Intraventricular Hemorrhage in Kangaroo Care vs. Incubator Care

NCT07473882 | Not Yet Recruiting

• 2 other identifiers: KANVIH_25/711PI25/01534
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

patient positioning; kangaroo-Mother care Method; Skin to Skin; Extremely Premature Infant; cerebral hemorrhage; incubator care

Outcome Measures

Primary Outcomes (1)

• Severe Intraventricular hemorrhage

  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.

  HIV appearance: from before 6 hours of life to at least 7 days of life

Study Arms (3)

Lateral kangaroo care

EXPERIMENTAL

The preterm infant will be placed unclothed against the parent's chest in a side-lying position, aligned along the midline. A NeoHelp™ polyethylene bag will be used, opened at the skin-to-skin contact area and covering the head and the exposed side of the body. A garment worn by the kangaroo care provider or a blanket will be added for additional warmth and support.

Procedure: Lateral

Prone Kangaroo care

EXPERIMENTAL

The preterm infant will be positioned prone against the parent's chest, upright, with the head turned 90° to one side. The NeoHelp™ bag will be used to cover the head and back while maintaining skin-to-skin contact, and the kangaroo care provider's clothing or a blanket will be added for additional warmth and support.

Procedure: Prone

Incubator care

ACTIVE COMPARATOR

Kangaroo care will not be provided during the first three days of life, and the infant will remain in the incubator. Bonding will be encouraged through containment and other supportive strategies.

Procedure: Incubator care

Interventions

Lateral PROCEDURE

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.

Lateral kangaroo care

Prone PROCEDURE

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.

Prone Kangaroo care

Incubator care PROCEDURE

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

Incubator care

Eligibility Criteria

• Age: 1 Minute - 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Preterm infants whose parents decline participation in the study.

Sponsors & Collaborators

• Hospital Universitario 12 de Octubre: lead
• 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

Study Sites (1)

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

MeSH Terms

Conditions

Premature Birth; Cerebral Hemorrhage

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Laura Collados Gómez

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Collados Gómez

CONTACT

+34686822609; laucol03@ucm.es

Maite Moral Pumarega

CONTACT

mmoralp@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

ES (1)