Clinical trials: Preterm and Term Infants
Preterm Birth, Premature Birth
Exposure to Plasticisers in the Neonatal Intensive Care Unit
Neonatal intensive care relies on indwelling plastic medical devices fundamental in respiratory support, intravenous catheterization, and nutrition.
- Conditions
- Preterm Birth, Premature Birth, Neurodevelopmental Disorders, Pulmonary Disease
- Trial name
- PLASTIC-NICU (NCT05404815)
- Where
- Belgium
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- University Hospital, Antwerp
Hemolytic Disease of Newborn, Neonatal Hyperbilirubinemia
Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn
We hypothesized that adopting a lower rather than a higher threshold for phototherapy discontinuation will be associated with reduced rates of rebound hyperbilirubinemia in term and late preterm neonates with hemolytic disease of…
- Trial name
- NCT04218318
- Testing
- phototherapy
- Where
- Saudi Arabia
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Ministry of Health, Saudi Arabia
Pre-Term, Breast Milk Expression
Preemie Milk Analyser Validation Study
This study aims to test and validate the Preemie Ecosystem- a new device and associated software package for measuring the nutrient (fat, protein and carbohydrate) content of the breast milk of the mothers of premature babies.
- Conditions
- Pre-Term, Breast Milk Expression, Nutrition Disorder, Infant
- Trial name
- NCT06486194
- Testing
- Targeted breast milk fortification using preemie device, Standard Breast milk fortification
- Where
- United Kingdom
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Transient Tachypnea of the Newborn, Neonatal Respiratory Distress
Efficacy of Misoprostol in Prevention of Neonatal Respiratory Morbidity in Parturient at Early Term Elective Caesarian Section
Neonatal respiratory morbidities represent a common group of post natal complications including respiratory distress syndrome, transient tachypnea of newborn, and persistent pulmonary hypertension of newborn.
- Trial name
- NCT04780412
- Testing
- Misoprostol
- Where
- Egypt
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Ain Shams University
Lower Respiratory Tract Infection
Evaluate the Safety and Efficacy of Nirsevimab in Healthy Preterm and Term Infants in China
The purpose of this study is to evaluate the Safety and Efficacy of Nirsevimab, in Healthy Preterm and Term Infants in China
- Trial name
- CHIMES (NCT05110261)
- Testing
- Nirsevimab
- Where
- 30 sites in China
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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
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
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
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
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
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
Skin Diseases
Topical Therapy for Prevention of Infections in Preterm Infants
The purpose of this study is to determine how to best take care of the skin of preterm infants in order to prevent infections through the skin.
- Trial name
- NCT00162747
- Testing
- Aquaphor, Sunflower Seed Oil
- Where
- Bangladesh
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Neuroimaging
Evaluation of the Implementation of the Hemispheric Dominance During Development
Many cognitive functions in human are based on asymmetric brain networks. For most adults, language is processed largely by the left hemisphere while other auditory treatments, such as voice recognition are rather based on the…
- Trial name
- HEMISPHERENOR (NCT02826733)
- Testing
- Electroencephalogram (EEG), Near Infra Red Spectroscopy (NIRS), magnetic resonance imaging (MRI)
- Where
- France
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Preterm Birth
NICU-HEALTH (Hospital Exposures and Long-Term Health)
The purpose of this study is to evaluate the impact of environmental exposures during the NICU hospitalization on preterm infant development. The research team is interested in both chemical and non-chemical exposures.
- Trial name
- NCT01963065
- Where
- United States
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
Respiratory Syncytial Virus (RSV)
Phase Ib/IIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term Infants
This trial employs a randomized, double-blind, placebo/positive control, and dose-finding design to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of SIBP-A16…
- Trial name
- NCT07363837
- Testing
- SIBP-A16 injection, Nirsevimab, SIBP-A16 buffer solution
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Shanghai Institute Of Biological Products
Neonatal Hypothermia, Brown Adipose Tissue
Investigation of the Mechanisms of the Tendency to Hypothermia in Newborns and Premature Neonates
Newborns have thermoregulatory mechanisms that differ from those of adults. Instead of producing heat through shivering, newborns primarily rely on non-shivering thermogenesis by the brown adipose tissue.
- Conditions
- Neonatal Hypothermia, Brown Adipose Tissue, Preterm and Term Infants, Neonate
- Trial name
- NCT06803069
- Where
- 2 sites in Hungary
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Pecs