Premature Infant DiseasePRE-CARENCT06256406
Effects of Confortable Environment, Kangaroo Care and Music Therapy in Newborns in Neonatal Intensive Care Unit
A study testing in the field of rehabilitation and neonatal care: the combination of Kangaroo care method and music therapy in people with Premature Infant Disease and Newborn Morbidity, run by Policlinico Universitario, Catania at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 0 days to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Premature Infant Disease, Newborn Morbidity
- What is being tested?
- in the field of rehabilitation and neonatal care: the combination of Kangaroo care method and music therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jun 2022to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- newborn hospitalized in NICU
Who cannot join
- not hospitalized in NICU,
- intubated infants,
- instable clinical condition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Neonatal intensive care unit
Catania, Sicily, 95100
Pasqua Betta, MD, +393396865409, mlbetta@yahoo.it
About this study
Official title: Comparative Evaluation Between Preterms and Newborns Undergoing Surgery. Effectiveness of a Multimodal Sensory Intervention on Newborns and Parents' Stress
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.
Read the 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.
- Conditions
- Premature Infant Disease, Newborn Morbidity
- Being tested
- in the field of rehabilitation and neonatal care: the combination of Kangaroo care method and music therapy
- Keywords
- Newborn, Kangaroo-Mother Care Method, Music Therapy, Intensive Care Units, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in the field of rehabilitation and neonatal care: the combination of Kangaroo care method and music therapyOther
Also called Kangaroo care method (only), Music therapy (only)
Kangaroo care is a practice involving skin-to-skin contact between the infant and a caregiver,. Music therapy is a therapeutic approach that utilizes the expressive and emotional qualities of music to address physical, emotional, cognitive needs of individuals.
| Study group | Role | What they receive |
|---|---|---|
| kangaroo care | Active comparator | Kangaroo care Arm subjected to Kangaroo care, a practice involving skin-to-skin contact between the infant and a caregiver. Receives: Other: in the field of rehabilitation and neonatal care: the combination of Kangaroo care method and music therapy |
| Music therapy | Active comparator | Music therapy Arm subjected to music therapy, a practise improving perception of newborns Receives: Other: in the field of rehabilitation and neonatal care: the combination of Kangaroo care method and music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on weight
the effects of kangaroo care and music therapy on anthropometric parameters (weight in grams)
Measured: from birth to the first 3 years of life
Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on SpO2
the effects of kangaroo care and music therapy on vital signs: saturation in percentage of SpO2
Measured: from birth to the first 3 years of life
Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on heart rate
the effects of kangaroo care and music therapy on vital signs: heart rate in beats for minutes
Measured: from birth to the first 3 years of life
Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on parenting stress index
the effects of kangaroo care and music therapy on scales: Parenting stress index.
Subscales:1) Parental Distress (PD): personal factors directly related to parenting; 2) Difficult Child (DC): temperament and behavior of the child that influence the parent-child relationship; 3) Parent-Child Dysfunctional Interactions (P-CDI): parent's perception of the child; whether or not expectations are being met, positive behaviors reinforced, etc.
Assessment Characteristics:36 items Minimum/Maximum Scores: 1) 12 - 60 in each subscale, 2) 36 - 180 total stress score Higher score showed more levels of stress
Measured: from birth to the first 3 years of life
Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on general movements
the effects of kangaroo care and music therapy on scales: General movement optimality scores (GMOS) It differentiated between normal general movements (median 39 [25-75th centile 37-41]), poor repertoire general movements (median 25 [22-29]), cramped-synchronized general movements (median 12 [10-14]).
Measured: from birth to the first 3 years of life
Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on neurological assessment
the effects of kangaroo care and music therapy on scales: Hammersmith Neurological Examination (HNE) HNE assess motor function and overall neurological status. The HNE includes two components: the Hammersmith Functional Motor Scale (HFMS) and the Hammersmith Spinal Muscular Atrophy Functional Rating Scale (HSMARS).
It is scored on a scale ranging from 0 to 66, with higher scores indicating better motor function.
Measured: from birth to the first 3 years of life
levels of noise in NICU
levels of noise in NICU (assessed as sound pressure levels measured using a dosimeter) in dBA. highter dBA corresponded to more noise
Measured: from birth to the first 3 years of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start20 Jun 2022
- Primary completion29 Feb 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature Infant DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Policlinico Universitario, Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pasqua Betta, Policlinico Universitario, Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256406
- Sponsor's protocol ID
- 122/2022/PO
- Acronym
- PRE-CARE
- Status last verified
- Feb 2024
- First submitted
- 24 Nov 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: newborns meeting predefined inclusion and exclusion criteria will be enrolled to evaluate the impact of environmental noise, kangaroo care, and music therapy during their hospitalization.
Publications
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.
PubMed 34444304