Clinical trials: Very Preterm Infant
Cerebral Palsy, Infant, Newborn, Disease
Effectiveness of Family Collaborative Physiotherapy Programs With High-risk Infants
High risk infant is defined as infant with a negative history of environmental and biological factors, which can lead to neuromotor development problems.
- Conditions
- Cerebral Palsy, Infant, Newborn, Disease, Infant, Small for Gestational Age, Infant Asphyxia
- Trial name
- NCT04035291
- Testing
- exercise
- Where
- Turkey (Türkiye)
- Volunteers
- 63 people
- Sponsor
- Sanko University
Prone Positioning, Bronchopulmonary Dysplasia
Prone Versus Supine Positioning and the Impact on Bronchopulmonary Dysplasia in Very Low Birth Weight Infants.
In this pilot study, the investigator team aims to evaluate whether standardized prone positioning compared to usual positioning improves moderate to severe bronchopulmonary dysplasia (BPD) rates as assessed at 36 weeks post…
- Trial name
- NCT04890158
- Testing
- Prone positioning for a total of 6 hours daily
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Montefiore Medical Center
Weight Gain
Effect of Hindmilk on Growth Velocity of Very Preterm Infants
Research question: Does feeding hindmilk improve weight gain in very preterm infants with poor growth velocity? Hypothesis: In very preterm infants (born less than 32 weeks gestation) with poor postnatal growth velocity (<15…
- Trial name
- NCT03637413
- Testing
- Hindmilk
- Where
- Canada
- Volunteers
- 34 people
- Sponsor
- Belal Alshaikh
Preterm Infant, Umbilical Cord Milking
Effect of Intact Umbilical Cord Milking on Neonatal and First Year Neurodevelopmental Outcomes in Very Preterm Infants.
The investigators hypothesise that intact umbilical cord milking (I-UCM) will reduce neonatal morbidity and improve long term neurodevelopmental outcome in very preterm infants.
- Trial name
- Cord-milking (NCT03200301)
- Testing
- Intact Umbilical Cord Milking
- Where
- India
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Jubilee Mission Medical College and Research Institute
Infant, Very Low Birth Weight
Human Milk Fortifier and Cytokine Profile
This is a research study investigating if adding human milk fortifier to a preterm babies breast milk feedings affects the baby's immune system.
- Trial name
- NCT00601081
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Christiana Care Health Services
Hypoxia Neonatal, Premature
Pulse Oximetry Measurement and Transfusions
The primary purpose of this observational study was to determine if pRBC transfusions decrease the frequency of intermittent hypoxia events in very low birth weight infants (VLBW) during the first six weeks of life.
- Conditions
- Hypoxia Neonatal, Premature, Blood Transfusion
- Trial name
- POMAT (NCT04249193)
- Testing
- Transfusion
- Where
- 3 sites in United States
- Volunteers
- 75 people
- Sponsor
- Christiana Care Health Services
Emotional Stress, Parents
VOICE Study in China 'Towards a Partnership Between Parents of Very Premature Infants and Healthcare Professionals'
Background: Admission to a Neonatal Intensive Care Unit (NICU) is associated with significant levels of parental stress and anxiety.
- Conditions
- Emotional Stress, Parents, Family Separation, Neonatal Intensive Care
- Trial name
- VOICE (NCT05385198)
- Testing
- VOICE care
- Volunteers
- 60 people
- Sponsor
- Hunan Children's Hospital
Prematurity
Human Milk Cream as a Caloric Supplement in Pre-Term Infants
Human milk is commonly considered to have 20 calories per ounce (kcal/oz). However, studies show that up to 65% of human milk may be less than the expected 20 kcal/oz which can greatly affect an infant's growth.
- Trial name
- NCT01487928
- Testing
- Human Milk Cream
- Where
- 2 sites in United States
- Volunteers
- 78 people
- Sponsor
- Baylor College of Medicine
Prematurity
Effect of Colostrum on Mucosal Immunity in Very Low Birth Weight (VLBWs) Premature Infants
Background: Infection in preterm infants is a common, costly, and devastating problem frequently causing death or sequelae for survivors.
- Trial name
- NCT01776268
- Testing
- Oral priming
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- Vanderbilt University Medical Center
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
Premature Infants, Very Low Birth Weight Infants
The Video System to Provide a Developmental Training Guide for Preterm Infants
This study aimed to establish a systematic developmental training guide protocol for parent-centered early intervention and verify the concept and feasibility of a video system for parent-centered in-home developmental therapy…
- Trial name
- NCT06965842
- Testing
- Parent-centered developmental training
- Where
- South Korea
- Volunteers
- 12 people
- Sponsor
- Seoul National University Hospital
Infant, Premature, Diseases, Circulatory and Respiratory Physiological Phenomena
Dose-finding for Dobutamine During Transitional Circulation in Very Preterm Infants
Single centre, dose finding trial to establish the minimum effective dose of dobutamine required to treat hemodynamic insufficiency, defined as low superior vena cava (SVC) flow, in infants below 33 weeks' gestation during…
- Trial name
- NeoCirc-002 (NCT06878742)
- Testing
- Intravenous dobutamine 5 mcg/kg/min, Intravenous dobutamine 7.5 mcg/kg/min, Intravenous dobutamine 10 mcg/kg/min
- Where
- 3 sites in Spain
- Volunteers
- 30 people
- Sponsor
- Instituto de Investigación Hospital Universitario La Paz
Neonatal SEPSIS, Very Low Birth Weight Baby
Efficacy of IgM Rich Immunoglobulin With Antibiotics for Bacterial Sepsis in Very Low Birth Weight Preterm Neonates
Study comprises of giving IVIG to half of the septic VLBW preterm neonates along with ongoing antibiotics and placebo to the other half. The immunoglobulin will be given for 3 days and neonates will be monitored for the results.
- Trial name
- IgMNS (NCT03403530)
- Testing
- IgM rich Immunoglobin
- Where
- India
- Volunteers
- 60 people
- Sponsor
- Sir Takhtasinhji General Hospital
Infant, Premature, Diseases, Bronchopulmonary Dysplasia
Appropriate Oxygen Levels for Extremely Preterm Infants: a Prospective Meta-analysis
The primary question to be addressed by this study is: compared with a functional oxygen saturation level (SpO2) of 91-95%, does targeting SpO2 85-89% in extremely preterm infants from birth or soon after, result in a difference…
- Conditions
- Infant, Premature, Diseases, Bronchopulmonary Dysplasia, Retinopathy of Prematurity, Infant, Newborn, Diseases
- Trial name
- NeOProM (NCT01124331)
- Testing
- Higher oxygen saturation target range (91%-95%), Lower oxygen saturation (85%-89%)
- Where
- 9 sites in Australia
- Volunteers
- 4,965 people
- Sponsor
- University of Sydney
Premature Infants, Very Premature Infants
Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants
A phase 2 randomised, three-arm, parallel-group, dose-ranging trial to determine safety, efficacy and optimal dosing of intravenous anakinra in premature neonates, with subcutaneous pharmacokinetic sub-study.
- Conditions
- Premature Infants, Very Premature Infants, Inflammation
- Trial name
- AP2 (NCT07254000)
- Testing
- Anakinra (Kineret®)
- Where
- 2 sites in Australia, New Zealand
- Volunteers
- 24 people
- Sponsor
- Monash Medical Centre
Nutrition Intervention, Quality Improvement
Optimizing Early Nutrition Management of Extremely and/or Very Preterm Infants
A clinical quality improvement bundle on early nutrition supplementation is developed to improving the clinical outcomes (including growth, organ function, and neurodevelopment outcomes) of extremely and/or very preterm infants.
- Conditions
- Nutrition Intervention, Quality Improvement, Preterm Infant
- Trial name
- NCT07538999
- Testing
- A nutritional improving bundle for the intervention group, Routine nutritional strategies for the control group
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Children's Hospital of Fudan University
Preterm Infants
Bifidobacterium Supplementation for Very Low Birth Weight Infants
Probiotic supplementation to preterm infants have been reported to be beneficial in neonatal intensive care unit (NICU). Our pilot study also showed accelerated feeding in preterm infants who received Bifidobacterium bifidum…
- Trial name
- Bifido(RCT) (NCT01375309)
- Testing
- Bifidobacterium bifidum supplementation
- Where
- Japan
- Volunteers
- 246 people
- Sponsor
- Tokyo Women's Medical University
Prematurity, Very Preterm Maturity of Infant
Sleep in SNOO Smart Sleeper Bassinet in Preterm Infants
The goal of this clinical trial is to compare sleeping in a SNOO Smart Sleeper bassinet (SNOO) with sleeping in traditional bassinet conditions in premature infants. The main questions it aims to answer are: 1.
- Trial name
- NCT05711927
- Testing
- SNOO Smart Sleeper, Traditional bassinet
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Columbia University
Babies Born Very Preterm
In-line Filtration to Reduce Systemic Inflammatory Response Syndrome in Babies Born Very prEtErm
While venous access is an essential part of caring for the preterm neonate potential severe adverse events, including contamination of fluids with bacteria, endotoxins and particulates could occur (Bethune 2001).
- Trial name
- FRISBEE (NCT02686060)
- Testing
- 0.2 micron positively charged PALL Corporation filters and 1.2 micro IV in-line filters used for lipid administration
- Where
- France
- Volunteers
- 160 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Infant, Low Birth Weight
A Randomized Clinical Trial on Supplementation of DHA and AA to Preterm Infants
A randomized, double-blind trial of docosahexaenoic and arachidonic acid supplementation in breast-fed preterm infants Background: Docosahexaenoic acid (DHA) and arachidonic acid (AA) are essential for preterm infants.
- Trial name
- NCT00226187
- Testing
- Supplement of fatty acid (DHA and AA)
- Where
- Norway
- Volunteers
- 140 people
- Sponsor
- University of Oslo