads to prolonged stimulation of the stress response with the body's inability to fully recover(Bergman, 2019a; Weber \& Harrison, 2019). It differs from a normal stress response because there is a lack of caregiver support, reassurance, or emotional attachment. Inadequate caregiver support prevents the stress response from being supported or the body returning to its initial functions.This stress causes the development of many other problems in addition to the increase in the problems that will develop due to preterm birth in their future lives. Therefore, minimizing this stress is of vital importance for preterm infants and their families (WHO, 2017; Ylijoki et al., 2020).
Studies on stress are generally aimed at young children and infants. However, in the neonatal period, "especially in preterm babies", this issue was not given enough attention and was almost completely ignored. Researching this issue will help to make serious changes and corrections in the working principles of the neonatal intensive care unit. For this reason, this study was planned to determine the effects of Kangaroo Care (KC) and Maternal Odor on preterm infants on Toxic Stress and to create evidence-based recommendations about these practices in the NICU setting.
- Being tested
- Exposure to maternal odor
- Keywords
- preterm infant, maternal odor, kangaroo care, cortisol
- Medical subject headings
- ACTH Syndrome, Ectopic, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to maternal odorBehavioural
Also called Kangaroo care
Exposure to maternal odor; the shirt worn by the mother is put in the baby's incubator, kangaroo care; mother lays her baby naked between her breasts
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | families were not allowed to enter the NICU |
| Maternal Odor | Active comparator | Babies compared only to the mother's odor Receives: Behavioral: Exposure to maternal odor |
| Kangaroo care | Active comparator | Babies given kangaroo care Receives: Behavioral: Exposure to maternal odor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mother odor relieves stress
Exposing preterm infants to maternal odor reduces stress for infants in the NICU exposed to a various stressors.
Measured: 6 months
Secondary outcomes (1)
Kangaroo care relieves stress
Kangaroo care for preterm infants reduces the stress of infants in the NICU exposed to various stressors more than maternal odor
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start1 Jan 2021
- Primary completion30 Sep 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Birth ComplicationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This research; It was planned as a Randomized Controlled Experimental Study. In the study, the effect of kangaroo care and maternal odor, which are independent variables, on the toxic stress level of preterms, which is the dependent variable, was tried to be determined. The study was carried out NICU at Anka Hospital, in Gaziantep, Turkey. The sample calculation of the research was made using the "Jamovi 1.8" program. The significance level was taken as 0.05 according to the power analysis performed to determine the sufficient sample size, and it was calculated that at least 30 patients should be included in each patient group in order to have a minimum theoretical power of 0.7. The study was planned to be conducted with a total of 135 patients, with 45 patients in each group.
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Nisantasi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alev Sivasli, Istanbul Nisantasi University
- Investigators
- Alev Sivasli, Principal investigator, Nisantasi University, İstanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607706
- Sponsor's protocol ID
- anka
- Status last verified
- Nov 2022
- First submitted
- 2 Nov 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Maternal Odor and Kangaroo Care on Serum Cortisol and Comfort Levels in Preterm Infants: a Randomised Trial
- ClinicalTrials.gov ID
- NCT05607706
- Acronym / sponsor ID
- anka
- Keywords
- preterm infant, maternal odor, kangaroo care, cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Istanbul Nisantasi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 7 Nov 2022 (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.
Aims and objectives: Studies on stress are generally aimed at young children and infants. However, in the neonatal period, "especially in preterm babies", this issue was not given enough attention and was almost completely ignored.
Background: They are exposed to different stressors. Too much stress will increase their problems in their future lives.
Design: This study was planned as a randomized study to determine the effects of Kangaroo Care and mother scent application on toxic stress in preterm infants in the Neonatal Intensive Care Unit environment and to create evidence-based recommendations regarding these applications.
Methods: Research data were collected from a total of 92 preterm babies born. Babies were divided into 3 groups, those who never met their mothers, only mother scent group and KC group. The mother's undershirt was used as the maternal odor. Vital signs, blood cortisol levels and Preterm Infant Comfort Scale scores were determined and recorded each group.The data were evaluated by statistical analysis. The CONSORT checklist for reporting qualitative research was used.
Results: In the group that never encountered mother and mother odor, Preterm Infant Comfort Scale, blood cortisol level and vital signs showed severe stress. It was found that maternal odor is effective in reducing this stress, but kangaroo care is much more effective in preventing stress.
Conclusion: if premature babies are deprived of their mother, the stress may be exposed to reaches toxic levels. It was determined that kangaroo care application during the treatment of these babies is a more effective method in reducing stress than the maternal odor application method.
Relevance to clinical practice: The results of this study will contribute to nurses' use of kangaroo care and maternal odor in the care of preterm babies to prevent stress and related complications.Therefore, it will improve the quality of care of preterm babies in the NICU.
Detailed description
About 15 million babies are born preterm every year around the world(Blencowe et al., 2013). This corresponds to more than one in every 10 babies born alive(Lincetto \& Banerjee, 2020). This situation, which is a serious problem all over the world, causes approximately 1 million children to die from complications related to preterm birth before the age of 5 years(Walani, 2020). Many of the living preterm babies also develop psychological and physical problems that require follow-up in adolescence, adulthood or lifelong (Kajantie et al., 2021; Manninen et al., 2022). Compared to term babies, preterm babies continue their lives with lower motor and neurological abilities in the later periods of their lives(Wolke et al., 2019). In addition, unlike full-term babies, hospitalization in the neonatal intensive care unit (NICU) after birth causes them to be exposed to many stress-inducing factors such as noise, nursing intervention and light (Larkin et al., 2019).
Stress is a term used to describe th eresponse of a person to both positive and negative events that he encounters daily throughout his life. Stressors can be physical, emotional, environmental or theoretical. Stressors can all affect the body's stress response equally. Stress response, also known as "fight or flight" response or general adaptation syndrome, includes physiological changes that ocur with an individual's encounter with or perceived stress. This stres response is a result of stimulation of the sympathetic nervous system resulting in a cascade of neuro-endocrine-immune responses, with reproducible physiologic effects that include an increase in respirations, heart rate, blood pressure, and overall oxygen consumption (Franke, 2014). Physiological consequences of stress, hypothalamus-pituitary-adrenal cortisol are regulated. In response to a stressor, there is an increase in the secretion of glucocorticoids, especially cortisol(Gunnar et al., 1991).There are three different types of stress. Positive stress; this type of stress is a normal part of life, a positive and normal stress response, and is essential for a child's growth and development. Positive stress responses are infrequent, short-lived, and mild. Tolerable stress; the stress that can be tolerated is more severe, frequent, or persistent. The body responds to a greater degree, and these biochemical responses have the potential to negatively affect brain architecture. Toxic stress; toxic stress leads to prolonged stimulation of the stress response with the body's inability to fully recover(Bergman, 2019a; Weber \& Harrison, 2019). It differs from a normal stress response because there is a lack of caregiver support, reassurance, or emotional attachment. Inadequate caregiver support prevents the stress response from being supported or the body returning to its initial functions.This stress causes the development of many other problems in addition to the increase in the problems that will develop due to preterm birth in their future lives. Therefore, minimizing this stress is of vital importance for preterm infants and their families (WHO, 2017; Ylijoki et al., 2020).
Studies on stress are generally aimed at young children and infants. However, in the neonatal period, "especially in preterm babies", this issue was not given enough attention and was almost completely ignored. Researching this issue will help to make serious changes and corrections in the working principles of the neonatal intensive care unit. For this reason, this study was planned to determine the effects of Kangaroo Care (KC) and Maternal Odor on preterm infants on Toxic Stress and to create evidence-based recommendations about these practices in the NICU setting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This research; It was planned as a Randomized Controlled Experimental Study. In the study, the effect of kangaroo care and maternal odor, which are independent variables, on the toxic stress level of preterms, which is the dependent variable, was tried to be determined. The study was carried out NICU at Anka Hospital, in Gaziantep, Turkey. The sample calculation of the research was made using the "Jamovi 1.8" program. The significance level was taken as 0.05 according to the power analysis performed to determine the sufficient sample size, and it was calculated that at least 30 patients should be included in each patient group in order to have a minimum theoretical power of 0.7. The study was planned to be conducted with a total of 135 patients, with 45 patients in each group.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –families were not allowed to enter the NICU |
| Maternal Odor | Active comparator | Behavioral: Exposure to maternal odorBabies compared only to the mother's odor |
| Kangaroo care | Active comparator | Behavioral: Exposure to maternal odorBabies given kangaroo care |
Who may qualify
- Ages
- 1 minute to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm infants hospitalized in the NICU for at least 15 days (babies born less than 37 weeks of gestation, greater than 28 weeks of gestation and between 1000-2500 g), babies with a first-minute Apgar score of 7 and above, and with no feeding problems, and who do not have brain-pituitary-adrenal axis problems, babies without congenital defects, and without respiratory problems (endotracheal intubation, mechanical ventilation support or nasal continuous positive airway pressure application), and with no cardiological problems, and who have not undergone surgery, and who have been given kangaroo care by a neonatal specialist, and with no suspected or no sepsis diagnosis, who are not treated with analgesics, sedatives, muscle relaxants because it may affect/pressure the stress situation, and whose mothers do not have a mental and physical problem/condition/health problem that prevents them from giving kangaroo care
Key exclusion criteria (1 listed)
- constitute the research population, were determined as follows. Babies who had a health problem during the study and had a hospitalization period of less than 15 days in the NICU were excluded from the study
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 |
|---|---|---|
| Exposure to maternal odorAlso: Kangaroo careExposure to maternal odor; the shirt worn by the mother is put in the baby's incubator, kangaroo care; mother lays her baby naked between her breasts | Behavioural | Kangaroo care, Maternal Odor |
Primary outcome
Mother odor relieves stress
Time frame: 6 months
Exposing preterm infants to maternal odor reduces stress for infants in the NICU exposed to a various stressors.
1 secondary outcome
Kangaroo care relieves stress
Time frame: 2 months
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 7 Nov 2022.
- Individual participant dataSharing planned: Yes
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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.
Alev Sivasli principal investigator
Nisantasi University, İstanbul, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure to maternal odor in people with Preterm Birth Complication and Stress Related Disorder, run by Istanbul Nisantasi 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 1 inclusion and 1 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 7 Nov 2022. 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?
Mother odor relieves stress (time frame: 6 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 7 Nov 2022.