Clinical trial NCT06589349: Effects of Kangaroo Care on Circadian Rhythm, Growth and Physiological Effects
Official title: Effects of Kangaroo Care on Circadian Rhythm, Growth and Physiological Effects of Newborns Effect of Parameters on Breast Milk Cortisol Levels: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Newborn; Vitality
Sleep
Preterm Labor
Care Pattern, Maternal
Lead sponsor: Selcuk University
Sponsor class: OTHER
Collaborators: name: Health Institutes of Turkey
First posted: 2024-09-19
Enrollment: 56
Sex: ALL
Minimum age (years): 28
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Newborn Circadian Rhythm Tracking Chart
timeFrame: First Day, (10:00-12:00 AM) - First Night (22:00- 24:00 PM)
measure: Breast milk cortisol levels Tracking Chart
timeFrame: First Day (12:00AM) - first Night (24:00 PM)
measure: Growth Tracking Chart
timeFrame: First Day (10:00 AM)
measure: Physiological Parameter Follow-up Form- body temperature (°C)
timeFrame: First Day (10:00 AM) and First Night (22:00 PM)
measure: Physiological Parameter Follow-up Form-oxygen saturation (mmHg)
timeFrame: First Day (10:00 AM) and First Night (22:00 PM)
measure: Physiological Parameter Follow-up Form-heart rate (min)
timeFrame: First Day (10:00AM) and First Night (22:00 PM)
measure: Physiological Parameter Follow-up Form-respiratory rate (min)
timeFrame: First Day (10:00 AM) and First Night (22:00 PM)
Secondary outcomes:
measure: Newborn Circadian Rhythm Tracking Chart
timeFrame: Second Day (10:00-12:00 AM) - Second Night (22:00-24:00 PM)
measure: Newborn Circadian Rhythm Tracking Chart
timeFrame: Third Day (10:00-12:00 AM) - Third Night (22:00-24:00 PM)
measure: Breast milk cortisol levels Tracking Chart
timeFrame: Second Day (12:00 AM) - Second Night (24:00 PM)
measure: Breast milk cortisol levels Tracking Chart
timeFrame: Third Day (12:00 AM) - Third Night (24:00 PM)
measure: Growth Tracking Chart
timeFrame: Second Day (10:00)
measure: Growth Tracking Chart
timeFrame: Third Day (10:00 AM)
measure: Physiological Parameter Follow-up Form- body temperature (°C)
timeFrame: Second Day (10:00 AM) - Second Night (22:00 PM)
measure: Physiological Parameter Follow-up Form-oxygen saturation (mmHg)
timeFrame: Second Day (10:00 AM) - Second Night (22:00 PM)
measure: Physiological Parameter Follow-up Form-heart rate (min)
timeFrame: Second Day (10:00 AM) - Second Night (22:00 PM)
measure: Physiological Parameter Follow-up Form-respiratory rate (min)
timeFrame: Second Day (10:00 AM) - Second Night (22:00 PM)
measure: Physiological Parameter Follow-up Form- body temperature (°C)
timeFrame: Third Day (10:00 AM) - Third Night (22:00 PM)
measure: Physiological Parameter Follow-up Form-oxygen saturation (mmHg)
timeFrame: Third Day (10:00 AM) - Third Night (22:00 PM)
measure: Physiological Parameter Follow-up Form-heart rate (min)
timeFrame: Third Day (10:00 AM) - Third Night (22:00 PM)
measure: Physiological Parameter Follow-up Form-respiratory rate (min)
timeFrame: Third Day (10:00 AM) - Third Night (22:00 PM)
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
state: Selcuklu
Study officials:
affiliation: Selcuk University
name: Sibel Kucukoglu, Prof
role: STUDY_DIRECTOR
References:
citation: Kucukoglu S, Yilmaz Kurt F, Aytekin Ozdemir A, Ozcan Z. The Effect of Kangaroo Care on Breastfeeding and Development in Preterm Neonates. J Pediatr Nurs. 2021 Sep-Oct;60:e31-e38. doi: 10.1016/j.pedn.2021.02.019. Epub 2021 Mar 6.
citation: Lan HY, Yin T, Chen JL, Chang YC, Liaw JJ. Factors Associated With Preterm Infants' Circadian Sleep/Wake Patterns at the Hospital. Clin Nurs Res. 2019 May;28(4):456-472. doi: 10.1177/1054773817724960. Epub 2017 Aug 9.
citation: Martin-Montero A, Gutierrez-Tobal GC, Gozal D, Barroso-Garcia V, Alvarez D, Del Campo F, Kheirandish-Gozal L, Hornero R. Bispectral Analysis of Heart Rate Variability to Characterize and Help Diagnose Pediatric Sleep Apnea. Entropy (Basel). 2021 Aug 6;23(8):1016. doi: 10.3390/e23081016.
citation: Gebuza G, Kazmierczak M, Lenska K. The effects of kangaroo mother care and music listening on physiological parameters, oxygen saturation, crying, awake state and sleep in infants in NICU. J Matern Fetal Neonatal Med. 2022 Oct;35(19):3659-3669. doi: 10.1080/14767058.2020.1836619. Epub 2020 Oct 20.