Intraventricular Hemorrhage in Kangaroo Care vs. Incubator Care

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.

Conditions

• Kangaroo Care
• Premature Infant
• IVH- Intraventricular Hemorrhage

Interventions

PROCEDURE

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.

PROCEDURE

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.

PROCEDURE

Incubator care

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

Sponsors & Collaborators

• Hospital Universitario La Fe

  collaborator OTHER

• Hospital Regional de Malaga

  collaborator OTHER

• Germans Trias i Pujol Hospital

  collaborator OTHER

• Hospital Universitario Vall d´Hebron

  collaborator UNKNOWN

• Hospital de Cruces

  collaborator OTHER

• Hospital Universitario 12 de Octubre

  lead OTHER

Principal Investigators

• Laura Collados Gómez · Universidad Complutense de Madrid

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Minute

Max Age

72 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2027-01-01

Primary Completion

2029-12-31

Completion

2029-12-31

Countries

• Spain

Study Locations