Kangaroo Care, Premature Infant, IVH- Intraventricular Hemorrhage
Conditions
Keywords
patient positioning, kangaroo-Mother care Method, Skin to Skin, Extremely Premature Infant, cerebral hemorrhage, incubator care
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.
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.
Interventions
PROCEDURELateral
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.
PROCEDUREProne
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.
PROCEDUREIncubator care
Kangaroo care will not be provided during the first three days of life, and the infant will remain in the incubator.
Sponsors
Hospital Universitario 12 de Octubre
Hospital Universitario La Fe
Hospital Regional de Malaga
Germans Trias i Pujol Hospital
Hospital Universitario Vall d´Hebron
Hospital de Cruces
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 72 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Spain
Contacts
CONTACTLaura Collados Gómez
CONTACTMaite Moral Pumarega
PRINCIPAL_INVESTIGATORLaura Collados Gómez
Universidad Complutense de Madrid
Outcome results
None listed