Abstract
Introduction: This study aims to assess the efficacy of the modified kangaroo care lateral position on the thermal stability of preterm neonates versus conventional kangaroo care prone position. Material and methods: A non-inferiority randomized parallel clinical trial. Kangaroo care will be performed in a lateral position for the experimental group and in a prone position for the control group preterm. The study will take place at the neonatal intensive care unit (NICU) of a University Hospital. The participants will be extremely premature infants (under 28 weeks of gestational age) along the first five days of life, hemodynamically stable, with mother or father willing to do kangaroo care and give their written consent to participate in the study. The sample size calculated was 35 participants in each group. When the premature infant is hemodynamically stable and one of the parents stays in the NICU, the patient will be randomized into two groups: an experimental group or a control group. The primary outcome is premature infant axillary temperature. Neonatal pain level and intraventricular hemorrhage are secondary outcomes. Discussion: There is no scientific evidence on modified kangaroo care lateral position. Furthermore, there is little evidence of increased intraventricular hemorrhage association with the lateral head position necessary in conventional or prone kangaroo care in extremely premature newborns. Kangaroo care is a priority intervention in neonatal units increasing the time of use more and more, making postural changes necessary to optimize comfort and minimize risks with kangaroo care lateral position as an alternative to conventional prone position kangaroo care. Meanwhile, it is essential to ensure that the conventional kangaroo care prone position, which requires the head to lay sideways, is a safe position in terms of preventing intraventricular hemorrhage in the first five days of life of children under 28 weeks of gestational age. Trial registration at clinicaltrials.gov: NCT03990116.
Highlights
The main aim of this study is to assess the efficacy of the modified kangaroo care lateral position on the thermal stability of preterm infants versus conventional kangaroo care prone position
No studies have currently been found that analyze the effectiveness of alternative kangaroo positions other than prone kangaroo care, aiming to contribute evidence of the effectiveness of lateral position Kangaroo care (KC) in terms of thermal stability and pain alleviation
The sample size for this secondary outcome was not calculated due to the heterogenous literature available about intraventricular hemorrhage (IVH) in relation to the risk that would be caused by the prone position compared with the other positions; and (f) pain is measured on the validated PIPP-R scale but not validated in Spanish; there is currently no validated scale in Spanish for assessing neonatal pain
Summary
This study aims to assess the efficacy of the modified kangaroo care lateral position on the thermal stability of preterm neonates versus conventional kangaroo care prone position. The participants will be extremely premature infants (under 28 weeks of gestational age) along the first five days of life, hemodynamically stable, with mother or father willing to do kangaroo care and give their written consent to participate in the study. Plentiful evidence is available on the benefits of prone kangaroo care, or skin-to-skin, such as lower mortality (RR 0.64; 95% [CI] 0.46, 0.89), reduced risk of neonatal sepsis (RR 0.53, 95% CI 0.34, 0.83), of hypothermia (RR 0.22; 95% CI 0.12, 0.41), of hypoglycemia (RR 0.12; 95% CI 0.05, 0.32), and of hospital readmissions (RR 0.42; 95% CI 0.23, 0.76) as well as greater hemodynamic stability (lower respiratory rate, greater peripheral oxygen saturation). Hypothermia is a major complication observed in extreme prematures due to thermoregulatory center’s physiological immaturity They have a greater relationship between the body surface and total body mass, vasomotor control immaturity and limited subcutaneous fat. Prematures are poikilotherm, having a body temperature that varies according to the outside temperature, so they need greater environmental control, including the temperature and the humidity [8]
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