Clinical trials: High-risk Infants
Asthma, Pulmonary Function
Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) Longer Term Follow Up
The overall aims of this protocol are to determine whether prenatal supplementation with vitamin C to pregnant smokers can improve pulmonary function at 10 years of age in their offspring.
- Conditions
- Asthma, Pulmonary Function, Wheezing, In Utero Nicotine
- Trial name
- VCSIP (NCT06106646)
- Testing
- No active intervention in this protocol (previously randomized to Vitamin C)
- Where
- 2 sites in United States
- Volunteers
- 225 people
- Sponsor
- Oregon Health and Science University
Food Allergy in Infants, Nut Allergy
The TreEat Study- Can Early Introduction of Tree Nuts Prevent Tree Nut Allergy in Infants With Peanut Allergy
Early and regular ingestion of the common allergens, peanut and egg has been shown to be an effective allergy prevention strategy. It is not clear whether this is also true of tree nut allergy.
- Trial name
- TreEat (NCT04801823)
- Testing
- Home introduction, Multi Nut oral food challenge
- Where
- Australia
- Volunteers
- 212 people
- Sponsor
- Murdoch Childrens Research Institute
Periventricular Leukomalacia
Telerehabilitation of Working Memory in Children With Periventricular Leukomalacia and Bilateral Cerebral Palsy
Periventricular Leukomalacia (PVL) is a white matter lesion surrounding the lateral ventricles of the brain occurring in the prenatal period, associated with a disorder of movement and posture, known as bilateral cerebral palsy.
- Trial name
- NCT02342990
- Testing
- Cluster B CogMed: an home-based and computer-based solution to improve working memory deficit, Cluster A No training. Delay start of CogMed
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- IRCCS Fondazione Stella Maris
Respiratory Distress Syndrome, Prematurity
Influence of Flow Rate Change on CO2 Levels During High Flow Nasal Ventilation (HFNV) in Preterm Infants.
Background Preterm infants often need respiratory support. HFNV is a non-invasive method with benefits over CPAP, such as reduced nasal trauma and improved feeding. Aim Study the impact of low (2 LPM) vs.
- Conditions
- Respiratory Distress Syndrome, Prematurity, Non Invasive Ventilation
- Trial name
- NCT06622902
- Testing
- change flow from 6 to 2 LPM. Follow TcCO2 for 3 hours, change flow from 2 to 6 LPM. Follow TcCO2 for 3h
- Where
- Israel
- Volunteers
- 45 people
- Sponsor
- Rambam Health Care Campus
Acute Lymphoblastic Leukemia
Treatment of Childhood Acute Lymphoblastic Leukemia
The purpose of this study is to reduce the side-effects and discomfort of anti-leukemia therapy, to attain long-term control of the disease and to hopefully eradicate it.
- Trial name
- NCT00165087
- Testing
- asparaginase (E. Coli), asparaginase (Erwina), dexrazoxane
- Where
- 10 sites in United States, Canada and 1 more
- Volunteers
- 491 people
- Sponsor
- Dana-Farber Cancer Institute
Respiratory Distress Syndrome
Effect of High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure
Respiratory distress syndrome (RDS) in preterm babies is caused by a deficiency of lung surfactant. The risk of RDS increases with decreasing gestational age, and is almost inevitable in babies born at less than 28 weeks…
- Trial name
- NCT05849116
- Volunteers
- 100 people
- Sponsor
- Assiut University
Allergic Diseases, Asthma
Vaginal Microbiome Exposure and Immune Responses in C-section Infants
The purpose of this research study is to assess at how differences in the microbiome (naturally occurring bacteria) of a baby may protect, or put a baby at risk, for allergic problems.
- Trial name
- NCT03567707
- Testing
- Vaginal seeding, Standard care, Post-seeding Care
- Where
- 2 sites in United States
- Volunteers
- 114 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Atopic Dermatitis, Eczema
Daily Use of Lipikar Balm AP From Birth in Infants at High Risk of Developing Atopic Dermatitis
There is a lack of prospective scientific data on the regular use of moisturizers in patients at risk of developing atopic dermatitis.
- Conditions
- Atopic Dermatitis, Eczema, Asthma, Food Allergies
- Trial name
- NCT01577628
- Testing
- Lipikar Balm AP
- Where
- 4 sites in United States, Canada
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Cosmetique Active International
Respiratory Distress Syndrome, Newborn, Bronchopulmonary Dysplasia
High Frequency Oscillatory Ventilation Combined With Intermittent Sigh Breaths: Effects on Blood Oxygenation and Stability of Oxygenation
Background: Ventilator induced lung injury (VILI) remains a problem in neonatology. High frequency oscillatory ventilation (HFOV) provides effective gas exchange with minimal pressure fluctuation around a continuous distending…
- Conditions
- Respiratory Distress Syndrome, Newborn, Bronchopulmonary Dysplasia, Ventilator Induced Lung Injury
- Trial name
- NCT01959009
- Testing
- HFOV combined with sigh breaths
- Where
- Denmark
- Volunteers
- 16 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Feeding Behavior, Chronic Lung Disease
Pilot Study Comparing Different Modes of Non-invasive Ventilation for the Oral Feeding of Preterm Infants
Preterm infants born before 28 weeks gestation are at risk for lung disease and require oxygen and pressure to keep their lungs open. This usually involves a device called nasal continuous positive airway pressure (nCPAP).
- Trial name
- CHOMP (NCT02055339)
- Testing
- Fisher & Paykel heated humidified high flow nasal cannula, InfantFlow/RAM nasal continuous positive airway pressure
- Where
- Canada
- Volunteers
- 25 people
- Sponsor
- Mount Sinai Hospital, Canada
Respiratory Distress Syndrome
Sustained Lung Inflation in the Delivery Room in Preterm Infants at High Risk of Respiratory Distress Syndrome
BACKGROUND. Sustained lung inflation (SLI) associated to an adequate PEEP may help the efficacy of the respiratory effort in lung of preterm infants at risk for respiratory distress syndrome (RDS) and reduce need of mechanical…
- Trial name
- SLIS (NCT01440868)
- Testing
- Sustained lung inflation
- Where
- Italy
- Volunteers
- 276 people
- Sponsor
- University of Florence
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
Cerebral Palsy
Motor Training for Infants With Cerebral Palsy
The intervention in this study, Let's Move, is a motor intervention for infants at risk for cerebral palsy. We will test the feasibility and acceptability of the intervention as well as preliminary effectiveness.
- Trial name
- NCT04886895
- Testing
- Let's Move Motor Intervention
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Neonatal Sepsis
Neonatal Sepsis Workup for High Risk Newborns - Evaluation of Need and Ways to Prevent
Sepsis is a significant cause of morbidity and mortality among newborns. Due to strict criteria and in order to diagnose and prevent early-onset group B streptococcal (EOGBS) sepsis, many infants undergo a sepsis workup due to…
- Trial name
- NCT02061150
- Where
- Israel
- Volunteers
- 800 people
- Sponsor
- Hillel Yaffe Medical Center
Premature Birth, Risk
The Effect of the Movement Imitation Therapy in Preterm (MIT-PB) in Motor Behavior's Quality.
This study aims to assess the effect of a parent-administered intervention program based on MIT-PB in preterm with abnormal general movements during the preterm period.
- Conditions
- Premature Birth, Risk, Early Intervention
- Trial name
- MIT-PB (NCT05319158)
- Testing
- MIT-PB, movement imitation therapy for preterm.
- Where
- 3 sites in Spain
- Volunteers
- 36 people
- Sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
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.
Bronchiolitis, Viral
High Flow Oxygen Therapy vs Standard Care in Infants With Viral Bronchiolitis
A randomized control trial of 130 infants admitted to the paediatric high care admission ward will be enrolled, and randomized to either "high flow humidified oxygen" or "standard therapy".
- Trial name
- NCT03252119
- Testing
- High flow humidified oxygen therapy
- Where
- South Africa
- Volunteers
- 28 people
- Sponsor
- Chris Hani Baragwanath Academic Hospital
Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN), Erythroblastosis, Fetal
A Study to Characterize the Clinical Course of Pregnant Women and Children at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn
The primary purpose of the study is to characterize the current standard of care, clinical course, and outcomes of pregnant women and their offspring at high risk for early onset severe hemolytic disease of the fetus and newborn…
- Trial name
- NCT03755128
- Testing
- No intervention
- Where
- 18 sites in United States, Australia and 7 more
- Volunteers
- 17 people
- Sponsor
- Janssen Research & Development, LLC
Intensive Care, Neonatal, Neonatal Respiratory Distress Syndrome
Breastfeeding Infants Receiving Respiratory Support Trial
The purpose of this study is to assess whether two methods of breathing support in babies called 'Humidified High-Flow Nasal Cannula' oxygen (HHFNC) and 'nasal Continuous Positive Airways Pressure' (nCPAP) are compatible with…
- Conditions
- Intensive Care, Neonatal, Neonatal Respiratory Distress Syndrome, Continuous Positive Airway Pressure, Breast Feeding
- Trial name
- BIRRST (NCT02999165)
- Testing
- Breast feeding, Nasogastric feeding
- Where
- United Kingdom
- Volunteers
- 1 people
- Sponsor
- Imperial College Healthcare NHS Trust
Attachment Disorders
Evaluating the Efficacy of ABC for High-Risk Parent and Infants
Attachment and Biobehavioral Catch-up (ABC) is a manualized 10-session intervention delivered in families' homes or other places of residence.
- Trial name
- NCT02647463
- Testing
- Attachment and Biobehavioral Catch-up (ABC)
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Stony Brook University