The Effect of Using Clinical Guidelines on Kangaroo Care on Newborn and Maternal Outcomes

NCT05807191 | Completed

• 1 other identifier: SelcukU-12-2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study was to determine the effect of the use of clinical guidelines in kangaroo care (KB) practice on neonatal and maternal outcomes in premature infants. The study was a single-blind, parallel group (experimental-control), randomized controlled experimental design with pretest-posttest design. It was carried out in the neonatal intensive care unit of Selçuk University Faculty of Medicine Hospital in Konya province. Study data were collected from 40 premature newborns between September 2022 and November 2022. Premature infants in the intervention (n = 20) and control groups (n = 20) were determined by randomization method.

Conditions

Premature Infants

Keywords

Kangaroo care; Evidence-based guideline; Prematurity; NICU

Outcome Measures

Primary Outcomes (5)

• Physiological parameters of the premature infant:respiration rate

  The infant's is respiratory rate per minute.

  Change from baseline and 70 min

• Physiological parameters of the premature infant:peak heart rate

  The infant's is heart rate per minute. Philips IntelliVue MP40 device was used to monitor heart rete.

  Change from baseline and 70 min

• Physiological parameters of the premature infant: oxygen saturation

  Oxygen saturation measures the percentage of oxyhemoglobin (oxygen-bound hemoglobin) in the blood, and it is represented as arterial oxygen saturation (SaO2) and venous oxygen saturation (SvO2). Philips IntelliVue MP40 device was used to monitor %SpO2.

  Change from baseline and 70 min

• Physiological parameters of the premature infant: body temperature

  Shows body temperature.

  Change from baseline and 70 min

• Comfort Behavior scale scores of the premature infant

  Comfort Behavior scale was used. The Neonatal Comfort Behavior Scale (NEAS) is a Likert-type scale consisting of six parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tone. Each item in the scale is scored from 1 to 5. It is evaluated over the total score. The lowest score that can be obtained from the Newborn Comfort Behavior Scale (NEAS) is 6, and the highest score is 30.

  Change from baseline and 70 min

Secondary Outcomes (2)

• Parent Satisfaction points

  baseline and 70 min

• Nurse Parent Support score

  baseline and 70 min

Study Arms (2)

Intervention Group

EXPERIMENTAL

Kangaroo care was applied for 65 minutes to premature infants by their mothers based on the kangaroo care guide.

Other: Kangaroo care based on kangaroo care guide

Control Group

NO INTERVENTION

Kangaroo care was routinely administered by the nurse for 65 minutes without using a kangaroo care guide.

Interventions

Kangaroo care based on kangaroo care guide OTHER

Under the supervision of the researcher, a kangaroo care practice was applied to premature babies by their mothers based on the kangaroo care guide. This practice took 65 minutes. In addition, before the application, the kangaroo application information was explained to the mothers through a brochure.

Intervention Group

Eligibility Criteria

• Age: 26 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• For premature infants;
• The baby is born before 36+6 weeks of gestation
• Stability of vital parameters at the time of application,
• Stable health status (cardiorespiratory stability, no congenital or chromosomal abnormalities, no history of intraventricular hemorrhage, no history of periventricular leukomalacia and NEC, no systemic and metabolic disorders),
• For mothers;
• Willingness to participate in the research
• Being able to read and write Turkish

You may not qualify if:

• For premature infants;
• Being connected to a mechanical ventilator
• Congenital or chromosomal abnormality
• Being with deprivation syndrome
• Having a history of intraventricular hemorrhage
• For mothers; Not being willing to care for kangaroos
• \- Having a physical disability to care for kangaroos

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (2)

Selcuk University

Konya, Selcuklu, 42060, Turkey (Türkiye)

Location

Selcuk University

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

• Rabia Ayça Özkan

  Konya Beyhekim Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Single blinding (to mothers) was performed in this study. Care provider blinding was performed because the mothers did not know whether kangaroo care was carried out in accordance with a guide. In addition, because the premature babies in the study would not know which group they were in, participant blinding was performed. In order to prevent bias in the analysis phase of the data; Analysis was done by an independent statistician. After the statistical analysis was completed and the report of the research was prepared, it was explained how the intervention and control groups were coded. The intervention group was coded with '1' while the control group was coded with the number '2'.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: parallel group (experimental-control)

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: April 11, 2023
• Study Start: July 4, 2022
• Primary Completion: October 24, 2022
• Study Completion: December 13, 2022
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)