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82 Infants Trials Near You
Power is an online platform that helps thousands of Infants 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 PowerCycled Phototherapy for Premature Infants
Columbus, Ohio
Cycled phototherapy (PT) is likely to increase survival over that with continuous PT among extremely premature infants (\< 750 g BW or \<27 weeks GA).
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:22 - 27
Key Eligibility Criteria
Disqualifiers:Hemolytic Disease, Major Anomaly, Nonbacterial Infection, Others
1700 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
Estimate the risks and benefits of active treatment versus expectant management of a symptomatic patent ductus arteriosus (sPDA) in premature infants.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:48 - 21
Key Eligibility Criteria
Disqualifiers:Cardiopulmonary Compromise, Congenital Heart Disease, Others
836 Participants Needed
Red Cell Transfusions for Premature Infants
Columbus, Ohio
The objective of the TOP trial is to determine whether higher hemoglobin thresholds for transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in the primary outcome of survival and rates of neurodevelopmental impairment (NDI) at 22-26 months of age, using standardized assessments by Bayley.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:< 48
Key Eligibility Criteria
Disqualifiers:Congenital Heart Disease, Anemia, Others
Must Not Be Taking:Erythropoietin
1824 Participants Needed
The objective of the NeoPlaTT trial is to test whether, among extremely preterm infants born at 23 0/7 to 26 6/7 weeks' gestation, a lower platelet transfusion threshold, compared to a higher threshold, improves survival without major or severe bleeding up to 40 0/7 weeks' postmenstrual age (PMA).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:1 - 48
Key Eligibility Criteria
Disqualifiers:Comfort Care, Thrombocytopenia, No Vitamin K, Others
2433 Participants Needed
Humidity Levels in Incubators for Preemies
Columbus, Ohio
The objective of the study is to assess 2 different initial incubator humidification protocols for infants \<25 weeks' gestation admitted to the neonatal intensive care unit (NICU). The hypothesis is that a higher starting humidity decreases dehydration and results in no difference in survival or morbidity. Higher (90%) and lower (70%) starting humidity will be compared.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:0 - 1
Key Eligibility Criteria
Disqualifiers:Congenital Skin Conditions, Outborn, Others
350 Participants Needed
Multisensory Intervention for Prematurity
Columbus, Ohio
This trial tests a new treatment for preterm babies that uses their mother's voice, touch, and scent to help their brain develop better. The treatment is aimed at babies born early who often have trouble with brain development. By giving these babies familiar and comforting sensory experiences, the treatment hopes to improve their long-term growth and abilities.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Age:32 - 36
Key Eligibility Criteria
Disqualifiers:Not Listed
248 Participants Needed
AR Formula vs Omeprazole for Infant Acid Reflux
Columbus, Ohio
The goal of this investigator-initiated, single-center, randomized controlled trial (RCT) is to compare the effects of four weeks of three therapies on clinical and mechanistic outcomes based on pH-Imp testing using a three-arm parallel design in NICU infants with objective GERD diagnosis. The three therapies being compared are natural maturation, proton pump inhibitor (PPI) use, and added rice (AR) formula use. The main goals are:
* to evaluate and compare the efficacy of the three commonly used treatment interventions used in the NICU for GERD in a randomized controlled manner with the primary endpoint of oral feeding success and absence of troublesome symptoms (as defined below).
* to characterize the mechanisms of primary end point (success or failure) using pH-Impedance metrics.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:1 - 8
Key Eligibility Criteria
Disqualifiers:Chromosomal Abnormalities, Congenital Syndromes, Others
Must Not Be Taking:Neuroactive Medications
369 Participants Needed
Olanzapine for Cancer-Related Nausea and Vomiting
Columbus, Ohio
Chemotherapy-induced nausea and vomiting (CINV) are among the most bothersome symptoms during cancer treatment according to children and their parents. Most children receiving highly emetogenic chemotherapy (HEC), including those receiving hematopoietic stem cell transplant (HSCT) conditioning, experience CIV despite receiving antiemetic prophylaxis. Olanzapine improves CINV control in adult cancer patients, has a track record of safe use in children with psychiatric illness, does not interact with chemotherapy and is inexpensive. We hypothesize that the addition of olanzapine to standard antiemetics will improve chemotherapy-induced vomiting (CIV) control in children receiving highly emetogenic chemotherapy
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:30 - 18
Key Eligibility Criteria
Disqualifiers:Pregnancy, ECG Abnormalities, Others
Must Be Taking:Antiemetics
200 Participants Needed
Lorlatinib for Brain Tumors
Columbus, Ohio
The goal of this study is to determine the response of the study drug loratinib in treating children who are newly diagnosed high-grade glioma with a fusion in ALK or ROS1. It will also evaluate the safety of lorlatinib when given with chemotherapy or after radiation therapy.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Early Phase 1
Age:1 - 21
Key Eligibility Criteria
Disqualifiers:Pregnancy, Organ Transplant, Psychiatric Disorder, Others
Must Not Be Taking:Investigational Drugs, Anti-cancer Agents
15 Participants Needed
Endoscopic Treatment vs. Shunt Surgery for Hydrocephalus
Columbus, Ohio
Hydrocephalus is a potentially debilitating neurological condition that primarily affects babies under a year of age and has traditionally been treated by inserting a shunt between the brain and the abdomen. A newer endoscopic procedure offers hope of shunt- free treatment that may reduce complications over a child's life, but it is not clear if the endoscopic procedure results in similar intellectual outcome as shunt. Therefore, the investigators propose a randomized trial to compare intellectual outcome and brain structural integrity between these two treatments, to help families make the best treatment decision for their baby.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:1+
Key Eligibility Criteria
Disqualifiers:Intraventricular Hemorrhage, High Mortality, Others
176 Participants Needed
MOMI PODS for Postpartum Health
Columbus, Ohio
The investigator's long-term goal is to mitigate pregnancy-related mortality (PRM) risk by systematically delivering integrated clinical and supportive care that is effective, equitable, and scalable. The investigator's central hypothesis is that the Multi-modal Maternal Infant Perinatal Outpatient Delivery System (MOMI PODS) will mitigate postpartum (PP) risk and reduce disparities in PP risk by improving biopsychosocial profiles and facilitating access to evidence-based clinical and supportive care. To test this hypothesis, the investigators will conduct a hybrid type 1 randomized controlled trial (RCT) of MOMI PODS versus enhanced usual care (EUC, which we will term MOMI CARE) among a total sample of 384 mother-infant dyads (192/group) following pregnancy affected by a cardiometabolic and/or mental health condition. The investigators will enroll participants on PP day 1 and collect data at baseline and 6 months and 1 year PP. The investigators will collect implementation and service data across sites.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Seizure Disorder, Major Infant Complications, Others
384 Participants Needed
Letermovir for Congenital CMV Infection
Columbus, Ohio
This is a Phase 1 single-arm open-label study of letermovir in neonates with symptomatic congenital Cytomegalovirus (CMV) disease. There will be two groups enrolled. Group 1 will be comprised of 4 subjects. Following documentation study inclusion and signing of informed consent, Group 1 subjects will receive one dose of oral letermovir (Study Day 0), using the dose bands. A full pharmacokinetics (PK) profile will then be obtained over the next 24 hours, and blood specimens will be shipped immediately to the University of Alabama at Birmingham (UAB) Pharmacokinetic Lab and processed in real time. Within = 7 days, pharmacokinetics (PK) results will be conveyed to the study site. If the Area Under the Curve (AUC24) is =100,000 ngxhr/mL (see footnote a in Table 1), the subject will initiate a 14-day course of once-daily oral letermovir at the same dose as utilized on Dose Finding Day. This duration of letermovir therapy was selected based upon our earlier observation in this population that patients with symptomatic congenital Cytomegalovirus (CMV) disease who achieve viral suppression to =2.5 log by day 14 of valganciclovir therapy and then maintain it over the next 4 months are statistically more likely to have improved hearing across the first two years of life (22). If the observed letermovir exposure of the subject is \> 100,000 ngxhr/mL, the once-daily oral letermovir dose that will be used will be adjusted down in 2.5 mg increments. Oral valganciclovir (16 mg/kg/dose BID) will begin within the first month of life, as standard of care; initiation of valganciclovir can be concomitant with or prior to initiation of the 14-day course of letermovir (but will not start before obtaining the pharmacokinetics (PK) specimens following the single dose of letermovir on the Dose Finding Day). This is similar to the intensification approach that has been evaluated in the management of patients infected with human immunodeficiency virus (23-25). The day that the 14-day course of letermovir begins for Group 1 subjects will be known as Study Day 1. Serial blood samples will be obtained on Study Days 1, 5, 10, and 14 for safety chemistry and hematology labs and for Cytomegalovirus (CMV) viral loads. Cytomegalovirus (CMV) viral load will be followed as well on Study Days 21 and 42 to assess for rebound in Cytomegalovirus (CMV) following cessation of letermovir treatment on Study Day 14. Saliva and urine viral loads will be followed at these timepoint as well. Full pharmacokinetics (PK) profiles for both letermovir and ganciclovir will be obtained on Study Day 10. In addition, sparse pharmacokinetics (PK) sampling will be obtained on Study Days 1, 5, and 14. Adverse events will be assessed at each study visit during treatment, and at Study Days 21 and 42 (4 weeks after the last study drug dose). Subjects then will continue on oral valganciclovir as routine clinical care to complete an anticipated 6 month duration of total therapy. The primary Objective is to determine the systemic exposure (AUC24) of letermovir following administration of oral letermovir granules in infants with symptomatic congenital CMV disease.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:0 - 90
Key Eligibility Criteria
Disqualifiers:HIV Exposure, Imminent Demise, Others
Must Be Taking:Valganciclovir
12 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
Emergency Care Action Plan for Infant Health
Cincinnati, Ohio
Infants with medical complexity (IMC) are a challenging population with more emergency department visits, inpatient stays, and higher healthcare costs than other children. IMC also experience lower quality emergency health care. The PI and team propose to adapt and put into place an emergency care action plan (ECAP) for IMC across four US hospitals, working directly with medical providers and families in each setting. After the tool is made available to providers and families, the PI and team will measure if the ECAP tool helps decrease the number of hospitalizations (primary research outcome) for IMC, as well as if the ECAP is feasible, acceptable, and useable for those using the ECAP over a one-year period.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:0 - 6
Key Eligibility Criteria
Disqualifiers:No Caregiver Consent, Others
500 Participants Needed
Dietary Intervention for Feeding Difficulties in Large Infants
Cincinnati, Ohio
Large for Gestational Age (LGA) infants have excess fat-mass (FM) proportion secondary to prolonged in utero exposure to an energy-rich environment. Our preliminary data suggest that excess FM proportion can be associated with oral feeding delay and a potentially modifiable therapeutic target to improve oral feeding outcomes. The objective of this study is to determine the impact of a short-term Fat-free mass (FFM)-indexed feeding on the oral intake volumes in LGA infants with oral feeding difficulties.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:1 - 10
Key Eligibility Criteria
Disqualifiers:Respiratory Support, Unsafe Swallowing, GI Surgery, Others
40 Participants Needed
The purpose of this study is to test the good and bad effects of the study drugs bortezomib and vorinostat when they are given in combination with chemotherapy commonly used to treat acute lymphoblastic leukemia (ALL) in infants. For example, adding these drugs could decrease the number of leukemia cells, but it could also cause additional side effects. Bortezomib and vorinostat have been approved by the US Food and Drug Administration (FDA) to treat other cancers in adults, but they have not been approved for treating children with leukemia. With this research, we plan to meet the following goals:
PRIMARY OBJECTIVE:
* Determine the tolerability of incorporating bortezomib and vorinostat into an ALL chemotherapy backbone for newly diagnosed infants with ALL.
SECONDARY OBJECTIVES:
* Estimate the event-free survival and overall survival of infants with ALL who are treated with bortezomib and vorinostat in combination with an ALL chemotherapy backbone.
* Measure minimal residual disease (MRD) positivity using both flow cytometry and PCR.
* Compare end of induction, end of consolidation, and end of reinduction MRD levels to Interfant99 (ClinicalTrials.gov registration ID number NCT00015873) participant outcomes.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:All
Key Eligibility Criteria
Disqualifiers:Prior Therapy, Mature B-cell ALL, AML, Down Syndrome, Others
50 Participants Needed
RSV Vaccination + Immunization for Respiratory Syncytial Virus
Cincinnati, Ohio
Respiratory Syncytial Virus (RSV) is the leading cause of lower respiratory tract infections (LRTIs) in infants and young children. It is also a leading cause of mortality in children \<5 years of age worldwide. Until recently, no Food and Drug Administration (FDA)-approved vaccines were available to prevent RSV infection. The only prophylactic product for RSV prevention recommended for infants was the monoclonal antibody palivizumab, but administration was limited to those with extreme prematurity, chronic lung disease, or hemodynamically significant congenital heart disease. However, in 2023, the FDA approved two products designed to prevent RSV lower respiratory tract disease (LRTD) in all infants: an active RSV vaccine based on the prefusion F protein (RSVpreF, ABRYSVO, Pfizer) administered during pregnancy, and a passive, long-acting monoclonal antibody (nirsevimab-alip \[henceforth referred to as nirsevimab\], BEYFORTUS, AstraZeneca) administered to infants at birth or at the start of their first RSV season. Both products were evaluated in Phase 3 pivotal clinical trials and have high efficacy in preventing LRTD caused by RSV in infants. Although there is no established correlate of protection against RSV, antibodies have been associated with protection across multiple studies. The clinical development plan for the products did not include comprehensive evaluations of the magnitude and durability of the immune response, nor were the two products tested in a single trial. This study is a prospective, randomized, open-label Phase 4 study with the primary objective of evaluating the magnitude and durability of RSV-specific neutralizing antibodies in infants through 12 months of life following either maternal RSV vaccination, infant nirsevimab administration, or both products combined.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Psychiatric Disease, Immune Impairment, Others
Must Not Be Taking:Immunosuppressants, Corticosteroids
400 Participants Needed
Sirolimus for Tuberous Sclerosis
Cincinnati, Ohio
This trial is testing sirolimus, a medication that helps control symptoms of Tuberous Sclerosis Complex (TSC), in infants. The goal is to prevent or delay seizures, which can impact long-term brain development. Sirolimus works by turning down the activity of a center in the body that doesn't function properly in TSC. Sirolimus has been studied for its potential to control seizures in pediatric patients with TSC and has shown promising results in improving seizure control.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:1 - 6
Key Eligibility Criteria
Disqualifiers:Seizures, Prematurity, Significant Illness, Others
Must Not Be Taking:Anticonvulsants, MTOR Inhibitors
64 Participants Needed
Babies with single ventricle congenital heart disease (SVCHD) are often diagnosed during pregnancy. While prenatal diagnosis has important clinical benefits, it is often stressful and overwhelming for parents, and many express a need for psychological support. HeartGPS is a psychological intervention for parents who receive their baby's diagnosis of SVCHD during pregnancy. It includes 8 sessions with a psychologist, coupled with tailored educational resources, and a personalized care plan. The intervention focuses on fostering parent psychological adjustment and wellbeing, and supporting parents to bond with their baby in ways that feel right for them. Through this study, the investigators will learn if HeartGPS is useful and effective for parents and their babies when it is offered in addition to usual fetal cardiac care. The investigators will examine the effects of the HeartGPS intervention on parental anxiety, depression, and traumatic stress; fetal and infant brain development; parent-infant bonding; and infant neurobehavioral and neurodevelopmental outcomes. The investigators will also explore mechanisms associated with stress biology during pregnancy, infant brain development and neurodevelopmental outcomes, and parent and infant intervention effects.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:DiGeorge Syndrome, Untreated Psychiatric, Others
104 Participants Needed
Why Other Patients Applied
"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
"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
Diuretic Therapy for Bronchopulmonary Dysplasia
Cincinnati, Ohio
Babies who are born prematurely often develop a chronic lung disease called bronchopulmonary dysplasia (BPD). BPD puts babies at higher risk for problems with growth and development. Diuretics, such as furosemide, are frequently used in the management of early BPD). Many clinicians use informal trials of therapy to see if a baby responds to diuretics in the short-term before starting chronic diuretic therapy. Despite frequent use of diuretics, it is unclear how many babies truly respond to therapy and if there are long-term benefits of diuretic treatment. Designing research studies to figure this out has been challenging. The Pragmatic Research on Diuretic Management in Early BPD (PRIMED) study is a feasibility pilot study to help us get information to design a larger trial of diuretic management for BPD. Key questions this study will answer include: (1) Can we use an N-of-1 trial to determine whether a particular baby responds to furosemide? In an N-of-1 trial, a baby is switched between furosemide and placebo to compare that particular infant's response on and off diuretics. It is a more rigorous approach to the informal trials of therapy that are often conducted in clinical care. We hope to learn how many babies have a short-term response to furosemide ("responders"); (2) how many babies will still be on respiratory support at the end of the N-of-1 trial? This will help us determine how many patients would be eligible to randomize to chronic diuretic therapy in the second phase of the larger trail, and (3) if a baby is identified as a short-term responder, how many parents and physicians would be willing to randomize the baby to chronic diuretics (3 months) versus placebo in the longer trial?
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:2 - 10
Key Eligibility Criteria
Disqualifiers:Congenital Anomalies, Electrolyte Imbalance, Others
Must Not Be Taking:Dexamethasone, Hydrocortisone, Long-acting Diuretics
30 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
Cannabidiol for Seizures
Cincinnati, Ohio
This trial tests a medication called GWP42003-P in children under 2 years old who have severe seizure disorders like TSC, LGS, or DS. The study will last over a year and will check if the medication is safe, how it moves through the body, and if it helps reduce seizures. These conditions often don't respond well to usual treatments, so new options are needed. Cannabidiol (pharmaceutical) is approved by the FDA for the treatment of seizures associated with DS, Lennox-Gastaut syndrome, and tuberous sclerosis complex in patients ≥1 year of age.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Age:1 - 23
Key Eligibility Criteria
Disqualifiers:Not Listed
27 Participants Needed
Gene Therapy for Congenital Hearing Loss
Cincinnati, Ohio
Regeneron is conducting a study of an investigational new drug called DB-OTO. DB-OTO is a gene therapy that is being developed to treat children who have hearing loss due to changes in the otoferlin gene.
The purpose of this study is to:
* Learn about the safety of DB-OTO
* Determine how well DB-OTO is tolerated (does not cause ongoing discomfort)
* Evaluate the efficacy of DB-OTO (how well DB-OTO works)
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:< 17
Key Eligibility Criteria
Disqualifiers:Cochlear Implants, Malignancies, Meningitis, Others
22 Participants Needed
Medically Tailored Groceries for Pregnancy
Cleveland, Ohio
Medically tailored groceries (MTG), involving grocery items to be prepared at home, selected by a nutritional professional based on a treatment plan, is a growing approach adopted by healthcare systems to address food insecurity in their patient populations, a leading contribution to health disparities such as poor birth outcomes within pregnant populations. However, transportation and other social needs can often hinder patient uptake of clinic-based approaches. Findings from this study will help to better understand how home delivery of MTGs, with and without supplemental education and support to improve food literacy, behavioral and health outcomes.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 55
Sex:Female
Key Eligibility Criteria
Disqualifiers:Under 18 Years Old
360 Participants Needed
Family Intervention Programs for Infant Development
Fort Wayne, Indiana
The proposed research is relevant to public health because of the critical importance of infant attachment and early experiences to the lifetime trajectory of mental health and socio-emotional functioning. This Randomized Clinical Trial addresses major gaps in available family-wide programs that can promote healthy development that best serve infants, mothers, fathers, and inter-parental relationships in cost-effective ways. This study also systematically tests for which families the interventions are most effective and rigorously tests the theoretical processes that link changes in mother-infant, father-infant, and mother-father interactions with infant and parent outcomes.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:6+
Key Eligibility Criteria
Disqualifiers:Infant Health Problems, Others
1005 Participants Needed
Iron-Fortified Formula for Infant Development
Pittsburgh, Pennsylvania
This trial studies the effects of a special baby formula on the growth of healthy infants over a few months. The goal is to see if the added nutrients help babies gain weight and develop normally. Babies will be fed as much formula as they want during this period. The American Academy of Pediatrics has strongly advocated nutrient fortification of infant formulas since 1969 to reduce the prevalence of iron-deficiency anemia.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:1 - 14
Key Eligibility Criteria
Disqualifiers:Health Conditions Impacting Feeding
440 Participants Needed
Talk With Me Baby for Infant Language Development
Morgantown, West Virginia
The goal of this clinical trial is to learn if the Talk With Me Baby (TWMB) program improves the home-language environment for at-risk families with children ages two to six months when primary care providers deliver the program during well-child checkups. The main question it aims to answer is:
Will the TWMB program increase the time a caregiver talks to their infant?
Participants will:
1. Come to at least four well-child checkups
2. Receive the TWMB program from the provider during the checkups
3. Record their conversations with their infant before they receive the program and after they receive the program four times.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:2 - 6
Key Eligibility Criteria
Disqualifiers:Cognitive Impairment, Developmental Delay, Others
66 Participants Needed
Bottle Nipples for Infants of Mothers with Obesity
Ann Arbor, Michigan
This study will help researchers learn more about how babies respond to bottle nipples with larger or smaller holes. Researchers guess that infants of mothers with obesity who did not lose weight prior to pregnancy will have the greatest Suck Effect on the challenging compared with the typical nipple.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:3+
Key Eligibility Criteria
Disqualifiers:Non-PLAN Study, Low Birth Weight, Others
30 Participants Needed
Neurofeedback for Traumatic Stress Disorders in New Mothers
Detroit, Michigan
This trial tests a mobile app that helps new mothers with PTSD manage their stress and improve their parenting skills. The goal is to see if this helps both the mothers' mental health and their babies' development.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Untreated Mental Illness, Epilepsy, Unsafe Living, Others
Must Not Be Taking:Benzodiazepines, Narcotics, Cannabis
40 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 Infants 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 Infants 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 Infants 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 Infants 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 Infants 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 Infants clinical trials?
Most recently, we added Emergency Care Action Plan for Infant Health, Prenatal Support Program for Premature Birth and Lorlatinib for Brain Tumors to the Power online platform.
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