Clinical trials: Term Infants, open to volunteers
Bronchopulmonary Dysplasia
MRI in BPD Subjects
The investigators are wanting to learn more about early development of the lungs and to help them better understand prematurity and the development of a breathing disorder call BPD (Bronchopulmonary Dysplasia)
- Trial name
- NCT03657693
- Testing
- NICU MRI, Polysomnography
- Where
- United States
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Neonatal Acidemia and Hypoxia
Hypoxia Profiles Identified in Term Newborns With Cord pH <7.00
Severe neonatal acidosis is an identified risk factor for neonatal encephalopathies and severe neurological sequelae such as cerebral palsy.
- Trial name
- RCFHypA (NCT07333599)
- Where
- France
- Volunteers
- 400 people
- Sponsor
- University Hospital, Strasbourg, France
Preterm Infant Development, Preterm Infant Health
Neonatal Data and Biobank to Study Factors Influencing Development in Preterm Infants Born at <32 Weeks' Gestation and/or <1500 g Birth Weight
The Neo-Life project aims to establish a prospective neonatal data and biobank to investigate factors influencing the short- and long-term development of very preterm infants.
- Conditions
- Preterm Infant Development, Preterm Infant Health, Prematurity Complications, Premature Birth
- Trial name
- Neo-Life (NCT07490912)
- Where
- Germany
- Volunteers
- 1,300 people
- Sponsor
- University Hospital of Cologne
Respiratory Distress Syndrome, Pre-term Infants
Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome
This is a 2-part, prospective, randomized, blinded, sham-controlled, multi-center study comparing preterm subjects with RDS who are treated with APC-0101 and nCPAP/NIV to subjects treated with nCPAP/NIV alone (Sham).
- Trial name
- NCT06776783
- Testing
- APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system), Control
- Where
- 31 sites in United States, Canada and 1 more
- Volunteers
- 520 people
- Sponsor
- Aerogen Pharma Limited
Childhood Overweight
Effects of Lifestyle Intervention on Childhood Outcomes in LGA Infants
Large-for-gestational-age (LGA) infants have a higher risk of metabolic disease later in life, and their postnatal growth in early childhood may be associated with long-term adverse outcomes.
- Trial name
- NCT04661449
- Testing
- Comprehensive lifestyle intervention
- Where
- China
- Volunteers
- 138 people
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Healthy Volunteers
Early Environmental and Maternal Determinants of Airway Inflammation in Wheezing Disorders in Infants
This study collects data on microbiological, genetic and environmental factors, as well as lung function parameters (e.g. spirometry, body plethysmography, lung-MRI) to assess the complex interaction of predisposing risk factors…
- Trial name
- NCT04286464
- Testing
- No intervention
- Where
- Switzerland
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Vertical Human Immunodeficiency Virus Transmission, HIV Infection Pediatric
Increasing Neonatal HIV Test and Treat to Maximize the Long-Term Impact on Infant Health and Novel Infant Antiretroviral Treatment
This study aims to improve HIV healthcare services for mothers living with HIV and their newborns in Tanzania and Mozambique. The main questions it aims to answer are: 1) does enhancing screening with maternal HIV viral load…
- Conditions
- Vertical Human Immunodeficiency Virus Transmission, HIV Infection Pediatric, Infant Death, Infant Morbidity
- Trial name
- LIFE2Scale (NCT06267508)
- Testing
- Maternal HIV viral load testing at delivery for VHT risk assessment
- Where
- 2 sites in Mozambique, Tanzania
- Volunteers
- 6,000 people
- Sponsor
- Michael Hoelscher
Healthy Term Infants
Evaluation of the Nutritional Value of a New Hydrolysed Rice Protein-based Formula
The goal of this interventional clinical trial is to compare the growth parameters of healthy term infants fed either a new experimental rice hydrolyzed rice protein-based formula or a control formula (standard cow's milk…
- Trial name
- RIGA (NCT07686224)
- Testing
- Rice formula (New formula based on hydrolysed rice proteins), Control formula (Standard cow's milk proteins-based formula)
- Where
- 10 sites in France
- Volunteers
- 156 people, healthy volunteers welcome
- Sponsor
- Health and Happiness Research Limited
Respiratory Distress Syndrome (& [Hyaline Membrane Disease]), Respiratory Distress Syndrome (Neonatal)
Surfactant Administration Methods in Preterm Infants With RDS: A Swedish Cohort Study
The goal of this observational study is to evaluate different methods of surfactant administration in preterm infants with respiratory distress syndrome (RDS).
- Conditions
- Respiratory Distress Syndrome (& [Hyaline Membrane Disease]), Respiratory Distress Syndrome (Neonatal), Respiratory Distress Syndrome (RDS), Respiratory Distress Syndrome of Newborn
- Trial name
- NCT07550218
- Where
- Sweden
- Volunteers
- 300 people
- Sponsor
- Vastra Gotaland Region
Preterm Infants, Term Infants
The Intestinal Innate Immune System in Newborns. Development and Inflammation in Health and Disease
The goal of this observational study is to determine the normal development of the human intestinal immune system in premature and mature neonatal life and to determine the pathophysiology behind life-threatening gastrointestinal…
- Conditions
- Preterm Infants, Term Infants, Necrotising Enterocolitis, Atresia; Bowel
- Trial name
- INTINE (NCT06092463)
- Where
- 2 sites in Denmark
- Volunteers
- 275 people, healthy volunteers welcome
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Maternal Health Services, Infant, Newborn
Comparing Integrative Midwife-led vs. Fragmented Inpatient Postpartum Care: Impact on Satisfaction and Transition to Motherhood
The goal of this clinical trial is to compare two different forms of postnatal care to find out which is most beneficial for mothers and their children after birth and with which they are most satisfied.
- Conditions
- Maternal Health Services, Infant, Newborn, Postnatal Care, Breast Feeding
- Trial name
- SMILE (NCT07077941)
- Testing
- Integrative care
- Where
- Austria
- Volunteers
- 784 people
- Sponsor
- Medical University of Vienna
Bronchopulmonary Dysplasia
Use of Mesenchymal Stem Cells in Pre-term Patients With Bronchopulmonary Dysplasia.
Bronchopulmonary dysplasia (BPD) is a disease that affects preterm newborn patients, preventing their lungs from developing properly.
- Trial name
- NCT06270199
- Testing
- Control, Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions, Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions
- Where
- 7 sites in Spain
- Volunteers
- 75 people
- Sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Lung Function
eCPAP Follow-up at School Age
The purpose of the study is to learn more about extended continuous positive airway pressure (eCPAP) in preterm infants that may be helpful for lung health.
- Trial name
- NCT07860931
- Testing
- Extended CPAP (eCPAP)
- Volunteers
- 95 people
- Sponsor
- Cynthia McEvoy
Gastrointestinal Tolerance, Gastrointestinal Symptoms
Gastrointestinal Symptoms and Tolerance in Infants Fed Goat or Cow's Milk-based Infant Formula
This randomized controlled double-blind study will compare the effect of a commercially available goat milk formula to a cow's milk formula on gastrointestinal symptoms and tolerance, and infections in infants.
- Conditions
- Gastrointestinal Tolerance, Gastrointestinal Symptoms, Infections, Quality of Life
- Trial name
- MESK-2 (NCT07342972)
- Testing
- Goat milk-based infant formula, Cow's milk-based infant formula
- Where
- Saudi Arabia
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Ausnutria Hyproca B.V.
Mucopolysaccharidosis II
An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007
This is a multiregional open-label extension (OLE) to assess the safety, tolerability, and efficacy of long-term treatment with tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant intravenous…
- Trial name
- NCT06075537
- Testing
- tividenofusp alfa
- Where
- 30 sites in United States, Argentina and 12 more
- Volunteers
- 99 people
- Sponsor
- Denali Therapeutics Inc.
Ankyloglossia
Long-term Follow-up of Infant Frenotomy/Frenectomy Through Early Childhood
Ankyloglossia (tongue tie) is an anatomically shortened lingual frenum that impairs appropriate tongue mobility. Initial clinical diagnosis of tongue tie usually begins during infancy with abnormal breastfeeding though not all…
- Trial name
- NCT07110948
- Testing
- Tongue tie release
- Where
- Canada
- Volunteers
- 500 people
- Sponsor
- University of Alberta
Congenital CMV Infection, Sensorineural Hearing Loss
Long-Term Outcomes of Children With Congenital CMV in New York State
PROACTIVE NYS is a long-term follow-up study of all infants who test positive for congenital Cytomegalovirus infection (CMV) throughout New York State on the Newborn Screen.
- Trial name
- PROACTIVE NYS (NCT06226558)
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Stony Brook University
Postpartum Anxiety, Postpartum Period
Short-Term Mindfulness Intervention for Anxiety and Maternal Attachment in NICU Mothers
This randomized controlled study aims to evaluate the effects of a short-term mindfulness-based stress reduction (MBSR) program on anxiety levels and maternal attachment in mothers whose infants are admitted to the Neonatal…
- Conditions
- Postpartum Anxiety, Postpartum Period, Maternal Behavior, Psychological Stress
- Trial name
- NCT07520435
- Testing
- Mindfulness-Based Stress Reduction (MBSR) Program
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Saglik Bilimleri Universitesi
Pregnancy Related
Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy
The study will include participants who were exposed to at least one dose of elafibranor either within the three weeks before conception or at any time during pregnancy (based on estimated last menstrual period [LMP]).
- Trial name
- NCT07556913
- Testing
- Elafibranor
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Ipsen
Premature - Weight 1000g-2499g or Gestation of 28-37weeks, Premature Baby 26 to 32 Weeks
Comparison of Two Early Treatments for Premature Babies and Their Effects Over Time
According to the latest World Health Organization report, prematurity is a major health issue, recognized as a significant vulnerability factor contributing to the emergence of neurodevelopmental disorders.
- Conditions
- Premature - Weight 1000g-2499g or Gestation of 28-37weeks, Premature Baby 26 to 32 Weeks, Premature Baby 33 to 36 Weeks, Premature Between 32 and 36 Weeks of Amenorrhoea
- Trial name
- PREMOTSENS (NCT07261046)
- Testing
- ATVV (Auditory, Tactile, Visual and Vestibular stimulation), Singing
- Where
- 2 sites in France
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Elsan