Infant, PrematureKCareInfantNCT07045402
Effect of Developmental Care on Comfort, Growth, and Oral Feeding Transition in Preterm Infants
A study testing Kangaroo Care + Maternal Voice + Fetal Position Group in people with Infant, Premature and Kangaroo Mother Care, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study aims to evaluate the effects of kangaroo care combined with maternal voice and fetal positioning on the comfort, growth, and transition to full oral feeding in preterm infants aged 30 to 34 weeks gestation. Read more about this study
- Who is it for?
- Ages 30 to 34 weeksHealthy volunteers can take part
- Conditions the study is for
- Infant, Premature, Kangaroo Mother Care, Comfort
- What is being tested?
- Kangaroo Care + Maternal Voice + Fetal Position Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2025to 10 Mar 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 30 to 34 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants with a gestational age between 30-34 weeks.
- The mother's ability to read and write.
- The infant must be fully enterally fed at the time of enrollment in the study.
- Infants who are being fed via orogastric tube at the time of enrollment.
- Infants whose mothers agree to engage in skin-to-skin contact for 1 hour, five sessions per week, with auditory stimulation (storytelling) for 15 minutes will be included in the study.
- Infants whose mothers cannot participate in the study (due to health issues or other reasons) or refuse kangaroo care will be placed in the control group, where routine service care will be applied.
Who cannot join
- Presence of a congenital anomaly or genetic disease.
- Requirement of ventilator support.
- Infants receiving antibiotics for sepsis or suspected sepsis.
- Administration of sedative treatment.
- Having an intracranial hemorrhage greater than grade II.
- The mother having a physical condition that prevents skin-to-skin contact.
- The mother using substances or alcohol.
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, 1 recruiting
- Recruiting
Fenerbahce University
Istanbul
About this study
Official title: The Effect of Kangaroo Care and Maternal Voice on Comfort, Anthropometric Measurements, and Transition to Oral Feeding in Preterm Infants
This randomized controlled study aims to evaluate the effects of kangaroo care combined with maternal voice and fetal positioning on the comfort, growth, and transition to full oral feeding in preterm infants aged 30 to 34 weeks gestation. After ethical approval, eligible infants in the neonatal clinic will be randomly assigned to either the intervention group receiving kangaroo care, maternal voice, and fetal positioning, or a control group receiving only fetal positioning in the incubator. The intervention involves daily one-hour kangaroo care sessions with maternal storytelling, followed by positioning in the lateral fetal posture, continuing at least five days per week until infants achieve full oral feeding. Infant comfort will be assessed regularly using the Neonatal Comfort Behavior Scale before feeding, immediately after kangaroo care, and after fetal positioning. Growth parameters, including weight, length, and head circumference, will be measured and recorded on kangaroo care days. The control group will receive routine fetal positioning without kangaroo care, with identical measurements taken. The study aims to determine whether kangaroo care combined with maternal voice and fetal positioning improves infant comfort, supports growth, and facilitates the transition to full oral feeding in preterm newborns.
Read the detailed description
After obtaining ethical approval for the study, all infants with a gestational age between 30 and 34 weeks in the Neonatal Clinic will be evaluated. After the infants are assigned to groups, the data collection phase will begin.
Before data collection, the researcher will provide necessary information about the study to the families of eligible newborns and answer their questions. Infants whose parents give written consent to participate will be included in the study. Information on the newborn and parent introductory information form will be recorded by the researcher. All procedures will be conducted between 08:00 and 16:00.
Group 1: Infants Receiving Kangaroo Care (Kangaroo Care + Mother's Voice + Fetal Position Group): Infants in this group, once clinically stable, will receive kangaroo care with their mothers for one hour immediately after enteral feeding at least five days a week until they transition to full oral feeding. During the first 15 minutes of skin-to-skin contact, the mother will read a story to the baby. After kangaroo care, infants will be placed in the incubator and positioned in the lateral fetal position for half an hour. During this process, interventions will be minimized unless necessary.
Until full oral feeding is achieved, comfort will be assessed using the Neonatal Comfort Behavior Scale at least five days a week, once daily: before feeding, immediately before ending kangaroo care (at 60 minutes), and 30 minutes after fetal positioning (at 90 minutes).
On the mornings of kangaroo care days, before feeding, the infant's growth will be evaluated: the infant will be weighed naked using a digital baby scale sensitive to ±10 grams; length and head circumference will be measured with a non-stretchable measuring tape and recorded.
Group 2: Control Group (Fetal Position Group): Infants in this group, whose mothers are not able to attend, will be placed in the incubator in the lateral fetal position for one and a half hours immediately after enteral feeding at least five days a week until full oral feeding is achieved.
The same measurements performed in the Kangaroo Care Group will be conducted and recorded for infants in this group until full oral feeding transition.
- Conditions
- Infant, Premature, Kangaroo Mother Care, Comfort, Feeding, Oral Feeding Performance, Facilitated Tucking
- Being tested
- Kangaroo Care + Maternal Voice + Fetal Position Group, control group
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo Care + Maternal Voice + Fetal Position GroupOther
After ethical approval, all infants with a gestational age between 30-34 weeks in Neonatal Intensive Care Unit will be assessed. Parents of eligible infants will be informed about the study and asked to provide written consent. The infants will then be assigned to one of two groups: kangaroo care + mother's voice + fetal position (n=34) or fetal position only (n=34). In the first group, after tube feeding, infants will receive one hour of kangaroo care with the mother, including reading a story for the first 15 minutes. After finishing kangaroo care,they will then be placed in a fetal position in an incubator for 30 minutes. Comfort levels, weight, length, and head circumference will be measured daily until oral feeding begins, and the impact of kangaroo care and the mother's voice on the transition to full oral feeding will be assessed. All procedures will occur between 08:00 and 16:00.
control groupOther
After ethical approval, all infants with a gestational age between 30-34 weeks in the Neonatal Intensıve Care Unit will be assessed. Parents of eligible infants will be informed about the study and asked to provide written consent. If infant is in the fetal position group, after being fed by a oral gastric tube, they will be placed in an incubator and positioned in a fetal position similar to that in the womb for one and a half hours. During all these procedures, infant's comfort levels will be assessed using a scale (form), and their weight, length, and head circumference will be measured every morning until they begin oral feeding. Additionally, the effect of the fetal position on infant's transition to full oral feeding will be evaluated.All procedures will take place between 08:00 and 16:00.
| Study group | Role | What they receive |
|---|---|---|
| Kangaroo Care + Maternal Voice + Fetal Position Group | Experimental | Infants in this group, once clinically stable, will receive kangaroo care with their mothers for one hour, at least five days a week, immediately after their enteral feeding until they transition to full oral feeding. During the first 15 minutes of skin-to-skin contact, the mother will tell a story to the infant. After the kangaroo care, the infants will be placed in an incubator, and a lateral fetal position will be maintained for half an hour. During this process, no intervention will be made unless necessary.
Until the infant transitions to full oral feeding, comfort will be assessed once a day, at least five days a week, using the Neonatal Comfort Behavior Scale: before feeding, immediately before finishing kangaroo care (at 60 minutes), and 30 minutes after the fetal position (at 90 minutes). On the days kangaroo care is applied, before feeding, the infant will be weighed using a ±10-gram sensitive digital baby scale, and their length and head circumference will be measured with Receives: Other: Kangaroo Care + Maternal Voice + Fetal Position Group |
| Control Group: (Fetal Position group) | Active comparator | Infants in this group, whose mothers are unavailable, will receive only lateral fetal positioning for one and a half hours immediately after their enteral feeding, at least five days a week, until they transition to full oral feeding, in the incubator.
Until the infant transitions to full oral feeding, the same measurements will be taken and recorded as those for the Kangaroo Group. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort
The scale is a Likert-type tool developed to assess the sedation and comfort needs, as well as pain and distress levels, of newborns monitored in intensive care units. The Numeric Rating Scales are based on the caregiver nurse's observations. Each item on the scale is scored from 1 to 5, and the total score is used for evaluation. The minimum possible score on the Neonatal Comfort Behavior Scale is 6, and the maximum is 30. A total score between 9 and 13 indicates that the infant is comfortable, while a score between 14 and 30 suggests that the infant is experiencing pain or distress, is uncomfortable, and requires comfort-providing interventions.
Measured: Until full oral feeding is achieved, evaluations will be conducted at least five days a week, once a day, at the following time points: before feeding, immediately before ending kangaroo care (at the 60th minute), and 30 minutes after placing the infant.
Transition to Oral Feeding
The time from the infant's inclusion in the study until the transition to full oral feeding will be evaluated.
Measured: From the date of study enrollment until the date of transition to full oral feeding, assessed for up to 8 weeks.
Secondary outcomes (1)
Anthropometric measurements
On the mornings of the days when kangaroo care will be applied, the infant's growth and development will be assessed before feeding. The baby will be weighed naked using a digital baby scale with ±10 grams sensitivity. Body length and head circumference will be measured using a non-flexible measuring tape.
Measured: From the first day of the intervention until the end of the 4-week study period, measurements will be taken at 9:00 a.m. prior to feeding on each day kangaroo care is provided.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start10 Feb 2025
- Primary completion10 Feb 2026 (estimated)
- Study completion10 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, PrematureStudies of the same condition, open and under way.
- More trials run by Fenerbahce 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Negarin Akbari, Fenerbahce University
- Investigators
- Canan GENÇ, Ph.D student, Principal investigator, Fenerbahce UniversityDuygu Gözen, Ph.D, Study chair, Koç UniversityNEGARIN Akbari, Ph.D, Study chair, Fenerbahce UniversityMelek Selalmaz, Ms.c, Principal investigator, ŞİŞLİ HAMİDİYE ETFAL TRAINING AND RESEARCH HOSPITALAli Bulbul, Doctor, Principal investigator, ŞİŞLİ HAMİDİYE ETFAL TRAINING AND RESEARCH HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045402
- Sponsor's protocol ID
- 4507
- Acronym
- KCareInfant
- Status last verified
- Sep 2025
- First submitted
- 4 Jun 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kangaroo Care and Maternal Voice on Comfort, Anthropometric Measurements, and Transition to Oral Feeding in Preterm Infants
- ClinicalTrials.gov ID
- NCT07045402
- Acronym / sponsor ID
- KCareInfant / 4507
- Conditions
- Infant, Premature, Kangaroo Mother Care, Comfort, Feeding, Oral Feeding Performance, Facilitated Tucking
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 10 Feb 2026 (estimated)
- Study completion
- 10 Mar 2026 (estimated)
- First posted
- 1 Jul 2025 (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.
This randomized controlled study aims to evaluate the effects of kangaroo care combined with maternal voice and fetal positioning on the comfort, growth, and transition to full oral feeding in preterm infants aged 30 to 34 weeks gestation. After ethical approval, eligible infants in the neonatal clinic will be randomly assigned to either the intervention group receiving kangaroo care, maternal voice, and fetal positioning, or a control group receiving only fetal positioning in the incubator. The intervention involves daily one-hour kangaroo care sessions with maternal storytelling, followed by positioning in the lateral fetal posture, continuing at least five days per week until infants achieve full oral feeding. Infant comfort will be assessed regularly using the Neonatal Comfort Behavior Scale before feeding, immediately after kangaroo care, and after fetal positioning. Growth parameters, including weight, length, and head circumference, will be measured and recorded on kangaroo care days. The control group will receive routine fetal positioning without kangaroo care, with identical measurements taken. The study aims to determine whether kangaroo care combined with maternal voice and fetal positioning improves infant comfort, supports growth, and facilitates the transition to full oral feeding in preterm newborns.
Detailed description
After obtaining ethical approval for the study, all infants with a gestational age between 30 and 34 weeks in the Neonatal Clinic will be evaluated. After the infants are assigned to groups, the data collection phase will begin.
Before data collection, the researcher will provide necessary information about the study to the families of eligible newborns and answer their questions. Infants whose parents give written consent to participate will be included in the study. Information on the newborn and parent introductory information form will be recorded by the researcher. All procedures will be conducted between 08:00 and 16:00.
Group 1: Infants Receiving Kangaroo Care (Kangaroo Care + Mother's Voice + Fetal Position Group): Infants in this group, once clinically stable, will receive kangaroo care with their mothers for one hour immediately after enteral feeding at least five days a week until they transition to full oral feeding. During the first 15 minutes of skin-to-skin contact, the mother will read a story to the baby. After kangaroo care, infants will be placed in the incubator and positioned in the lateral fetal position for half an hour. During this process, interventions will be minimized unless necessary.
Until full oral feeding is achieved, comfort will be assessed using the Neonatal Comfort Behavior Scale at least five days a week, once daily: before feeding, immediately before ending kangaroo care (at 60 minutes), and 30 minutes after fetal positioning (at 90 minutes).
On the mornings of kangaroo care days, before feeding, the infant's growth will be evaluated: the infant will be weighed naked using a digital baby scale sensitive to ±10 grams; length and head circumference will be measured with a non-stretchable measuring tape and recorded.
Group 2: Control Group (Fetal Position Group): Infants in this group, whose mothers are not able to attend, will be placed in the incubator in the lateral fetal position for one and a half hours immediately after enteral feeding at least five days a week until full oral feeding is achieved.
The same measurements performed in the Kangaroo Care Group will be conducted and recorded for infants in this group until full oral feeding transition.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kangaroo Care + Maternal Voice + Fetal Position Group | Experimental | Other: Kangaroo Care + Maternal Voice + Fetal Position GroupInfants in this group, once clinically stable, will receive kangaroo care with their mothers for one hour, at least five days a week, immediately after their enteral feeding until they transition to full oral feeding. During the first 15 minutes of skin-to-skin contact, the mother will tell a story to the infant. After the kangaroo care, the infants will be placed in an incubator, and a lateral fetal position will be maintained for half an hour. During this process, no intervention will be made unless necessary. Until the infant transitions to full oral feeding, comfort will be assessed once a day, at least five days a week, using the Neonatal Comfort Behavior Scale: before feeding, immediately before finishing kangaroo care (at 60 minutes), and 30 minutes after the fetal position (at 90 minutes). On the days kangaroo care is applied, before feeding, the infant will be weighed using a ±10-gram sensitive digital baby scale, and their length and head circumference will be measured with |
| Control Group: (Fetal Position group) | Active comparator | Other: control groupInfants in this group, whose mothers are unavailable, will receive only lateral fetal positioning for one and a half hours immediately after their enteral feeding, at least five days a week, until they transition to full oral feeding, in the incubator. Until the infant transitions to full oral feeding, the same measurements will be taken and recorded as those for the Kangaroo Group. |
Who may qualify
- Ages
- 30 to 34 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Infants with a gestational age between 30-34 weeks.
- The mother's ability to read and write.
- The infant must be fully enterally fed at the time of enrollment in the study.
- Infants who are being fed via orogastric tube at the time of enrollment.
- Infants whose mothers agree to engage in skin-to-skin contact for 1 hour, five sessions per week, with auditory stimulation (storytelling) for 15 minutes will be included in the study.
Key exclusion criteria (7 listed)
- Presence of a congenital anomaly or genetic disease.
- Requirement of ventilator support.
- Infants receiving antibiotics for sepsis or suspected sepsis.
- Administration of sedative treatment.
- Having an intracranial hemorrhage greater than grade II.
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 |
|---|---|---|
| Kangaroo Care + Maternal Voice + Fetal Position GroupAfter ethical approval, all infants with a gestational age between 30-34 weeks in Neonatal Intensive Care Unit will be assessed. Parents of eligible infants will be informed about the study and asked to provide written consent. The infants will then be assigned to one of two groups: kangaroo care + mother's voice + fetal position (n=34) or fetal position only (n=34). In the first group, after tube feeding, infants will receive one hour of kangaroo care with the mother, including reading a story for the first 15 minutes. After finishing kangaroo care,they will then be placed in a fetal position in an incubator for 30 minutes. Comfort levels, weight, length, and head circumference will be measured daily until oral feeding begins, and the impact of kangaroo care and the mother's voice on the transition to full oral feeding will be assessed. All procedures will occur between 08:00 and 16:00. | Other | Kangaroo Care + Maternal Voice + Fetal Position Group |
| control groupAfter ethical approval, all infants with a gestational age between 30-34 weeks in the Neonatal Intensıve Care Unit will be assessed. Parents of eligible infants will be informed about the study and asked to provide written consent. If infant is in the fetal position group, after being fed by a oral gastric tube, they will be placed in an incubator and positioned in a fetal position similar to that in the womb for one and a half hours. During all these procedures, infant's comfort levels will be assessed using a scale (form), and their weight, length, and head circumference will be measured every morning until they begin oral feeding. Additionally, the effect of the fetal position on infant's transition to full oral feeding will be evaluated.All procedures will take place between 08:00 and 16:00. | Other | Control Group: (Fetal Position group) |
Primary outcome
Comfort
Time frame: Until full oral feeding is achieved, evaluations will be conducted at least five days a week, once a day, at the following time points: before feeding, immediately before ending kangaroo care (at the 60th minute), and 30 minutes after placing the infant.
The scale is a Likert-type tool developed to assess the sedation and comfort needs, as well as pain and distress levels, of newborns monitored in intensive care units. The Numeric Rating Scales are based on the caregiver nurse's observations. Each item on the scale is scored from 1 to 5, and the total score is used for evaluation. The minimum possible score on the Neonatal Comfort Behavior Scale is 6, and the maximum is 30. A total score between 9 and 13 indicates that the infant is comfortable, while a score between 14 and 30 suggests that the infant is experiencing pain or distress, is uncomfortable, and requires comfort-providing interventions.
Transition to Oral Feeding
Time frame: From the date of study enrollment until the date of transition to full oral feeding, assessed for up to 8 weeks.
The time from the infant's inclusion in the study until the transition to full oral feeding will be evaluated.
1 secondary outcome
Anthropometric measurements
Time frame: From the first day of the intervention until the end of the 4-week study period, measurements will be taken at 9:00 a.m. prior to feeding on each day kangaroo care is provided.
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 4 Sep 2025.
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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.
Canan GENÇ, Ph.D student principal investigator
Fenerbahce University
Duygu Gözen, Ph.D study chair
Koç University
NEGARIN Akbari, Ph.D study chair
Fenerbahce 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 Kangaroo Care + Maternal Voice + Fetal Position Group in people with Infant, Premature and Kangaroo Mother Care, run by Fenerbahce 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: looking for participants now, as of the sponsor's last update on 4 Sep 2025. 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 Negarin Akbari, Ph.D (00905352679510, negarin.akbari@fbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comfort (time frame: Until full oral feeding is achieved, evaluations will be conducted at least five days a week, once a day, at the following time points: before feeding, immediately before ending kangaroo care (at the 60th minute), and 30 minutes after placing the infant.). The study lists 2 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 4 Sep 2025.