Efficacy of Lateral Kangaroo Care in Hemodynamic Stabilization of Premature Infant.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-10

Study Completion Date

2021-11-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Kangaroo Care Premature Infant Body Temperature

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Lateral kangaroo

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

Group Type EXPERIMENTAL

Lateral

Intervention Type PROCEDURE

Posture lateral kangaroo care

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

Group Type ACTIVE_COMPARATOR

Prone

Intervention Type PROCEDURE

Posture prone kangaroo care

Interventions

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Lateral

Posture lateral kangaroo care

Intervention Type PROCEDURE

Prone

Posture prone kangaroo care

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

1 Minute

Maximum Eligible Age

5 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No