Clinical trials: High Risk Infant
Bottle Feeding
Effect of Infant Formulas Containing a New Fat Blend or the New Fat Blend Plus Fiber in Healthy Term Infants
The primary objective of the study was to compare stool composition (stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents) of infants randomized to receive either standard formula, or 1…
- Trial name
- 9055A1-2000 (NCT02031003)
- Testing
- Infant formula
- Where
- 4 sites in Taiwan
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Gestational Diabetes, Obesity
Healthy Diet for Healthy Moms and Babies
The purpose of this clinical study is to collect baseline information on dietary habits and metabolic risk factors, and to examine the effects of a dietary intervention focusing on fiber and antioxidant rich berries on the…
- Conditions
- Gestational Diabetes, Obesity, Pregnancy, High Risk
- Trial name
- NCT03467503
- Testing
- Blueberry + soluble fiber
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- University of Nevada, Las Vegas
Type 1 Diabetes
M1no-Study - Early Identification of Infants With High Type 1 Diabetes Risk for Participation in Primary Prevention Trials
The goal of this observational study is to identify newborns at increased genetic risk of developing type 1 diabetes-specific beta-cell autoantibodies in order to determine eligibility for participation in primary prevention…
- Trial name
- M1N0 (NCT07670143)
- Where
- 5 sites in Italy
- Volunteers
- 50,000 people, healthy volunteers welcome
- Sponsor
- IRCCS San Raffaele
Immunity
A Clinical Study to Investigate the Effect of a Partially Hydrolysed Infant Formula With Added Synbiotics on the Development of Allergic Manifestations in Infants at High Risk of Developing Allergy
With the rising prevalence of allergic diseases and the subsequent risk of developing other immune-related disorders, primary prevention of allergy has become a major priority.
- Trial name
- MAESTRO (NCT03062995)
- Testing
- Infant Formula with added synbiotics, Standard Infant formula
- Volunteers
- healthy volunteers welcome
- Sponsor
- Nutricia Research
Pregnancy, High Risk
PRISMA Maternal and Newborn Health Study
Access to quality antenatal care (ANC) and postnatal care (PNC), including maternal, newborn, and infant services, is integral to reducing adverse pregnancy-related health outcomes and promoting positive birth experiences.
- Trial name
- PRiSMA-MNH (NCT05904145)
- Where
- 5 sites in Ghana, India and 3 more
- Volunteers
- 267,897 people, healthy volunteers welcome
- Sponsor
- George Washington University
Prematurity, Low Birth Weight
Paternal Involvement in Nursing Guidance and Breastfeeding Self-Efficacy in Mothers of High-Risk Newborns
This study aims to evaluate whether a structured nursing guidance program that increases fathers' participation in the care of hospitalized high-risk newborns improves maternal outcomes compared with routine nursing care.
- Conditions
- Prematurity, Low Birth Weight, Respiratory Distress Syndrome, Newborn, Neonatal Hyperbilirubinemia
- Trial name
- NCT07834008
- Testing
- step-by-step parent education, active father participation in breastfeeding support
- Where
- Taiwan
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Taipei Medical University Shuang Ho Hospital
Anemia, Iron Deficiency
Adherence With Iron Sprinkles Among High-Risk Infants
Compared with iron drops, iron sprinkles supplied for 3 months to high-risk children beginning at age 5-7 months will increase adherence and reduce the rates of anemia and iron deficiency.
- Trial name
- NCT00136266
- Testing
- Ferrous sulphate drops with vitamins A, D, and C, Ferrous fumarate sprinkles with vitamins and minerals
- Where
- 2 sites in United States
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention
Infant Development, Infant,Premature
Pacifier Activated Device and Mother's Voice in Infants at High-risk for Cerebral Palsy
The study seeks to determine the efficacy of non-nutritive suck (NNS) training using a pacifier-activated device (PAM) with mothers' voice to condition suck-strength and rhythmicity, in improving the feeding and developmental…
- Conditions
- Infant Development, Infant,Premature, Hydrocephalus, Neonatal Encephalopathy
- Trial name
- NCT03230032
- Testing
- pacifier-activated device
- Where
- United States
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Nationwide Children's Hospital
Hypoxic-Ischemic Encephalopathy, Hypoglycemia
Quantitative Assessment of Sucking for Early Diagnosis of Brain Injury in Infants at High Risk
The main goal of this study is to quantitatively assess the sucking and feeding activity of infants at high risk of neurological impairment (preterm infants and term infants at risk of abnormal neurodevelopment) during oral…
- Conditions
- Hypoxic-Ischemic Encephalopathy, Hypoglycemia, Neonatal Abstinence Syndrome
- Trial name
- NCT03246243
- Testing
- nfant feeding solution
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
Infant Development, Sensory Disorder
The Prechtl's General Movement Assessment, Hammersmith Infant Neurological Examination and Sensory Profile-2
In the Neonatal Intensive Care Unit (NICU), infants encounter many sensory stimuli (excessive noise, bright lights, painful medical applications, etc.) that are not present in the uterus.
- Conditions
- Infant Development, Sensory Disorder, Sensory Processing Disorder, Motor Delay
- Trial name
- highrisk (NCT05217199)
- Testing
- Measurements
- Where
- Turkey (Türkiye)
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Kahramanmaras Sutcu Imam University
Neonatal Jaundice
Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice (Chicago)
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…
- Trial name
- NCT05521607
- Testing
- Picterus Jaundice Pro (JP)
- Where
- United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Picterus AS
HIV Infections
A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants
This study examines the effects of an infant formula containing increased calories, as compared to commercial formulas, when given during the first 6 months of life.
- Trial name
- NCT00000873
- Testing
- Infant Formula
- Where
- 72 sites in United States, Brazil and 2 more
- Volunteers
- 2,400 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Obstructive Sleep Apnea, Pregnancy Induced Hypertension
Sleep Quality in Pregnancy and Its Impact on Pregnancy Outcomes
Hypothesis:Sleep Disorders are very common during pregnancy but the their exact role in causation of pregnancy related disorders is yet to be determined.
- Conditions
- Obstructive Sleep Apnea, Pregnancy Induced Hypertension, High-Risk Pregnancy, Restless Leg Syndrome
- Trial name
- NCT02016638
- Testing
- Polysomnography and ambulatory blood pressure recording
- Where
- India
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- All India Institute of Medical Sciences
Cystic Fibrosis, Bronchiectasis
Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements
The impact of high-frequency chest wall oscillation therapy on spirometry values (Forced Expiratory Volume, Forced Vital Capacity, Peak Expiratory Flow, Forced Expiratory Flow and Tidal Volume is investigated during use of…
- Trial name
- NCT03534986
- Testing
- International Biophysics AffloVest, Hill-Rom The Vest, Respirtech inCourage
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- International Biophysics Corporation
Neonatal Disease, Altitude Hypoxia
Reference Interval for SPO2 in Neonates at High Altitudes During First 2 Hours and Umbilical Artery Blood Gas
Pulse oximetry offers real time and non-invasive estimation of arterial oxygen saturation in a cost-effective way, and has become a critical tool in guiding the usage of supplemental oxygen in sick newborns.
- Trial name
- NCT05468515
- Testing
- pulse oxygen saturation
- Where
- China
- Volunteers
- 956 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Fudan University
Sudden Unexplained Infant Death, Apnea of Newborn
Advanced Wireless Sensors for Neonatal Care in the Delivery Room
The goals of this observational study is to assess whether a new advanced wireless skin sensor vital sign monitoring system can effectively monitor the vital signs of healthy newborn infants (≥ 35 weeks gestational age).
- Conditions
- Sudden Unexplained Infant Death, Apnea of Newborn, Newborn Morbidity, Newborn Asphyxia
- Trial name
- AWARD (NCT06693817)
- Testing
- Wireless skin sensors vital sign monitoring system, Wired vital sign monitoring system
- Where
- 5 sites in Brazil, Canada and 2 more
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Guilherme Sant'Anna, MD
Stress, Psychological, Preterm Infants
Multimedia Admission Orientation in NICU
The effect of a multimedia admission orientation on the parental stress, uncertainty, and knowledge of primary caregivers of high-risk infants in a neonatal intensive care unit: a quasi-randomized controlled trial study.
- Conditions
- Stress, Psychological, Preterm Infants, Intensive Care Units, Neonatal, Education
- Trial name
- NCT05214248
- Testing
- a multimedia admission orientation
- Where
- Taiwan
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- National Taipei University of Nursing and Health Sciences
Premature Birth, Cerebral Palsy
Neuro-biomechanical Determinants for Motor Behavior in High-risk Infants
This project focuses on motor development, muscle growth and muscle activity. Using advanced, instrumented tests such as , the link between muscles and the movement characteristics will be studied.
- Conditions
- Premature Birth, Cerebral Palsy, Neurodevelopmental Disorders, Brain Injuries
- Trial name
- BAMBI (NCT06111898)
- Testing
- No Intervention
- Where
- Switzerland
- Volunteers
- 348 people, healthy volunteers welcome
- Sponsor
- University Hospital, Geneva
Respiratory Syncytial Virus Infections
A Sudy to Evaluate the Efficacy and Safety of TNM001 in High-risk Infants
This study is a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, and immunogenicity of TNM001 in high-risk infants when entering their RSV season.
- Trial name
- NCT06710925
- Testing
- TNM001
- Where
- 2 sites in China
- Volunteers
- 315 people, healthy volunteers welcome
- Sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.
Autism or Autistic Traits, Healthy
Development of Prosocial Behaviors and Related Brain Network in Infants of High and Low Risk of ASD
The goal of this observational study is to compare the developmental trajectories of prosocial behaviors and functional network connections in infants and toddlers at high and low risk of autism spectrum disorder (ASD).
- Trial name
- NCT06329245
- Testing
- Do not take any interventions
- Where
- China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Fudan University