[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"low-birth-weight\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:low-birth-weight":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100558026","admission-to-kangaroo-mother-care-kmc-ward-and-maternal-postpartum-depression-100558026",false,"NCT06545760","Admission to Kangaroo Mother Care (KMC) Ward and Maternal Postpartum Depression","Admission to the Kangaroo Mother Care Ward and Maternal Postpartum Depression: A Randomized Controlled Trial","KMC PPD","Inclusion Criteria:\n\n-AIM #1-2 and #5\n\nMothers to newborns who are:\n\n1\\) Birthweight between 1000-2000gm 2) Admitted to the Women and Neonates Hospital-University Teaching Hospital Neonatal Intensive Care Unit (WNH-UTH NICU) (\\>48hrs) 3) Stable preterm eligible for continuing kangaroo mother care (KMC) in the NICU or NICU discharge 4) 16+ years of age (Mother) 5) Residing within Lusaka Province with no intensions to relocate in the coming 18 months\n\n* AIM #3\n\n  1. Parents (mothers and fathers) whose newborn has been enrolled in the study\n  2. Trusted family member or friend of the mother whose newborns is enrolled into the study\n  3. 16+ years of age (mothers and fathers)\n  4. 18+ years of age (family members)\n* AIM # 4:\n\n  1. Fathers whose newborn has been enrolled into the study\n  2. 16+ years of age (father)\n\nExclusion Criteria:\n\n* AIM #1-2 and #5\n\n  1. Mothers who are on treatment for depression and\u002For anxiety\n  2. Mothers who did not consent\n  3. Underage mothers (16-17 years of age) whose parent(s) has not provided consent for their participation in the study\n* AIM #3\n\n  1\\) Family members of parents who do not consent to study participation\n* AIM # 4:\n\n  1. Fathers who are on treatment for depression and\u002For anxiety\n  2. Fathers who did not provide informed consent\n  3. Underage fathers (16-17 years of age) whose parent(s) has not provided consent for their participation in the study","ALL","1 Day","89 Years",{"count":21,"type":22},1908,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to learn if extended admission to the Kangaroo Mother Care (KMC) ward helps to prevent postpartum depression in mothers of low birthweight infants in a low-resource setting whose newborns were admitted to the neonatal intensive care unit (NICU) more than standard of care KMC. The main questions it aims to answer are:\n\n* Does longer KMC decrease the incidence of postpartum depression in mothers of low birthweight infants in a low-resource setting?\n* Does longer KMC improve neurodevelopmental outcomes of low birthweight infants at 6, 12, and 18 months in a low-resource setting?\n* What are the barriers to practicing KMC in low birthweight infants following hospital discharge in a low-resource setting?\n* What is the prevalence of paternal depression in a low resource setting?\n* Is it cost effective to admit preterm mother-infant dyads to the KMC ward following NICU discharge?\n\nResearchers will compare (extended admission to the KMC ward) to (standard of care KMC) to see if extended KMC decreases PPD in mothers of preterm infants in low-resource settings.\n\nParticipants (infants) will:\n\n* At time of discharge from the NICU, when clinically stable, spend either \\\u003C 2 days in the KMC ward with their mothers or spend longer in the KMC ward until discharge.\n* Return to clinic at routine follow-up visits (at 2 weeks and at 6-8 weeks) where mothers will be screened for postpartum depression and fathers will be screened for depression.\n* Return to clinic for neurodevelopmental screening at 6, 12, and 18 months where mothers will be screened for postpartum depression and perceived social support and fathers will be screened for depression.",[28,29,30,31,32],"Low Birth Weight","Kangaroo Mother Care","Postpartum Depression","Neurodevelopmental Outcome","Pre-Term",[34,29,35,36],"Low resource setting","Paternal depression","Cost-effectiveness","RECRUITING","2026-06-18",{"date":40,"type":41},"2026-06-22","ACTUAL",{"date":43,"type":41},"2024-12-01",{"date":45,"type":22},"2027-09-30",{"name":47,"class":48},"University of Alabama at Birmingham","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":49},"100507667","increased-risk-of-non-alcoholic-fatty-liver-disease-in-low-birth-weight-individuals-100507667","NCT05890365","Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals","Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals - Extended Validation.","Inclusion Criteria:\n\n* 250 healthy, men and women born with a low birth weight (birth weight (BW) \\\u003C10% of the population) and 50 born with a normal birth weight controls (BW between 50-90% of the population)\n* born at term (weeks 39-41)\n\nExclusion Criteria:\n\n* BMI\\>35 kg\u002Fm2\n* Disease\u002Fmedication known to affect primary outcome\n* Self-reported high physical activity level\n* Alcohol intake above general recommendations.\n* Metabolic\u002Fliver disease\n* Weight gain\u002Floss of \\>3 kg within the past 6 months","34 Years","49 Years",{"count":60,"type":22},300,"OBSERVATIONAL","The investigators recently demonstrated a increase in liver fat in early middle-aged LBW compared to normal birth weight (NBW) men, and 20% of the LBW - but none of the normal birth weight (NBW) - men had previously unknown non-alcoholic fatty liver disease (NAFLD). Here the investigators will further examine the Increased risk of non-alcoholic fatty liver disease in low birth weight individuals by performing a validation study.",[64,28],"Non-Alcoholic Fatty Liver Disease",[66,67,68,69],"Metabolic disease","Adipose tissue biology","Liver fat","Non-alcoholic fatty liver disease","2026-06-09",{"date":72,"type":41},"2026-06-11",{"date":74,"type":41},"2023-12-14",{"date":76,"type":22},"2026-12",{"name":78,"class":48},"Steno Diabetes Center Copenhagen",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":23,"phases":92,"briefSummary":94,"conditions":95,"keywords":100,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":4},"100635484","phase-3-periodontal-disease-and-small-vulnerable-newborns-in-rural-nepal-a-community-based-trial-100635484","NCT07553286","Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial","Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Randomized Trial","Inclusion Criteria:\n\n* Married women of reproductive age (15-35 years).\n* Living in the study area who are pregnant and consent to participate.\n\nExclusion Criteria:\n\n* Currently pregnant women.\n* Women who are sterilized or use long-acting contraceptive methods or are divorced or widowed.\n* Women identified as pregnant ≥12 gestational weeks based upon date of last menstrual period.",true,"FEMALE","15 Years","35 Years",{"count":91,"type":22},2280,[93],"PHASE3","Periodontal disease in pregnant women has been implicated as a potential risk factor for adverse pregnancy outcomes, including being born preterm, small-for-gestational age, and\u002For low birth weight. Infants who have at least one of these outcomes, known as small vulnerable newborns (SVN)), are at increased risk of early death and poor infant growth and development. Rigorous, high-quality randomized trials are needed to evaluate whether improving the periodontal health of pregnant women can reduce the risk of adverse pregnancy outcomes in areas like South Asia, where these outcomes are common and neonatal mortality remains high. This study is a community-based, randomized controlled trial (n=2,280) to evaluate a package of oral health interventions delivered to pregnant women in the first trimester until delivery on the incidence of SVNs in rural Sarlahi District, Nepal. The intervention package will include a daily antiseptic oral rinse and intensive oral hygiene education and instruction. Both intervention and control groups will be provided a manual toothbrush and toothpaste. The investigators will determine intervention effects on incidence of SVNs and individual outcomes of preterm birth, small-for-gestational age, and low birth weight. In a biospecimen sub-study (n=200), the investigators will collect venous blood, gingival crevicular fluid, and plaque in early and late pregnancy to explore relationships between subgingival inflammation, systemic inflammation, and SVN types and other adverse pregnancy outcomes. If efficacious, a low-cost package of oral health interventions - including an antiseptic oral rinse, intensive oral hygiene education and instruction, and provision of a manual toothbrush and toothpaste - could improve maternal and newborn outcomes at this critical time of growth and development.",[96,28,97,98,99],"Preterm Birth","Small Vulnerable Newborn","Small-for-gestational Age","Periodontal Disease",[101,102,103,104,105,106,107,108,109,110,111,112,113],"Nepal","Oral health","Small Vulnerable Newborns","Preterm birth","Periodontal disease","Low birth weight","Small-for-gestational age","Pregnancy","Antenatal care","Dental health","Gingivitis","Antiseptic oral rinse","Oral hygiene","NOT_YET_RECRUITING","2026-04-27",{"date":117,"type":41},"2026-05-01",{"date":119,"type":22},"2026-07-01",{"date":121,"type":22},"2028-12-31",{"name":123,"class":48},"Johns Hopkins Bloomberg School of Public Health"]