Kangaroo Position in Preterm Newborn Infants Under Oxygen Therapy
NCT ID: NCT06170892
Last Updated: 2023-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
60 participants
INTERVENTIONAL
2023-01-01
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
MC was integrated into Humanized Care for low birth weight newborns, alleviating pain symptoms, improving the sleep-wake state, stimulating neuropsychomotor and sensory development, in addition to reducing stress.
Consisting of three stages, the first stage begins with the detection of a high-risk pregnancy until the birth of the child, and when necessary continues in the NICU or Conventional Neonatal Intermediate Care Unit (UCINCo) during the newborn's hospitalization period. born (NB), the second stage takes place at the Canguru Neonatal Intermediate Care Unit (UCINCa) where the person responsible, with the support of the multidisciplinary team, participates in most of the care carried out in the NB and finally the third stage, which covers the period of dehospitalization, as well as monitoring the development of the newborn and providing guidance to their family, monitoring occurs between the maternity ward where the patient was hospitalized and the Basic Health Unit (UBS).
Through a biopsychosocial intervention and based on the following pillars, the MC promotes welcoming newborns and their families, respect for individualities, promotion of skin-to-skin contact and involvement of the mother and father in the care of the newborn, promoting the encouraging breastfeeding and sensorimotor development, integrating the line of care for PTNBs and/or those with low birth weight (LBW), as well as their families. The kangaroo position (CP), which is part of the MC strategy, favors emotional bonding, cardiorespiratory, physiological and body temperature stability.
Newborns who need to remain hospitalized in the NICU or UCINCo may require oxygen therapy support, due to the possibility of presenting hypoxia, hyaline membrane disease, bronchopulmonary dysplasia, heart failure and pulmonary hypertension, among others.
It is extremely important to observe newborns who are using oxygen therapy, facilitating their weaning as early as possible, since, in high quantities and prolonged use, it can result in hyperoxia, especially in premature newborns, increasing risks of oxygen toxicity, reabsorption atelectasis, ventilation depression and retinopathy of prematurity13,15,16. From this perspective, this study aims to highlight the effects of the kangaroo position on the vital signs and respiratory comfort of premature and low birth weight newborns using oxygen therapy admitted to a Conventional Intermediate Neonatal Care Unit.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Kangaroo method
The newborns were placed in the kangaroo position in a single session, and the variables were identified before, during and after the application of the technique.
Kangaroo method
The newborns were placed in the kangaroo position in a single session, and the variables were identified before, during and after the application of the technique.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Kangaroo method
The newborns were placed in the kangaroo position in a single session, and the variables were identified before, during and after the application of the technique.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* up to twenty-eight days of life;
* using supplemental circulating oxygen
Exclusion Criteria
* intracranial hypertension;
* intracranial hemorrhage;
* congenital heart disease
* pneumothorax;
* pneumatocele;
* active bleeding;
* mechanical ventilation
2 Days
28 Days
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universidade Metodista de Piracicaba
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rodrigo Santiago Barbosa Rocha, Phd
Principal investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universidade do Estado do Pará
Belém, Pará, Brazil
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Rodrigo S Rocha, Phd
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Srinath BK, Shah J, Kumar P, Shah PS. Kangaroo care by fathers and mothers: comparison of physiological and stress responses in preterm infants. J Perinatol. 2016 May;36(5):401-4. doi: 10.1038/jp.2015.196. Epub 2015 Dec 17.
Dargahiyan Z, Ghasemi F, Karami K, Valizadeh F, Mohammadi R. A comparative study of the effects of Kangaroo care by mothers and maternal grandmothers on the vital signs of hospitalized preterm newborns: a randomized controlled clinical trial study. Trials. 2023 Apr 14;24(1):275. doi: 10.1186/s13063-023-07288-y.
El-Farrash RA, Shinkar DM, Ragab DA, Salem RM, Saad WE, Farag AS, Salama DH, Sakr MF. Longer duration of kangaroo care improves neurobehavioral performance and feeding in preterm infants: a randomized controlled trial. Pediatr Res. 2020 Mar;87(4):683-688. doi: 10.1038/s41390-019-0558-6. Epub 2019 Sep 7.
Ferber SG, Makhoul IR. Neurobehavioural assessment of skin-to-skin effects on reaction to pain in preterm infants: a randomized, controlled within-subject trial. Acta Paediatr. 2008 Feb;97(2):171-6. doi: 10.1111/j.1651-2227.2007.00607.x. Epub 2008 Jan 3.
Span LC, van Dokkum NH, Ravensbergen AG, Bos AF, Jaschke AC. Combining Kangaroo Care and Live-Performed Music Therapy: Effects on Physiological Stability and Neurological Functioning in Extremely and Very Preterm Infants. Int J Environ Res Public Health. 2021 Jun 18;18(12):6580. doi: 10.3390/ijerph18126580.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
5.983.115
Identifier Type: -
Identifier Source: org_study_id