Lateral Kangaroo Care in Hemodynamic Stability of Extremely Preterm Infants: Protocol Study for a Non-Inferiority Randomized Controlled Trial CANGULAT

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.