Clinical trials: Pre-Term Birth
Preterm Birth Complication
SOon HOme Study About Preterm Infants
The goal of this randomized controlled trial without medication neither device (for procedure) is to compare the average length of hospital stay of infants weaned from the incubator at a weight greater than or equal to 1400 grams…
- Trial name
- SOHO (NCT06593808)
- Testing
- Weaning from the incubator to open coat at a weight greater than or equal to 1400 grams
- Where
- Italy
- Volunteers
- 82 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Premature Birth of Newborn, Enterocolitis, Necrotizing
A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome
The purpose of this study is to determine whether antibiotics given immediately after birth alter the development of the developing preterm infant's microbiome, which may further alter overall clinical outcomes.
- Trial name
- NCT02477423
- Testing
- Ampicillin, Gentamicins
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- University of Chicago
Music Therapy
Premature Family Music Therapy Intervention (PFMI)
The music therapy intervention it is dedicated to premature baby and their family at the Neonatal Intensive Care Unit (NICU)of the Woman-Child department "Hospital Del Ponte".
- Trial name
- PFMI (NCT04335240)
- Testing
- Premature family music therapy intervention to support parenting, attachment bond and preterm development
- Where
- Italy
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Ospedale di Circolo - Fondazione Macchi
Parenteral Nutrition-Associated Liver Disease
Low Dose Parenteral Fat for Prevention of Parenteral Nutrition Associated Cholestasis in Preterm Neonates
The goal of the study is to determine if parenteral nutrition-associated cholestasis (PNAC) is related to the amount of parenteral (intravenous) fat administered to premature babies until full enteral nutrition is achieved.
- Trial name
- NCT01050660
- Testing
- Intravenous fat emulsion, Restriction of intravenous fat emulsion to 1 gm/kg/d
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Yale University
Preterm Birth, Breast Milk Expression
Targeting Human Milk Fortification to Improve Preterm Infant Growth and Brain Development
This study is a randomized trial comparing 2 methods of human milk fortification for preterm infants in the neonatal intensive care unit (NICU).
- Conditions
- Preterm Birth, Breast Milk Expression, Nutrition Disorder, Infant, Brain Development Abnormality
- Trial name
- NCT03977259
- Testing
- Individually targeted fortification
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- Brigham and Women's Hospital
Infant, Newborn, Diseases, Infant Development
Probiotics and the Neurodevelopment in the Premature Infant <32 Weeks Gestational Age and <1500g
Unicentric, quasi-experimental, cohort study to evaluate the effect of combining two probiotics (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748) in the neurodevelopment of preterm neonates below 32…
- Trial name
- NCT05945017
- Testing
- Infloran® -Berne, Switzerland- (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748
- Where
- Spain
- Volunteers
- 233 people
- Sponsor
- Fundacion Clinic per a la Recerca Biomédica
Deglutition Disorder
Effect of Pre-emptive Transcutaneous Neuro-muscular Electrical Stimulation for Dysphagia in Long Term Intubated Patients
It was well known that long term intubation caused a various kind of abnormal presentations of dysphagia such as the increased aspiration risk, the decreased gag reflex, mucosal pathology, the airway stenosis and so on.
- Trial name
- NCT01202968
- Testing
- Transcutaneous neuro-muscular electrical stimulation
- Where
- South Korea
- Sponsor
- Ulsan University Hospital
Enteral Nutrition
Early Exclusive Enteral Nutrition in Early Preterm Infants
Enteral nutrition in preterm infants is usually started and advanced slowly until reaching full enteral feeds. Most preterm infants born before 34 weeks gestation require parenteral fluids to maintain normal blood sugar level and…
- Trial name
- NCT03708068
- Testing
- Early exclusive enteral nutrition
- Where
- 3 sites in Canada
- Volunteers
- 69 people
- Sponsor
- Belal Alshaikh
Infant, Newborn, Infant, Low Birth Weight
Dexamethasone Therapy in VLBW Infants at Risk of CLD
Infants who are on breathing support are often treated with steroids (dexamethasone); however, the best timing of therapy is not known.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Dexamethasone (NCT00011362)
- Testing
- Dexamethasone Early, Dexamethasone Late
- Where
- 13 sites in United States
- Volunteers
- 371 people
- Sponsor
- NICHD Neonatal Research Network
Extremely Low Birth Weight Infants
Post-Extubation Assessment of Clinical Stability in ELBW Infants
This is an observational, proof-of-concept, feasibility study that aims to evaluate the feasibility of a monitoring system that integrates clinical data, high-resolution waveforms from the bedside monitor, regional oxygenation…
- Trial name
- PEACE (NCT06037083)
- Testing
- Oxygen saturation probe, Near infrared spectroscopy sensors, Electrical impedance tomography
- Where
- 2 sites in Canada
- Volunteers
- 20 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
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
Moral Distress
The Interplay Between Moral Distress, Moral Resilience, and Mental Health Outcomes Among Neonatal Care Providers
Due to highly specialized medical care neonatal care providers are faced with numerous responsibilities which makes neonatal care a particularly challenging and stressful work environment.
- Trial name
- MoD (NCT06836323)
- Where
- Switzerland
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Infant, Extremely Premature
Description of Practices Implemented in the Birth of Living Children Before 24 Weeks of Amenorrhea
Every year, at the Nice University Hospital, about sixty deliveries take place before 24 weeks of amenorrhea. The child is not viable because of his extreme immaturity.
- Trial name
- NCT03403894
- Testing
- Asking caregivers in their practice
- Where
- France
- Volunteers
- 35 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Premature; Infant, Light-for-dates, Breastfeeding
Probiotics and Early Microbial Contact in Preterm Neonates
Probiotics are live microbes which, when administered in sufficient amounts, confer a health benefit to the host. According to recent clinical trials, administration of probiotics to very low birth weight infants significantly…
- Trial name
- ProPre (NCT01454661)
- Testing
- LGG, LGG+Bb-12
- Where
- Finland
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Turku University Hospital
Persistent Ductus Arteriosus
Betamethasone and Closure of Ductus Arteriosus
The ductus arteriosus (DA) normally closes after birth as a result of exposure to oxygen. Its persistence of DA (PDA) occurs in 20 to 50% of very preterm infants and is associated with significant morbidity and mortality…
- Trial name
- CELESTE (NCT05987202)
- Testing
- DA closure in a population of premature infants
- Where
- France
- Volunteers
- 51 people
- Sponsor
- Hospices Civils de Lyon
Prematurity, Oxidative Injury
Comparison of Different Oxygen Delivery Strategies During Resuscitation of Babies
Preterm infants are born with immature lungs and often require help with breathing shortly after birth. This currently involves administering 100% oxygen.
- Conditions
- Prematurity, Oxidative Injury, Respiratory Distress
- Trial name
- NCT00356902
- Testing
- titration of oxygen during resuscitation
- Where
- Canada
- Volunteers
- 215 people
- Sponsor
- University of Calgary
Feeding; Difficult, Newborn, Premature
A New Intervention Method to Enhance Oral Feeding Ability in Premature Infants: A Randomized Controlled Trial
Indonesia is the fifth country with the highest number of premature infants in the world. Research has shown that as many as 40% to 70% of premature infants exhibit both immature and atypical feeding skills and those requiring…
- Trial name
- NCT04945967
- Testing
- New Method, Conventional Method
- Where
- Indonesia
- Volunteers
- 70 people
- Sponsor
- Universitas Indonesia
Preterm
Co-regulation and Interaction in the NICU
Preterm infants are exposed to multiple stressors each day, posing a risk of toxic stress that can impact their developing brains during a critical period of sensitivity.
- Trial name
- CORI (NCT06753435)
- Where
- Sweden
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Linkoeping University
Malaria, Sexually Transmitted Diseases
Gestational Sulfadoxine-pyrimethamine and Azithromycin Treatment to Prevent Preterm Birth
The purpose of this study is to examine whether treatment of pregnant Malawian women with repeated doses of sulfadoxine-pyrimethamine and azithromycin antibiotics will prevent preterm deliveries and result in other health…
- Conditions
- Malaria, Sexually Transmitted Diseases, Preterm Birth, Pregnancy
- Trial name
- NCT00131235
- Testing
- Sulfadoxine-pyrimethamine treatment twice during pregnancy, Sulfadoxine-pyrimethamine at 4-week intervals, Sulfadoxine-pyrimethamine every 4 weeks + azithromycin twice
- Where
- Malawi
- Volunteers
- 1,320 people, healthy volunteers welcome
- Sponsor
- Tampere University
Resuscitation
Co2 Monitoring at Preterm Delivery-Observational Study
CO2 data, serving as a proxy marker for tidal volume, might enable titration of tidal volume/pressure thereby providing optimal ventilation during neonatal resuscitation.
- Trial name
- COSTA (NCT04699708)
- Testing
- Carbon dioxide monitoring
- Where
- 2 sites in United Kingdom
- Volunteers
- 150 people
- Sponsor
- South Tees Hospitals NHS Foundation Trust
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