Kangaroo CareNCT04252547
Effect of Kangaroo Care on Test Weighing
A study testing Kangaroo Care in people with Kangaroo Care and Weight Gain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The study will be conducted with the Crossover Randomized Controlled Method. The infants who have attained oral feeding in the neonatal intensive care unit will be divided into two groups via randomization in the computer environment. Read more about this study
- Who is it for?
- Ages 32 to 40 weeksHealthy volunteers can take part
- Conditions the study is for
- Kangaroo Care, Weight Gain, Oxygen Saturation
- What is being tested?
- Kangaroo Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Jun 2024to 9 Jan 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 32 to 40 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Agreeing to participate in the study for parents.
- The inclusion criteria for infants were as follows;
- Attaining to oral feeding by the physician in the neonatal intensive care unit
- Being born at 26-36+6 gestational week which is determined according to the mother's last period cycle
- Being at 32-39+6 postmenstrual week during the time they are included in the study
- Having body weight of 1500 grams and above
- Being breastfed at least once
- Having no health problems other than being preterm
Who cannot join
- The exclusion criteria for infants were as follows;
- Suffering from gastrointestinal, neurological or genetic diseases (such as necrotizing enterocolitis, intracranial bleeding, hydrocephalia, omphalocele, down syndrome, gastroschisis) and other diseases
- Having a condition obstructing oral feeding (such as cleft palate, cleft lip, facial muscle paralysis, craniofacial abnormalities etc.)
- Receiving oxygen support
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Duygu Gözen, Assoc. Prof. contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medipol University
Istanbul, Istanbul
Canan Uzun, BSN, 05372828808, cananuzun5561@gmail.com
Duygu Gözen, Assoc. Prof., dgozen@istanbul.edu.tr
About this study
Official title: The Effect Of Kangaroo Mother Care On Test Weighing In Preterm Infants
The study will be conducted with the Crossover Randomized Controlled Method. The infants who have attained oral feeding in the neonatal intensive care unit will be divided into two groups via randomization in the computer environment. After the randomization, kangaroo care will be applied to the infants in Group 1 during the first feeding hour when they are included in the study and they will be breastfed by their mothers without any other application during the next feeding. On the other hand, no application will be performed on the infants in Group 2 during the first feeding hour when they are included in the study and kangaroo care will be applied to them during the second feeding hour. The infants in both groups will be breastfed by their mothers during the feeding hours.
Read the detailed description
Test weighing is a feeding evaluation method which is used for evaluating the increase in infant's body weight and the amount of food intake before and after breastfeeding. Each gram is evaluated to be equivalent to one cc breast milk. The aim of the study is to evaluate the effect of kangaroo care applied to the preterm infants that have attained oral feeding and are breastfed by their mothers, on their physiological parameters, feeding condition and body weight increase. After weighing the infant only in his/her diaper before the feeding and applying kangaroo care in which skin-to-skin contact will be provided for half an hour, the mother will breastfeed the infant. The infant will be weighed once again after the feeding without diaper change and the effect of kangaroo care on test weighing and physiological parameters during the feeding process will be evaluated. Sample size of the study has been determined by the power analysis, in line with the results obtained from the studies which have been conducted using a similar research method. According to the analysis results, it has been calculated as 23 for each group and 46 in total. Parents of the infants meeting the study inclusion criteria will be informed both in written and verbally and then the study will be conducted with mothers who agree to participate in the study with their infants.
- Conditions
- Kangaroo Care, Weight Gain, Oxygen Saturation, Heart Rate
- Being tested
- Kangaroo Care, Control
- Keywords
- kangaroo care, test weighing, Heart rate, oxygen saturation, preterm infants
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo CareOther
The preprocedural measurements (weight, heart rate, and oxygen saturation) will be recorded before the first feeding hour when they are included in the study and then they will be held on their mothers' chest for skin-to-skin kangaroo care for half an hour. Their heart rate and oxygen saturation will be recorded for half an hour. At the end of the kangaroo care, the infant will be breastfed by his/her mother. A chronometer will be started at that moment he/she begins sucking and terminated when he/she stops. The infant's heart rate and oxygen saturation will also continue to be recorded during the breastfeeding process. When the breastfeeding process is over, the infant will be allowed to rest in his/her mother's arms for two minutes and his/her physiological parameters will be recorded. Following the breastfeeding process, the infant will be weight is measured without a diaper change and his/her weight will be recorded. Then he/she will be taken back in the incubator to sleep.
ControlOther
The preprocedural measurements (weight, heart rate, and oxygen saturation) will be recorded before feeding when they are included in the study and then they will be breastfed by their mothers. The chronometer will be started at that moment he/she begins sucking and terminated when he/she stops. Also, the infant's heart rate and oxygen saturation will continue to be recorded during the breastfeeding process. When the breastfeeding process is over, the infant will be allowed to rest in his/her mother's arms for two minutes and his/her physiological parameters will be recorded. Following the breastfeeding process, the infant will be weighed without a diaper change and his/her weight will be recorded. When the care process is over, it will be taken back in the incubator to sleep.
| Study group | Role | What they receive |
|---|---|---|
| Grup 1 | Experimental | -"During the Procedure" Group 1 The preprocedural measurements(weight, heart rate and oxygen saturation ) will be applied to the infants in Group 1 before the first feeding hour when they are included in the study and then they will be held on their mothers' chest for skin-to-skin kangaroo care for half an hour. Their heart rate and oxygen saturation will be recorded for half an hour. At the end of the kangaroo care, the infant will be breastfed by his/her mother.
During the second feeding hour, his/her heart rate and oxygen saturation will begin to be recorded ten minutes before the feeding hour. The data will be recorded for ten minutes and then the infant will be taken out of the incubator and weight is measured only in his/her clean diaper. He/she will be handed over to the mother to breastfeed. Receives: Other: Kangaroo Care; Other: Control |
| Grup 2 | Experimental | - "During the Procedure" Group 2 The preprocedural measurements will be applied to the infants in Group 2 before the first feeding hour when they are included in the study and then they will be breastfed by their mothers.
The preprocedural measurements (weight, heart rate and oxygen saturation) will be applied to the infant during the second feeding hour and then he/she will be held on his/her mothers' chest for skin-to-skin kangaroo care for half an hour. Their heart rate and oxygen saturation will be recorded for half an hour. At the end of the kangaroo care, the infant will be breastfed by his/her mother. Receives: Other: Kangaroo Care; Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test Weighing
The infants' body weight before and after feeding will be measured using an 'Infant Scale'. The infants will be weighed naked only in their diaper before and after feeding, in order to evaluate the amount of milk they have received from their mothers' breast.
Measured: Change the body weight before feeding to after feeding at 1 day
Secondary outcomes (2)
Heart Rate
A device branded "Masimo Brand Radical 7 Pulse Oximetry" will be used to determine the infants' oxygen saturation and pulse rate. Heart rate of all the infants in Group 1 and Group 2 will begin to be recorded ten minutes before the first and second feeding hours when they are included in the study.
Measured: Change the Heart Rate 10 minutes before feeding to 2 minutes after feeding
Oxygen Saturation
A device branded "Masimo Brand Radical 7 Pulse Oximetry" will be used to determine the infants' oxygen saturation and pulse rate. Oxygen Saturation of all the infants in Group 1 and Group 2 will begin to be recorded ten minutes before the first and second feeding hours when they are included in the study.
Measured: Change the Oxygen Saturation 10 minutes before feeding to 2 minutes after feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start9 Jun 2024
- Primary completion9 Sep 2025 (estimated)
- Study completion9 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kangaroo CareStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Canan Genç, Istanbul University - Cerrahpasa
- Investigators
- Duygu Gözen, Assoc. Prof., Principal investigator, Istanbul University Cerrahpaşa Florence Nightingale Faculty of NursingAyhan Taştekin, prof., Principal investigator, Istanbul Medipol University, Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252547
- Sponsor's protocol ID
- 10840098-604.01.01-E.53511
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2020
- Last updated
- 2 May 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 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Kangaroo Mother Care On Test Weighing In Preterm Infants
- ClinicalTrials.gov ID
- NCT04252547
- Acronym / sponsor ID
- 10840098-604.01.01-E.53511
- Conditions
- Kangaroo Care, Weight Gain, Oxygen Saturation, Heart Rate
- Keywords
- kangaroo care, test weighing, Heart rate, oxygen saturation, preterm infants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 9 Jun 2024 (actual)
- Primary completion
- 9 Sep 2025 (estimated)
- Study completion
- 9 Jan 2026 (estimated)
- First posted
- 5 Feb 2020 (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 study will be conducted with the Crossover Randomized Controlled Method. The infants who have attained oral feeding in the neonatal intensive care unit will be divided into two groups via randomization in the computer environment. After the randomization, kangaroo care will be applied to the infants in Group 1 during the first feeding hour when they are included in the study and they will be breastfed by their mothers without any other application during the next feeding. On the other hand, no application will be performed on the infants in Group 2 during the first feeding hour when they are included in the study and kangaroo care will be applied to them during the second feeding hour. The infants in both groups will be breastfed by their mothers during the feeding hours.
Detailed description
Test weighing is a feeding evaluation method which is used for evaluating the increase in infant's body weight and the amount of food intake before and after breastfeeding. Each gram is evaluated to be equivalent to one cc breast milk. The aim of the study is to evaluate the effect of kangaroo care applied to the preterm infants that have attained oral feeding and are breastfed by their mothers, on their physiological parameters, feeding condition and body weight increase. After weighing the infant only in his/her diaper before the feeding and applying kangaroo care in which skin-to-skin contact will be provided for half an hour, the mother will breastfeed the infant. The infant will be weighed once again after the feeding without diaper change and the effect of kangaroo care on test weighing and physiological parameters during the feeding process will be evaluated. Sample size of the study has been determined by the power analysis, in line with the results obtained from the studies which have been conducted using a similar research method. According to the analysis results, it has been calculated as 23 for each group and 46 in total. Parents of the infants meeting the study inclusion criteria will be informed both in written and verbally and then the study will be conducted with mothers who agree to participate in the study with their infants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grup 1 | Experimental | Other: Kangaroo Care, Other: Control-"During the Procedure" Group 1 The preprocedural measurements(weight, heart rate and oxygen saturation ) will be applied to the infants in Group 1 before the first feeding hour when they are included in the study and then they will be held on their mothers' chest for skin-to-skin kangaroo care for half an hour. Their heart rate and oxygen saturation will be recorded for half an hour. At the end of the kangaroo care, the infant will be breastfed by his/her mother. During the second feeding hour, his/her heart rate and oxygen saturation will begin to be recorded ten minutes before the feeding hour. The data will be recorded for ten minutes and then the infant will be taken out of the incubator and weight is measured only in his/her clean diaper. He/she will be handed over to the mother to breastfeed. |
| Grup 2 | Experimental | Other: Kangaroo Care, Other: Control- "During the Procedure" Group 2 The preprocedural measurements will be applied to the infants in Group 2 before the first feeding hour when they are included in the study and then they will be breastfed by their mothers. The preprocedural measurements (weight, heart rate and oxygen saturation) will be applied to the infant during the second feeding hour and then he/she will be held on his/her mothers' chest for skin-to-skin kangaroo care for half an hour. Their heart rate and oxygen saturation will be recorded for half an hour. At the end of the kangaroo care, the infant will be breastfed by his/her mother. |
Who may qualify
- Ages
- 32 to 40 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Agreeing to participate in the study for parents.
- The inclusion criteria for infants were as follows;
- Attaining to oral feeding by the physician in the neonatal intensive care unit
- Being born at 26-36+6 gestational week which is determined according to the mother's last period cycle
- Being at 32-39+6 postmenstrual week during the time they are included in the study
Key exclusion criteria (4 listed)
- The exclusion criteria for infants were as follows;
- Suffering from gastrointestinal, neurological or genetic diseases (such as necrotizing enterocolitis, intracranial bleeding, hydrocephalia, omphalocele, down syndrome, gastroschisis) and other diseases
- Having a condition obstructing oral feeding (such as cleft palate, cleft lip, facial muscle paralysis, craniofacial abnormalities etc.)
- Receiving oxygen support
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 CareThe preprocedural measurements (weight, heart rate, and oxygen saturation) will be recorded before the first feeding hour when they are included in the study and then they will be held on their mothers' chest for skin-to-skin kangaroo care for half an hour. Their heart rate and oxygen saturation will be recorded for half an hour. At the end of the kangaroo care, the infant will be breastfed by his/her mother. A chronometer will be started at that moment he/she begins sucking and terminated when he/she stops. The infant's heart rate and oxygen saturation will also continue to be recorded during the breastfeeding process. When the breastfeeding process is over, the infant will be allowed to rest in his/her mother's arms for two minutes and his/her physiological parameters will be recorded. Following the breastfeeding process, the infant will be weight is measured without a diaper change and his/her weight will be recorded. Then he/she will be taken back in the incubator to sleep. | Other | Grup 1, Grup 2 |
| ControlThe preprocedural measurements (weight, heart rate, and oxygen saturation) will be recorded before feeding when they are included in the study and then they will be breastfed by their mothers. The chronometer will be started at that moment he/she begins sucking and terminated when he/she stops. Also, the infant's heart rate and oxygen saturation will continue to be recorded during the breastfeeding process. When the breastfeeding process is over, the infant will be allowed to rest in his/her mother's arms for two minutes and his/her physiological parameters will be recorded. Following the breastfeeding process, the infant will be weighed without a diaper change and his/her weight will be recorded. When the care process is over, it will be taken back in the incubator to sleep. | Other | Grup 1, Grup 2 |
Primary outcome
Test Weighing
Time frame: Change the body weight before feeding to after feeding at 1 day
The infants' body weight before and after feeding will be measured using an 'Infant Scale'. The infants will be weighed naked only in their diaper before and after feeding, in order to evaluate the amount of milk they have received from their mothers' breast.
2 secondary outcomes
Heart Rate
Time frame: Change the Heart Rate 10 minutes before feeding to 2 minutes after feeding
Oxygen Saturation
Time frame: Change the Oxygen Saturation 10 minutes before feeding to 2 minutes after feeding
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 May 2025.
Related trials for Kangaroo Care
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Maternal Sensory Interventions in Newborns
Neonatal Intensive Care Unit, Hospitalized Newborn
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Admission to Kangaroo Mother Care (KMC) Ward and Maternal Postpartum Depression
Low Birth Weight, Kangaroo Mother Care
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The Effect of Kangaroo Care on Pain in Infants Receiving Phototherapy
Procedural Pain, Neonatal Hyperbilirubinemia
Not yet recruiting
The Effect of the Side Kangaroo Position in Newborns Undergoing Noninvasive Mechanical Ventilation
Newborn Care
Active, not recruiting
Effect of Kangaroo Mother Care on Energy Utilization in Preterm Neonates
Impact of Kangroo on Neonates
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.
Duygu Gözen, Assoc. Prof. contact
Duygu Gözen, Assoc. Prof. principal investigator
Istanbul University Cerrahpaşa Florence Nightingale Faculty of Nursing
Ayhan Taştekin, prof. principal investigator
Istanbul Medipol University, Pediatrics
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 in people with Kangaroo Care and Weight Gain, run by Istanbul University - Cerrahpasa 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 8 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: looking for participants now, as of the sponsor's last update on 2 May 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 Canan Genç, BSN ((0216) 910 19 07, cananuzun5561@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test Weighing (time frame: Change the body weight before feeding to after feeding at 1 day). 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 May 2025.