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40 Infant Development Trials Near You
Power is an online platform that helps thousands of Infant Development 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 PowerBabies 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
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
Parental Education for Child Development
Chicago, Illinois
The overall goal of this study is to understand how common conditions in childhood develop and if by providing specific health education and resources to parents/caregivers we can promote healthy development. This study will provide information and instruction on several aspects of infant care including, sleep, nutrition, building a healthy relationship with your baby, and healthy screen time use.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:< 26
Key Eligibility Criteria
Disqualifiers:Preterm Birth, Dysphagia, Specialized Diet, Others
1800 Participants Needed
Attachment-Focused Parenting Program for Child Development
College Park, Maryland
Growing evidence demonstrates that secure attachment in childhood predicts children's healthy social, biological, and behavioral functioning, whereas insecure attachment predicts behavior problems and physiological dysregulation; thus, efforts to foster secure attachment are crucial for promoting the healthy development of children and families. This proposal describes a randomized controlled trial (RCT) of an innovative intervention program that can be widely implemented designed to foster children's secure attachment, promote healthy physiological regulation, and reduce the risk for behavior problems: The Circle of Security ® Parenting (COS-P) intervention. To this end, investigators will conduct an RCT with 249 parent-child dyads enrolled or are eligible but not yet enrolled in two diverse Early Head Start (EHS) programs.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:8+
Key Eligibility Criteria
Disqualifiers:Language Fluency
249 Participants Needed
Rosie Chatbot Assistance for Pregnancy and Infant Care
College Park, Maryland
Rosie the Chatbot is an educational chatbot that moms can have on their computers or cellphones and will work by moms typing in their questions about pregnancy, health, infant milestones, and other variety of health related topics and receiving back a response immediately. Rosie only provides information from verified sources such as children's hospitals, health organizations and government agencies. Rosie does not ask moms to provide any personal information on her or her child, her chat is completely confidential, it works in English and Spanish and will be free.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:14 - 99
Sex:Female
Key Eligibility Criteria
Disqualifiers:Non-hispanic White, Others
400 Participants Needed
Parent-Mediated Social Training for Developmental Delay
Baltimore, Maryland
This study is being done to examine the feasibility and impact of the Infant Achievements caregiver coaching treatment on caregiver child-engagement strategies used during play with their infant. The investigators will examine effects on infants' social and communication behavior. This randomized controlled trial will compare caregivers and infants in the Infant Achievements (IA) coaching group to caregivers and infants in the Caregiver Education (CE) no-coaching group. A total of 64 eligible participants (16 children plus their caregiver per group) will participate in the study.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:8 - 12
Key Eligibility Criteria
Disqualifiers:Head Injury, Seizure Disorder, Aggression, Others
64 Participants Needed
Teacher Training for Infant Development
Baltimore, Maryland
The goal of the research study is to increase teachers' implementation of evidence-based practices in Early Head Start classrooms through the delivery of a professional development (PD) training intervention. The main questions that the study aims to answer are:
1. Does teacher participation in a PD intervention improve the use of evidence-based practices from pre- to posttest?
2. To what extent is the PD intervention feasible to implement in an established child care program?
3. To what extent is the PD program acceptable to teachers?
Participants will attend PD workshops and participate in content-related job-embedded coaching sessions during the implementation of the study.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Outside Baltimore, Non-English Speaking
15 Participants Needed
mABC Intervention for Opioid Addiction
Newark, Delaware
This study will assess the efficacy of the modified Attachment and Biobehavioral Catch-Up (mABC) Intervention, adapted for use with peripartum mothers receiving medication-assisted treatment for opioid use disorder. The investigators expect that mothers who receive the modified Attachment and Biobehavioral Catch-up Intervention will show more nurturing and sensitive parenting and more adaptive physiological regulation than parents who receive a control intervention. The investigators expect that infants whose mothers receive the modified Attachment and Biobehavioral Catch-up will show better outcomes in attachment, behavior, and physiological regulation than infants of parents who receive the control intervention.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Must Be Taking:Medication-assisted Treatment
200 Participants Needed
Neonatal Massage for Infant Development
Saint Louis, Missouri
The goal of this study is to learn about brain connectivity and if massaging babies shortly after birth has an impact. Half of the recruited babies will receive massage daily while the other half will not, and differences will be observed.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Active Psychosis, Mania, Suicidal, Others
80 Participants Needed
Multisensory Intervention for Premature Birth
Saint Louis, Missouri
This trial aims to help preterm babies and their parents by using a structured program called SENSE. The program includes activities like massage and skin-to-skin contact that parents can do regularly. These activities are designed to support the baby's development and improve parent-child bonding. The SENSE program is a structured sensory-based program developed to maximize the benefit of parent-directed, positive sensory exposures in the NICU.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:1 - 7
Key Eligibility Criteria
Disqualifiers:Congenital Anomaly, High Threat Of Death, Others
215 Participants Needed
Social Media-Based Parenting Program for Postpartum Depression
Philadelphia, Pennsylvania
The long-term goal is to develop effective parenting strategies to facilitate optimal child development for mothers suffering with PPD symptoms. The overall objective for this application is to study whether this program combined with online depression treatment leads to more responsive parenting (target) and signals improved child language, socioemotional and cognitive development (outcomes) compared to depression treatment alone. Findings from this application can be used to inform a future study to test the effectiveness and implementation of this social media-based parenting program.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Suicidality, Severe Depression, Premature Birth, Others
95 Participants Needed
Home Visiting for Mother and Infant Well-being
New York, New York
MIHOPE is a multi-state study of home visiting programs authorized under the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) program. The study is required by the federal Patient Protection and Affordable Care Act of 2010 (ACA), which created the MIECHV program. It is being conducted by MDRC under contract to the Administration for Children and Families within the US Department of Health and Human Services. In conducting the research, MDRC has subcontracted portions of the research to Mathematica Policy Research, Johns Hopkins University, Columbia University, University of Georgia, and James Bell Associates.
MIHOPE is randomly assigned 4,229 families nationally to home visiting services or to a comparison group that will receive referrals to other services in the community. The study is seeking to include 88 local home visiting programs (sites) that are funded through MIECHV in approximately 12 states. Data will be collected from families, local home visiting programs, and state and federal administrative data systems to assess the effects of the programs on family outcomes and to learn more about how the programs are run. Sites included in the evaluation will be using one of four national service models (Nurse Family Partnership, Healthy Families America, Parents as Teachers, and Early Head Start-Home Visiting Option) that states have chosen for most of their MIECHV funding. MIHOPE will inform the federal government about the effectiveness of the MIECHV program in its first few years of operation, and it will provide information to help states develop and strengthen home visiting programs in the future. Research findings will be disseminated through a report to Congress in 2015; reports on program impacts, implementation, and on the relationship between program features and program impacts; journal articles; and practitioner briefs.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:15+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Already Enrolled, Foster Care, Homeless, Others
4232 Participants Needed
This study will assess whether the promotion of emotional exchange between mother and infant during the first four months of life improves primarily mother-child early relational health (ERH) and secondarily child neurodevelopmental and maternal mental health outcomes. In prior research on preterm infants, a similar intervention demonstrated increased quality of maternal caregiving behaviors and significant improvements in premature infants' neurodevelopment across multiple domains, including social-relatedness and attention problems. The goal of the emotional exchange intervention is to help mothers provide appropriate stimulation crucial for social, emotional, and neurobehavioral development, by helping the mother and child become attuned, or 'in sync', with each other. Measures of ERH, such as bonding, maternal sensitivity, and mother-child emotional connection will be compared between two groups: one receiving newborn parenting education and the other undergoing facilitated emotional exchange. Assessments will involve videos of mother-infant interactions during each intervention session and follow-up surveys conducted as part of a linked Institutional Review Board-approved study. Data collected in this study will contribute to understanding the underlying mechanisms of mother-infant interactions and their role in shaping optimal neurodevelopmental trajectories for infants and maternal mental health.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:12 - 72
Key Eligibility Criteria
Disqualifiers:Preterm Birth, Post-term Birth, Substance Abuse, Others
132 Participants Needed
Cue-Based Feeding for Low Birth Weight Infants
Birmingham, Alabama
In this parallel-group randomized controlled trial, very low birthweight infants will be randomly assigned in a 1:1 ratio to either cue-based (intervention group) or clinician-driven feeding (control group). For infants in the intervention group, Speech therapists and nurses will use their cue-based assessment training to aid in clinical management of oral feeding. For infants in the control group, clinicians caring for these infants will define the feeding plan based on their daily assessment.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:28 - 32
Key Eligibility Criteria
Disqualifiers:Congenital Anomalies, Cardiovascular Symptoms, Necrotizing Enterocolitis
74 Participants Needed
Cognitive Training for Premature Infant Development
Birmingham, Alabama
This study will test the hypothesis that in preterm infants a caregiver-implemented early developmental intervention (EDI) using finger puppets to develop joint attention and encourage interactive communication with routine EDI care including Bookworm training compared with routine EDI care including Bookworm training alone will increase the Ages and Stages Questionnaire® score at 12 months corrected age.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:1 - 17
Key Eligibility Criteria
Disqualifiers:Major Malformation, Known Syndrome, Others
188 Participants Needed
Parent Informational Session for Child Development
Memphis, Tennessee
The goal of this clinical trial is to examine the impact of an educational intervention on infant motor skill development. The main question it aims to answer is: Question 1) Does exposure to an educational intervention on infant development positively impact infant motor skill development? Researchers will compare the intervention group to the treatment as usual group see if there are differences in infant motor skill development.
The purpose of the proposed study is to determine if tummy time, play positions, screen time, and use of baby gear impacts early motor skill development in children. This is a Pilot study. A Pilot study is a small study that is carried out to collect information that will help in the planning of a larger study with the same topic.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:1 - 4
Key Eligibility Criteria
Disqualifiers:Infant Care By Non-parent, Others
50 Participants Needed
Why Other Patients Applied
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
"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'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
"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
Music Therapy for Premature Infants
New Haven, Connecticut
The investigators are conducting a two-site randomized control trial with the aim of defining the impact of music (M) without or with parent voice (MPV) on very preterm infants' acute and cumulative stress, intranetwork connectivity on term brain MRI, and language and other neurodevelopmental outcomes at two years corrected age. This is based on the hypothesis that infants in MPV arm are expected to experience the greatest benefit compared with infants receiving standard care.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:24 - 30
Key Eligibility Criteria
Disqualifiers:Genetic Anomalies, Severe Brain Injury, Others
243 Participants Needed
PALS Program for Developmental Delay
Burlington, Vermont
The INTACT trial is a multisite pilot feasibility study aimed at testing the effectiveness of the INTACT Intervention program in improving neurodevelopmental outcomes in infants prenatally exposed to cannabinoids. The trial will enroll 20 birthing parent/infant dyads across three sites and will evaluate feasibility endpoints rather than clinical outcomes. The study duration is 22 months, including study start-up, enrollment and intervention, and data analysis and manuscript preparation.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:< 7
Key Eligibility Criteria
Disqualifiers:Illicit Drug Use, Major Birth Defects, Others
Must Not Be Taking:Opiates, Heroin, Cocaine, Others
20 Participants Needed
Early Diagnosis Practices for Cerebral Palsy
Montreal, Quebec
In this research, the investigators are using an implementation science approach to enhance the uptake of a clinical practice guideline for earlier diagnosis of cerebral palsy (i.e. what is being implemented) in neonatal follow-up clinics across Canada. This clinical practice guideline should be part of what neonatal follow-up specialists do in their routine clinical work with children born preterm. However, there is a wide variability in practice. The goal of this project is to harmonize practices in the neonatal follow-up community in agreement with international recommendations for earlier diagnosis of cerebral palsy. This research will measure if clinicians are truly following the clinical practice guideline. If not, implementation strategies that address barriers and leverage on facilitators will be deployed for successful uptake of the clinical practice guideline. This research will also assess whether implementation of the clinical practice guideline is associated with better patient outcomes.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:2 - 30
Key Eligibility Criteria
Disqualifiers:Death, Major Malformation, Moved Outside Canada
2000 Participants Needed
Prone Positioner Device for Infant Development
Kansas City, Missouri
The goal of this clinical trial is to learn about the use of the Prone Positioner in pediatric patients with tracheostomies (trachs). The main question\[s\] it aims to answer are:
* What is the fit and satisfaction of the device?
* Does the device fulfill the goal of allowing infants with trachs participate in tummy time
* What aesthetic feedback will the study team receive on the prone positioner from families, therapists, and nursing staff.
Participants will be placed in the Prone Positioner, they will be monitored for their comfort/satisfaction with use, and how well they are able to be receive ventilation while in the device. Parents of these infants, as well as healthcare providers, will be surveyed on thoughts/suggestions for the Prone Positioner.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:44 - 24
Key Eligibility Criteria
Disqualifiers:Age > 24 Months, Medically Unstable, Recent Surgery, Weightbearing Restrictions, Others
30 Participants Needed
Developmental Care for Congenital Heart Defects
Boston, Massachusetts
The proposed study includes a newborn developmental intervention to improve neurodevelopmental (ND) and medical outcomes for infants with congenital heart disease (CHD) with improved parent well-being. Literature documents long-term ND disabilities for children with CHD, caused by the negative effects of the hospital environment on the developing newborn brain. The cardiac intensive care unit (CICU), while necessary to save the life of the infant with CHD, exposes infants to overwhelming stress through painful procedures, invasive lines and tubes, toxic sensory stimulation, and separation from family. The combination of these negative experiences disrupts the infant's brain maturation and subsequent neurodevelopment. Individualized developmental care (IDC) is an intervention that minimizes the mismatch between infant neurobiological needs and the harsh hospital environment, thereby diminishing the frequency and severity of adverse effects. Core components of IDC include support for parent engagement, caregiving provided in a way to reduce infant stress, providing a soothing environment and appropriately positioning to enhance musculoskeletal and motor development. Research shows that IDC improves outcomes for preterm infants with enhanced brain structure and function, cognitive skills, executive functioning, behavioral outcomes, and family satisfaction from infancy to school age. Despite all the positive evidence for IDC, my past research showed most CICUs do not implement IDC due to lack of staff education and no evidence supporting IDC in CHD.
The investigators propose the first randomized controlled trial to evaluate the efficacy of IDR as an intervention for children with CHD. The investigators hypothesize infants receiving IDC provided in the hospital, compared to those not receiving IDC, will show improved medical outcomes (including shorter hospital stay, improved oral feeding, increased growth), improved developmental competence, and increased parent coping at the time of discharge home and 3 months after discharge. With support from the Children's Heart Foundation, the investigators can demonstrate the feasibility and safety of implementing IDC in the CICU, the potential to improve the ND outcome for infants with CHD and increase parent well-being. This study would serve as the needed pilot study to request funding for a larger multicenter trial which would impact CICU care of infants with CHD and their families around the world.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:< 4
Key Eligibility Criteria
Disqualifiers:Cardiac Arrest, CPR, ECMO, VAD, Others
30 Participants Needed
Metformin for Infant Brain Injury
Boston, Massachusetts
Infants with hypoxic-ischemic encephalopathy (HIE) are at high risk for neurodevelopmental impairment, despite current standards of care. Adjunctive treatments to promote brain repair are needed. The antidiabetic drug metformin has recently been recognized as a neurorestorative agent, but, to date, has not been used in infants. Herein, the investigator describes a clinical trial with the aim of demonstrating the safety and feasibility of metformin use to improve neurodevelopmental outcomes in infants with HIE.
Stay on current meds
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Age:3 - 6
Key Eligibility Criteria
Disqualifiers:Genetic Disorders, Liver Disease, Others
Must Not Be Taking:Antidiabetics, Steroids, Diuretics, Others
30 Participants Needed
Ketogenic Diet for Infantile Spasms
Boston, Massachusetts
Epileptic spasms (ES) are a predominantly infantile seizure type observed frequently in certain genetic disorders. Ketogenic diet (high ratio of fat to carbohydrate/protein) is an established non-medication treatment for difficult to control seizures, including ES. Because ES are associated with worse developmental and cognitive outcomes if not detected or treated quickly and effectively, this trial aims to test the ketogenic diet to prevent ES in this high-risk population. This trial is a single-center pilot study of 10 infants with genetic seizure disorders to establish if the protocol of early ketogenic diet administration and ES evaluation is safe and feasible.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Age:0 - 9
Key Eligibility Criteria
Disqualifiers:Epileptic Spasms, Cortical Malformation, Others
Must Be Taking:Ketogenic Diet
10 Participants Needed
Targeted Milk Fortification for Premature Infants
Boston, Massachusetts
This study is a randomized trial comparing 2 methods of human milk fortification for preterm infants in the neonatal intensive care unit (NICU). All participating infants will receive a human milk diet comprising maternal and/or donor milk plus multi-component and modular fortifiers. In one group (control), the milk will be fortified according to routine standard of care. In the other group (intervention), the fortification will be individually targeted based on the results of point-of-care human milk analysis. Outcomes include physical growth in the NICU and after discharge, brain structure by magnetic resonance imaging at term equivalent age, and neurodevelopment at 2 years.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:1 - 21
Key Eligibility Criteria
Disqualifiers:Congenital Anomaly, Growth Restriction, Others
130 Participants Needed
Baby Navigator Intervention for Social Communication Disorder
Tallahassee, Florida
A confluence of empirical research on poverty, environmental risk factors, and brain development shows that early experiences are uniquely powerful in the first years of life, providing further impetus for early detection and intervention. Measures of early-developing social communication skills offer a viable solution for earlier detection of children with language delays and subsequent educational challenges. The investigators propose testing a new technology-supported platform with three parent-mediated intervention components for babies with early communication delays using mobile technology: 1) the Social Communication Growth Charts, a self-guided app to explore video clips illustrating early milestones and to chart their child's development; 2) Baby Navigator Webinar, webinars open to the public designed as a companion to the Growth Charts; and 3) Mobile Coaching, individual weekly telehealth sessions to coach parents in their everyday activities. The investigators propose using a multiphase optimization strategy (MOST) as a framework for development, optimization, and evaluation of our dynamic web intervention platform. The Investigators will recruit 80 children with communication delays at 12-18 months of age. Families will be invited to the Social Communication Growth Charts bundled with the Baby Navigator Webinar. At 18-21 months, slow responders will be randomized to continue the bundle with or without Mobile Coaching, and responders will continue the bundle. This study will enhance the sustainability, scalability, and lead to transformative changes to efficiently and effectively improve healthcare delivery via the use of innovative technology, an implementation science methodology, and user-friendly tools and web platform.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:12 - 18
Key Eligibility Criteria
Disqualifiers:Over 18 Months, Autism, Others
80 Participants Needed
High-Dose DHA for Bronchopulmonary Dysplasia
Québec, Quebec
This one-stage individual participant data (IPD) meta-analysis study will aim to determine whether high-dose docosahexaenoic acid (DHA) enteral supplementation during the neonatal period is associated with the risk for severe bronchopulmonary dysplasia (BPD) at 36 weeks' postmenstrual age (PMA) compared to control, in contemporary cohorts of preterm infants born at less than 29 weeks of gestation. The association between high-dose DHA and severe BPD will also be explored in important subgroups according to sex, gestational age, small-for-gestational age and mode of delivery.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:< 14
Key Eligibility Criteria
Disqualifiers:Born After 2010, Others
Must Be Taking:High-dose DHA
1801 Participants Needed
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Frequently Asked Questions
How much do Infant Development 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 Infant Development 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 Infant Development 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 Infant Development 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 Infant Development 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 Infant Development clinical trials?
Most recently, we added Cue-Based Feeding for Low Birth Weight Infants, Metformin for Infant Brain Injury and Music Therapy for Premature Infants to the Power online platform.
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