Clinical trials: Preterm and Term Infants
Preterm Infants
Food Habit Programming: Influence of Genetics and Early Nutrition in a Population of Preterm Infants
Influence of neonatal nutrition and growth on psychomotor development of 2 years preterm infants.-Joint influence of environmental factor (early nutrition) and genetics factors on feeding behaviour setting- up in a particular…
- Trial name
- Polynuca (NCT00663572)
- Where
- France
- Volunteers
- 234 people
- Sponsor
- Nantes University Hospital
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
Periodontal Diseases, Premature Birth
Prevention of Pre-Term Birth by Treatment of Periodontal Disease
The aim of the study is to investigate, in an Australian population of pregnant women, whether the treatment of periodontal disease during pregnancy prevents pre-term birth and other complications of pregnancy.
- Conditions
- Periodontal Diseases, Premature Birth, Pre-Eclampsia
- Trial name
- NCT00133926
- Testing
- Treatment of periodontal disease
- Where
- Australia
- Volunteers
- 1,094 people
- Sponsor
- King Edward Memorial Hospital
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, Enterocolitis, Necrotizing
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Ulcerative-necrotizing enterocolitis (ECUN) is an infectious and inflammatory disease of the digestive tract, which can lead to intestinal necrosis or perforation.
- Trial name
- NECO2 (NCT05882448)
- Testing
- laparotomy, Laparoscopy
- Where
- 2 sites in France
- Volunteers
- 54 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Prematurity, Infections, NIRS
The Peripheral(-Muscle) Oxygenation and Perfusion Score as a New Non-invasive Tool to Predict Elevations in C-reactive Protein Levels in Neonates
This is a prospective, single-center Phase II observational study investigating the predictive value of the "Peripheral(-muscle) Oxygenation and Perfusion Score" (POP-Score), a novel non-invasive composite index, for early…
- Conditions
- Prematurity, Infections, NIRS, Near Infrared Spectroscopy, Preterm Neonates
- Trial name
- POP-Score (NCT07109856)
- Testing
- POP-Score Assessment, Near-Infrared Spectroscopy (NIRS)
- Where
- Austria
- Volunteers
- 93 people
- Sponsor
- Medical University of Graz
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
Infant, Newborn, Hypotension
Hypotension in Neonates
This observational study collects information on the current incidence and management of hypotension in babies born at term or late preterm that are admitted to Neonatal Intensive Care Units (NICUs) within the Neonatal Research…
- Conditions
- Infant, Newborn, Hypotension, Blood Pressure
- Trial name
- NCT00882284
- Where
- 17 sites in United States
- Volunteers
- 820 people
- Sponsor
- NICHD Neonatal Research Network
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
Transient Tachypnea of the Newborn, PPHN
Evaluation of the Prevalence of Persistent Pulmonary Hypertension in Neonates
Transient Tachypnea of the Newborn (TTN) is one of the common causes of neonatal respiratory distress as a result of delayed clearance of fetal lung fluid. Neonates with TTN usually require noninvasive respiratory support (e.g.
- Trial name
- PRE-HIFREQ (NCT03499418)
- Testing
- modified Silverman scale, echocardiography
- Where
- Poland
- Sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, Poland
Neonatal Intensive Care
Neonatal Mask Seal; a Two-handed Versus One-handed Approach: The NeoSeal Study
When babies can't breathe effectively, we can use a facemask to give them breaths and oxygen. The mask can be held with one or two hands, depending on the preference of the doctor.
- Trial name
- NeoSeal (NCT06740344)
- Testing
- Two-handed facemask hold, Control: One-handed facemask hold
- Where
- Ireland
- Volunteers
- 110 people
- Sponsor
- University College Dublin
Infection, Bacterial, Infection Prevention
Optimising Kangaroo Care to Reduce Neonatal Severe Infection/Sepsis and Resistant Bacterial Colonisation Among High-risk Infants in NICU.
NeoDeco is a pragmatic, multicenter, parallel-group, cluster-randomised hybrid effectiveness-implementation trial designed to evaluate the impact of implementing optimised Kangaroo Care (KC) at the unit level compared to standard…
- Trial name
- NeoDeco (NCT05993442)
- Testing
- Optimised kangaroo care
- Where
- 24 sites in Greece, Italy and 3 more
- Volunteers
- 3,080 people
- Sponsor
- PENTA Foundation
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
Children Born Very Prematurely in Relation to Structural Brain Abnormalities
Magnetic Resonance Spectroscopy at Term-equivalent Age and Executive Functions at 5 Years of Age Corrected in Very Preterm Infants
EPIRMEX is a complementary study to the national cohort EPIPAGE 2 the INSERM Unit 953 is responsible. The objective of this study is to evaluate at the age of 5 years corrected executive functions in children born very…
- Trial name
- EPIRMEX (NCT02851537)
- Testing
- an advanced technique as magnetic resonance spectroscopy (MRS)
- Volunteers
- 100 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Necrotizing Enterocolitis, Intestinal Perforation
Necrotizing Enterocolitis and Bowel Perforation in Very Preterm Infants - Long-term Follow up
Necrotizing enterocolitis (NEC) is a gastrointestinal syndrome characterized by transmural inflammation and necrosis of the large and/or small bowel and subsequent intramural gas-forming organisms into the intestinal wall.
- Conditions
- Necrotizing Enterocolitis, Intestinal Perforation, Premature Infant Disease
- Trial name
- NOR-NEC (NCT06757582)
- Where
- Norway
- Volunteers
- 150 people
- Sponsor
- University Hospital of North Norway
Retinopathy of Prematurity (ROP)
Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)
The main purpose of this study is to evaluate the long-term efficacy and safety outcomes following short-term exposure to rhIGF-1/rhIGFBP-3 versus standard neonatal care in Study ROPP-2008-01 (NCT01096784).
- Trial name
- PEDAL (NCT02386839)
- Testing
- rhIGF-1/rhIGFBP-3
- Where
- 16 sites in United States, Italy and 4 more
- Volunteers
- 76 people
- Sponsor
- Shire
Preterm Infant Development, Preterm Infant Health
Neonatal Data and Biobank to Study Factors Influencing Development in Preterm Infants Born at <32 Weeks' Gestation and/or <1500 g Birth Weight
The Neo-Life project aims to establish a prospective neonatal data and biobank to investigate factors influencing the short- and long-term development of very preterm infants.
- Conditions
- Preterm Infant Development, Preterm Infant Health, Prematurity Complications, Premature Birth
- Trial name
- Neo-Life (NCT07490912)
- Where
- Germany
- Volunteers
- 1,300 people
- Sponsor
- University Hospital of Cologne
Preterm, Father-Child Relations
The SUPPORTED Study - First-time Fathers of Preterm Infants.
The purpose is to support first-time fathers of premature infants in early parenthood by promoting early paternal-infant relationships.
- Trial name
- NCT06116747
- Testing
- Intervention
- Where
- Denmark
- Volunteers
- 915 people, healthy volunteers welcome
- Sponsor
- Hvidovre University Hospital
Neurodevelopmental Disorders, Motor Skills Disorders
Motor Development and Early Predictors of Psychomotor Outcomes in Preterm and Term Infants Assessed by MOS-R and Caregiver Questionnaire at 18 and 36 Months
This study examines how early motor behavior in infants relates to their later psychomotor development. Researchers will observe both preterm and full-term infants during the first months of life, using video-based assessments to…
- Conditions
- Neurodevelopmental Disorders, Motor Skills Disorders, Infant, Premature Development, Infant, Term Development
- Trial name
- NCT07296003
- Testing
- Vojta method
- Where
- 3 sites in Czechia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Masaryk University
Procedural Pain, Pre-Term
Multimodal Approach to the Ontogenesis of Nociception in Very Preterm and Term Infants
The management of pain related to venipuncture remains insufficient in very preterm infants (VPI. The separation between the mother (father) and her(his) child can aggravate the short-term painful experience of the newborn.
- Conditions
- Procedural Pain, Pre-Term, Venipuncture
- Trial name
- NOCI-Prem (NCT05404594)
- Testing
- Maternal vocal contact
- Where
- France
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University Hospital, Strasbourg, France