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Набор скоро начнётся NCT06589349

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

Без фазы С лечением Newborn; Vitality Sleep Preterm Labor Care Pattern, Maternal

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Kangaroo Care.
Кому может быть актуально
Состояния в реестре: Newborn; Vitality, Sleep, Preterm Labor, Care Pattern, Maternal. Базовые параметры: 28 Weeks — 37 Weeks · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

Effects of Kangaroo Care on Circadian Rhythm, Growth and Physiological Effects of Newborns Effect of Parameters on Breast Milk Cortisol Levels: Randomized Controlled Study

Обзор

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

Подробное описание

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.

Вмешательства

  • Поведенческое 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

Первичные конечные точки

  • Newborn Circadian Rhythm Tracking Chart [Срок оценки: First Day, (10:00-12:00 AM) - First Night (22:00- 24:00 PM)]
  • Breast milk cortisol levels Tracking Chart [Срок оценки: First Day (12:00AM) - first Night (24:00 PM)]
  • Growth Tracking Chart [Срок оценки: First Day (10:00 AM)]
  • Physiological Parameter Follow-up Form- body temperature (°C) [Срок оценки: First Day (10:00 AM) and First Night (22:00 PM)]
  • Physiological Parameter Follow-up Form-oxygen saturation (mmHg) [Срок оценки: First Day (10:00 AM) and First Night (22:00 PM)]
  • Physiological Parameter Follow-up Form-heart rate (min) [Срок оценки: First Day (10:00AM) and First Night (22:00 PM)]
  • Physiological Parameter Follow-up Form-respiratory rate (min) [Срок оценки: First Day (10:00 AM) and First Night (22:00 PM)]
Вторичные конечные точки (12)
  • Newborn Circadian Rhythm Tracking Chart [Срок оценки: Second Day (10:00-12:00 AM) - Second Night (22:00-24:00 PM)]
  • Newborn Circadian Rhythm Tracking Chart [Срок оценки: Third Day (10:00-12:00 AM) - Third Night (22:00-24:00 PM)]
  • Breast milk cortisol levels Tracking Chart [Срок оценки: Second Day (12:00 AM) - Second Night (24:00 PM)]
  • Breast milk cortisol levels Tracking Chart [Срок оценки: Third Day (12:00 AM) - Third Night (24:00 PM)]
  • Growth Tracking Chart [Срок оценки: Second Day (10:00)]
  • Growth Tracking Chart [Срок оценки: Third Day (10:00 AM)]
  • Physiological Parameter Follow-up Form- body temperature (°C) [Срок оценки: Second Day (10:00 AM) - Second Night (22:00 PM)]
  • Physiological Parameter Follow-up Form-oxygen saturation (mmHg) [Срок оценки: Second Day (10:00 AM) - Second Night (22:00 PM)]
  • Physiological Parameter Follow-up Form-heart rate (min) [Срок оценки: Second Day (10:00 AM) - Second Night (22:00 PM)]
  • Physiological Parameter Follow-up Form-respiratory rate (min) [Срок оценки: Second Day (10:00 AM) - Second Night (22:00 PM)]
  • Physiological Parameter Follow-up Form- body temperature (°C) [Срок оценки: Third Day (10:00 AM) - Third Night (22:00 PM)]
  • Physiological Parameter Follow-up Form-oxygen saturation (mmHg) [Срок оценки: Third Day (10:00 AM) - Third Night (22:00 PM)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Selcuk University — Konya

Публикации

  • 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. PMID 33750645
  • 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. PMID 28793784
  • 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. PMID 34441156
  • 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. PMID 33081550

Идентификаторы

NCT: NCT06589349 · SelcukUni2535

Первоисточники (государственные реестры)

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