The Effect of Kangaroo Care After Cardiac Surgery

Infant ALL Clinical Trial

Official title:

The Effect of Kangaroo Care on Vital Signs of Infants After Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06400446
• Other study ID #: ISU-23-259
• Status: Recruiting
• Phase: N/A
• Start date: November 19, 2023
• Est. completion date: May 20, 2024

Study information

• Verified date: April 2024
• Source: Istinye University
• Contact: Selvinaz Albayrak, Asst Prof
• Phone: +905438708905
• Email: selvinaz.albayrak[@]istinye.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 20, 2024
• Est. primary completion date: May 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 30 Days

Eligibility

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

Related Conditions & MeSH terms

• Infant ALL

Intervention

Other:
• Standard care
The babies in this group will receive the standard care of the unit. The vital signs and pain scores of the babies will be recorded before the mother's visit for seven days. The vital signs and pain scores of the infants who received the standard care of the unit during one hour, which is the time of the mother's visit, will be recorded every 15 minutes for a total of 4 times. The vital signs and pain scores of the infant will be recorded in the first 15 minutes after the mother's visit.
• Kangaroo care
Kangaroo care will be applied to the experimental group for seven days. Kangaroo care will be started for the babies in the intervention group when the baby is extubated, when the baby starts oral feeding and when the chest incision is closed. Consistent with previous research, mothers will provide skin-to-skin contact for at least 1 hour per day for seven days, starting immediately after feeding. The vital signs and pain scores of the babies will be recorded during the kangaroo care of the mother for seven days. During the kangaroo care, vital signs and pain scores of the infants will be recorded every 15 minutes for a total of 4 times. The vital signs and pain scores of the infant will be recorded in the first 15 minutes after the mother's visit.

Locations

Country	Name	City	State
Turkey	Selvinaz Albayrak	Istanbul	Zeytinburnu

Sponsors (1)

Lead Sponsor	Collaborator
Istinye University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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 — View 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 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in oxygen saturation	Oxygen saturation will be monitored.	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.
Primary	Change in heart rate	Heart rate will be monitored.	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.
Primary	Change in respiratory rate	Respiratory rate will be monitored.	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.
Primary	Change in blood pressure	Blood pressure will be monitored.	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.
Primary	Change in level of pain	The infants' pain level will be measured using the CRIES(Crying, Requires O2, Increased vital signs,Expression, Sleepless). The scale is used in the evaluation of postoperative pain in premature babies (between 32-36 weeks of gestation) and postoperative pain. Starting from the thirty-second gestational week, it is preferred in neonates and children between 6 months, especially in intensive care units.The Scale was developed by Krechel & Bildner, 1995. Crying status, oxygen saturation, heart rate and/or blood pressure, facial expression and sleep status are the parameters used in the evaluation. Each parameter is scored out of two; a score of 3-4 indicates mild to moderate pain; values of five and above indicate severe pain.	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.