Clinical trial NCT06256406: Effects of Confortable Environment, Kangaroo Care and Music Therapy in Newborns in Neonatal Intensive Care Unit
Official title: Comparative Evaluation Between Preterms and Newborns Undergoing Surgery. Effectiveness of a Multimodal Sensory Intervention on Newborns and Parents' Stress
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature Infant Disease
Newborn Morbidity
Keywords: Newborn
Kangaroo-Mother Care Method
Music Therapy
Intensive Care Units, Neonatal
Lead sponsor: Policlinico Universitario, Catania
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study adopts a comprehensive approach to explore the effects of three interventions on the well-being and development of newborns in the Neonatal Intensive Care Unit (NICU). The interventions include optimizing the NICU environment for comfort, implementing kangaroo care for parent-infant bonding, and integrating music therapy. The research focuses on two distinct groups within the NICU: premature infants and those undergoing surgical procedures. By examining these interventions across these groups, the study aims to provide nuanced insights into enhancing the holistic care of newborns in critical care settings, tailoring approaches to the unique needs of each population.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Creating a comfortable environment, implementing kangaroo care, and incorporating music therapy are crucial interventions for newborns hospitalized in the Neonatal Intensive Care Unit (NICU). These strategies not only contribute to the physical well-being of the infants but also play a significant role in promoting their emotional and developmental health.

Detailed description: The well-being of newborns in the Neonatal Intensive Care Unit (NICU) is paramount, and establishing a comfortable environment is a fundamental aspect of their care. This involves controlling factors such as temperature, lighting, and noise to mimic the conditions of the womb, creating a soothing and supportive atmosphere for their fragile development. A calm environment is essential for premature infants, as it can contribute to improved weight gain, better sleep patterns, and overall physiological stability.

Kangaroo care, a practice involving skin-to-skin contact between the infant and a caregiver, has proven to be a transformative intervention in NICU settings. This method not only fosters the bond between the baby and their parent but also offers numerous physiological benefits. Kangaroo care has been associated with stabilized heart and respiratory rates, enhanced weight gain, and improved neurodevelopmental outcomes. The close physical contact provides a sense of security and comfort, mimicking the warmth and safety of the mother's womb.

Incorporating music therapy into the care routine of NICU infants has demonstrated positive effects on their well-being. Music has the power to reduce stress, stabilize vital signs, and promote better sleep patterns. Live or recorded lullabies, specifically designed for preterm infants, have been shown to have a calming influence and aid in the regulation of physiological functions. Additionally, music therapy can serve as a valuable tool for parents, offering a means of bonding with their hospitalized newborns and alleviating the stress associated with the NICU experience.

In conclusion, the utility of a comfortable environment, kangaroo care, and music therapy for newborns in the NICU extends beyond basic medical care. These interventions recognize the holistic needs of premature or ill infants, addressing both their physical and emotional requirements. By prioritizing a nurturing and supportive environment, healthcare providers aim to optimize the developmental trajectory of these vulnerable newborns, fostering better outcomes for their long-term health and well-being.

Eligibility criteria: Inclusion Criteria:

* newborn hospitalized in NICU

Exclusion Criteria:

* not hospitalized in NICU,
* intubated infants,
* instable clinical condition

Primary outcomes:
measure: Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on weight
timeFrame: from birth to the first 3 years of life
measure: Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on SpO2
timeFrame: from birth to the first 3 years of life
measure: Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on heart rate
timeFrame: from birth to the first 3 years of life
measure: Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on parenting stress index
timeFrame: from birth to the first 3 years of life
measure: Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on general movements
timeFrame: from birth to the first 3 years of life
measure: Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on neurological assessment
timeFrame: from birth to the first 3 years of life
measure: levels of noise in NICU
timeFrame: from birth to the first 3 years of life
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Neonatal intensive care unit
state: Sicily
Study officials:
References:
citation: Bieleninik L, Ettenberger M, Epstein S, Elefant C, Arnon S. Potential Psychological and Biological Mechanisms Underlying the Effectiveness of Neonatal Music Therapy during Kangaroo Mother Care for Preterm Infants and Their Parents. Int J Environ Res Public Health. 2021 Aug 13;18(16):8557. doi: 10.3390/ijerph18168557.