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NCT Number: NCT06589349

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

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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Key information

Conditions

Newborn; Vitality Care Pattern, Maternal Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Preterm Labor Sleep Urogenital Diseases

Age range

28 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk University

Konya, Selcuklu, 42100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kangaroo Care

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

Primary outcomes

  1. Newborn Circadian Rhythm Tracking Chart

    Time frame: 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

  2. Breast milk cortisol levels Tracking Chart

    Time frame: 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

  3. Growth Tracking Chart

    Time frame: 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.

  4. Physiological Parameter Follow-up Form- body temperature (°C)

    Time frame: 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.

  5. Physiological Parameter Follow-up Form-oxygen saturation (mmHg)

    Time frame: 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.

  6. Physiological Parameter Follow-up Form-heart rate (min)

    Time frame: 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.

  7. Physiological Parameter Follow-up Form-respiratory rate (min)

    Time frame: 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.

Secondary outcomes

  1. Newborn Circadian Rhythm Tracking Chart

    Time frame: 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

  2. Newborn Circadian Rhythm Tracking Chart

    Time frame: Third Day (10:00-12:00 AM) - Third 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

  3. Breast milk cortisol levels Tracking Chart

    Time frame: 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

  4. Breast milk cortisol levels Tracking Chart

    Time frame: Third Day (12:00 AM) - Third 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

  5. Growth Tracking Chart

    Time frame: 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.

  6. Growth Tracking Chart

    Time frame: Third 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.

  7. Physiological Parameter Follow-up Form- body temperature (°C)

    Time frame: 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.

  8. Physiological Parameter Follow-up Form-oxygen saturation (mmHg)

    Time frame: 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.

  9. Physiological Parameter Follow-up Form-heart rate (min)

    Time frame: 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.

  10. Physiological Parameter Follow-up Form-respiratory rate (min)

    Time frame: 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.

  11. Physiological Parameter Follow-up Form- body temperature (°C)

    Time frame: Third Day (10:00 AM) - Third 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 third day.

  12. Physiological Parameter Follow-up Form-oxygen saturation (mmHg)

    Time frame: Third Day (10:00 AM) - Third 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 third day.

  13. Physiological Parameter Follow-up Form-heart rate (min)

    Time frame: Third Day (10:00 AM) - Third 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 third day.

  14. Physiological Parameter Follow-up Form-respiratory rate (min)

    Time frame: Third Day (10:00 AM) - Third 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 third day.

Study contacts

Contact information is provided by the study sponsor or research team.

Sibel Kucukoglu, Prof

CONTACT

[email protected]

+903322230789 ext. 31623

Sponsors and collaborators

Lead sponsor

Sibel Küçükoğlu

Other

Collaborators

  • Health Institutes of Turkey

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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