NCT07473882

Intraventricular Hemorrhage in Kangaroo Care vs. Incubator Care

Kangaroo Care in Extremely Preterm Newborns Versus Incubator Care and Intraventricular Hemorrhage: A Multicenter RCT

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 314 (estimated)
• Sponsor: Hospital Universitario 12 de Octubre · Academic / Other
• Sex: All
• Age: 1 Minute – 72 Hours
• Healthy volunteers: Not accepted

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.

Detailed description

This protocol describes a multicenter, randomized, parallel-group clinical trial designed to evaluate the safety and effects of early kangaroo care on cerebral stability in extremely preterm newborns during the first 72 hours of life. Participants will be randomly assigned to one of three postural management strategies: side-lying kangaroo care, prone kangaroo care, or conventional incubator care. The study includes standardized implementation of the intervention across centers, serial clinical and neurological monitoring, as well as brain imaging and noninvasive cerebral oxygenation monitoring to assess the physiological effects associated with each position. Analyses will follow the intention-to-treat principle, comparing safety and clinical outcomes between groups while adjusting for relevant perinatal factors. The design incorporates quality control procedures, staff training, blinded image assessment, and ethical and regulatory safeguards to ensure methodological rigor and patient protection.

Conditions

• Kangaroo Care
• Premature Infant
• IVH- Intraventricular Hemorrhage

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2027-01-01
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

1 site across 1 country: Spain