Efficacy of Lateral Kangaroo Care in Hemodynamic Stabilization of Premature Infant. (Cangulat)

Efficacy of Lateral Kangaroo Care in Hemodynamic Stabilization of Premature Infant

The objetive of the study is to evaluate the non-inferiority or the equivalence of the kangaroo care position, in lateral versus traditional one in prone measuring the stability of several parameters in premature infants less than 28 weeks of gestational age during the first 5 days of life.

Study Overview

• Status: Unknown
• Conditions: Premature Infant; Body Temperature; Kangaroo Care
• Intervention / Treatment: Procedure: Lateral; Procedure: Prone

Detailed Description

A non-inferiority clinical trial, controlled, randomized and not blinded has been designed. The non-equivalent, experimental group consist on neonates less than 28 weeks of gestational age who are placed in lateral position while they are on kangaroo care during the first 5 days of life. On the other hand, the control group include neonates less than 28 weeks of gestational age who are in traditional prone position during kangaroo care on the first 5 days of life.

To define the sample size a power of 80% is assumed (β=0,20) and a 95% confidence interval (α=0,05) with a difference of 0,3ºC (SD 0,16) (9,10) in the axillary temperature. A non inferiority margin of 0.2ºC is established and a 10% sample size loss has been assumed. So a sample size of 35 premature in each group has been estimated.

A non probabilistic and consecutive sampling has been defined. The allocation into the experimental (lateral position) or control group (prone position) is going to be randomized.

The main outcome variable is the axillary temperature. However other clinical variables as pain, changes in the vital signs, HIV incidence rate are going to be measured as well.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Collados, PhD; Phone Number: +34686822609; Email: laura.collados@salud.madrid.org

Study Locations

• Spain
  • Madrid, Spain, 28030
    • Recruiting
    • Laura Collados Gómez
    • Contact: Laura Collados Gómez, phD; Phone Number: 686822609; Email: laura.collados@salud.madrid.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 5 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Premature under 28 weeks of gestational age with mother / father who wants kangaroo care.

Exclusion Criteria:

• Premature infants with mechanical ventilation in high frequency mode,
• Premature infants in the immediate postoperative period of major surgery,
• Premature infants with malformations of the abdominal Wall
• Premature infants who require immobilization
• Premature infants who do not tolerate kangaroo care: hemodynamic, thermal instability or increased stress
• Premature infants with duration of kangaroo care of less than 60 minutes.
• Also excluded are those patients where the kangaroo care provider has an anatomical limitation for carrying out kangaroo care.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lateral kangaroo; Placing the infant in lateral on the parents chest, keeping the head neutral and limbs flexed towards body midline	Procedure: Lateral; Posture lateral kangaroo care
Active Comparator: Prone Kangaroo; placing the baby in upright and ventral position between mother's breasts or over the father chest, in skin-to skin contact with no clothes in between and with lower limbs flexed	Procedure: Prone; Posture prone kangaroo care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from skin temperature	Change from skin temperature after kangaroo care Peripheral temperature of the premature measured in the axilla with Braun® PRT2000 thermometer and the continuous temperature monitoring sensor of Giraffe ® incubators (AirLife TM infant skin temperature probe)	T0: baseline; T1: 30 minutes after to start kangaroo care; T2: 30 minutes after to finish kangaroo care

Collaborators and Investigators

• Sponsor: Laura Collados Gomez
• Investigators: Principal Investigator: Laura Collados, phD, Hospital Universitario 12 de octubre

Publications and helpful links

General Publications

• Collados-Gomez L, Esteban-Gonzalo L, Lopez-Lopez C, Jimenez-Fernandez L, Piris-Borregas S, Garcia-Garcia E, Fernandez-Gonzalo JC, Martinez-Miguel E. Lateral Kangaroo Care in Hemodynamic Stability of Extremely Preterm Infants: Protocol Study for a Non-Inferiority Randomized Controlled Trial CANGULAT. Int J Environ Res Public Health. 2021 Dec 28;19(1):293. doi: 10.3390/ijerph19010293.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2019
• Primary Completion (Anticipated): May 31, 2020
• Study Completion (Anticipated): May 31, 2020

Study Registration Dates

• First Submitted: May 23, 2019
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (Actual): June 18, 2019

Study Record Updates

• Last Update Posted (Actual): June 18, 2019
• Last Update Submitted That Met QC Criteria: June 17, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Kangaroo-Mother Care Method; Patient Positioning; skin to skin; Extremely Premature infant
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: NEO_nur_19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No