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75 Neonates Trials Near You
Power is an online platform that helps thousands of Neonates patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerThis trial tests a mix of a steroid and a lung-helping substance on very premature babies to reduce severe lung problems or death. The treatment works by reducing lung inflammation and helping the lungs stay open. Steroids like dexamethasone have been used to treat and prevent chronic lung disease in infants, showing beneficial effects.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:< 48
Key Eligibility Criteria
Disqualifiers:Terminal Illness, Major Malformations, Others
Must Be Taking:Surfactant
1160 Participants Needed
Hydrocortisone for Bronchopulmonary Dysplasia
Columbus, Ohio
The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life. Infants will be randomized to receive hydrocortisone or placebo. This study will determine if hydrocortisone improves infants'survival without moderate or severe BPD and will be associated with improvement in survival without moderate or severe neurodevelopmental impairment at 22 - 26 months corrected age.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Age:< 30
Key Eligibility Criteria
Disqualifiers:Not Listed
800 Participants Needed
Intensive Infant Rehabilitation for Perinatal Stroke
Columbus, Ohio
This trial is testing a new therapy program called I-ACQUIRE for infants who have had a stroke. The program involves intensive sessions with therapists to help improve movement and strength. The study will compare two different amounts of therapy to usual treatments to see which works best.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:8 - 36
Key Eligibility Criteria
Disqualifiers:Uncontrolled Seizures, Fragile Health, Others
Must Not Be Taking:Botulinum Toxin
216 Participants Needed
Valacyclovir for Neonatal Herpes
Columbus, Ohio
A Phase 1 study that will determine the valacyclovir dose that results in a systemic acyclovir exposure comparable to 10 mg/kg of parenterally administered acyclovir, which is an AUC0-12 of 24,000 ngxhr/mL to 48,000 ngxhr/mL. Neonates at risk of acquiring neonatal HSV will be enrolled in one of 2 cohorts. Cohort 1 will be comprised of eight subjects who will receive an initial dose of 10ml/kg of oral valacyclovir. Samples for PK assessments will be obtained to assess the exposure concentration. If the safety profile and the drug exposure concentrations in Cohort 1 are acceptable, eight new subjects will be enrolled in Cohort 2. The dose that these subjects will receive will be predicated upon the pharmacokinetic data from Cohort 1.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:1 - 2
Key Eligibility Criteria
Disqualifiers:Neonatal HSV, Sepsis, Renal Anomalies, Others
Must Not Be Taking:Acyclovir, Ganciclovir, Famciclovir, Others
16 Participants Needed
Aspirin for Preterm Birth
Columbus, Ohio
This is a phase-III multi-center double-blind randomized clinical trial of 1,800 individuals with a history of prior preterm birth at less than 35 weeks gestation who are randomized to either 162 mg aspirin or 81 mg aspirin daily. The study drug will be initiated between 10 and 15 weeks gestation and continued through 36 weeks, 6 days gestation. The primary endpoint is recurrent preterm delivery or fetal death prior to 35 weeks, 0 days gestation.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:14+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Hypertension, Renal Disease, Cardiac Disease, Others
Must Not Be Taking:Anticoagulants, Glucocorticoids
1800 Participants Needed
Periviable GOALS DST for Premature Birth
Columbus, Ohio
This trial tests a tool called Periviable GOALS DST, which helps parents of extremely premature babies make informed decisions by providing clear information and helping them clarify their values. It targets pregnant patients at risk of delivering very early.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Under 18, Incarcerated, Medically Unstable, Others
216 Participants Needed
Symptom-Based Dosing for Neonatal Abstinence Syndrome
Kettering, Ohio
This clinical trial will help us learn more about how to best care for babies with Neonatal Opioid Withdrawal Syndrome, also called NOWS. Babies with NOWS often have tremors, a hard time sleeping, excessive crying, and trouble feeding. Some babies that have NOWS need medicine. Doctors have two ways of providing medicine that are widely used today:
1. Scheduled opioid taper approach. The baby gets medicine at regular times. As symptoms get better, the amount of medicine the baby gets decreases until the baby no longer needs medicine. This is called a medicine taper.
2. Symptom-based approach. The baby will only get medicine when they show signs of NOWS, instead of at regular times. If the baby is showing no signs of NOWS, no medicine will be given.
We are doing the OPTimize NOW study to figure out the best way to give medicine to babies with NOWS.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:1 - 48
Key Eligibility Criteria
Disqualifiers:Major Birth Defects, Neonatal Encephalopathy, Respiratory Support, Others
480 Participants Needed
NGAL Monitoring for Pediatric Acute Kidney Injury
Cincinnati, Ohio
This study will follow patients admitted to the PICU with sepsis, NICU with sepsis or after abdominal surgery, or CICU who are identified as being at risk for developing acute kidney injury. The investigators will use risk-stratification, biomarker testing, and a functional assessment to predict children and neonates who will become fluid overloaded and develop severe acute kidney injury.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:< 25
Key Eligibility Criteria
Disqualifiers:Chronic Kidney Disease, Kidney Transplant, Ongoing AKI, Others
1380 Participants Needed
Buprenorphine for Opioid Addiction during Pregnancy
Cincinnati, Ohio
This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Participants in MOMs will be offered the opportunity to enroll in this sub-study, which is designed to evaluate conceptual models of the mechanisms by which extended-release buprenorphine (BUP-XR), may improve mother-infant outcomes, compared to sublingual buprenorphine (BUP-SL). The additional data collected in this sub-study will be combined with data from the main MOMs trial.
It is hypothesized that: (1) the buprenorphine blood levels will vary, depending on which formulation of buprenorphine was received, (2) the variation in buprenorphine blood levels will be associated with fetal behavior (including fetal heart rate variability) (3) the variation in buprenorphine blood levels will be associated with differences in mother outcomes (including medication adherence and illicit opioid use) (4) the variation in buprenorphine blood levels and in fetal behavior will be associated with infant outcomes (including neonatal opioid withdrawal syndrome and infant development).
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Age:18 - 41
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
97 Participants Needed
Buprenorphine for Opioid Addiction during Pregnancy
Cincinnati, Ohio
The primary objective of this study is to evaluate the impact of treating opioid use disorder (OUD) in pregnant women with extended-release buprenorphine (BUP-XR), compared to sublingual buprenorphine (BUP-SL), on mother and infant outcomes. The primary hypothesis is that the BUP-XR group will not have greater illicit opioid use than the BUP-SL group during pregnancy (non-inferiority).
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Age:18 - 41
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
140 Participants Needed
Health Screening and Referral for Premature Birth
Cincinnati, Ohio
Up to a quarter of the families with preterm infants have unmet social needs, such as housing or job insecurity, which represent adverse social determinants of health (SDOH). Preterm infants are especially vulnerable to the social conditions they grow up in, with sustained impacts on function across multiple organ systems. The goal of this study is to translate an established model of SDOH screening and referral from the outpatient setting to the NICU, thereby maximizing the potential to offset the effects of adverse SDOH on vulnerable mother-preterm infant dyads.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Infant Death, Late Discharge, Others
882 Participants Needed
Buprenorphine for Opioid Use Disorder in Pregnancy
Huntington, West Virginia
This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Caretakers of the infants delivered by MOMs participants will be offered the opportunity to enroll in this sub-study, which is designed to evaluate the impact of extended-release buprenorphine (BUP-XR), relative to sublingual buprenorphine (BUP-SL), on infant neurodevelopment. The additional data collected in this sub-study will be combined with data from the main MOMs trial.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
200 Participants Needed
The proposed A/Z modification of a supraglottic airway (SGA) incorporates an opening in the SGA body that enables access to the endotracheal tube (ETT) through the body of the SGA without the need of using an exchange catheter, thus enabling an ETT to move in the body of the SGA and convert a supraglottic to endotracheal ventilation. In its original form an adaptor made from same material currently used in the endotracheal tubes can make ventilation through the proposed airway device possible in exactly the same manner of a conventional SGA currently used. This adapter also known as the R-piece can be replaced with an ETT. The modification also allows placement of SGA over an existing ETT to convert and endotracheal (ET) to supraglottic (SG) mode of ventilation without the need to use an exchange catheter.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Difficult Airway, BMI >35, GERD, Others
100 Participants Needed
Therapeutic Speech Device for Premature Birth
Chagrin Falls, Ohio
The goal of this clinical study is to test a new, novel medical device designed to improve speech sound differentiation among hospitalized preterm infants. The device is designed to be used at an age equivalent to 32 weeks of gestation or older and to integrate readily into clinical practice for use by nurses and therapists staffing Level II to Level IV NICUs. Preterm born infants are at high risk for neurosensory impairments and developmental delays. In the NICU, infants are often deprived of infant-directed parental speech because of numerous challenges to parental visitation, resulting in reduced differentiation of speech sounds, altered brain structure and poor language outcomes.
The study will explore the effectiveness of a novel medical device designed for infant learning through contingent sucking on a pacifier equipped with a sensor for suck pressure/timing, connected to a speaker that delivers mother's voice.
The study will test the hypothesis that there will be a greater response difference between speech sounds on EEG, for infants receiving the suck-contingent mother's voice intervention than for infants hearing the same amount of non-contingent mother's voice from a speaker device.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:32 - 35
Key Eligibility Criteria
Disqualifiers:Ventilation, Congenital Malformations, Genetic Hearing Loss, Others
Must Not Be Taking:Sedatives, Seizure Medications
203 Participants Needed
Neonate WGS Testing for Genetic Disorders
Pittsburgh, Pennsylvania
The purpose of this study is to understand how the use of whole genome sequencing (WGS) may be able to increase the speed with which a diagnosis is made for patients in an intensive care unit population. This is not an assessment of a new device, test, or technology. This project is an investigation of the utility of this technology in clinical care when compared to standard of care testing. The study will look at the ability to more quickly diagnose a patient (time to diagnosis and efficacy of testing) as compared to standard of care testing. The study will also look at the impact of WGS on patient outcomes and cost of clinical care.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:< 1
Key Eligibility Criteria
Disqualifiers:Known Diagnosis, Major Anomaly, Infection, Others
400 Participants Needed
Antibiotics for Neonatal Infections
Pittsburgh, Pennsylvania
The goal of the NANO trial is to study the longstanding clinical practice of empirically administering intravenous antibiotics to extremely low birthweight (ELBW) infants in the first days of life. In this 802-subject multicenter placebo-controlled randomized clinical trial, the hypothesis to be tested is that the incidence of adverse outcomes is higher in babies receiving empiric antibiotics (EA) in the first week of life compared to babies receiving placebo. The study targets a population of ELBW infants in whom the clinical decision to use or not use EA is currently most challenging -- infants that are clinically stable that did not have a known exposure to intraamniotic infection and were not born preterm for maternal indications. The primary outcome is the composite outcome of late-onset sepsis (LOS), necrotizing enterocolitis (NEC), or death during the index hospitalization. Secondary safety outcomes will include total antibiotic days, days to full enteral feedings, and common morbidities in preterm infants that have previously been linked to EA, e.g. retinopathy of prematurity and bronchopulmonary dysplasia. Weight and length z-score, and head circumference, are standard measures to be collected weekly by clinical team per a standardized protocol.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:23 - 4
Key Eligibility Criteria
Disqualifiers:Maternal Infection, Respiratory Insufficiency, Hemodynamic Instability, Major Congenital Anomalies, Others
Must Not Be Taking:Antibiotics
802 Participants Needed
Glucose Control for Gestational Diabetes
Pittsburgh, Pennsylvania
The purpose of this study is to assess whether a liberal intrapartum glycemic target range compared to usual care standard control ranges will lead to a decrease in the rate of neonatal hypoglycemia among pregnant patients in labor with diabetes.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Major Fetal Anomalies, Planned Cesarean
218 Participants Needed
CPAP for Premature Birth
Indianapolis, Indiana
A Pragmatic Randomized Controlled Pilot Trial to Evaluate the Impact of Early Prophylactic Continuous Positive Airway Pressure with or without Supplemental Oxygen in Spontaneously Breathing Late Preterm Newborn Infants Born by Cesarean Delivery, Compared to No Early Prophylactic Continuous Positive Airway Pressure with or without Supplemental Oxygen, on the Need for Further Respiratory Support Leading to NICU Admissions.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:1 - 5
Key Eligibility Criteria
Disqualifiers:Congenital Anomalies, Pulmonary Hypoplasia, Others
120 Participants Needed
Pravastatin for Preeclampsia Prevention
Pittsburgh, Pennsylvania
The primary purpose of this pilot study is to determine the pharmacokinetic (PK) parameters and collect preliminary safety data for pravastatin when used as a prophylactic daily treatment in pregnant women at high risk of preeclampsia.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
48 Participants Needed
Smartphone-based Screening Tool for Neonatal Jaundice
Chicago, Illinois
A cross-sectional conductive study at the University of Chicago Medicine facilities (hospital and outreach clinics) to enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:1 - 14
Key Eligibility Criteria
Disqualifiers:Inborn Disease, Skin Disease, Phototherapy, Others
250 Participants Needed
Why Other Patients Applied
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
Lacosamide for Neonatal Seizures
Charlottesville, Virginia
The purpose of the study is to evaluate the efficacy of lacosamide (LCM) versus an Active Comparator chosen based on standard of care (StOC) in severe and nonsevere seizure burden (defined as total minutes of electroencephalographic neonatal seizures (ENS) per hour) in neonates with seizures that are not adequately controlled with previous anti-epileptic drug (AED) treatment.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:< 28
Key Eligibility Criteria
Disqualifiers:Metabolic Disturbances, Prenatal Drug Use, ECG Abnormality, Others
Must Be Taking:Phenobarbital, Levetiracetam, Midazolam
32 Participants Needed
NICU2HOME+ App for Premature Birth
Chicago, Illinois
The purpose of this project is to provide a stepwise, methodical approach to developing and testing the ability of Neonatal Intensive Care Unit 2 Home (NICU2HOME+) to support diverse Illinois families of premature infants during and after their Neonatal Intensive Care Unit (NICU) stays in an effort to address health equity, improve parenting, and reduce costs. There are 3 objectives of the study: 1) Identify and assess the requirements for expansion of NICU2HOME+, a suite of mobile patient education and engagement applications with Electronic Medical Record (EMR) integration that is culturally appropriate and customized to the needs of a diverse population of patients and families to 3 additional level III Illinois NICUS; 2) develop and deploy NICU2HOME+ to these 3 additional NICUs; and 3)determine if it is effective in: a) addressing health equity issues, b) improving parenting self-efficacy and satisfaction, and c) improving NICU outcomes such as a reduced length of stay and lower readmission rates that result in lower healthcare costs.
All research recruitment and participation will take place in the following spaces:
1. Northwestern Medicine's Central DuPage Hospital (25 N.Winfield Rd., Winfield, IL)- NICU, Postpartum, and Research Offices
2. Northwest Community Hospital (800 W. Central Rd., Arlington Heights, IL)- NICU,Postpartum, and Research Offices
3. Rush University Medical Center (Chicago, IL)- NICU, Postpartum, and Research Offices
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
413 Participants Needed
Patient Navigation Program for Pregnancy
Chicago, Illinois
The Partnering with Antenatal Navigators to Transform Health in Pregnancy (PATH) study aims to evaluate whether an antenatal patient navigation program improves maternal health, neonatal health, pregnant women's experiences, and health care utilization outcomes among low-income pregnant women and their neonates. Patient navigation is an individualized, barrier-focused, longitudinal, patient-centered intervention that offers support for a defined set of health services. In this randomized controlled trial, pregnant women who are randomized to receive antenatal patient navigation will be compared to pregnant women who are randomized to receive usual care. Navigators will support pregnant women from before 20 weeks of gestation through 2 weeks postpartum. The PATH intervention will be grounded in understanding and addressing factors that influence health and access to care in order to promote self-efficacy, enhance access, and sustain long-term engagement.
The main objectives of the study are to:
1. Evaluate whether PATH, compared to usual care, improves maternal health outcomes. We hypothesize the PATH model of antenatal patient navigation for low-income women will reduce the incidence of a composite of adverse maternal outcomes, all of which are known to be increased among women with barriers to care.
2. Evaluate whether PATH, compared to usual care, improves perinatal health outcomes. We hypothesize PATH will reduce the incidence of a composite of adverse perinatal outcomes. We will also investigate neonatal/pediatric health care utilization.
3. Evaluate patient, clinician, navigator, and healthcare system experiences with PATH in preparation for widespread implementation and dissemination of the PATH obstetric navigation model. This aim will be accomplished through investigating patient-reported outcomes, completing qualitative and process mapping interviews with navigated participants, and completing qualitative and process mapping interviews with clinicians, navigators, and health administrators.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:16 - 50
Sex:Female
Key Eligibility Criteria
Disqualifiers:Transfer Care, Prior PATH, Others
600 Participants Needed
ROSE Program for Preventing Postpartum Depression
Chicago, Illinois
The goal of this clinical trial is to evaluate the impact of ROSE in individuals with adverse childhood experiences. The main question it aims to answer is, compared to enhanced treatment as usual, does the delivery of ROSE within a collaborative care model improve depressive symptom trajectories and prevent the development of perinatal depression.
Participants will be randomized to either enhanced treatment as usual or the ROSE intervention, delivered by a care manager within a perinatal collaborative care program. They will complete self-reported surveys of their depression symptoms every 4 weeks to inform their symptom trajectories. They will also complete clinical interviews to establish any incident diagnoses of a major depressive episode.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Major Depressive Episode, Substance Use Disorder, Others
76 Participants Needed
Prophylactic Surfactant for Neonatal Respiratory Distress Syndrome
Evanston, Illinois
The purpose of this study is to explore the question: Does prophylactic administration of exogenous surfactant in the delivery room, using a minimally-invasive technique, improve outcome in preterm infants 22-29 weeks' gestation compared to rescue treatment using the same technique?
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:0 - 15
Key Eligibility Criteria
Disqualifiers:Congenital Anomalies, Alternate Respiratory Distress
200 Participants Needed
Dexmedetomidine for Neonatal Encephalopathy
Hamilton, Ontario
About \~3/ 1000 live-born newborns may suffer from brain injury due to a transient drop in oxygen supply to the brain during the birth process. The degree of brain injury that ensues in the first 72 hours after the injury is directly proportional to the severity of long-term childhood disabilities (e.g., cerebral palsy and developmental delays). Whole-body cooling during the first 3 days of life is proven effective in reducing the severity of brain injury. However, cooling therapy leads to pain, shivering, stress, and discomfort. The best way to alleviate the pain and agitation of cooled newborns is unknown. Standard practice is to provide morphine infusion to reduce pain. Recently, a new drug called "dexmedetomidine" has been tested in small studies and has been found to be safe during cooling in newborns. Dexmedetomidine has added beneficial effects such as anti-inflammation, faster recovery, and shorter hospital stays. This study is going to test the feasibility of conducting a future clinical trial to compare the effects of using Dexmedetomidine versus morphine in the management of cooling-related pain/agitation on the severity of brain injury in the first week of life. The study will also examine the effect of dexmedetomidine compared to morphine on short-term clinical outcomes, parental experiences and developmental outcomes at 1 year.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:< 20
Key Eligibility Criteria
Disqualifiers:Congenital Brain Malformations, Major Chromosomal Anomaly, Congenital Neuromuscular Disorder, Others
50 Participants Needed
Brief Behavioral Activation Treatment for Postpartum Depression
Evanston, Illinois
SUMMIT's (Scaling Up Maternal Mental health care by Increasing access to Treatment) overarching goal is to examine the scalability and patient-centered provision of brief, evidence-based psychological treatments for perinatal depression and anxiety (N=1226). Specifically, and through a multi-site, randomized, pragmatic trial, the trial examines whether a brief, behavioral activation (BA) treatment delivered via telemedicine is as effective as the same treatment delivered in person; and whether BA delivered by non-mental health providers (e.g., nurses), with appropriate training is as effective as when delivered by specialist providers (psychiatrists, psychologists and social workers) in reducing perinatal depressive and anxiety symptoms. The study will be conducted in Toronto, NorthShore University HealthSystem in Evanston and surrounding areas including Chicago, and North Carolina. The trial will also identify relevant underlying implementation processes and determine whether, and to what extent, these strategies work differentially for certain women over others.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
1230 Participants Needed
Infasurf Aero™ for Neonatal Respiratory Distress Syndrome
Buffalo, New York
The purpose of this clinical study is to determine the effectiveness and safety of Infasurf® administered through the InfasurfAero™, a novel oral airway delivery device specifically designed to give Infasurf in a less complicated way and without the need for a breathing tube or interrupting nasal respiratory support.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:29 - 36
Key Eligibility Criteria
Disqualifiers:Congenital Anomaly, Airway Abnormality, Others
220 Participants Needed
Teleneonatology for Newborn Illness
Mississauga, Ontario
The purpose of this study is to evaluate the impact of real-time audio-video telemedicine consults with a neonatologist (termed teleneonatology) on the early health outcomes of at-risk neonates delivered in community hospitals.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:0+
Key Eligibility Criteria
Disqualifiers:Birth Outside Hospital, Severe Anomaly, Others
947 Participants Needed
NDPP-NextGen for Diabetes Risk Reduction
Winston-Salem, North Carolina
The goal of this clinical trial is to test an enhanced version of the National Diabetes Prevention Program (NDPP-NextGen) that is tailored to young women in childbearing years. The investigators will recruit 360 women aged 18-39 years with overweight/obesity who are not currently pregnant, but likely to conceive within 24 months. Women will be randomized to NDPP-NextGen or a usual care control group. The NDPP-NextGen group will participate in the adapted NDPP online group class across 12 months, and the control group will get a packet of information about how to be healthy before, during and after pregnancy.
The main goals of the study are:
1. to assess effects of NDPP-NextGen on pre-pregnancy blood sugar and early pregnancy BMI
2. to assess effects of NDPP-NextGen on weight gain and behavioral outcomes during pregnancy
3. to explore effects of NDPP-NextGen on infant's percentage of fat tissue at birth
All participants will complete up to 4 research visits: baseline, conception, mid-pregnancy, and delivery. These visits will include:
1. Questionnaires about health, diet, activity, smoking, self-confidence, and depression
2. Body size measurements
3. Fasted blood draws
Participants will also be asked to weigh themselves weekly using home scales that are connected to the research database. At the delivery visit, investigators will measure the baby's body size and collect a cord blood sample.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 39
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Diabetes, Long-acting Contraceptives, Others
403 Participants Needed
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We started Power when my dad was diagnosed with multiple myeloma, and I struggled to help him access the latest immunotherapy. Hopefully Power makes it simpler for you to explore promising new treatments, during what is probably a difficult time.
Bask GillCEO at Power
Frequently Asked Questions
How much do Neonates clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Neonates clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Neonates trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Neonates is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Neonates medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Neonates clinical trials?
Most recently, we added Early Literacy Program for Preterm Infants, NGAL Monitoring for Pediatric Acute Kidney Injury and T-piece Resuscitator vs Ventilator for Preterm Birth to the Power online platform.
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