Intraventricular Hemorrhage in Kangaroo Care vs. Incubator Care
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-72
SponsorHospital Universitario 12 de Octubre
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Lateral
Procedure/Surgerylateral 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/Surgeryprone 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/SurgeryKangaroo care will not be provided during the first three days of life, and the infant will remain in the incubator.
Treatment groups
314 Participants
are divided into 3 treatment groupsGroup A: Lateral kangaroo careExperimental treatment 1 intervention
Group B: Prone Kangaroo careExperimental treatment 1 intervention
Group C: Incubator careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
HIV appearance: from before 6 hours of life to at least 7 days of lifeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital Universitario 12 de Octubre
Lead sponsor
Hospital Universitario La Fe
Collaborator
Hospital Regional de Malaga
Collaborator
Germans Trias i Pujol Hospital
Collaborator
Hospital Universitario Vall d´Hebron
Collaborator
Hospital de Cruces
Collaborator
Source ClinicalTrials.gov
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