Clinical trials: Very Preterm Infants
Anti-infecting Agents, Local
Efficacy Study Comparing 2% Chlorhexidine in 70% Isopropyl Alcohol Versus 2% Aqueous Chlorhexidine
The purpose of this study is to compare the efficacy of two different antiseptic solutions (2%chlorhexidine in 70% alcohol with 2% aqueous chlorhexidine)when used in a standardized controlled manner in cleansing the skin of…
- Trial name
- NCT01270776
- Testing
- 2% aqueous chlorhexidine, 2% Chlorhexidine 70% isopropyl alcohol
- Where
- Canada
- Volunteers
- 462 people
- Sponsor
- Mount Sinai Hospital, Canada
Respiratory Insufficiency of Prematurity
Canadian Oxygen Trial (COT)
Study Question: In infants who are born at gestational ages of 23 0/7 to 27 6/7 weeks, does lowering the concentration of supplemental oxygen to target an arterial oxygen saturation by pulse oximetry (SpO2)of 85-89% compared with…
- Trial name
- COT (NCT00637169)
- Testing
- Titration of oxygen therapy
- Where
- 23 sites in United States, Argentina and 4 more
- Volunteers
- 1,201 people
- Sponsor
- McMaster University
Oral Disorders
Acquisition of Full Oral Feeding and Further Oral Disorders in Extremely Preterm Infants
Extremely premature infants (born before 29 weeks) frequently present oral disorders. The management of these patients require assisted ventilation, enteral nutrition, and intensive daily care (procedural pain, exposure to pain…
- Trial name
- ORAPREM (NCT06648083)
- Testing
- Food autonomy
- Where
- France
- Volunteers
- 170 people
- Sponsor
- Hospices Civils de Lyon
Children Born Extremely Premature, Disturbance of Visuo-spatial Working Memory
Long-term Effects of Visual Spatial Working Memory Training Program Performed at Preschool Age in Very Preterm Infants With Visual Spatial Working Memory Deficit. A Randomized Controlled Trial
Prematurity tends to increase in France in recent years and more children born extremely premature infants survive. If severe impairments have stabilized, the majority of former extremely premature children have…
- Trial name
- EPIREMED (NCT02757794)
- Testing
- computerized cognitive remediation program, standard remediation
- Where
- 18 sites in France
- Volunteers
- 166 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Neonatal, Pain Measurement
Assessment of the NIPE in Very Premature Infant Ventilated and Sedated in Neonatal Reanimation.
The Newborn Infant Parasympathetic Evaluation (NIPE) was developed as a method of analysis of the heart rate variability. The monitor gives a value between 0 (low value of the parasympathetic component) and 100 (high value of the…
- Conditions
- Neonatal, Pain Measurement, Reanimation
- Trial name
- NIPEpréma (NCT05223790)
- Testing
- Pain measurement during care procedures in neonatal reanimation
- Where
- France
- Volunteers
- 50 people
- Sponsor
- University Hospital, Lille
Respiratory Distress Syndrome In Premature Infants
Safety and Efficacy Study of the Draeger Babylog VN500 Device in HFOV Mode in VLBW Neonates
The purpose of this study is to determine the safety and effectiveness of the Babylog VN500 in high frequency oscillatory ventilation (HFOV) mode as a method for treating very low birth weight (VLBW) neonates requiring invasive…
- Trial name
- NCT02445040
- Testing
- Babylog VN500 in HFOV Mode
- Where
- 14 sites in United States
- Volunteers
- 225 people
- Sponsor
- Draeger Medical Systems, Inc.
Nutrition of Preterm Infants
Early Total Enteral Feeding Versus Conventional Enteral Feeding in Stable Very Low Birth Weight Infants
The purpose of this study is to compare the effect of early total oral feeding versus conventional oral feeding in stable VLBW infants.
- Trial name
- NCT02187978
- Testing
- Early total enteral feeding (ETEF), Conventional enteral feeding (CEF)
- Where
- India
- Volunteers
- 180 people
- Sponsor
- Lady Hardinge Medical College
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
BPD - Bronchopulmonary Dysplasia, VLBW - Very Low Birth Weight Infant
Duodenal Feeds in Very Low Birth Weight Infants
Premature infants have high rates of bronchopulmonary dysplasia (BPD) due to prematurity of the participants' lungs and the need for prolonged respiratory support.
- Conditions
- BPD - Bronchopulmonary Dysplasia, VLBW - Very Low Birth Weight Infant, Feeding Disorder Neonatal, Feeding; Difficult, Newborn
- Trial name
- NCT04246333
- Testing
- Mode of Delivery of Feeds
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins All Children's Hospital
Very Low Birth Weight Baby, Premature Birth
Human-derived Human Milk Fortifiers (H2MF), Gut Microbiota and Oxidative Stress in Premature Infants
This is a randomized controlled trial of a human-derived human milk fortifier (H2MF) vs standard bovine-derived human milk fortifier (HMF) evaluating fecal microbiota and fecal and urinary biomarkers of oxidative stress in…
- Conditions
- Very Low Birth Weight Baby, Premature Birth, Microbial Colonization, Oxidative Stress
- Trial name
- NCT03214822
- Testing
- H2MF
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- University of Manitoba
Nutrition Disorder, Infant
Effects of Two Different Parenteral Nutrition Regimes on Nutrient Intakes, Growth and Plasma Electrolytes in Very Low Birth Weight Infants
A single-center retrospective observational study comparing two cohorts of very low birth weight (VLBW, birth weight < 1500 grams) infants who received parenteral nutrition (PN) either before or after a concentrated PN regime was…
- Trial name
- PUMPA (NCT04085484)
- Testing
- More concentrated parenteral nutrition solution
- Where
- Sweden
- Volunteers
- 134 people
- Sponsor
- Umeå University
Respiratory Distress Syndrome
Caffeine Treatment in in the Delivery Room
Background. In recent years, particular attention has been paid to all interventions that could help reduce the need for mechanical ventilation MV and, therefore, the risk of BPD.
- Trial name
- CAFROOM (NCT04044976)
- Testing
- Caffeine Citrate
- Where
- Italy
- Volunteers
- 42 people
- Sponsor
- University of Florence
Immunomodulation Effect
Effect of Autologous Cord Blood-mononuclear Cells Infusion on Immune Microenvironment in Infants Born Very Preterm in NICU
Multi-omics (analysis of peripheral blood immune cells subset, peripheral blood MNCs transcriptome, soluble inflammatory cytokine profile in blood and airway secretion, lung and gut microbiota, and the interaction) analysis was…
- Trial name
- NCT05087498
- Testing
- autologous cord blood mononuclear cells, normal saline
- Where
- China
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Guangdong Women and Children Hospital
Cerebral Autoregulation, Preterm Birth
Transitional Cerebrovascular Reactivity in Very Preterm Infants
The transitional period, defined as the first 72 hours after preterm birth, is often characterized by a significant hemodynamic instability and may also be associated with an impairment of cerebral autoregulation, with relevant…
- Conditions
- Cerebral Autoregulation, Preterm Birth, Premature Infant Disease
- Trial name
- NCT04423016
- Testing
- Near Infrared Spectroscopy monitoring, Electrical velocimetry and pulse oximetry
- Where
- Italy
- Volunteers
- 72 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Infant, Premature, Diseases
Novel Human Milk Based Human Milk Fortifier
The primary objective is to assess weight gain of VLBW infants fed human milk supplemented with a novel human milk-based fortifier, in comparison to use of other fortifiers (historic controls).
- Trial name
- MHMHMF (NCT04478487)
- Testing
- Medolac human milk based human milk fortifier (MHMHMF)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Northwest Health
Preterm Infant, Growth
Using a New Human Milk Fortifier to Optimize Feeding
This study aims to compare the safety and efficacy of a new HMF and those of other HMF used before in very preterm infants.
- Trial name
- NCT04283799
- Testing
- A new human milk fortifier
- Where
- 7 sites in China
- Volunteers
- 276 people
- Sponsor
- Children's Hospital of Fudan University
Infant, Very Low Birth Weight
Efficacy of Prophylactic Glycerin Suppositories for Feeding Intolerance in Very Low Birth Weight Preterm Infants: a Randomized Trial
To evaluate the efficacy of prophylactic glycerin suppositories will accelerate the elimination of meconium from the large intestine and thus reduce the incidence of feeding intolerance in very low birth weight (VLBW) infants
- Trial name
- NCT01799629
- Testing
- Glycerin suppositories
- Where
- 3 sites in Saudi Arabia
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- King Faisal Specialist Hospital & Research Center
Postnatal Growth Failure of Preterm Infants, Human Milk Fortification
Target Versus Standard Human Milk Fortification in Very Low Birth Weight Preterm Infants
The prevention of postnatal growth failure in very low birth weight (VLBW) preterm infants is of utmost importance. Standard fortification is the most commonly used supplementation practice but it does not consider the native…
- Trial name
- NCT02716337
- Testing
- Addition of human milk fortifiers according to human milk analysis
- Volunteers
- 10 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Respiratory Distress Syndrome RDS, Preterm Birth
Early Prediction of Lung Injury in Preterm Infants Score
The main hypothesis is that even preterm infants considered "stable" receiving non-invasive ventilation may be at risk of developing BPD due to an inhomogeneous distribution of ventilation.
- Trial name
- EPLIPS (NCT07265583)
- Where
- Italy
- Volunteers
- 104 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
Bronchopulmonary Dysplasia, Necrotizing Enterocolitis
Effects of Delayed Cord Clamping in Very Low Birth Weight Infants
The purpose of this study was to see if a brief delay in cord clamping for 30 to 45 seconds would result in higher hematocrit levels, fewer transfusions, healthier lungs, and better motor function at 40 wks and 7 months of age.
- Conditions
- Bronchopulmonary Dysplasia, Necrotizing Enterocolitis, Intraventricular Hemorrhage, Late Onset Neonatal Sepsis
- Trial name
- NCT00840983
- Testing
- delayed cord clamping
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- University of Rhode Island