Clinical trial NCT06400446: The Effect of Kangaroo Care After Cardiac Surgery
Official title: The Effect of Kangaroo Care on Vital Signs of Infants After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infant ALL
Keywords: Kangaroo care
Infant
Cardiac surgery
Vital signs
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to investigate the effects of kangaroo care on the vital signs of infants undergoing cardiac surgery.

Hypothesis 1 (H1): Oxygen saturation levels of babies who are given kangaroo care are higher than babies who are not given kangaroo care.

Hypothesis 2 (H2): The peak heart rate of infants who receive kangaroo care is lower than infants who do not receive kangaroo care.

Hypothesis 3 (H3): The respiratory rate of infants who receive kangaroo care is lower than infants who do not receive kangaroo care.

Hypothesis 4 (H4): The arterial blood pressure of infants who receive kangaroo care is lower than infants who do not receive kangaroo care.

Hypothesis 5 (H5): The pain score of infants who received kangaroo care is lower than infants who did not receive kangaroo care.

Detailed description: Kangaroo care has been found to be a feasible intervention before and after cardiac surgery to support infants with congenital heart disease, but it has been stated that formal standards and procedures need to be developed to transform kangaroo care into practice. Skin-to-skin contact is a low-cost, low-risk intervention that supports comfort and contributes to physiological stability in infants before and after neonatal cardiac surgery. It positively affects the pain level of infants. Clinical studies on the application of kangaroo mother care on infants undergoing cardiac surgery are limited in the literature.

Eligibility criteria: Inclusion Criteria:

* The gestational week of the infant is greater than 37 weeks
* Cardiac surgery operation within the first 30 days of life
* The infant's chest incision is closed

Exclusion Criteria:

* The infant has non-cardiac congenital defects or syndrome
* Intubation of the infant

Primary outcomes:
measure: Change in oxygen saturation
timeFrame: Data will be collected immediately before care is given, at 15 minutes during care, and at 15 minutes after care is given. The change in these time intervals will be evaluated.
measure: Change in heart rate
timeFrame: Data will be collected immediately before care is given, at 15 minutes during care, and at 15 minutes after care is given. The change in these time intervals will be evaluated.
measure: Change in respiratory rate
timeFrame: Data will be collected immediately before care is given, at 15 minutes during care, and at 15 minutes after care is given. The change in these time intervals will be evaluated.
measure: Change in blood pressure
timeFrame: Data will be collected immediately before care is given, at 15 minutes during care, and at 15 minutes after care is given. The change in these time intervals will be evaluated.
measure: Change in level of pain
timeFrame: Data will be collected immediately before care is given, at 15 minutes during care, and at 15 minutes after care is given. The change in these time intervals will be evaluated.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Selvinaz Albayrak
state: Zeytinburnu
Study officials:
affiliation: Istanbul Health Sciences University Mehmet Akif Ersoy Chest Heart and Vascular Surgery Training and Research Hospital Paediatric Cardiovascular Surgery Intensive Care Unit
name: Dilara Cengizli, Nurse
role: PRINCIPAL_INVESTIGATOR
References:
citation: Solaz-Garcia A, Lara-Canton I, Pinilla-Gonzalez A, Montejano-Lozoya R, Gimeno-Navarro A, Sanchez-Illana A, Marco-Pinol A, Vento M, Saenz-Gonzalez P. Impact of Kangaroo Care on Premature Infants' Oxygenation: Systematic Review. Neonatology. 2022;119(5):537-546. doi: 10.1159/000525014. Epub 2022 Jun 22.
citation: Kelley-Quon LI, Kenney BD, Bartman T, Thomas R, Robinson V, Nwomeh BC, Bapat R. Safety and feasibility of skin-to-skin care for surgical infants: A quality improvement project. J Pediatr Surg. 2019 Nov;54(11):2428-2434. doi: 10.1016/j.jpedsurg.2019.02.016. Epub 2019 Feb 28.
citation: Lisanti AJ, Vittner D, Medoff-Cooper B, Fogel J, Wernovsky G, Butler S. Individualized Family-Centered Developmental Care: An Essential Model to Address the Unique Needs of Infants With Congenital Heart Disease. J Cardiovasc Nurs. 2019 Jan/Feb;34(1):85-93. doi: 10.1097/JCN.0000000000000546.