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

Laura Collados Gomez

Status: Completed

Conditions: Body Temperature; Premature Infant; Kangaroo Care

Treatments: Procedure: Prone; Procedure: Lateral

Study type: Interventional

Funder types: Other

Identifiers

NCT03990116

NEO_nur_19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 1 minute to 5 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Lateral kangaroo

Experimental group

Description:

Placing the infant in lateral on the parents chest, keeping the head neutral and limbs flexed towards body midline

Treatment:

Procedure: Lateral

Prone Kangaroo

Active Comparator group

Description:

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

Treatment:

Procedure: Prone