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| ID | Type | Description | Link |
|---|---|---|---|
| PI25/01534 | Other Grant/Funding Number | Instituto de Salud Carlos III |
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| Name | Class |
|---|---|
| Hospital Universitario La Fe | OTHER |
| Hospital Regional de Malaga | OTHER |
| Germans Trias i Pujol Hospital | OTHER |
| Hospital Universitario Vall d´Hebron |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Collados Gómez | Contact | +34686822609 | laucol03@ucm.es | |
| Maite Moral Pumarega | Contact | mmoralp@salud.madrid.org |
| Name | Affiliation | Role |
|---|---|---|
| Laura Collados Gómez | Universidad Complutense de Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario 12 de Octubre | Madrid | Spain |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D016684 | Prone Position |
| ID | Term |
|---|---|
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| UNKNOWN |
| Hospital de Cruces | OTHER |
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| 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. |
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| Incubator care | Procedure | Kangaroo care will not be provided during the first three days of life, and the infant will remain in the incubator. |
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| D000091642 | Urogenital Diseases |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |