Clinical trials: Preterm and Term Infants
Transient Tachypnea of the Newborn
Physiologically Based Cord Clamping To Improve Neonatal Outcomes After Elective Cesarean Delivery
Before birth, the baby's lungs are filled with fluid and babies do not use the lungs to breathe, as the oxygen comes from the placenta. As delivery approaches, the lungs begin to absorb the fluid.
- Trial name
- PhyCord1 (NCT06278415)
- Testing
- Physiological based cord clamping, Differed cord clamping
- Where
- 2 sites in Belgium
- Volunteers
- 50 people
- Sponsor
- Queen Fabiola Children's University Hospital
Pre-Term
MusicHyperBrain Study With Preterm Infants and Their Parents
Inter-personal brain coupling between preterm infants, their parents and a musician during Creative Music Therapy using functional near-infrared imaging (fNIRI) hyperscanning and systemic physiology measurements
- Trial name
- NCT05383586
- Testing
- Creative Music Therapy
- Where
- Switzerland
- Volunteers
- 20 people
- Sponsor
- University of Zurich
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
Neonates
NICU-TECH RM9L-RS Probe ME Feasibility Study
Use of a new ultrasound device designed for babies to look at the catheters in veins and arteries as well as the blood vessel itself.
- Trial name
- NCT01181596
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- GE Healthcare
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
Transient Tachypnea of the Newborn
nHFOV Versus nCPAP in Transient Tachypnea of the Newborn
In this prospective, randomised clinical trial the investigators aim to assess if nasal high frequency oscillatory ventilation (nHFOV) could be used as the primary modality of respiratory support in late preterm and term infants…
- Trial name
- NCT03006354
- Testing
- nHFOV, nCPAP
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- The Hospital for Sick Children
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
Extreme Prematurity - Less Than 28 Weeks, Infant, Extremely Premature
The UK 22 Week Study
In the UK, babies born at 22 weeks of pregnancy have only been offered survival-focused care (sometimes called resuscitation or stabilisation) since 2019.
- Conditions
- Extreme Prematurity - Less Than 28 Weeks, Infant, Extremely Premature, Neonatal and Perinatal Conditions, Intensive Care, Neonatal
- Trial name
- NCT07616778
- Testing
- Not applicable (observational study)
- Where
- 50 sites in United Kingdom
- Volunteers
- 100 people
- Sponsor
- Imperial College London
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
Pain, Newborn
The Effects of Different Procedures on Pain Levels at Preterm and Term Infants in Neonatal Intensive Care Unit
Accurate assessment of pain in neonates in the neonatal intensive care unit (NICU) is vital because of the high prevalence of painful experiences, including both daily procedural pain and postoperative pain, in this population.
- Conditions
- Pain, Newborn, Preterm, Term
- Trial name
- PAIN (NCT05077345)
- Where
- Turkey (Türkiye)
- Volunteers
- 196 people
- Sponsor
- Sanko University
Neonatal Disease, Nursing Caries
Effect of an Incubator Cover on Term and Preterm Neonates' Vital Signs
The aim of this study is to evaluate the effect of an incubator cover on the vital signs of term and preterm neonates hospitalized in a neonatal intensive care unit.
- Trial name
- NCT05892809
- Testing
- use an incubator cover
- Where
- Turkey (Türkiye)
- Volunteers
- 91 people
- Sponsor
- Maltepe University
Chorioamnionitis, Puerperal Endometritis
Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term
The aims of this study are to determine whether antibiotics administered routinely in women presenting with premature rupture of membranes later than the 37+0 weeks of gestation can alter the rate of maternal and neonatal…
- Conditions
- Chorioamnionitis, Puerperal Endometritis, Neonatal Early Onset Sepsis, Neonatal Meningitis
- Trial name
- NCT01633294
- Testing
- Ampicillin + gentamicin
- Where
- Portugal
- Volunteers
- 161 people
- Sponsor
- Hospital de Santa Maria, Portugal
Lung Disease
Safety and Efficacy Study of Nitric Oxide for Inhalation on Chronic Lung Disease in Premature Babies
The purpose of this study is to assess the safety and efficacy of inhaled nitric oxide to reduce the risk of chronic lung disease in pre-term infants with respiratory distress, and to assess the long-term effects of the therapy…
- Trial name
- NCT00551642
- Testing
- Nitric oxide
- Where
- 35 sites in Belgium, Finland and 7 more
- Volunteers
- 800 people
- Sponsor
- Mallinckrodt
Retinopathy of Prematurity (ROP)
Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090
This is a follow-up study to evaluate the long term outcome of babies treated in the FIREFLEYE study.
- Trial name
- FIREFLEYE next (NCT04015180)
- Testing
- Eylea (Aflibercept, BAY86-5321), Laser photocoagulation
- Where
- 55 sites in Argentina, Belgium and 22 more
- Volunteers
- 100 people
- Sponsor
- Bayer
Bronchopulmonary Dysplasia, Respiratory Tract Infections
Long-term Safety and Efficacy Follow-up Study of PNEUMOSTEM® in Patients Who Completed PNEUMOSTEM® Phase-I Study
This is a 5-year long-term follow-up study of open label, single-center, phase I clinical trial to evaluate the safety and efficacy of PNEUMOSTEM® in premature infants with bronchopulmonary dysplasia.
- Conditions
- Bronchopulmonary Dysplasia, Respiratory Tract Infections, Premature Birth of Newborn
- Trial name
- NCT02023788
- Testing
- PNEUMOSTEM
- Where
- South Korea
- Volunteers
- 8 people
- Sponsor
- Medipost Co Ltd.