Clinical trials: Preterm and Term Infants
Gastroesophageal Reflux
A Pharmacokinetics, Pharmacodynamics and Safety Study of Rabeprazole in New Born Infants With Gastroesophageal Reflux Disease (GERD)
The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, and the safety of rabeprazole sodium for the treatment of gastroesophageal reflux disease (GERD) in newborns and pre-term infants.
- Trial name
- NCT00855361
- Testing
- Rabeprazole sodium
- Where
- 19 sites in United States, Germany and 2 more
- Volunteers
- 69 people
- Sponsor
- Janssen Research & Development, LLC
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
Premature, Necrotizing Enterocolitis
Intestinal Perfusion After Feeding in Preterm and Term Infants
This is a pilot exploratory observational prospective cohort phase I study. In this study, we will gather preliminary data to evaluate (i) the magnitude of changes in blood flow in the bowel before and after feeding and (ii) the…
- Trial name
- NCT06319326
- Testing
- Evaluation of intestinal perfusion with color Doppler abdominal ultrasound before and after feeding.
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- The Hospital for Sick Children
Retinopathy of Prematurity
Long Term Outcome of Intravitreal Ranibizumab for ROP
premature infants who had a history of intravitreal injection of (Ranibizumab) not less than one year were examined for refractive state and biometry
- Trial name
- NCT04537065
- Testing
- cycloplegic refraction
- Where
- Egypt
- Volunteers
- 140 people
- Sponsor
- Ameera Gamal Abdelhameed
Hyperbilirubinemia, Neonatal
Development of TcB Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants
Thirteen hospitals in China will participate in the study, which aims to provide data on transcutaneous bilirubin (TcB) levels for the first 168 hr after birth in term and late-preterm neonates, and develop an hour-specific TcB…
- Trial name
- NCT01763632
- Testing
- Transcutaneous bilirubinometry
- Where
- 16 sites in China
- Volunteers
- 19,601 people, healthy volunteers welcome
- Sponsor
- Nanjing Medical University
Neonatal Hyperbilirubinemia
Accuracy of TcB Measurements During and After Phototherapy
This study aimed to assess the accuracy of transcutaneous bilirubin measurements in term and late-preterm infants undergoing phototherapy.
- Trial name
- NCT07080398
- Testing
- serum bilirubin level measurement
- Where
- Turkey (Türkiye)
- Volunteers
- 90 people
- Sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
Respiratory Distress Syndrome, Preterm Pregnancy
Less Invasive Surfactant Administration in Late Preterm or Early Term Born Infants
The aim of this study is to see if giving less invasive surfactant administration (LISA) during high-flow nasal cannula (HFNC) oxygen treatment reduces the need for invasive ventilation in babies with breathing problems born 2-6…
- Conditions
- Respiratory Distress Syndrome, Preterm Pregnancy, Surfactant Deficiency Syndrome Neonatal
- Trial name
- NCT06421506
- Testing
- Less invasive surfactant administration during high flow nasal cannula treatment
- Where
- United Kingdom
- Volunteers
- 245 people
- Sponsor
- King's College Hospital NHS Trust
Prematurity
Human Milk Cream as a Caloric Supplement in Pre-Term Infants
Human milk is commonly considered to have 20 calories per ounce (kcal/oz). However, studies show that up to 65% of human milk may be less than the expected 20 kcal/oz which can greatly affect an infant's growth.
- Trial name
- NCT01487928
- Testing
- Human Milk Cream
- Where
- 2 sites in United States
- Volunteers
- 78 people
- Sponsor
- Baylor College of Medicine
Retinopathy of Prematurity
Time Outside Target Oxygen Saturation Range in Preterm Infants and Long Term Outcomes and Preterm Infants
The purpose of this study is to determine if there is a relationship between time spent out the targeted oxygen saturation range in preterm infants is associated with long-term outcomes such as Retinopathy of Prematurity.
- Trial name
- SAT01ROP (NCT00845624)
- Where
- United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- University of Virginia
Infant, Very Low Birth Weight
Randomized Study of Human-Milk Based Nutrition Versus Formula in Premature Infants
The purpose of this study is to determine whether very low birth weight infants (less than or equal to 1250g or about 2 3/4 pounds) born prematurely fed a diet of only human milk and human milk-derived nutrition have better…
- Trial name
- NCT00506584
- Testing
- Pasteurized human milk and pasteurized human milk fortifier, Human milk fortifier (bovine-based), pre-term formula, Pre-term/term formula
- Where
- 13 sites in United States, Austria
- Volunteers
- 260 people
- Sponsor
- Prolacta Bioscience
Neonates, Respiratory Distress
Non-invasive Secondary Respiratory Support in Late Preterm and Term Infants
The aim of the present work is to compare between various modes of non-invasive respiratory support (including NCPAP, NIPPV, and NHFOV) as secondary respiratory support modes in late preterm and term neonates as regards the need…
- Conditions
- Neonates, Respiratory Distress, Non- Invasive Ventilation
- Trial name
- NCT07000071
- Testing
- NCPAP, NIPPV, NHFOV
- Where
- Egypt
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Alexandria University
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
Prematurity
Observational Study of Choline, Its Metabolites, and Phospholipids in Preterm Infants
To study concentrations of choline, its metabolites, and phospholipids in cord blood and remnants of clinically indicated blood samples
- Trial name
- NEO-CHOLIN (NCT02027584)
- Testing
- collection of remnant of clinically indicated blood sample
- Where
- Germany
- Volunteers
- 414 people, healthy volunteers welcome
- Sponsor
- University Hospital Tuebingen
Hypoxic-Ischemic Encephalopathy, Periventricular Leukomalacia
Evaluation of Long-Term Gait Development in Infants With Neonatal Encephalopathy Using Infant Treadmill
There have been many studies on the use of running training in older children to improve gait development in children with cerebral palsy.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Periventricular Leukomalacia, Intraventricular Hemorrhage Neonatal, Bilirubin Encephalopathy
- Trial name
- NCT03534466
- Testing
- Baby treadmill, Conventional physical rehabilitation training
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Children's Hospital of Fudan University
Premature Birth
Cleanser Versus Only Water
The aim of this study is to determine the effect of the newborn's first bath with a cleaning product and only water on the barrier function of the skin.
- Trial name
- NCT04720989
- Testing
- Bathing With Baby Cleanser and water, Bathing With only Water
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Akdeniz University
Cesarean Section, Infant Conditions
Intact-cord Stabilisation and Physiology-based Cord Clamping in Caesarean Sections
This is a feasibility study with historical control designed to evaluate whether delivery of the placenta prior to umbilical cord clamping at caesarean sections is a feasible, safe and acceptable way of facilitating intact-cord…
- Trial name
- INTACT (NCT05461950)
- Testing
- Extrauterine placental transfusion and physiology-based umbilical cord clamping, Extrauterine placental transfusion, intact cord stabilisation and physiology-based umbilical cord clamping, Delayed umbilical cord clamping
- Where
- Norway
- Volunteers
- 263 people
- Sponsor
- Helse Møre og Romsdal HF
Respiratory Syncytial Virus Infection
Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)
The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of clesrovimab in healthy pre-term and full-term infants.
- Trial name
- CLEVER (NCT04767373)
- Testing
- Clesrovimab
- Where
- 217 sites in United States, Argentina and 22 more
- Volunteers
- 3,632 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Preterm Birth, Healthy
A Study Evaluating Sleep, Stress and Infant Nutrition Using a Chatbot
20 parents with healthy preterm infants (born at <37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment and 20 parents with healthy full-term infants (born at ≥37 weeks of gestation), age…
- Trial name
- NCT03630679
- Where
- Singapore
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
Habituation, Psychophysiological, Preterm, Infant
Habituation's Mechanisms in Preterm and Term Infants
Each year in France, 7 % of newborns are born preterm (before 37 weeks of gestational age (GA)). The investigators called very preterm infants those who were born before 33 weeks of GA.
- Trial name
- HABIPREMA (NCT02496104)
- Testing
- Package n°1 of the APIB
- Where
- France
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- University Hospital, Brest
Lung Diseases, Bronchopulmonary Dysplasia
Prolonged Outcomes After Nitric Oxide (PrONOx)
The purpose of this study is to look at the long term consequences of prematurity in infants treated with inhaled nitric oxide (iNO) while in the neonatal intensive care unit.
- Conditions
- Lung Diseases, Bronchopulmonary Dysplasia, Premature Birth, Developmental Disabilities
- Trial name
- NCT00234247
- Testing
- Long Term Follow-Up
- Volunteers
- 652 people
- Sponsor
- University of Pittsburgh