Clinical trials: Infant, Newborn
Mycobacterium Tuberculosis Infection
Evaluation of Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Tb Infection in Infants
The trial is designed as a phase III, double-blind, multicenter, randomized, single administration, active-controlled, parallel-group design with two groups of newborn infants receiving either VPM1002 or BCG SII (1:1 allocation)…
- Trial name
- VPM1002 (NCT04351685)
- Testing
- VPM1002, BCG SII
- Where
- 12 sites in Gabon, Kenya and 3 more
- Volunteers
- 6,940 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Cystic Fibrosis, Cystic Fibrosis in Children
Effect of Parental Attitude on Functional and Physical Level of Children With Cystic Fibrosis
Some parents may be more protective of children with CF due to concerns about worsening of the disease due to infection, which can affect their functional level.
- Trial name
- NCT06306508
- Where
- Turkey (Türkiye)
- Volunteers
- 43 people
- Sponsor
- Halic University
Premature Infant Disease
A Randomized Controlled Trial to Evaluate the Effect of White Noises and Parental Voices As Protectors Against Noise Damage in a Neonatal Intensive Care Unit
The goal of this Randomized Controlled Trial is to test the efficacy of listening to white noises and parental voices against environmental noise damage in premature babies admitted to the Newborn Intensive Care Unit.
- Trial name
- NCT06150404
- Testing
- White Noises and Maternal and/or Paternal voices
- Where
- Italy
- Volunteers
- 11 people
- Sponsor
- Istituto Giannina Gaslini
Quality of Care
Evaluation of a Nurse Mentorship and Digital Health Package Intervention in Kenya
The investigators will conduct a cluster randomized controlled trial in maternity facilities in Kenya to evaluate the impact of a maternal and neonatal health package intervention on patient and provider outcomes.
- Trial name
- NCT05110521
- Testing
- PROMPTS, MENTORS
- Where
- Kenya
- Volunteers
- 10,992 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
Cystic Fibrosis
Psychosocial Factors and Quality of Life in the Effect of Fear of COVID-19 With Cystic Fibrosis
The purpose of this study; The COVID-19 pandemic is to investigate the effects of COVID-19 fear levels of patients with cystic fibrosis on the psychosocial and quality of life levels of individuals.
- Trial name
- NCT05195216
- Testing
- Survey Form, The Hospital Anxiety and Depression Scale, The Fear of COVID-19 Scale,World Health Organization Quality of Life Scale- Bref Form
- Where
- Turkey (Türkiye)
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Elif Kabasakal
Rotavirus Infections
A Phase II Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine
The purpose of this study is to determine the serum IgA response of three dose levels of the oral RV3-BB vaccine when administered in a neonatal schedule or when administered as a high dose in an infant schedule.
- Trial name
- NCT03483116
- Testing
- RV3-BB
- Where
- Malawi
- Volunteers
- 711 people, healthy volunteers welcome
- Sponsor
- Murdoch Childrens Research Institute
Opioid-use Disorder, Neonatal Abstinence Syndrome
MOM NEST Study: Maternal Opioid Medication: Naltrexone Efficacy Study
This is a multi-center prospective comparative cohort study examining the safety, efficacy, pharmacokinetics, and pharmacogenomics of naltrexone for pregnant women with opioid use disorder.
- Conditions
- Opioid-use Disorder, Neonatal Abstinence Syndrome, Pregnancy, High Risk, Alcohol Use Disorder
- Trial name
- NCT03718104
- Testing
- Pharmacokinetic analysis, Safety and Efficacy, Genetic and epigenetic analysis
- Where
- 2 sites in United States
- Volunteers
- 46 people
- Sponsor
- Boston Medical Center
Cystic Fibrosis (CF), Gene Therapy
A Prospective, Single-center, Open-label Study of Inhaled BMD003 (CFTR mRNA) in Chinese Adults With Cystic Fibrosis
The study uses a prospective, single-center, open-label clinical trial design to evaluate the safety and efficacy of inhaled BMD003 (CFTR mRNA) in adult Chinese patients with cystic fibrosis.
- Trial name
- NCT06963008
- Testing
- inhaled BMD003(CFTR mRNA)
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Peking Union Medical College Hospital
Bronchopulmonary Dysplasia
Follow-up Safety and Efficacy Evaluation on Subjects Who Completed PNEUMOSTEM® Phase-II Clinical Trial
This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM® versus placebo, for the treatment of BPD in premature infants.
- Trial name
- NCT01897987
- Testing
- Pneumostem®, normal saline
- Where
- 2 sites in South Korea
- Volunteers
- 62 people
- Sponsor
- Medipost Co Ltd.
Patent Ductus Arteriosus in Preterm Infants
Noninvasive Hemodynamics Assessment of Preterms With Successful Medical Closure of PDA
The aim of our study was to use Electrical Cardiometry EC to monitor hemodynamic alternations during pharmacological closure of hemodynamically significant patent ductus arteriosus (hsPDA) in preterm neonates
- Trial name
- NCT06606015
- Testing
- I.V Paracetamol., Echocardiography., Electrical Cardiometry
- Where
- Egypt
- Volunteers
- 43 people
- Sponsor
- Tanta University
Low Birth Weight Babies, Preterm Babies
Use of a Foot Length Card to Improve Careseeking Practices of Vulnerable Newborns in Sarlahi District, Nepal
This study will evaluate whether or not provision of a simple card ("footlength card") that allows identification of low birth weight and/or preterm babies through measurement of the length of a baby's foot, can improve basic…
- Trial name
- NCT02802332
- Testing
- Footlength Card
- Where
- Nepal
- Volunteers
- 4,574 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Infant, Premature, Diseases, Nutrition, Enteral
Evaluation of Gastric Residuals and Feedings Progression
This study evaluates the utility of measuring gastric residuals in premature infants born between 26+0 and 33+6 weeks and to determine if its routine use is related with a delay in feedings advancement in this babies compared…
- Trial name
- REGAP (NCT04064398)
- Testing
- Aspiration of gastric residuals
- Where
- Chile
- Volunteers
- 203 people
- Sponsor
- Pontificia Universidad Catolica de Chile
Exocrine Pancreatic Insufficiency, Cystic Fibrosis
SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis
Liprotamase powder is a non-porcine, soluble and stable mixture of three digestive enzymes including lipase, protease, and amylase.
- Trial name
- NCT02279498
- Testing
- Liprotamase, porcine (pig) PERT
- Where
- 54 sites in United States, Canada and 5 more
- Volunteers
- 128 people
- Sponsor
- Anthera Pharmaceuticals
Infant, Newborn, Diseases, Bowel Sounds
Detection of Infant GastrointEstinal Activity Using Sound Technology
This pilot study aims to evaluate the feasibility and safety of continuous bowel sound monitoring in healthy term newborn infants using a novel wireless acoustic monitoring system.
- Conditions
- Infant, Newborn, Diseases, Bowel Sounds, Physiologic Monitoring, Wearable Sensors
- Trial name
- DIGEST (NCT07743216)
- Volunteers
- 10 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Healthy
SurePulse Oximeter - a Targeted Oxygenation Observation
This clinical investigation will investigate how accurate the SurePulse VS and SurePulse VS Patch (VSP) are for measuring blood oxygen levels (oxygen saturation).
- Trial name
- SPO-TOO (NCT05756816)
- Testing
- SurePulse VSP, SurePulse VS
- Where
- United Kingdom
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Surepulse Medical Limited
Malaria
Age of Exposure and Immunity to Malaria in Infants
The overall objective is to evaluate the effect of exposure to Plasmodium (P.) falciparum erythrocytic stage antigens during different periods of infancy on the development of naturally acquired immunity (NAI).
- Trial name
- NCT00231452
- Testing
- Sulfadoxine-pyrimethamine (SP) + Artesunate (AS)
- Where
- Mozambique
- Volunteers
- 349 people, healthy volunteers welcome
- Sponsor
- Hospital Clinic of Barcelona
Bronchopulmonary Dysplasia
The Role of Volatile Organic Compounds (VOCs), Airway Mucins and the Microbiome in the Early Prediction of Bronchopulmonary Dysplasia (BPD)
Bronchopulmonary dysplasia (BPD), the most common respiratory complication of extremely preterm birth, significantly impacts healthcare with high morbidity and mortality rates.
- Trial name
- INFANCY (NCT06342752)
- Testing
- Breath test, Throat swabs, Placental samples
- Where
- Belgium
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- University Hospital, Antwerp
Cystic Fibrosis
Mapping Chemical and Microbiological Heterogeneity Throughout Explanted Cystic Fibrosis Lung Specimens
There is plenty of evidence to suggest that the lung is not uniform. The internal surface area is 30 times that of skin, and the different bronchioles/bronchi/alveoli differ greatly in blood perfusion, temperature, oxygen…
- Trial name
- NCT02128711
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- University of Minnesota
Choking in Infants, Cardiopulmonary Resuscitation (CPR)
Parental Knowledge of First Aid for Choking and Cardiopulmonary Resuscitation in Infants Under One Year of Age
This study aims to assess the knowledge of parents regarding first aid for choking and cardiopulmonary resuscitation (CPR) in infants under one year of age.
- Conditions
- Choking in Infants, Cardiopulmonary Resuscitation (CPR), First Aid Training, Parental Knowledg
- Trial name
- NCT06976463
- Where
- Poland
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Andrzej Frycz Modrzewski Krakow University
Cystic Fibrosis, Chronic Disease
Feasibility of a Goal-based Agenda Setting Intervention
This study aims to assess the feasibility of a new, brief intervention, the 'coopeRATE Prompt', for informing conversations between patients and physicians in routine tele-health and in-person adult Cystic Fibrosis (CF) care.
- Trial name
- NCT04696484
- Testing
- coopeRATE Prompt
- Where
- 4 sites in United States
- Volunteers
- 219 people
- Sponsor
- Dartmouth-Hitchcock Medical Center