[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neonatal-pain\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neonatal-pain":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,66,101],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":36,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":65},"100601587","phase-1-fentanyl-intranasal-for-retinopathy-of-prematurity-screening-in-preterm-infants-100601587",false,"NCT07112430","Fentanyl Intranasal for Retinopathy of Prematurity Screening in Preterm Infants","Intranasal Fentanyl to Reduce Pain Intensity Associated With Retinopathy of Prematurity Screening in Preterm Infants: A Randomized Control Trial","FIREFLY","Inclusion Criteria\n\n* Preterm infants born ≤31 weeks gestational age and\u002For with birth weight \\\u003C1250 g\n* Scheduled to undergo routine retinopathy of prematurity (ROP) screening as part of standard NICU care\n* Clinically stable at the time of screening, defined as not requiring acute resuscitative support (no bag-mask ventilation, intubation, or chest compressions within the preceding 24 hours) and maintaining stable cardiorespiratory parameters on baseline respiratory support\n* Written informed consent obtained from a parent or legally authorized representative\n\nExclusion Criteria\n\n* Congenital anomalies or conditions affecting the nasal passages that would interfere with intranasal drug administration\n* Receipt of systemic opioids, benzodiazepines, barbiturates, or other sedative\u002Fanalgesic medications within 24 hours prior to the ROP examination\n* Known hypersensitivity or prior adverse reaction to fentanyl","ALL",{"count":19,"type":20},58,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The goal of this clinical trial is to learn whether intranasal fentanyl (a pain medicine given as a nasal spray) can reduce pain and is safe to use during routine eye examinations for retinopathy of prematurity (ROP) in preterm infants. ROP is an eye condition that can affect babies born too early and requires regular eye examinations. The main questions this study aims to answer are: Does intranasal fentanyl lower pain during ROP screening? Is intranasal fentanyl safe for preterm infants? Researchers will compare intranasal fentanyl with a placebo (a saltwater spray that contains no medicine) to determine whether the medicine lowers pain during ROP screening.\n\nParticipants will receive either intranasal fentanyl or placebo before their routine ROP eye examination, in addition to the standard comfort measures normally used during the procedure. Researchers will measure participants' pain and monitor their heart rate, oxygen levels, and any side effects during and after the examination.",[27,28,29,30,31,32,33,34,35],"Neonatal Pain","Retinopathy of Prematurity (ROP)","Pain Management","Infant, Premature","Fentanyl","Infant, Newborn","Neonatal Intensive Care Units","Analgesia","Intranasal Drug Administration",[37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52],"intranasal fentanyl","fentanyl","neonatal analgesia","procedural pain","ROP screening","Retinopathy of Prematurity","Preterm infants","Premature infants","infant pain","Non-invasive analgesia","Opioid analgesia","Intranasal drug delivery","Neonatal intensive care","NICU","Pain management in neonates","Infant procedural sedation","NOT_YET_RECRUITING","2026-06-26",{"date":56,"type":57},"2026-06-30","ACTUAL",{"date":59,"type":20},"2026-09-09",{"date":61,"type":20},"2028-06-01",{"name":63,"class":64},"Marsha Campbell-Yeo","OTHER",1,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":17,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":65},"100641703","mother3sense-study-100641703","NCT07651592","MOTHER3SENSE Study","Effects of Maternal Voice, Touch, and Scent on Pain and Stress in Newborns: A Comparison of Three Sensory Interventions","MOTHER3SENSE","Inclusion Criteria:\n\n* Term newborns born between 37 and 42 weeks of gestation\n* Newborns without respiratory, cardiac, metabolic, neurological, or infectious diseases\n* Newborns not requiring oxygen therapy, phototherapy, or intravenous treatment\n* Newborns scheduled to undergo a routine heel lance procedure (metabolic screening or blood sampling)\n* Mothers willing to participate in the study\n* Written informed consent provided by the parent or legal guardian\n* Normal vital signs before the procedure (heart rate, respiratory rate, and oxygen saturation within normal limits)\n\nExclusion Criteria:\n\n* Preterm (\\\u003C37 weeks) or post-term (\\>42 weeks) newborns\n* Presence of congenital anomalies or neurological disorders\n* Requirement for oxygen therapy, phototherapy, or intravenous treatment\n* Respiratory, cardiac, metabolic, neurological, or infectious disease\n* Abnormal vital signs before the procedure\n* Parent or legal guardian refusal to provide informed consent",true,"0 Days","28 Days",{"count":78,"type":20},120,[80],"NA","This randomized controlled trial aims to compare the effects of maternal voice, touch, and scent on pain and stress levels in newborns during a routine heel lance procedure. Newborns will be randomly assigned to one of three intervention groups or a control group. Pain and stress responses will be assessed using validated neonatal pain and physiological measures. The findings of this study may help identify effective, low-cost, and non-pharmacological interventions that can be used to reduce pain and stress in newborns during routine clinical procedures.",[27,83],"Stress, Psychological",[85,86,87,88,89,90,91],"Newborn","Maternal","Voice","Touch","Scent","Heel Lance","pain","2026-06-11",{"date":94,"type":57},"2026-06-16",{"date":96,"type":20},"2026-07-01",{"date":98,"type":20},"2026-10-30",{"name":100,"class":64},"Kilis 7 Aralik University",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":74,"sex":17,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":21,"phases":112,"briefSummary":113,"conditions":114,"keywords":115,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":65},"100564054","shotblocker-during-intramuscular-injection-randomized-control-trial-100564054","NCT06624176","ShotBlocker During Intramuscular Injection Randomized Control Trial","The Effect of ShotBlocker on Pain in Full Term Infants Undergoing Intramuscular Injection: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Infants born at UMass Memorial Medical Center (UMMMC) via vaginal delivery or cesarean delivery and under the care of the nursery team\n* Term infants (37 to 42 weeks gestational age)\n* No acute illness that causes pain\n* Apgar score above 7 at 5 minutes\n* Have successfully attempted at least one oral feeding\n* No circumcision in the last 6 hours\n* Parental consent for Hepatitis B vaccine\n\nExclusion Criteria:\n\n* Swallow dysfunction\n* Congenital or genetic abnormalities\n* Infants who were exposed to sedatives within the last 12 hours\n* Infants with skin on thigh, hand, or foot that is not intact\n* Diagnosis of Neonatal Abstinence Syndrome (NAS)\n* Infants who are simultaneously receiving Hepatitis B Immunoglobulin or Nirsevimab (RSV vaccine)\n* Department of Children and Families (DCF) custody","37 Weeks","42 Weeks",{"count":111,"type":20},200,[80],"The objective of this trial is to evaluate the effect of Bionix ShotBlocker on pain of injection of the first Hepatitis B vaccine in healthy newborns. ShotBlocker is a pain reducing tool used in babies, children, and adults for injections. Swaddling during the injection and administration of oral sucrose prior to the injection are established standards of care for painful procedures in neonates. The investigators hypothesize that the use of ShotBlocker in addition to swaddling and oral sucrose administration will lessen the pain response.",[27],[116,27,117],"ShotBlocker","Needlestick","RECRUITING","2026-06-02",{"date":121,"type":57},"2026-06-04",{"date":123,"type":57},"2024-01-10",{"date":125,"type":20},"2026-10-01",{"name":127,"class":64},"Lauren Fortier"]