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

S

Sibel Küçükoğlu

Status

Not yet enrolling

Conditions

Care Pattern, Maternal
Newborn; Vitality
Sleep
Preterm Labor

Treatments

Behavioral: Kangaroo Care

Study type

Interventional

Funder types

Other

Identifiers

NCT06589349
SelcukUni2535

Details and patient eligibility

About

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

Full 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.

Enrollment

56 estimated patients

Sex

All

Ages

28 to 37 weeks old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

56 participants in 2 patient groups

kangaroo care group
Experimental group
Description:
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.
Treatment:
Behavioral: Kangaroo Care
Control Group
No Intervention group
Description:
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

Trial contacts and locations

1

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Central trial contact

Sibel Kucukoglu, Prof

Data sourced from clinicaltrials.gov

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