Intraventricular Hemorrhage in Kangaroo Care vs. Incubator Care

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-72
SponsorHospital Universitario 12 de Octubre

About this trial

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 criteria

Qualifiers

Preterm infants born at 28 weeks of gestational age or less, admitted to the NICU and born at the study center (inborn), less than 72 hours old, with a parent or legal guardian present who is willing to provide kangaroo care.

Disqualifiers

Preterm infants in the immediate postoperative period following major surgery.

Preterm infants with congenital abdominal wall malformations.

Preterm infants requiring immobilization.

Preterm infants who are clinically unstable and unable to tolerate kangaroo care.

Trial design

Treatments tested in this trial

  • Lateral
  • Prone
  • Incubator care

Treatment groups

314 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Hospital Universitario 12 de Octubre

Lead sponsor

Hospital Universitario La Fe

Collaborator

Hospital Regional de Malaga

Collaborator

Germans Trias i Pujol Hospital

Collaborator

Hospital Universitario Vall d´Hebron

Collaborator

Hospital de Cruces

Collaborator