Effects of Kangaroo Care on Circadian Rhythm, Growth and Physiological Effects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-15

Study Completion Date

2025-04-15

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Newborn; Vitality Sleep Preterm Labor Care Pattern, Maternal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

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.

Study Groups

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kangaroo care group

Kangaroo care will be performed twice a day, in the morning and evening, for three days, between 10:00 in the morning and 22:00 in the evening, 1 hour after the treatment and care practices applied to the baby. 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.

Group Type EXPERIMENTAL

Kangaroo Care

Intervention Type BEHAVIORAL

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

Control Group

Babies in the control group will be followed routinely in an incubator/cotton. It will be monitored for 70 minutes without any procedure or application, and as in the experimental group, stimuli that will disturb the baby during this period will be tried to be controlled. If mothers in this group want to do kangaroo care, they will be encouraged, not prevented. However, mothers in this group who start giving kangaroo care at least twice a day for three days will be excluded from the study. To measure breast milk cortisol levels, samples of mothers in the control group will be collected by expressing breast milk at 12:00

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Kangaroo 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

28 Weeks

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes