Effects of Kangaroo Care on Circadian Rhythm, Growth and Physiological Effects
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age28-37
SponsorSibel Küçükoğlu
About this trial
This study was planned to investigate the effect of premature babies receiving regular kangaroo care in the NICU on circadian rhythm, growth and physiological parameters, and breast milk cortisol levels
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Being between 28+0-37 weeks of pregnancy,
Birth weight >1000 g,
APGAR score >7 at the 5th minute after birth,
Ability to feed every 2-3 hours
Disqualifiers
Getting mechanical ventilation support
Undergoing surgery
Having diseases and disorders such as congenital brain malformations, meningitis, seizures, encephalopathy, congenital abnormalities, history of intraventricular bleeding, herpes, sepsis and heart or metabolic diseases.
Taking medication that affects sleep patterns, such as theophylline, phenobarbital, midazolam, caffeine, fentalnil
Trial design
Design model
Parallel
Treatments tested in this trial
Kangaroo Care
BehavioralPhysiological parameters will be measured in the Day (10:00) - Night (22:00) cycle for 3 days, just before being taken into kangaroo care in the experimental group, and when the kangaroo care is terminated, the baby will be measured in the mother's arms. Then, the mother and baby will be placed in kangaroo care for a minimum of 70 minutes
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: kangaroo care groupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Newborn Circadian Rhythm Tracking Chart
To measure circadian rhythms, BIS spectrometry will be attached to the baby's forehead area, as specified in the user manual, after the babies in the experimental and control groups are given group care in the morning and evening The device provides a different application to babies as it records the duration of being in "awake, REM, N-REM/ STAGE I, N-REM/ STAGE II, N-REM/ STAGE III, N-REM/ STAGE IV" measured in 5-minute periods. It will not be done. The sensor will be removed from the baby's forehead at the next care hour. At the end of 3 days, records will be taken from the BIS monitor and recorded in the "Newborn Circadian Rhythm Tracking Chart
Time frame
First Day, (10:00-12:00 AM) - First Night (22:00- 24:00 PM)2
Breast milk cortisol levels Tracking Chart
To measure breast milk cortisol levels, breast milk samples will be collected by the researcher by expressing breast milk at 12.00 on the 1st, 2nd and 3rd days of the experimental and control groups. This period was determined by considering the possibility of terminating kangaroo care in the experimental group as it coincided with the babies' care and feeding hours at 12:00, and the times when the mother would want to receive kangaroo care for more than 70 minutes, and the maximum kangaroo care would last 120 minutes
Time frame
First Day (12:00AM) - first Night (24:00 PM)3
Growth Tracking Chart
The chart was created by the researcher in such a way that body weight (g) from growth parameters would be recorded daily for 3 days.
Time frame
First Day (10:00 AM)4
Physiological Parameter Follow-up Form- body temperature (°C)
Body temperature (°C) found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the first day.
Time frame
First Day (10:00 AM) and First Night (22:00 PM)Secondary outcomes
1
Newborn Circadian Rhythm Tracking Chart
To measure circadian rhythms, BIS spectrometry will be attached to the baby's forehead area, as specified in the user manual, after the babies in the experimental and control groups are given group care in the morning and evening The device provides a different application to babies as it records the duration of being in "awake, REM, N-REM/ STAGE I, N-REM/ STAGE II, N-REM/ STAGE III, N-REM/ STAGE IV" measured in 5-minute periods. It will not be done. The sensor will be removed from the baby's forehead at the next care hour. At the end of 3 days, records will be taken from the BIS monitor and recorded in the "Newborn Circadian Rhythm Tracking Chart
Time frame
Second Day (10:00-12:00 AM) - Second Night (22:00-24:00 PM)2
Newborn Circadian Rhythm Tracking Chart
To measure circadian rhythms, BIS spectrometry will be attached to the baby's forehead area, as specified in the user manual, after the babies in the experimental and control groups are given group care in the morning and evening The device provides a different application to babies as it records the duration of being in "awake, REM, N-REM/ STAGE I, N-REM/ STAGE II, N-REM/ STAGE III, N-REM/ STAGE IV" measured in 5-minute periods. It will not be done. The sensor will be removed from the baby's forehead at the next care hour. At the end of 3 days, records will be taken from the BIS monitor and recorded in the "Newborn Circadian Rhythm Tracking Chart
Time frame
Third Day (10:00-12:00 AM) - Third Night (22:00-24:00 PM)3
Breast milk cortisol levels Tracking Chart
To measure breast milk cortisol levels, breast milk samples will be collected by the researcher by expressing breast milk at 12.00 on the 1st, 2nd and 3rd days of the experimental and control groups. This period was determined by considering the possibility of terminating kangaroo care in the experimental group as it coincided with the babies' care and feeding hours at 12:00, and the times when the mother would want to receive kangaroo care for more than 70 minutes, and the maximum kangaroo care would last 120 minutes
Time frame
Second Day (12:00 AM) - Second Night (24:00 PM)4
Breast milk cortisol levels Tracking Chart
To measure breast milk cortisol levels, breast milk samples will be collected by the researcher by expressing breast milk at 12.00 on the 1st, 2nd and 3rd days of the experimental and control groups. This period was determined by considering the possibility of terminating kangaroo care in the experimental group as it coincided with the babies' care and feeding hours at 12:00, and the times when the mother would want to receive kangaroo care for more than 70 minutes, and the maximum kangaroo care would last 120 minutes
Time frame
Third Day (12:00 AM) - Third Night (24:00 PM)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sibel Küçükoğlu
Lead sponsor
Selcuk University
Sponsor institution
Health Institutes of Turkey
Collaborator
Source ClinicalTrials.gov
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