Clinical trials: Infant, Newborn, Disease
Cystic Fibrosis
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor
This is a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter study in people with cystic fibrosis (CF) who are homozygous for the F508del CF transmembrane conductance regulator (CFTR) gene mutation.
- Trial name
- NCT02347657
- Testing
- VX-661 Plus Ivacaftor Combination, Ivacaftor
- Where
- 74 sites in United States, Canada and 10 more
- Volunteers
- 510 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Obstructive Sleep Apnea, Cleft Palate
Comparing the Side-lying Sleep Positioning to Back-lying in Infants With Cleft Palate
The craniofacial abnormalities found in infants and children with cleft palate (CP) lead to increased risk of obstructive sleep apnoea (OSA).
- Trial name
- SLUMBRS2 (NCT04478201)
- Testing
- back sleep positioning, side sleep positioning
- Where
- 11 sites in United Kingdom
- Volunteers
- 244 people
- Sponsor
- Manchester University NHS Foundation Trust
Peanut Allergy
Early Peanut Introduction: Translation to Clinical Practice
The recent finding that early introduction of peanut can prevent ~70-90% of peanut allergy is a major step towards prevention of food allergy.
- Trial name
- EPI (NCT03019328)
- Testing
- Peanut in diet
- Where
- 2 sites in United States
- Volunteers
- 333 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Congenital Heart Disease
Fibrinogen Concentrate vs Cryoprecipitate
One of the most common hemostatic derangements in pediatric open- heart surgery is an acute acquired hypofibrinogenemia. This compromises fibrin clot generation and platelet aggregation, resulting in increased bleeding and…
- Trial name
- NCT03014700
- Testing
- Fibrinogen Concentrate, Cryoprecipitate
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Stanford University
Severe Bronchopulmonary Dysplasia
PNEUMOSTEM for the Prevention and Treatment of Severe BPD in Premature Infants
This study is to evaluate the efficacy and safety of PNEUMOSTEM® for the Prevention and Treatment of Severe Bronchopulmonary Dysplasia (Severe BPD) in Premature Infants.
- Trial name
- NCT03392467
- Testing
- PNEUMOSTEM
- Where
- 2 sites in South Korea
- Volunteers
- 60 people
- Sponsor
- Medipost Co Ltd.
Obstetric Labor Complications, Post-partum Hemorrhage
Improving Maternal and Child Health in India: Evaluating Demand and Supply Side Strategies (IMATCHINE)
The study evaluates the impact of a new conditional cash transfer (CCT) program (Thayi Bhagya Yojana) to promote child birth in obstetric facilities in the state of Karnataka, India in order to determine its policy value and to…
- Conditions
- Obstetric Labor Complications, Post-partum Hemorrhage, Sepsis, Pre-eclampsia
- Trial name
- IMATCHINE (NCT01480544)
- Testing
- Experimental: Treatment 1, Experimental: Treatment 2
- Where
- India
- Volunteers
- 14,990 people
- Sponsor
- Duke University
Cystic Fibrosis
Clinical Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of POL6014 in Patients With CF
"This is a randomised, double-blind, placebo-controlled multi-centre study to investigate safety and tolerability and to provide pharmacokinetic and pharmacodynamics information of orally inhaled multiple doses (80 mg, 160 mg or…
- Trial name
- NCT03748199
- Testing
- POL6014
- Where
- 4 sites in Germany
- Volunteers
- 32 people
- Sponsor
- Santhera Pharmaceuticals
Respiratory Tract Diseases, Abnormal Mucus Secretions
A Clinical Trial to Compare the Efficacy and Safety of 1-week Treatment of Intravenous N-acetylcysteine (NAC) 600 mg Twice Daily, Ambroxol Hydrochloride 30 mg Twice Daily and Placebo as Expectorant Therapies in Adult Chinese Patients With Respiratory Tract Diseases and Abnormal Mucus Secretions
This is a phase 3, multicenter, randomized, rater- and patient-blind, placebo- and active-controlled, 3-arm parallel group clinical trial.
- Trial name
- NCT03843541
- Testing
- N-acetylcysteine (NAC) 600 mg, Ambroxol hydrochloride 30 mg
- Where
- 32 sites in China
- Volunteers
- 333 people
- Sponsor
- Zambon SpA
Placental Transfusion
Delivery Room Assistance With the Placental Circulation Intact
Preterm newborns receiving placental transfusion at birth (a volume of blood coming from the placenta towards the newborn till the cord is left unclamped) have better neonatal outcomes (in particular reduction of intraventricular…
- Trial name
- PCI-T (NCT02671305)
- Testing
- placental circulation intact, cord milking
- Where
- 8 sites in Italy
- Volunteers
- 212 people
- Sponsor
- University of Florence
Lysosomal Acid Lipase Deficiency
An Expanded Access Protocol for Sebelipase Alfa for Patients With Lysosomal Acid Lipase Deficiency
This is an open-label, multicenter expanded access protocol to allow patients with a confirmed diagnosis of Lysosomal Acid Lipase (LAL) Deficiency in the United States (US), access to sebelipase alfa (recombinant lysosomal acid…
- Trial name
- NCT02376751
- Testing
- sebelipase alfa
- Sponsor
- Alexion Pharmaceuticals, Inc.
PreTerm Birth, PreTerm Neonate
Trial of Immediate vs. Delayed Cord Clamping in the Preterm Neonate
To determine the short and long term effects of placental transfusion at birth by milking and delayed cord clamping of the umbilical cord in neonates born between 24 weeks 0 days and 34 weeks 0 days weeks' gestation.
- Trial name
- NCT00579839
- Testing
- Delayed Cord Clamping, Immediate Cord Clamping
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of Oklahoma
Maternal Attachment, Breastfeeding
Reciprocal Mother-Infant Voice Exposure in the Neonatal Intensive Care Unit
This randomized controlled trial evaluates the effect of reciprocal maternal-infant voice exposure on maternal attachment and breastfeeding outcomes in a neonatal intensive care unit (NICU).
- Conditions
- Maternal Attachment, Breastfeeding, Transient Tachypnea of the Newborn, Neonatal Intensive Care Unit
- Trial name
- NCT07597954
- Testing
- Reciprocal Voice Exposure Group
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Biruni University
Sickle Cell Disease
PK Study of Ticagrelor in Children Aged Less Than 24 Months, With Sickle Cell Disease (HESTIA4)
The purpose of this Phase I study is to investigate the pharmacokinetic properties of ticagrelor in pediatric patients from 0 to less than 24 months with sickle cell disease.
- Trial name
- HESTIA4 (NCT03492931)
- Testing
- Ticagrelor
- Where
- 8 sites in Belgium, Italy and 4 more
- Volunteers
- 21 people
- Sponsor
- AstraZeneca
Medication Adherence, Cystic Fibrosis
Interactive Mobile Health Information to Enhance Patient Care at a Cystic Fibrosis Center
Real-world adherence to inhaled and oral therapies for cystic fibrosis (CF) patients remains discouragingly low, ranging between 31-53% for inhaled antibiotics and 41-72% for hypertonic saline.
- Trial name
- MOMMI3CFCM (NCT03052231)
- Testing
- caremessage
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Landon Pediatric Foundation
Cystic Fibrosis
A Study to Evaluate Efficacy of Ivacaftor in Subjects With Cystic Fibrosis Who Have a 3849 + 10KB C→T or D1152H CFTR Mutation
This study will evaluate the efficacy of ivacaftor treatment in subjects with CF 6 years of age and older who have a 3849 + 10KB C→T or D1152H CFTR mutation.
- Trial name
- NCT03068312
- Testing
- Ivacaftor
- Where
- Israel
- Volunteers
- 38 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
Comparing Laboratory Blood Glucose Results With HemoCue Glucose 201 RT
There are very few studies comparing the accuracy, sensitivity and specificity of HemoCue glucose 201 RT system with the laboratory gold standard.
- Trial name
- CFRD (NCT01883037)
- Testing
- Blood glucose results
- Where
- United Kingdom
- Volunteers
- 70 people
- Sponsor
- Royal Brompton & Harefield NHS Foundation Trust
Cystic Fibrosis
Phase I Pilot Study of Gene Therapy for Cystic Fibrosis Using Cationic Liposome Mediated Gene Transfer
OBJECTIVES: Determine whether copies of the cystic fibrosis gene (pGT-1) can be delivered to the cells lining the nose of cystic fibrosis patients using cationic liposome (DMRIE/DOPE) mediated gene transfer.
- Trial name
- NCT00004471
- Testing
- pGT-1 gene lipid complex
- Volunteers
- 9 people
- Sponsor
- University of Alabama at Birmingham
Temperature, Preterm
Body Temperature in Preterm Neonates: Creating a Data Model
The aim of this study is to examine the relationship between the characteristics, medical history, interventions performed within the first six hours, and follow-up findings of preterm newborns receiving respiratory support and…
- Trial name
- NCT07176364
- Where
- Turkey (Türkiye)
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Acibadem University
Infantile Colic
Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant With Colic Not Responding to Conventional Treatment
This phase IIa study is designed as a multi-centre, single country, randomised, double-blind, placebo controlled study in three parallel groups, with the aim to evaluate the efficacy and safety of Nepadutant given at two oral…
- Trial name
- nocry-a (NCT01309009)
- Testing
- Nepadutant oral solution
- Sponsor
- Menarini Group
Water-Electrolyte Imbalance, Intensive Care Units
Fluid Overload and Pulmonary Function
Esophageal atresia is a rare but severe malformation, and it requires early surgery. Coloesophagoplasty is surgical repair of the esophageal with an isoperistaltic transverse colon graft.
- Conditions
- Water-Electrolyte Imbalance, Intensive Care Units, Pediatric, Critical Illness
- Trial name
- NCT05129930
- Where
- Russia
- Volunteers
- 40 people
- Sponsor
- Pirogov Russian National Research Medical University