Intraventricular Hemorrhage in Kangaroo Care vs. Incubator Care (KANVIH)

March 11, 2026 updated by: Hospital Universitario 12 de Octubre

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
314

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Laura Collados Gómez
  • Phone Number: +34686822609
  • Email: laucol03@ucm.es

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
        • Principal Investigator:
          • Ana Gimeno Navarro
        • Contact:
        • Principal Investigator:
          • Elena Carrillo Messa
        • Principal Investigator:
          • Begoña Loureiro González
        • Principal Investigator:
          • Gemma Ginovart Galiana
        • Principal Investigator:
          • Tomás Sánchez Tamayo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lateral kangaroo care
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
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.
Experimental: Prone Kangaroo care
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
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.
Active Comparator: 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.
Procedure: Incubator care
Kangaroo care will not be provided during the first three days of life, and the infant will remain in the incubator.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Severe Intraventricular hemorrhage
Time Frame: 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.
HIV appearance: from before 6 hours of life to at least 7 days of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Universitario 12 de Octubre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Germans Trias i Pujol Hospital
Hospital Universitario La Fe
Hospital Regional de Malaga
Hospital de Cruces
Hospital Universitario Vall d´Hebron

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laura Collados Gómez, Universidad Complutense de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KANVIH_25/711
  • PI25/01534 (Other Grant/Funding Number: Instituto de Salud Carlos III)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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