NCT06170892

Brief Summary

The kangaroo position, which is part of the Kangaroo Method strategy, is widely used in the Neonatal Intensive Care Unit and Neonatal Intermediate Care Units and aims to promote emotional bonding, cardiorespiratory, physiological and body temperature stability, in However, there is still little scientific evidence when it comes to newborns undergoing oxygen therapy. Identify, quantify and analyze the influence of the kangaroo position on the vital signs and respiratory comfort of preterm newborns using supplemental oxygen. To collect data, a physiotherapeutic assessment form suitable for clinical analysis was used. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

12 months

First QC Date

December 3, 2023

Last Update Submit

December 11, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Heart rate

    heart rate assessment on the heart monitor

    1 year

  • respiratory frequency rate

    assessment of respiratory rate in 60 seconds

    1 year

Study Arms (1)

Kangaroo method

EXPERIMENTAL

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.

Other: Kangaroo method

Interventions

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

Eligibility Criteria

Age2 Days - 28 Days
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • newborns with a gestational age of 28 to 36 weeks and 6 days,
  • up to twenty-eight days of life;
  • using supplemental circulating oxygen

You may not qualify if:

  • neuromuscular disease;
  • intracranial hypertension;
  • intracranial hemorrhage;
  • congenital heart disease
  • pneumothorax;
  • pneumatocele;
  • active bleeding;
  • mechanical ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade do Estado do Pará

Belém, Pará, 66055-490, Brazil

RECRUITING

Related Publications (5)

  • 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.

MeSH Terms

Interventions

Kangaroo-Mother Care Method

Intervention Hierarchy (Ancestors)

Patient PositioningPatient CareTherapeuticsInfant CareChild CareHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 3, 2023

First Posted

December 14, 2023

Study Start

January 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

December 14, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations