[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"group-2-skin-to-skin-care-ssc-followed-by-carrier-care-cc-followed-by-family-choice\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:group-2-skin-to-skin-care-ssc-followed-by-carrier-care-cc-followed-by-family-choice":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":16,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100603903","early-phase-1-carrier-care-an-innovative-approach-to-support-small-babies-in-the-nicu-100603903",false,"NCT07142564","Carrier Care: An Innovative Approach to Support Small Babies in the NICU","Inclusion Criteria:\n\nNeonates who:\n\n* are admitted to the hospital\n* who have an estimated length of stay equal to or greater than fifteen (15) days\n* weighing greater than or equal to 1800 grams at the time of enrollment\n* that are medically stable (free of significant apnea, bradycardia, or desaturations) within the past 48 hours\n\nExclusion Criteria:\n\n* infants who require oxygen therapy or positive pressure respiratory support\n* infants who have central intravenous lines (e.g., Broviac or peripherally inserted central catheter)\n* caregivers who are prisoners\n* caregivers who cannot read or speak English","ALL","9 Months",{"count":18,"type":19},100,"ESTIMATED","INTERVENTIONAL",[22],"EARLY_PHASE1","The significance of skin-to-skin care (SSC) for neonatal infants is well-documented, highlighting its benefits for both the infant and the caregiver. The World Health Organization (WHO) has emphasized the necessity of positioning the infant on the mother after birth in a manner to prevent Sudden Unexpected Postnatal Collapse (SUPC) and accidental drops and falls. SSC is also recommended for 8 hours a day for the first few weeks of life to promote a secure attachment in the infant and bonding with the caregiver.\n\nDespite these established benefits, some families hesitate to engage in skin-to-skin care (SSC) because it is often only done in private settings and requires the caregiver to use their arms to hold the infant in place. Babywearing, or holding the infant to the body of the caregiver using a cloth or infant carrying device, can promote prolonged contact between the caregiver and infant without requiring the caregiver to hold the infant in place with their arms. Babywearing can also be done in more public settings (e.g., grocery store) as the caregiver can remain clothed during babywearing. The purpose of this study is to investigate whether babywearing using a babywearing device, referred to in this study as Carrier Care (CC), is at least as feasible and effective as SSC. This research will evaluate several physiological parameters of the infant, including cardiorespiratory stability, thermoregulation, and oxygen saturation levels. Certified babywearing educators will instruct research participants to ensure proper use of baby carriers and the safety of infants as outlined by the current hospital policy for babywearing.\n\nThis study will utilize an amplitude-integrated electroencephalogram (aEEG), a non-invasive, bedside monitoring tool commonly used in neonatal intensive care units (NICUs) to assess brain activity, particularly in premature infants. The aEEG provides a simplified and continuous recording of cortical activity, offering valuable insights into neurological development, including sleep-wake cycling. In this study, the aEEG will be used to evaluate the presence of sleep-wake patterns as a proxy for brain maturation. Data will be collected by placing EEG electrodes on the infant for a total duration of 12 hours: 4 hours prior to the intervention (baseline), 4 hours during the intervention (defined as skin-to-skin contact or carrier care), and 4 hours post-intervention. Recordings will occur on day 3 of the randomized activity to assess potential changes in brain activity associated with the intervention during this critical period of neurodevelopment. Dau 4 or 5 will be used as backup.",[25,26],"Group 1: Carrier Care (CC) Followed by Skin-to-Skin Care (SSC) Followed by Family Choice","Group 2: Skin-to-Skin Care (SSC) Followed by Carrier Care (CC) Followed by Family Choice",[28,29,30,31],"carrier care","skin-to-skin care (ssc)","infant carrier","babywearing","NOT_YET_RECRUITING","2026-07-17",{"date":35,"type":36},"2026-07-20","ACTUAL",{"date":38,"type":19},"2026-09-01",{"date":40,"type":19},"2028-09-30",{"name":42,"class":43},"University of Arizona","OTHER"]