Clinical trials: Very Preterm Infants
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
Infant, Newborn, Infant, Low Birth Weight
Cerebral Function Monitoring in Premature Infants
This observational study tests the feasibility of enrolling subjects and obtaining an amplitude-integrated electroencephalogram (aEEG) within the first 72 hours of life, a second aEEG recording between 72-168 hours of life, and…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NCT00873847
- Where
- 8 sites in United States
- Volunteers
- 102 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Premature, Diseases, Infant, Small for Gestational Age
Optimizing Individual Nutrition in Preterm Very Low Birth Weight Infants
In preterm infants fed human milk, milk needs to be fortified to meet nutrient recommendations. Fortification can be 1) standard, 2) individualized (adjusted based on daily human milk nutrient analysis and milk volume), or 3)…
- Trial name
- NCT02372136
- Testing
- Individualized Nutrition, Optimized nutrition
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of Texas Southwestern Medical Center
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
Preterm Infants, Respiratory Distress Syndrome
Diaphragm Electrical Activity of Preterm Infants on nCPAP With Binasal Prongs Versus RAM Cannula
Preterm babies have immature lungs and frequent pauses in their breathing which often necessitates breathing support. Nasal Continuous Positive Airway Pressure (nCPAP) is one of the most commonly used tools, but the standard…
- Conditions
- Preterm Infants, Respiratory Distress Syndrome, CPAP, RAM Cannula
- Trial name
- NCT03121781
- Testing
- respiratory support- interface
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- Sunnybrook Health Sciences Centre
Very Preterm Infant, Very Low Birth Weight Infants
The Use of Early Fortification in Preterm Infants
Very premature or very low birth weight (VLBW) infants are at risk of suboptimal growth after birth, making adequate nutrition essential.
- Trial name
- NCT07861984
- Testing
- Early Fortification, Standard Fortification
- Where
- Indonesia
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Universitas Indonesia
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
Apnea of Prematurity, Preterm Birth
Hemodynamic Responses to Cardio-respiratory Events in Preterm Infants
Intermittent episodes of hypoxemia and/or bradycardia, also defined as cardio-respiratory events (CRE) are very frequent in preterm infants and may result in transient hypoxia and hypoperfusion of target organs, with possible…
- Conditions
- Apnea of Prematurity, Preterm Birth, Patent Ductus Arteriosus, Hypoxia, Brain
- Trial name
- NCT04184245
- Where
- Italy
- Volunteers
- 42 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
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
Extra Uterine Growth Restriction, Premature Infant Disease
Does Starting Feeds on the First Day of Life Help Premature Infants Reach Full Volume Feeds Sooner?
Feeding advancements in ELBW infants have evolved over decades. The fear of causing mortality and morbidity, notably NEC, have made providers cautious when advancing feeds.
- Conditions
- Extra Uterine Growth Restriction, Premature Infant Disease, VLBW - Very Low Birth Weight Infant
- Trial name
- NCT06731439
- Testing
- Starting feeds within 6 hours of life, Standard feeding protocol
- Where
- United States
- Volunteers
- 248 people
- Sponsor
- University of Tennessee
ROP, Jaundice, Neonatal
Hyperbilirubinemia and Retinopathy of Prematurity in Preterm Infants: a Retrospective Study.
The goal of this retrospective observational study is to [learn about the correlation between hyperbilirubinemia and retinopathy of prematurity in preterm infants.
- Conditions
- ROP, Jaundice, Neonatal, Premature, Very Low Birth Weight Infant
- Trial name
- biliROP (NCT05806684)
- Testing
- ROP
- Where
- Italy
- Volunteers
- 1,586 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Preterm Birth
NICU-HEALTH (Hospital Exposures and Long-Term Health)
The purpose of this study is to evaluate the impact of environmental exposures during the NICU hospitalization on preterm infant development. The research team is interested in both chemical and non-chemical exposures.
- Trial name
- NCT01963065
- Where
- United States
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
Infant, Newborn, Infant, Low Birth Weight
Physiologic Definition of Bronchopulmonary Dysplasia
This observational study was conducted to design and test a physiologic definition for bronchopulmonary dysplasia at 36 weeks of life.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- PhysiologicDef (NCT01223287)
- Where
- 21 sites in United States
- Volunteers
- 410 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Very Low Birth Weight
High Protein and High Energy Intakes and Physical Activity on Growth of Extremely Low Birth Weight Infants
The aim of this study is to evaluate the effect of increasing amino acid and energy intake during parenteral and enteral nutrition with and without the stimulation of the infant's physical activity, on growth of extremely low…
- Trial name
- NCT03374033
- Testing
- NUTR +, STIMUL +
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- Università Politecnica delle Marche
Infant, Premature, Diseases, Respiratory Distress Syndrome, Newborn
Exogenous Surfactant in Very Preterm Neonates in Prevention of Bronchopulmonary Dysplasia
Advances in perinatal care have made it possible to improve the survival of the most immature neonates, but at the cost of an increase in the population at risk of developing bronchopulmonary dysplasia (BPD).
- Conditions
- Infant, Premature, Diseases, Respiratory Distress Syndrome, Newborn, Bronchopulmonary Dysplasia
- Trial name
- CURDYS (NCT01039285)
- Testing
- Curosurf, Air
- Where
- 13 sites in France
- Volunteers
- 118 people
- Sponsor
- Jean Michel Hascoet
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
Atopic Dermatitis
Probiotics and Breastmilk Decrease Risk of Atopic Dermatitis in Premature Infants
The purpose of this study is assess if the use of probiotic in very low weight could be other benefits a long time, as reduce atopic disease in this children.
- Trial name
- NCT06035835
- Testing
- Lacticaseibacillus rhamnosus, Lactobacillus acidophilus + Bifidobacterium bifidum
- Volunteers
- 437 people
- Sponsor
- José Uberos Fernández
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
Bronchopulmonary Dysplasia, Very Low Birth Weight
Preterm Infant Inhaled Albuterol Dosing
The purpose of this study is to help determine the best dose of inhaled albuterol sulfate in premature babies at risk of developing bronchopulmonary dysplasia (BPD).
- Trial name
- NCT02447250
- Testing
- Varied albuterol dose response
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Oregon Health and Science University
Bronchopulmonary Dysplasia, Intraventricular Hemorrhage
The Efect of Azithromicyn on Bronchopulmonary Displasia in Extremely Preterm and Very Preterm Infant
This study was to see the effectiveness of azithromycin in preventing the incidence of bronchopulmonary dysphasia in extremely preterm and very premature infants.
- Conditions
- Bronchopulmonary Dysplasia, Intraventricular Hemorrhage, Necrotizing Enterocolitis
- Trial name
- NCT05311228
- Testing
- Azithromycin Powder
- Where
- Indonesia
- Volunteers
- 120 people
- Sponsor
- Universitas Indonesia