Intraventricular Hemorrhage in Kangaroo Care vs. Incubator Care

NCT07473882 — Not applicable, Not yet recruiting, 314 participants, Hospital Universitario 12 de Octubre

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

Registry	NCT07473882, acronym KANVIH
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	314 (Estimated)
Sponsor	Hospital Universitario 12 de Octubre (Other); collaborators: Hospital Universitario La Fe, Hospital Regional de Malaga, Germans Trias i Pujol Hospital, Hospital Universitario Vall d´Hebron, Hospital de Cruces
Conditions	Kangaroo Care, Premature Infant, IVH- Intraventricular Hemorrhage
Interventions	Lateral, Prone, Incubator care (Procedure)
Dates	start 2027-01-01 (estimated), primary completion 2029-12-31 (estimated), completion 2029-12-31 (estimated), first posted 2026-03-16, last updated 2026-03-16
Locations	1 site in Spain

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Lateral kangaroo care	Experimental	Procedure: Lateral	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.
Prone Kangaroo care	Experimental	Procedure: Prone	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.
Incubator care	Active comparator	Procedure: Incubator care	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.

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

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: All, ages: 1 Minute to 72 Hours

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

+Locations (1)

Facility	City	Country	Status
Hospital Universitario 12 de Octubre	Madrid	Spain

+Investigators

Laura Collados Gómez, Principal investigator, Universidad Complutense de Madrid