Care Pattern, Maternal, Newborn; Vitality, Preterm Labor, Sleep
Conditions
Brief summary
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
Detailed description
Kangaroo Care (KC) may have positive effects on biological phase markers of immature circadian rhythms in newborns. KC provides circadian rhythm development by reducing the stress of newborns. Skin-to- skin contact intervention, which is similar to kangaroo care, affects the ẞ-endorphin concentration, which reduces pain in premature babies, and is known to reduce cortisol levels. KC, which supports exclusive breastfeeding and breastfeeding, can affect the circadian rhythm in newborns by providing information about the time of day to newborns through the increase in breastfeeding rates and the hormones and immune elements contained in breast milk. Although there are a limited number of studies in the literature examining the circadian rhythm or sleep-wake cycle of babies in the neonatal intensive care unit, no study has been found examining the circadian rhythm of babies receiving regular kangaroo care using brain imaging methods. In this respect, the study has unique value. In addition, within the scope of the study, regular kangaroo care for three days had a positive effect on the growth and physiological parameters of babies any studies examining the effect of breast milk on cortisol levels No study was found.
Interventions
BEHAVIORALKangaroo Care
Physiological 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
Sponsors
Health Institutes of Turkey
Sibel Küçükoğlu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Masking description
The sample size of the study was calculated using the G power program. In the power analysis performed with the t test, one-way hypothesis, 0.80 effect size, 90% power, 0.05 significance level, assignment rate: 1, it was determined that a total of 56 preterm babies (Experiment: 28, Control: 28) would provide sufficient sample size.
Intervention model description
In the study, randomization will be done by stratifying according to type of nutrition (breast milk-formula milk) and week of gestation (28-31+6 32-37), as it may affect sleep. After the blocks are created, the groups included in the study will be randomly assigned to the layers with the letters A and B, using the random numbers table obtained in the computer environment (www.random.org). Which group the children included in the study will be included in will be determined by an independent statistician and will be given to the researcher in a sealed envelope
Eligibility
Sex/Gender
ALL
Age
28 Weeks to 37 Weeks
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 * Having developed intraventricular hemorrhage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physiological Parameter Follow-up Form-respiratory rate (min) | First Day (10:00 AM) and First Night (22:00 PM) | Respiratory rate found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the first day. |
| Newborn Circadian Rhythm Tracking Chart | First Day, (10:00-12:00 AM) - First Night (22:00- 24:00 PM) | 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 |
| Breast milk cortisol levels Tracking Chart | First Day (12:00AM) - first Night (24:00 PM) | 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 |
| Growth Tracking Chart | First Day (10:00 AM) | 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. |
| Physiological Parameter Follow-up Form- body temperature (°C) | First Day (10:00 AM) and First Night (22:00 PM) | Body temperature (°C) found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the first day. |
| Physiological Parameter Follow-up Form-oxygen saturation (mmHg) | First Day (10:00 AM) and First Night (22:00 PM) | Oxygen saturation found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the first day. |
| Physiological Parameter Follow-up Form-heart rate (min) | First Day (10:00AM) and First Night (22:00 PM) | Heart rate found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the first day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Newborn Circadian Rhythm Tracking Chart | Second Day (10:00-12:00 AM) - Second Night (22:00-24:00 PM) | 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 |
| Breast milk cortisol levels Tracking Chart | Second Day (12:00 AM) - Second Night (24:00 PM) | 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 |
| Growth Tracking Chart | Second Day (10:00) | 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. |
| Physiological Parameter Follow-up Form- body temperature (°C) | Second Day (10:00 AM) - Second Night (22:00 PM) | Body temperature (°C) found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the second day. |
| Physiological Parameter Follow-up Form-oxygen saturation (mmHg) | Second Day (10:00 AM) - Second Night (22:00 PM) | Oxygen saturation found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the second day. |
| Physiological Parameter Follow-up Form-heart rate (min) | Second Day (10:00 AM) - Second Night (22:00 PM) | Heart rate found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the second day. |
| Physiological Parameter Follow-up Form-respiratory rate (min) | Second Day (10:00 AM) - Second Night (22:00 PM) | Respiratory rate found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the second day. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactSibel Kucukoglu, Prof
Outcome results
None listed