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

NCT06589349 | Not Yet Recruiting

• 1 other identifier: SelcukUni2535
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Conditions

Newborn; Vitality; Sleep; Preterm Labor; Care Pattern, Maternal

Outcome Measures

Primary Outcomes (7)

• Newborn Circadian Rhythm Tracking Chart

  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

  First Day, (10:00-12:00 AM) - First Night (22:00- 24:00 PM)

• Breast milk cortisol levels Tracking Chart

  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

  First Day (12:00AM) - first Night (24:00 PM)

• Growth Tracking Chart

  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.

  First Day (10:00 AM)

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

  Body temperature (°C) found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the first day.

  First Day (10:00 AM) and First Night (22:00 PM)

• Physiological Parameter Follow-up Form-oxygen saturation (mmHg)

  Oxygen saturation found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the first day.

  First Day (10:00 AM) and First Night (22:00 PM)

• Physiological Parameter Follow-up Form-heart rate (min)

  Heart rate found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the first day.

  First Day (10:00AM) and First Night (22:00 PM)

• Physiological Parameter Follow-up Form-respiratory rate (min)

  Respiratory rate found in the Physiological Parameter Follow-up Form will be measured at 10:00 and 22:00 on the first day.

  First Day (10:00 AM) and First Night (22:00 PM)

Secondary Outcomes (14)

• Newborn Circadian Rhythm Tracking Chart

  Second Day (10:00-12:00 AM) - Second Night (22:00-24:00 PM)

• Newborn Circadian Rhythm Tracking Chart

  Third Day (10:00-12:00 AM) - Third Night (22:00-24:00 PM)

• Breast milk cortisol levels Tracking Chart

  Second Day (12:00 AM) - Second Night (24:00 PM)

• Breast milk cortisol levels Tracking Chart

  Third Day (12:00 AM) - Third Night (24:00 PM)

• Growth Tracking Chart

  Second Day (10:00)

Study Arms (2)

kangaroo care group

EXPERIMENTAL

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.

Behavioral: Kangaroo Care

Control Group

NO INTERVENTION

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

Interventions

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

kangaroo care group

Eligibility Criteria

• Age: 28 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sibel Küçükoğlu: lead
• Health Institutes of Turkey: collaborator

Study Sites (1)

Selcuk University

Konya, Selcuklu, 42100, Turkey (Türkiye)

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 RESULT

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

Kangaroo-Mother Care Method

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Sibel Kucukoglu, Prof

  Selcuk University

  STUDY DIRECTOR

Central Study Contacts

Sibel Kucukoglu, Prof

CONTACT

+903322230789; s_nadaroglu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Responsible researcher (Prof)

Model Details: 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

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: September 19, 2024
• Study Start: September 15, 2024
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)