Clinical trials: Preterm and Term Infants
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
Anemia, Iron Deficiency
Effect of Timing of Umbilical Cord Clamping on Anaemia at 8 and 12 Months and Later Neurodevelopment
The investigators plan a study to randomize 540 children in Nepal to early (≤30 seconds) or late (≥180 seconds) clamping of the umbilical cord at birth.
- Conditions
- Anemia, Iron Deficiency, Neonatal Jaundice
- Trial name
- NCT02222805
- Testing
- Early (≤30 seconds) cord clamping, Delayed (≤180 seconds) cord clamping
- Where
- Nepal
- Volunteers
- 540 people, healthy volunteers welcome
- Sponsor
- Uppsala University
Lung-protective Ventilation, Respiratory Function Monitor
Optimization of Ventilation Strategies in Preterm and Term Infants in a Single-center Intervention Study
This study was a non-blinded, non-randomized intervention study in a single-center clinical setting, analyzing ventilation quality with and without RFM visibility.
- Trial name
- NCT05512689
- Testing
- Ventilations while using a respiratory function monitor
- Where
- Austria
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Medical University of Vienna
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
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
RSV Immunization, Healthy Volunteer
Study of a Single Intramuscular Dose of Nirsevimab in the Prevention of Hospitalizations Due to Respiratory Syncytial Virus (RSV) Infection in Healthy Term and Preterm Infants During the First Year of Life
The purpose of this study was to determine the efficacy and safety of a single intramuscular (IM) dose of nirsevimab, compared to no intervention, for the prevention of hospitalizations due to lower respiratory tract infection…
- Trial name
- NCT05437510
- Testing
- Nirsevimab
- Where
- 240 sites in France, Germany and 1 more
- Volunteers
- 8,057 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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
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
Latent Iron Deficiency at Birth
Latent Iron Deficiency at Birth Influences Auditory Neural Maturation in Late Preterm and Term Infants
This study evaluates auditory neural maturation by auditory brainstem evoked response in late preterm and term infants with in utero iron deficiency compared with neonates with normal in utero iron status.
- Trial name
- NCT02503397
- Testing
- Auditory brainstem evoked response (ABR)
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Sir Ganga Ram Hospital
Cerebral Palsy, Prematurity
Study of Generalized Movements for Early Prediction of Cerebral Palsy
The purpose of this study is to assess the predictive value of generalized movements in preterm and term infants who are at risk for development of cerebral palsy.
- Trial name
- NCT00749008
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Charles R. Neal,
Patent Ductus Arteriosus, Persistent Pulmonary Hypertension of the Newborn
Plethismographic Perfusion Index in Neonates
Photoplethismography will be measured and compared in newborns suffering from patent ductus arteriosus and normal controls.
- Trial name
- NCT02380040
- Testing
- PPG
- Where
- Israel
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Shaare Zedek Medical Center
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
Pertussis
Pertussis Immunization During Pregnancy: Effect in Term and Preterm Infants
Young infants are most vulnerable to severe disease and even death when infected with Bordetella Pertussis. The current vaccines and vaccination programs do not guarantee protection of neonates.
- Trial name
- MAMA (NCT02511327)
- Testing
- Infant pertussis vaccination
- Where
- Belgium
- Volunteers
- 232 people, healthy volunteers welcome
- Sponsor
- Universiteit Antwerpen
Pre-term Infant
Growth and Safety of Two Partially-hydrolyzed Feeding Systems for Preterm Infants
This is an open-label trial consisting of two sub-studies to be conducted sequentially with the purpose of evaluating the safety and suitability of a two feeding systems in pre-term infants (one containing HMOs and one without…
- Trial name
- NCT04639518
- Testing
- Preterm formulas with HMO, Preterm formulas without HMO
- Where
- 4 sites in Germany, Poland and 1 more
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Respiratory Distress, Transient Tachypnea of the Newborn
Effect of Supine or Prone Position After Caesarean Birth
Respiratory Distress is a frequent clinical diagnosis of babies delivered by elective Caesarean birth. There has been no study comparing the efficacy of immediately positioning a newly born infant prone vs.
- Conditions
- Respiratory Distress, Transient Tachypnea of the Newborn, Delayed Transition of the Newborn, Persistent Pulmonary Hypertension
- Trial name
- NCT01310153
- Testing
- prone positioning, Supine
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
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
Parent-Child Relations, Parents
Therapist Education and Massage for Parent Infant-Outcomes
The Therapist Education and Massage for Parent-Infant Outcomes program is evidence-based and includes infant massage, physical therapy interventions including developmental support and play activities to promote infant…
- Conditions
- Parent-Child Relations, Parents, Extreme Prematurity
- Trial name
- TEMPO (NCT04121897)
- Testing
- Therapist Education and Massage for Parents of Extremely Preterm Infants
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
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
Premature Birth
Theory of Mind in Preschool Children, School Children, Youths and Adults Born Preterm or Full-term
This study tests preschoolers, school children, youths and young adults, who were born preterm or full-term, in their theory of mind abilities.
- Trial name
- NCT02628015
- Where
- Germany
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- University of Bonn
Infant, Newborn, Infant, Low Birth Weight
Inflammatory Cytokines Associated With Perinatal Brain Injury
This observational study assessed whether measurements of certain pro-inflammatory and anti-inflammatory cytokines in the blood (either singly or in combination) at birth and/or up to day of life 21 can predict cerebral palsy at…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Cytokines (NCT01035697)
- Where
- 18 sites in United States
- Volunteers
- 1,067 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network