Clinical trials: High-risk Infants
Infant, Premature, Premature Birth
Comparing IM vs. Vaginal Progesterone for Pre-term Birth
This is a randomized controlled trial comparing weekly intramuscular injection of 17 alpha hydroxylprogesterone caproate with daily vaginal progesterone in women with singleton pregnancies and history of prior spontaneous preterm…
- Trial name
- NCT00579553
- Testing
- Intramuscular Progesterone, Vaginal Progesterone
- Where
- United States
- Volunteers
- 174 people, healthy volunteers welcome
- Sponsor
- University of Oklahoma
Bronchopulmonary Dysplasia, Child Development
Enteral High-dose DHA Supplementation on Bronchopulmonary Dysplasia in Very Preterm Infants: a Collaborative Study
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…
- Conditions
- Bronchopulmonary Dysplasia, Child Development, Neonatal and Perinatal Conditions
- Trial name
- NCT05915806
- Testing
- High-dose DHA, Control
- Where
- Canada
- Volunteers
- 1,801 people, healthy volunteers welcome
- Sponsor
- CHU de Quebec-Universite Laval
High-risk Pregnancy, Breast Feeding
Effect of Hypnobreastfeeding Education in High-Risk Pregnant Women
It is thought that hypnobreastfeeding training given to high-risk pregnant women will reduce anxiety levels, increase lactation, encourage breastfeeding, reduce the perception of insufficient milk, and facilitate adaptation to…
- Trial name
- NCT07281339
- Testing
- Hypnobreastfeeding Education
- Where
- Turkey (Türkiye)
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Amasya 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
Healthy
Effects of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Chinese Infants
The purpose of this study is to demonstrate the efficacy of infant formula having proportion of palmitate in the sn-2 position comparable to human milk in Chinese term infants.
- Trial name
- NCT00480948
- Testing
- Infant formula feeding (InFat™), Control
- Where
- China
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Enzymotec
Respiratory Support
Effects of Nasal High Flow Therapy on Ventilation and Gas Exchange in Healthy Newborns
Nasal High Flow (NHF) and CPAP are established forms of respiratory support in neonates and often produce similar clinical outcomes.
- Trial name
- NCT02632825
- Testing
- Nasal High Flow
- Where
- Armenia
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Research Center of Maternal and Child Health Protection, Armenia
Cystic Fibrosis, Bronchiectasis
Effect of HFCWO 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
- NCT03628456
- Testing
- International Biophysics AffloVest, Hill-Rom Monarch
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- International Biophysics Corporation
Gestational Diabetes Mellitus in Pregnancy, Cognitive Impairment
Gestational Diabetes Mother-infant Cohort
The bi-directional dynamic cohort study is to learn about the effects of prenatal exposure to high blood glucose levels and postnatal nurturing environment factors on delayed language development in children.
- Conditions
- Gestational Diabetes Mellitus in Pregnancy, Cognitive Impairment, Cohort Study
- Trial name
- NCT06021691
- Testing
- Acquired nurturing environment
- Where
- China
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Gansu Provincial Maternal and Child Health Care Hospital
Pregnancy, Postpartum
HIIT vs MICT During Pregnancy and Health and Birth Outcomes in Mothers and Children
Regular exercise during pregnancy and postpartum leads to health benefits for mother and child. Inactivity during pregnancy and after delivery is now treated as risky behavior.
- Conditions
- Pregnancy, Postpartum, Childbirth, Health Status
- Trial name
- HIIT MAMA (NCT05009433)
- Testing
- High intensity interval training program for pregnant women, Moderate intensity continuous training program for pregnant women, Standard obstetric care with extended education on healthy lifestyle
- Where
- Poland
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Gdansk University of Physical Education and Sport
Risky Baby
Short-term Neonatal and Parental Outcomes in Low- and High-Risk Infants
This study aimed to evaluate the short-term neonatal and parental outcomes in low- and high-risk infants following a single-session family care education intervention. A total of 34 parent-infant dyads were included.
- Trial name
- NCT07534748
- Testing
- Family Care Intervention
- Where
- Turkey (Türkiye)
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Inonu University
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.
Infant, Newborn, Diseases, Sepsis
Prevention of Perinatal Sepsis (PoPS): Evaluation of Chlorhexidine Wipes of Birth Canal and Newborn
The purpose of this study is to evaluate whether use of the disinfectant chlorhexidine administered to the birth canal during labour and newborn at delivery can protect a woman and her baby from bacterial infections after birth.
- Conditions
- Infant, Newborn, Diseases, Sepsis, Puerperal Infection
- Trial name
- NCT00136370
- Testing
- Chlorhexidine, Birth canal wipe, sterile water external genital wipe
- Where
- South Africa
- Volunteers
- 8,000 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention
High Flow Nasal Cannula
Work of Breathing and Oxygen Saturation in Infants Receiving High Flow Nasal Cannula (HFNC)
The purpose of this study is to compare work of breathing on different levels of high flow respiratory support on infants born between 27 and 37 weeks gestation.
- Trial name
- NCT03529994
- Testing
- Enrollment
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Christiana Care Health Services
Healthy Mothers, Healthy Infants
Maternal High Fibre Fermented Diet Effect on Breastfed Infant Gut Microbiome
Breastfeeding is recommended for babies from birth to six months old because breast milk provides all the nutrients babies need for growth and development.
- Trial name
- MumBabyGut (NCT06977113)
- Testing
- High Fibre Fermented Food Diet, Control Habitual Diet
- Where
- United Kingdom
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- University of Glasgow
Cystic Fibrosis
Bone Microarchitecture in Young Cystic Fibrosis Patients
Patients with cystic fibrosis are at risk of developing low bone mineral density (BMD) potentially leading to pathological fractures at adult age.
- Trial name
- NCT01788267
- Testing
- scan examination HR-pQCT
- Where
- France
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
Autism, Cerebral Palsy
Near-infrared Spectroscopy and Electroencephalography to Assess Cortical Activation During Motor Tasks in Infants and Toddlers With and Without Cerebral Palsy
Background: New ways to study the brain as people move include near-infrared spectroscopy (NIRS) and electroencephalography (EEG).
- Trial name
- NCT03434080
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- National Institutes of Health Clinical Center (CC)
Hypertension
A Comparative Single-Dose Pharmacokinetic (PK) and Safety Study of Azilsartan Medoxomil in Children With Hypertension and in Healthy Adults
The purpose of this study was to assess the pharmacokinetics (PK) and safety of a single dose of azilsartan medoxomil in children with hypertension, and comparative PK in healthy adults.
- Trial name
- NCT01078376
- Testing
- Azilsartan medoxomil (TAK-491)
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Takeda
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
Breastfeeding, Patient Simulation
Comparison of Baby Dolls for Teaching Newborn Positioning and Attachment
In this baby doll comparison study, clinical lactation specialists will complete two back-to-back video-based simulations (telesimulations) focused on newborn positioning and attachment.
- Conditions
- Breastfeeding, Patient Simulation, High Fidelity Simulation Training
- Trial name
- NCT04715724
- Testing
- Positioning and Attachment video-based simulation (telesimulation)
- Where
- United States
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- LiquidGoldConcept
Infant, Premature, Erythropoietin
High-Dose Erythropoietin in Extremely Premature Infants to Prevent/Attenuate Brain Injury: A Phase II Study
The highest risk for perinatal brain injury occurs among extremely premature infants who weigh less than 1250 grams at birth. Such perinatal brain injury is currently irreversible, associated with neurodevelopmental disability…
- Conditions
- Infant, Premature, Erythropoietin, Brain Injury, Intraventricular Hemorrhage
- Trial name
- NCT00589953
- Testing
- Erythropoietin
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Atlantic Health System