Intraventricular Hemorrhage in Kangaroo Care vs. Incubator Care

Condition(s) studied

Investigational drug(s) / intervention(s)

Lateral: lateral Kangaroo care position: The preterm infant will be placed unclothed against the parent's chest in a side-lying position, aligned along the midline.

Prone: prone kangaroo care position: The preterm infant will be positioned prone against the parent's chest, upright, with the head turned 90° to one side.

Incubator care: Kangaroo care will not be provided during the first three days of life, and the infant will remain in the incubator.

Study summary

This clinical study aims to find out whether kangaroo care (skin-to-skin contact between parents and their extremely premature newborns) can help protect the babies' brains by reducing the risk of bleeding in the brain during the first days of life. To do this, the extremely premature newborns will be randomly assigned to one of three groups: kangaroo care in a side-lying position, kangaroo care in a face-down position, or standard care in an incubator. Researchers will monitor the babies for signs of brain bleeding and other health measures to determine which approach is safest. The main hypothesis is that kangaroo care in the side-lying position may lower the risk of severe brain bleeding compared with the other positions or remaining in the incubator.

Eligibility

Primary outcome measure(s)

• Severe Intraventricular hemorrhage — HIV appearance: from before 6 hours of life to at least 7 days of life
  Peri-intraventricular hemorrhages are defined according to Papile's classification, with HIV ≥ grade 3 identified as severe intraventricular hemorrhage. HIV will be screened for using transfontanellar ultrasound at the anterior fontanelle.

Trial sites (1)

More Hospital Universitario 12 de Octubre trials in Spain

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