Infant ALLNCT06400446
The Effect of Kangaroo Care After Cardiac Surgery
A study testing Kangaroo care in people with Infant ALL, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effects of kangaroo care on the vital signs of infants undergoing cardiac surgery. Hypothesis 1 (H1): Oxygen saturation levels of babies who are given kangaroo care are higher than babies who are not given kangaroo care. Read more about this study
- Who is it for?
- Ages 1 day to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Infant ALL
- What is being tested?
- Kangaroo care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Nov 2023to 20 May 2024
- 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 day to 30 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The gestational week of the infant is greater than 37 weeks
- Cardiac surgery operation within the first 30 days of life
- The infant's chest incision is closed
Who cannot join
- The infant has non-cardiac congenital defects or syndrome
- Intubation of the infant
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Selvinaz Albayrak
Istanbul, Zeytinburnu, 34360
Dilara Cengizli, Nurse, +905437636949, dilara.cengizli@stu.istinye.edu.tr
About this study
Official title: The Effect of Kangaroo Care on Vital Signs of Infants After Cardiac Surgery
The aim of this study was to investigate the effects of kangaroo care on the vital signs of infants undergoing cardiac surgery.
Hypothesis 1 (H1): Oxygen saturation levels of babies who are given kangaroo care are higher than babies who are not given kangaroo care.
Read more
Hypothesis 2 (H2): The peak heart rate of infants who receive kangaroo care is lower than infants who do not receive kangaroo care.
Hypothesis 3 (H3): The respiratory rate of infants who receive kangaroo care is lower than infants who do not receive kangaroo care.
Hypothesis 4 (H4): The arterial blood pressure of infants who receive kangaroo care is lower than infants who do not receive kangaroo care.
Hypothesis 5 (H5): The pain score of infants who received kangaroo care is lower than infants who did not receive kangaroo care.
Read the detailed description
Kangaroo care has been found to be a feasible intervention before and after cardiac surgery to support infants with congenital heart disease, but it has been stated that formal standards and procedures need to be developed to transform kangaroo care into practice. Skin-to-skin contact is a low-cost, low-risk intervention that supports comfort and contributes to physiological stability in infants before and after neonatal cardiac surgery. It positively affects the pain level of infants. Clinical studies on the application of kangaroo mother care on infants undergoing cardiac surgery are limited in the literature.
- Conditions
- Infant ALL
- Being tested
- Standard care, Kangaroo care
- Keywords
- Kangaroo care, Infant, Cardiac surgery, Vital signs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard careOther
The babies in this group will receive the standard care of the unit. The vital signs and pain scores of the babies will be recorded before the mother's visit for seven days. The vital signs and pain scores of the infants who received the standard care of the unit during one hour, which is the time of the mother's visit, will be recorded every 15 minutes for a total of 4 times. The vital signs and pain scores of the infant will be recorded in the first 15 minutes after the mother's visit.
Kangaroo careOther
Kangaroo care will be applied to the experimental group for seven days. Kangaroo care will be started for the babies in the intervention group when the baby is extubated, when the baby starts oral feeding and when the chest incision is closed. Consistent with previous research, mothers will provide skin-to-skin contact for at least 1 hour per day for seven days, starting immediately after feeding. The vital signs and pain scores of the babies will be recorded during the kangaroo care of the mother for seven days. During the kangaroo care, vital signs and pain scores of the infants will be recorded every 15 minutes for a total of 4 times. The vital signs and pain scores of the infant will be recorded in the first 15 minutes after the mother's visit.
| Study group | Role | What they receive |
|---|---|---|
| Control group (standard care) | Other | The babies in this group will receive the standard care of the unit. Receives: Other: Standard care |
| Experimental group (Kangaroo care) | Experimental | Kangaroo care will be applied to the experimental group for seven days. Receives: Other: Kangaroo care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in oxygen saturation
Oxygen saturation will be monitored.
Measured: Data will be collected immediately before care is given, at 15 minutes during care, and at 15 minutes after care is given. The change in these time intervals will be evaluated.
Change in heart rate
Heart rate will be monitored.
Measured: Data will be collected immediately before care is given, at 15 minutes during care, and at 15 minutes after care is given. The change in these time intervals will be evaluated.
Change in respiratory rate
Respiratory rate will be monitored.
Measured: Data will be collected immediately before care is given, at 15 minutes during care, and at 15 minutes after care is given. The change in these time intervals will be evaluated.
Change in blood pressure
Blood pressure will be monitored.
Measured: Data will be collected immediately before care is given, at 15 minutes during care, and at 15 minutes after care is given. The change in these time intervals will be evaluated.
Change in level of pain
The infants' pain level will be measured using the CRIES(Crying, Requires O2, Increased vital signs,Expression, Sleepless). The scale is used in the evaluation of postoperative pain in premature babies (between 32-36 weeks of gestation) and postoperative pain. Starting from the thirty-second gestational week, it is preferred in neonates and children between 6 months, especially in intensive care units.The Scale was developed by Krechel \& Bildner, 1995. Crying status, oxygen saturation, heart rate and/or blood pressure, facial expression and sleep status are the parameters used in the evaluation. Each parameter is scored out of two; a score of 3-4 indicates mild to moderate pain; values of five and above indicate severe pain.
Measured: Data will be collected immediately before care is given, at 15 minutes during care, and at 15 minutes after care is given. The change in these time intervals will be evaluated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start19 Nov 2023
- Primary completion20 May 2024 (estimated)
- Study completion20 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infant ALLStudies of the same condition, open and under way.
- More trials run by Istinye 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dilara Cengizli, Nurse, Principal investigator, Istanbul Health Sciences University Mehmet Akif Ersoy Chest Heart and Vascular Surgery Training and Research Hospital Paediatric Cardiovascular Surgery Intensive Care Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400446
- Sponsor's protocol ID
- ISU-23-259
- Status last verified
- Apr 2024
- First submitted
- 1 May 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Solaz-Garcia A, Lara-Canton I, Pinilla-Gonzalez A, Montejano-Lozoya R, Gimeno-Navarro A, Sanchez-Illana A, Marco-Pinol A, Vento M, Saenz-Gonzalez P. Impact of Kangaroo Care on Premature Infants' Oxygenation: Systematic Review. Neonatology. 2022;119(5):537-546. doi: 10.1159/000525014. Epub 2022 Jun 22.
PubMed 35732143Kelley-Quon LI, Kenney BD, Bartman T, Thomas R, Robinson V, Nwomeh BC, Bapat R. Safety and feasibility of skin-to-skin care for surgical infants: A quality improvement project. J Pediatr Surg. 2019 Nov;54(11):2428-2434. doi: 10.1016/j.jpedsurg.2019.02.016. Epub 2019 Feb 28.
PubMed 30879741Lisanti AJ, Vittner D, Medoff-Cooper B, Fogel J, Wernovsky G, Butler S. Individualized Family-Centered Developmental Care: An Essential Model to Address the Unique Needs of Infants With Congenital Heart Disease. J Cardiovasc Nurs. 2019 Jan/Feb;34(1):85-93. doi: 10.1097/JCN.0000000000000546.
PubMed 30303895
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kangaroo Care on Vital Signs of Infants After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06400446
- Acronym / sponsor ID
- ISU-23-259
- Conditions
- Infant ALL
- Keywords
- Kangaroo care, Infant, Cardiac surgery, Vital signs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 19 Nov 2023 (actual)
- Primary completion
- 20 May 2024 (estimated)
- Study completion
- 20 May 2024 (estimated)
- First posted
- 6 May 2024 (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 aim of this study was to investigate the effects of kangaroo care on the vital signs of infants undergoing cardiac surgery.
Hypothesis 1 (H1): Oxygen saturation levels of babies who are given kangaroo care are higher than babies who are not given kangaroo care.
Hypothesis 2 (H2): The peak heart rate of infants who receive kangaroo care is lower than infants who do not receive kangaroo care.
Hypothesis 3 (H3): The respiratory rate of infants who receive kangaroo care is lower than infants who do not receive kangaroo care.
Hypothesis 4 (H4): The arterial blood pressure of infants who receive kangaroo care is lower than infants who do not receive kangaroo care.
Hypothesis 5 (H5): The pain score of infants who received kangaroo care is lower than infants who did not receive kangaroo care.
Detailed description
Kangaroo care has been found to be a feasible intervention before and after cardiac surgery to support infants with congenital heart disease, but it has been stated that formal standards and procedures need to be developed to transform kangaroo care into practice. Skin-to-skin contact is a low-cost, low-risk intervention that supports comfort and contributes to physiological stability in infants before and after neonatal cardiac surgery. It positively affects the pain level of infants. Clinical studies on the application of kangaroo mother care on infants undergoing cardiac surgery are limited in the literature.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (standard care) | Other | Other: Standard careThe babies in this group will receive the standard care of the unit. |
| Experimental group (Kangaroo care) | Experimental | Other: Kangaroo careKangaroo care will be applied to the experimental group for seven days. |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The gestational week of the infant is greater than 37 weeks
- Cardiac surgery operation within the first 30 days of life
- The infant's chest incision is closed
Key exclusion criteria (2 listed)
- The infant has non-cardiac congenital defects or syndrome
- Intubation of the infant
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 |
|---|---|---|
| Standard careThe babies in this group will receive the standard care of the unit. The vital signs and pain scores of the babies will be recorded before the mother's visit for seven days. The vital signs and pain scores of the infants who received the standard care of the unit during one hour, which is the time of the mother's visit, will be recorded every 15 minutes for a total of 4 times. The vital signs and pain scores of the infant will be recorded in the first 15 minutes after the mother's visit. | Other | Control group (standard care) |
| Kangaroo careKangaroo care will be applied to the experimental group for seven days. Kangaroo care will be started for the babies in the intervention group when the baby is extubated, when the baby starts oral feeding and when the chest incision is closed. Consistent with previous research, mothers will provide skin-to-skin contact for at least 1 hour per day for seven days, starting immediately after feeding. The vital signs and pain scores of the babies will be recorded during the kangaroo care of the mother for seven days. During the kangaroo care, vital signs and pain scores of the infants will be recorded every 15 minutes for a total of 4 times. The vital signs and pain scores of the infant will be recorded in the first 15 minutes after the mother's visit. | Other | Experimental group (Kangaroo care) |
Primary outcome
Change in oxygen saturation
Time frame: Data will be collected immediately before care is given, at 15 minutes during care, and at 15 minutes after care is given. The change in these time intervals will be evaluated.
Oxygen saturation will be monitored.
Change in heart rate
Time frame: Data will be collected immediately before care is given, at 15 minutes during care, and at 15 minutes after care is given. The change in these time intervals will be evaluated.
Heart rate will be monitored.
Change in respiratory rate
Time frame: Data will be collected immediately before care is given, at 15 minutes during care, and at 15 minutes after care is given. The change in these time intervals will be evaluated.
Respiratory rate will be monitored.
Change in blood pressure
Time frame: Data will be collected immediately before care is given, at 15 minutes during care, and at 15 minutes after care is given. The change in these time intervals will be evaluated.
Blood pressure will be monitored.
Change in level of pain
Time frame: Data will be collected immediately before care is given, at 15 minutes during care, and at 15 minutes after care is given. The change in these time intervals will be evaluated.
The infants' pain level will be measured using the CRIES(Crying, Requires O2, Increased vital signs,Expression, Sleepless). The scale is used in the evaluation of postoperative pain in premature babies (between 32-36 weeks of gestation) and postoperative pain. Starting from the thirty-second gestational week, it is preferred in neonates and children between 6 months, especially in intensive care units.The Scale was developed by Krechel \& Bildner, 1995. Crying status, oxygen saturation, heart rate and/or blood pressure, facial expression and sleep status are the parameters used in the evaluation. Each parameter is scored out of two; a score of 3-4 indicates mild to moderate pain; values of five and above indicate severe pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Results publication: PubMed 35732143Solaz-Garcia A, Lara-Canton I, Pinilla-Gonzalez A, Montejano-Lozoya R, Gimeno-Navarro A, Sanchez-Illana A, Marco-Pinol A, Vento M, Saenz-Gonzalez P. Impact of Kangaroo Care on Premature Infants' Oxygenation: Systematic Review. Neonatology. 2022;119(5):537-546. doi: 10.1159/000525014. Epub 2022 Jun 22.
- Results publication: PubMed 30879741Kelley-Quon LI, Kenney BD, Bartman T, Thomas R, Robinson V, Nwomeh BC, Bapat R. Safety and feasibility of skin-to-skin care for surgical infants: A quality improvement project. J Pediatr Surg. 2019 Nov;54(11):2428-2434. doi: 10.1016/j.jpedsurg.2019.02.016. Epub 2019 Feb 28.
- Results publication: PubMed 30303895Lisanti AJ, Vittner D, Medoff-Cooper B, Fogel J, Wernovsky G, Butler S. Individualized Family-Centered Developmental Care: An Essential Model to Address the Unique Needs of Infants With Congenital Heart Disease. J Cardiovasc Nurs. 2019 Jan/Feb;34(1):85-93. doi: 10.1097/JCN.0000000000000546.
- Individual participant dataSharing planned: No
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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.
Dilara Cengizli, Nurse principal investigator
Istanbul Health Sciences University Mehmet Akif Ersoy Chest Heart and Vascular Surgery Training and Research Hospital Paediatric Cardiovascular Surgery Intensive Care Unit
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 Infant ALL, run by Istinye 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Selvinaz Albayrak, Asst Prof (+905438708905, selvinaz.albayrak@istinye.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in oxygen saturation (time frame: Data will be collected immediately before care is given, at 15 minutes during care, and at 15 minutes after care is given. The change in these time intervals will be evaluated.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06400446, which also lists 3 linked publications.
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 6 May 2024.