Clinical trials: Infant, Newborn, Disease
Retinopathy of Prematurity
A 24-week Study Evaluating the Effectiveness and Safety of Lucentis® 0.2mg in Retinopathy of Prematurity Participants in China
This is a 24-week, multicenter, open-label, single-arm, observational, post approval commitment study, which is designed to collect effectiveness, safety and other clinical information of intravitreal ranibizumab 0.2 mg for the…
- Trial name
- NCT05576792
- Testing
- Ranibizumab
- Where
- China
- Volunteers
- 62 people
- Sponsor
- Novartis Pharmaceuticals
Bronchopulmonary Dysplasia, Encephalomalacia
Randomized Trial of Hydrocortisone in Very Preterm High-Risk Infants
The purpose of this study is to determine whether treatment of very preterm infants at high-risk for lung and brain injury with low dose hydrocortisone results in improved pulmonary and neurologic outcomes.
- Conditions
- Bronchopulmonary Dysplasia, Encephalomalacia, Premature Birth
- Trial name
- NCT00167544
- Testing
- Hydrocortisone
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Nationwide Children's Hospital
Premature Infants, Very Premature Infants
Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants
A phase 2 randomised, three-arm, parallel-group, dose-ranging trial to determine safety, efficacy and optimal dosing of intravenous anakinra in premature neonates, with subcutaneous pharmacokinetic sub-study.
- Conditions
- Premature Infants, Very Premature Infants, Inflammation
- Trial name
- AP2 (NCT07254000)
- Testing
- Anakinra (Kineret®)
- Where
- 2 sites in Australia, New Zealand
- Volunteers
- 24 people
- Sponsor
- Monash Medical Centre
Colic
Study to Evaluate Efficacy and Safety of Oral Doses of Hyoscine Butylbromide for the Treatment of Occasional Abdominal Pain, Cramping, and Discomfort
Study to determine whether hyoscine butylbromide can provide adequate symptomatic relief of a single episode - defined as lasting not longer than 1 day - and multiple episodes of abdominal pain or discomfort associated with…
- Trial name
- NCT02242292
- Testing
- Hyoscine butylbromide
- Volunteers
- 527 people
- Sponsor
- Boehringer Ingelheim
Cystic Fibrosis
Non-contrast Lung Perfusion Mapping Applied for New Insights in Cystic Fibrosis
Cystic fibrosis (CF) results in the thickening of mucus in the lungs and other organs due to dysfunction of a transmembrane conductance protein.
- Trial name
- NCT04467957
- Testing
- Initiation of CFTR Modulator, Hyperpolarized Xenon 129
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Preterm Birth Complication, Preterm Birth
Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities
The goal of this clinical trial is to learn if a personalized prenatal support program [(Personalized Toolkit Building a Comprehensive Approach to Resource optimization and Empowerment in Pregnancy \& Beyond, (PTBCARE+)] works to…
- Conditions
- Preterm Birth Complication, Preterm Birth, Preterm Birth Recurrence, Preeclampsia
- Trial name
- PTBCARE+ (NCT06915428)
- Testing
- Care coordination, Electronic massage, support gift #1
- Where
- United States
- Volunteers
- 1,228 people
- Sponsor
- University of North Carolina, Chapel Hill
Cystic Fibrosis
Study of N91115 in Patients With Cystic Fibrosis Homozygous F508del-CFTR Mutation
This Phase 1b study in F508del-CFTR homozygous CF patients is being conducted to assess the safety of N91115 as the sole cystic fibrosis transmembrane conductance regulator (CFTR) modulator at doses near the expected therapeutic…
- Trial name
- SNO4 (NCT02275936)
- Testing
- N91115
- Where
- 19 sites in United States
- Volunteers
- 51 people
- Sponsor
- Nivalis Therapeutics, Inc.
Neonatal Abstinence Syndrome
Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy
The purpose of this study is to show non-inferiority between two medications used for medical treatment of withdrawal seen in Neonatal Abstinence Syndrome (NAS), Clonidine and Morphine Sulfate (used in routine care) on length of…
- Trial name
- NCT03092011
- Testing
- Clonidine, Morphine Sulfate
- Where
- United States
- Volunteers
- 69 people
- Sponsor
- The Cooper Health System
Cystic Fibrosis
Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study
This study assesses the aerosol delivery characteristics (measured by nebulization time, serum and sputum tobramycin pharmacokinetic parameters) and safety of tobramycin administered for inhalation by PARI eFlow rapid electronic…
- Trial name
- NCT00420836
- Testing
- Tobramycin
- Volunteers
- 20 people
- Sponsor
- Novartis
Newborn, Infant, Disease, Neurodevelopmental Disorders
Perinatal Covid-19 Infection, NO Pathway, and Minipuberty
Some evidence exists that SARS-COV-2 may infect pituitary axis, and therefore may alter hypothalamic function. Whether perinatal COVID-19 is associated with alterations in the maturation of the Hypothalamic-Pituitary-Gonadal…
- Trial name
- miniNO-COVID (NCT04952870)
- Testing
- Inhaled NO, routine care
- Where
- 2 sites in France, Greece
- Volunteers
- 180 people
- Sponsor
- University Hospital, Lille
Cystic Fibrosis, Glucose Metabolism Disorders
One Year Glargine Treatment in CFRD Children and Adolescents
Glargine treatment can improve the clinical features in Cystic Fibrosis patients affected by glucose derangements
- Trial name
- NCT00483769
- Testing
- Glargine
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Federico II University
Cystic Fibrosis
Capsule Endoscopy in Cystic Fibrosis
Cystic Fibrosis patients continue to have bowel problems even after adequate pancreatic enzyme supplementation. There may be pathology of the lining of the bowel. Capsule endoscopy will be used to photograph the entire bowel.
- Trial name
- NCT00333957
- Where
- Israel
- Volunteers
- 200 people
- Sponsor
- Hadassah Medical Organization
Pulmonary Disease
Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia
Inhaled nitric oxide in preterm babies with respiratory failure or ventilator dependence will: 1. decrease the incidence of Bronchopulmonary Dysplasia (BPD) or death 2.
- Trial name
- NO-BPD (NCT01503801)
- Testing
- Nitric Oxide, respiratory support
- Where
- China
- Volunteers
- 400 people
- Sponsor
- Fudan University
Cystic Fibrosis, Digestive System Disease
A Comprehensive Approach To Relief Of Digestive Symptoms In Cystic Fibrosis: CARDS-CF
Development of a new patient reported outcome measure (PROM) that will measure the daily burden of gastrointestinal symptoms over the previous 24 hour period for people with cystic fibrosis.
- Conditions
- Cystic Fibrosis, Digestive System Disease, Genetic Disease, Respiratory Tract Diseases
- Trial name
- CARDS-CF (NCT05251467)
- Testing
- Focus group, Patient interview (n = approximately 10), Questionnaire (n = 180)
- Where
- United Kingdom
- Volunteers
- 350 people
- Sponsor
- Nottingham University Hospitals NHS Trust
Cystic Fibrosis (CF)
Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis
The goal of this clinical trial is to support the development of personalized therapy tailored to each patient's individual characteristics.
- Trial name
- NCT07809867
- Testing
- Elexacaftor, Tezacaftor, Ivacaftor, Ivacaftor (VX-770)
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Istituto Giannina Gaslini
Pregnancy Complications, Maternal Death
Nutrition Optimalization Among Pregnant Women to Improve Maternal and Neonatal Outcome in DKI Jakarta
The goal of this MONAS Study is to learn about comprehensive monitoring and nutritional intervention among pregnant women in order to improve maternal and neonatal outcomes. The main questions it aims to answer are: 1.
- Conditions
- Pregnancy Complications, Maternal Death, Preeclampsia, Intrauterine Infection
- Trial name
- MONAS (NCT06268509)
- Testing
- Nutritional panel laboratory examination, Pregnancy supplements (other than provided by Ministry of Health), Fetomaternal ultrasound
- Where
- Indonesia
- Volunteers
- 245 people
- Sponsor
- Dr Cipto Mangunkusumo General Hospital
Spinal Muscular Atrophy Type I
Study of Safety, Tolerability and Efficacy of GB221 in Infants With Spinal Muscular Atrophy Type 1
GB221 is a gene therapy that delivers a working SMN1 gene to the motor neurons of people with spinal muscular atrophy (SMA) Type 1. This study will evaluate the safety, tolerability and efficacy of GB221 in two groups: 1.
- Trial name
- NCT07070999
- Testing
- GB221
- Where
- Brazil
- Volunteers
- 22 people
- Sponsor
- Gemma Biotherapeutics
Colic, Nephropathy
Neonatal Outcome of Children With Antenatal Colic Hyperechogenicity
Fetal colic hyper-echogenicity is a presenting symptoms for cystinuria lysinuria. A few cases of fetuses with dibasic protein intolerance (more complex prognosis) presented with colic hyper-echogenicity antenatal.
- Trial name
- COLONECHOGENE (NCT04983069)
- Where
- France
- Volunteers
- 400 people
- Sponsor
- University Hospital, Montpellier
Umbilical Hernia
Visible vs. Non-Visible Mesh in Underlay Positon After Repair of Umbilical Hernias
The purpose of this study is to determine the exact position of a mesh which is placed in underlay position in umbilical hernia in vitro.
- Trial name
- NANEP (NCT03200405)
- Testing
- DynaMeshVisible, DynaMeshCICAT
- Where
- Germany
- Volunteers
- 31 people
- Sponsor
- Wuerzburg University Hospital
Infantile Colic
Clinical Trial of L. Reuteri in Infantile Colic 2017
RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 17938 to significantly reduce the duration of crying time and fussines in infants from 15days to 4 months of age with colic, feed with human milk (30% sample)…
- Trial name
- Colic2017 (NCT03360253)
- Testing
- L. reuteri DSM 17938 in drops
- Where
- Mexico
- Volunteers
- 244 people
- Sponsor
- Innovacion y Desarrollo de Estrategias en Salud
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