Clinical trials: Infant Outcomes
Child Development
The Effect of a New Infant Formula on Growth and Cognition in Healthy Term Infants
This study is a multicenter, double-blind, randomized, controlled, parallel-designed, prospective trial and is intended to evaluate the nutritive effects of two staged study formulas on growth and cognitive outcomes.
- Trial name
- NCT04508257
- Testing
- Oral feeding of Investigational Formula (Stage 1&2), Oral feeding of Control formula (Stage 1&2), Breast feeding
- Where
- 3 sites in China
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
Fetal Distress, Perinatal Asphyxia
Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings
The PRISM pilot feasibility study consists of two phases to determine: 1) to delivery practices, rates of primary and secondary outcomes, and feasibility of enrollment rates, and 2) to assess the feasibility and acceptability of…
- Conditions
- Fetal Distress, Perinatal Asphyxia, Birth Asphyxia, Stillbirth
- Trial name
- PRISM (NCT05946681)
- Where
- Zambia
- Volunteers
- 1,017 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
Premature Infant, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
Preventing Vulnerable Child Syndrome in the NICU With Cognitive Behavioral Therapy (PreVNT Trial)
This study is being done to see if outcomes for both a premature infant's parents and the infant born prematurely who have spent time in the neonatal intensive care unit (NICU) can be improved through parent cognitive behavioral…
- Conditions
- Premature Infant, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Development, Child, Parent-Child Relations
- Trial name
- PreVNT (NCT03906435)
- Testing
- Cognitive Behavioral Therapy
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Feeding Intolernce
Feeding Intolerance in Preterm Infant
To determine the incidence and risk factors of feeding intolerance in preterm infants. To assess the outcome of feeding intolerance in preterm infants.
- Trial name
- NCT06693557
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Assiut University
Integrated Community-based Intervention Package, Breastfeeding, Exclusive
An Integrated Community-based Intervention Package in Improving Maternal and Neonatal Health Outcomes
This study aims to improve maternal, neonatal and infant health outcomes through an integrated community-based intervention package in Jimma Zone, Southwest Ethiopia.
- Conditions
- Integrated Community-based Intervention Package, Breastfeeding, Exclusive, Morbidity;Newborn, Complementary Feeding
- Trial name
- ICBIP-MNH) (NCT05517577)
- Testing
- Behaviour Change Communication and Male involvement intervention
- Where
- Ethiopia
- Volunteers
- 624 people, healthy volunteers welcome
- Sponsor
- Jimma University
Cerebral Palsy, Cerebral Palsy (CP)
Assessing Intellectual and Motor Outcomes in High-risk Infants
Cerebral palsy (CP) is a condition when a baby has a brain injury that affects their movement and muscle tone. Some people with CP can have other developmental issues, like learning impairments, but many do not and have isolated…
- Conditions
- Cerebral Palsy, Cerebral Palsy (CP), Cerebral Palsy Children, High-risk Infants
- Trial name
- AIM-High (NCT06857539)
- Where
- 4 sites in Ireland
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- University College Cork
Cognitive Change
Improved Cognitive Outcomes Associated With Feihe HMO With DHA/ARA in Infant Formula
The goal of this interventional clinical trial is to test the effectiveness of improving cognitive development in newly born infants fed with Feihe investigational formula product containing HMO, and DHA/ARA.
- Trial name
- NCT06146387
- Testing
- Investigational Formula, Control Formula, Breastfeeding
- Where
- 3 sites in China
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
Vitamin D Deficiency
Maternal Vit D Supplements & Infant and Maternal Biomarkers & Outcomes in Southern Ethiopia
Synthesis of vitamin D in the skin through the action of sunlight is a major source of vitamin D in parts of the world where foods are not fortified with the vitamin.
- Trial name
- NCT02210884
- Testing
- Vitamin D
- Where
- Ethiopia
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Oklahoma State University
Maternal Psychological Distress, Prenatal Stress
Roo Study on Mom and Baby Well-Being
This study employs a randomized controlled trial of an established intervention, Mindfulness Based Cognitive Therapy (MBCT) adapted for pregnancy, to examine effects on various aspects of maternal psychological stress during…
- Conditions
- Maternal Psychological Distress, Prenatal Stress, Infant Development, Functional Neuroimaging
- Trial name
- NCT03809598
- Testing
- Mindfulness Based Cognitive Therapy
- Where
- United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Oregon Health and Science University
Opioid-use Disorder, Opioid Use, Unspecified
Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
The objective of this study is to better understand the comprehensive integration of both clinical and genetic factors that will help to identify mothers who could be at an increased risk of poor response to opioid substitution…
- Conditions
- Opioid-use Disorder, Opioid Use, Unspecified, Buprenorphine Dependence
- Trial name
- Mother/BabyOUD (NCT03923374)
- Testing
- Subutex / Buprenorphine, Fetal & Neonatal MRI, DNA/Genetic/Pharmacokenetic Blood Draws
- Where
- United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Senthil Sadhasivam
Sleep Problem, Neurobehavioral Manifestations
NapBiome: Targeting Gut Microbiota and Sleep Rhythm to Improve Developmental and Behavioral Outcomes in Early Childhood
The gut-brain axis plays a crucial role in the regulation and development of psychological and physical processes. The first year of life is a critical period for the development of the gut microbiome, which parallels important…
- Trial name
- NapBiome (NCT06396689)
- Testing
- Synbiotic
- Where
- 2 sites in Switzerland
- Volunteers
- 380 people, healthy volunteers welcome
- Sponsor
- Petra Zimmermann
Premature Birth
Feeding and Transition to Home for Preterms at Social Risk
Premature infants are at high risk of suboptimal health and development. This randomized clinical trial evaluated the impact of a developmentally based intervention, H-HOPE (Hospital-home transition: optimizing prematures'…
- Trial name
- H-HOPE (NCT02041923)
- Testing
- H-HOPE, Attention Control
- Where
- 2 sites in United States
- Volunteers
- 198 people, healthy volunteers welcome
- Sponsor
- University of Illinois Chicago
Cystic Fibrosis
Role of Body Fat Distribution in Metabolic and Pulmonary Decline in Cystic Fibrosis (ORBIT-CF)
Nutrition and body composition, the amount of muscle and fat in the body, has a role in overall health. This study wants to learn more about how nutrition and body composition affects health outcomes like glucose tolerance and…
- Trial name
- NCT04002882
- Where
- 2 sites in United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Emory University
Retinopathy of Prematurity
Time Outside Target Oxygen Saturation Range in Preterm Infants and Long Term Outcomes and Preterm Infants
The purpose of this study is to determine if there is a relationship between time spent out the targeted oxygen saturation range in preterm infants is associated with long-term outcomes such as Retinopathy of Prematurity.
- Trial name
- SAT01ROP (NCT00845624)
- Where
- United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- University of Virginia
Tissue Oxygenation
The Correlation Between Tissue Oxygenations Using NIRS and Clinical Outcomes in Very Preterm Infants.
With the development of neonatal critical medicine, the survival rate of premature infants has gradually increased, and the incidence of late complications has significantly decreased, but preterm delivery is still the main cause…
- Trial name
- TCBTOUNACOIVPI (NCT06483867)
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- The First Hospital of Jilin University
Gross Motor Development Delay
The Effects of Playful Pathways
The purpose of this study is to evaluate infants ages 0-6 months of age before and after an 8 week developmental and educational "caregiver and baby" interactive program as well as 3 month following the conclusion of the program.
- Trial name
- NCT06139549
- Testing
- Gross motor development group session
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Arkansas Colleges of Health Education
Outcome Assessment
Thailand Birth and Infant Outcomes Study
The goal of this observational study is to examine national trends in mode of delivery and to assess associations between cesarean section and early-life health outcomes using routinely collected health data in Thailand.
- Trial name
- NCT07498192
- Where
- Thailand
- Volunteers
- 10,300 people, healthy volunteers welcome
- Sponsor
- Mead Johnson Nutrition
Acute Kidney Injury, Chronic Kidney Disease
Outcomes of Neonatal Acute Kidney Injury In Premature Infants
The objective of this protocol is to investigate the impact of prematurity, with or without associated acute kidney injury (AKI), on the future risk of chronic kidney disease (CKD) by establishing a patient registry and…
- Trial name
- NCT02375854
- Testing
- Observation
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Premature Babies
BEADI - The Bliss Cluster Randomised Control Trial on the Effects of Active Dissemination of Information (BEADI)
BEADI is a dissemination trial, on standards of care of premature babies. The main objective of BEADI is to assess whether an innovative 'active' strategy for the dissemination of neonatal information (evidence reviews…
- Trial name
- BEADI (NCT00831168)
- Testing
- Effects of Active Dissemination
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Confidential Enquiry into Maternal and Child Health
Premature Birth of Newborn
Supporting and Enhancing NICU Sensory Experiences (SENSE)
Seventy preterm infants born less than or equal to 32 weeks gestation were put into either the sensory-based intervention (experiment) group or traditional care (control) group. Consecutive admissions at St.
- Trial name
- SENSE (NCT03316547)
- Testing
- SENSE Program
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine