Kangaroo CareKANVIHNCT07473882
Intraventricular Hemorrhage in Kangaroo Care vs. Incubator Care
A study testing Lateral, Prone and Incubator care in people with Kangaroo Care and Premature Infant, run by Hospital Universitario 12 de Octubre at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 minute to 72 hours
- Conditions the study is for
- Kangaroo Care, Premature Infant, IVH- Intraventricular Hemorrhage
- What is being tested?
- Lateral, Prone and Incubator care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2027to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maite Moral Pumarega contact
Spain1 site
Hospital Universitario 12 de Octubre
Madrid
Laura Collados Gómez, +34686822609, laucol03@ucm.es
Elena Carrillo Messa
About this study
Official title: 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.
Read the 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.
- Being tested
- Lateral, Prone, Incubator care
- Keywords
- patient positioning, kangaroo-Mother care Method, Skin to Skin, Extremely Premature Infant, cerebral hemorrhage, incubator care
- Medical subject headings
- Premature Birth, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LateralProcedure or surgery
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.
ProneProcedure or surgery
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 careProcedure or surgery
Kangaroo care will not be provided during the first three days of life, and the infant will remain in the incubator.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Incubator care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: HIV appearance: from before 6 hours of life to at least 7 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kangaroo CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario 12 de Octubre
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario La Fe, Hospital Regional de Malaga, Germans Trias i Pujol Hospital, Hospital Universitario Vall d´Hebron, Hospital de Cruces
- Responsible party
- Sponsor
- Investigators
- Laura Collados Gómez, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473882
- Sponsor's protocol ID
- KANVIH_25/711
- Other IDs
- PI25/01534
- Acronym
- KANVIH
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kangaroo Care in Extremely Preterm Newborns Versus Incubator Care and Intraventricular Hemorrhage: A Multicenter RCT
- ClinicalTrials.gov ID
- NCT07473882
- Acronym / sponsor ID
- KANVIH / KANVIH_25/711
- Keywords
- patient positioning, kangaroo-Mother care Method, Skin to Skin, Extremely Premature Infant, cerebral hemorrhage, incubator care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- Hospital Universitario 12 de OctubreUniversity, hospital or other
- Collaborators
- Hospital Universitario La Fe, Hospital Regional de Malaga, Germans Trias i Pujol Hospital, Hospital Universitario Vall d´Hebron, Hospital de Cruces
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lateral kangaroo care | Experimental | Procedure: LateralThe 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: ProneThe 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 careKangaroo 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. |
Who may qualify
- Ages
- 1 minute to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laterallateral 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 or surgery | Lateral kangaroo care |
| Proneprone 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 or surgery | Prone Kangaroo care |
| Incubator careKangaroo care will not be provided during the first three days of life, and the infant will remain in the incubator. | Procedure or surgery | Incubator care |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Kangaroo Care
Active, not recruiting
Maternal Sensory Interventions in Newborns
Neonatal Intensive Care Unit, Hospitalized Newborn
Recruiting
Admission to Kangaroo Mother Care (KMC) Ward and Maternal Postpartum Depression
Low Birth Weight, Kangaroo Mother Care
Recruiting
The Effect of Kangaroo Care on Pain in Infants Receiving Phototherapy
Procedural Pain, Neonatal Hyperbilirubinemia
Not yet recruiting
The Effect of the Side Kangaroo Position in Newborns Undergoing Noninvasive Mechanical Ventilation
Newborn Care
Active, not recruiting
Effect of Kangaroo Mother Care on Energy Utilization in Preterm Neonates
Impact of Kangroo on Neonates
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maite Moral Pumarega contact
Laura Collados Gómez principal investigator
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral, Prone and Incubator care in people with Kangaroo Care and Premature Infant, run by Hospital Universitario 12 de Octubre at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Collados Gómez (+34686822609, laucol03@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe Intraventricular hemorrhage (time frame: HIV appearance: from before 6 hours of life to at least 7 days of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.