[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neonatal-death\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neonatal-death":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100453696","chv-neo-community-based-digital-communication-to-support-neonatal-health-100453696",false,"NCT05187897","CHV-NEO: Community-based Digital Communication to Support Neonatal Health","Inclusion Criteria:\n\n* Pregnant\n* 26-36 weeks gestation\n* Daily access to a mobile phone (own or shared)\n* Willing to receive SMS\n* Age ≥14 years\n* Able to read and respond to text messages in English, Kiswahili or Luo, or have someone in the household who can help\n* Receiving antenatal care at study facility\n* Plan to be in the area for at least 3 months postpartum\n\nExclusion Criteria:\n\n* participating in another study\n* previously participated in this study",true,"FEMALE","14 Years",{"count":19,"type":20},3000,"ESTIMATED","INTERVENTIONAL",[23],"NA","Neonatal mortality (defined as death in the first 28 days of life) remains unacceptably high in sub-Sarahan Africa. The concentrated risk of neonatal illness in the first weeks of life and its potential to rapidly deteriorate means that expanding mothers' access to timely information and support during this period is critical to reducing neonatal mortality. This cluster-randomized control trial aims to integrate a 2 way interactive SMS text messaging intervention into existing digital infrastructure supporting Community Health Volunteer (CHV) workflow in Western Kenya (dCHT) to enable remote communication by mothers with CHVs between home visits.",[26,27],"Neonatal Death","Perinatal Death",[29,30,31,32,33,34,35],"SMS","Essential Newborn Care","Kenya","Community Health Volunteer","Neonate","mHealth","Implementation Science","RECRUITING","2025-12-05",{"date":39,"type":40},"2025-12-11","ACTUAL",{"date":42,"type":40},"2024-01-10",{"date":44,"type":20},"2026-06-30",{"name":46,"class":47},"University of Washington","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":48},"100497933","phase-4-vitality-in-infants-via-azithromycin-for-neonates-trial-100497933","NCT05763693","Vitality in Infants Via Azithromycin for Neonates Trial","VIVANT","Inclusion Criteria:\n\n* Aged 1-27 days old\n* Birthweight \\\u003C 2500 g and\u002For weight-for-height Z score \\\u003C- 2 standard deviations at enrollment\n* Weigh at least 1500 g at time of enrollment\n* Able to feed orally\n* Family intends to stay in the study area for at least 6 months\n* Written informed consent from at least one caregiver\n* Afebrile\n* Caregiver at least 18 years old\n* No known allergy to macrolides\n* No hepatic failure manifested by neonatal jaundice\n* Not currently an inpatient at the clinic\n* Not being transferred to a hospital for clinical complications\n\nExclusion Criteria:\n\n* Birthweight \\> 2500 g\n* Weigh less than 1500 g at time of enrollment\n* Unable to feed orally\n* Family planning to move within 6 months\n* Mother\u002F caregiver not willing to participate\n* Allergic to macrolides\n* Hepatic failure manifested by neonatal jaundice\n* Currently being seen as an inpatient at the clinic\n* Currently being transferred to a hospital for clinical complications","ALL","1 Day","27 Days",{"count":60,"type":20},4000,[62],"PHASE4","Nearly half of child deaths occur during the neonatal period, and 80% of those occur in babies with low birthweight. Although tremendous progress has been made towards reducing under-five mortality globally, declines in neonatal mortality lag behind those observed in older children. Low birthweight babies are at increased risk of poor outcomes compared to those who are term-appropriate for gestational age, including mortality, stunting, and growth failure. Recent evidence has demonstrated that the incidence of wasting and linear growth failure is highest between birth and 3 months of age, substantially earlier than previously thought. Interventions are urgently needed to improve outcomes in low birthweight babies; however, these interventions must not interfere with breastfeeding and thus some well-established interventions used to treat or prevent malnutrition in older children cannot be considered. The investigators recently demonstrated that biannual mass azithromycin distribution reduces all-cause childhood mortality by approximately 25% in infants aged 1-5 months, with stronger effects seen in underweight infants. This study did not include neonates due to the risk of infantile hypertrophic pyloric stenosis (IHPS) that has been hypothesized to be associated with macrolide use during early infancy. However, our study team documented only a single case of IHPS among 21,833 neonates enrolled in a trial of azithromycin versus placebo administered to neonates aged 8-27 days for prevention of infant mortality, documenting no major risk of IHPS associated with azithromycin. Here, the investigators propose an individually randomized trial where participants will receive a single oral dose of azithromycin (administered either during the neontal period or 21 days after enrollment), two does of oral azithromycin spaced 21 days apart, or two doses of placebo to evalute if azithromycin improves nutritional outcome and reduces infectious burden among neonates aged 1-27 days who are either low birthweight (\\\u003C2500 g at birth) or underweight (weight-for-age Z-score \\\u003C -2 at enrollment). The primary outcome will be weight-for-age Z-score at 6 months of age compared between arms. The investigators anticipate that the results of this study will provide definitive evidence on azithromycin as an early intervention for low birthweight\u002Funderweight neonates, who are at the highest risk of adverse outcomes.",[26,65,66],"Infectious Disease","Nutritional Deficiency",[68,69],"Low birth weight","underweight neonates","NOT_YET_RECRUITING","2025-08-28",{"date":73,"type":40},"2025-08-29",{"date":75,"type":20},"2026-04",{"date":77,"type":20},"2030-04",{"name":79,"class":47},"University of California, San Francisco"]