Clinical trials: Very Preterm Infants
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
Preterm Infant Development, Preterm Infant Health
Neonatal Data and Biobank to Study Factors Influencing Development in Preterm Infants Born at <32 Weeks' Gestation and/or <1500 g Birth Weight
The Neo-Life project aims to establish a prospective neonatal data and biobank to investigate factors influencing the short- and long-term development of very preterm infants.
- Conditions
- Preterm Infant Development, Preterm Infant Health, Prematurity Complications, Premature Birth
- Trial name
- Neo-Life (NCT07490912)
- Where
- Germany
- Volunteers
- 1,300 people
- Sponsor
- University Hospital of Cologne
Extreme Prematurity
Protein for Premies
Although expressed breast milk is considered the optimal nutritional source for preterm infants, the macronutrient content is insufficient to enable optimal growth during neonatal intensive care.
- Trial name
- NCT01773902
- Testing
- High Dose Protein (Individualized), High Dose Protein (Standardized), Standard Protein Supplementation
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- University Hospital Tuebingen
Late-Onset Neonatal Sepsis, Extreme Prematurity
Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis
Fluid-unresponsive hypotension needing cardiotropic drug treatment is a serious complication in very preterm neonates with suspected late-onset sepsis (LOS; defined as culture positive or negative bloodstream infection or…
- Conditions
- Late-Onset Neonatal Sepsis, Extreme Prematurity, Neonatal Hypotension
- Trial name
- NCT05347238
- Testing
- Dopamine, Norepinephrine
- Where
- 22 sites in United States, Canada and 3 more
- Volunteers
- 550 people
- Sponsor
- Mount Sinai Hospital, Canada
Crying, Sleep
Cycled Light and Crying of Preterm Infants
This study shows that cycled light during neonatal care reduces infant's fussing and crying behavior at 5 and 11 weeks corrected age and improves growth during neonatal care.
- Trial name
- NCT01513226
- Testing
- Cycled light
- Volunteers
- 37 people
- Sponsor
- University Children's Hospital, Zurich
Very Preterm Infant, Very Low Birthweight
LIFT-UP: Randomized Controlled Trial of Fortification of Human Milk
The goal of the LIFT-UP randomized controlled trial is to evaluate the efficacy of feeding routinely and fortified human milk using a standardized clinical protocol to very low birthweight (VLBW) or very preterm (VPT) infants in…
- Trial name
- LIFT-UP RCT (NCT06765863)
- Testing
- Human Milk Fortifier, Volume targets
- Where
- 4 sites in India
- Volunteers
- 776 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
Apnea of Prematurity
A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants
The purpose of this study is to determine whether nasal intermittent positive pressure ventilation (NIPPV) reduces the need for endotracheal intubation in very low birth weight infants with persistent apnea who fail nasal…
- Trial name
- NCT03298035
- Testing
- NCPAP as mode for apnea prevention, NIPPV as rescue mode for apnea prevention
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- The University of Texas Health Science Center, Houston
BPD - Bronchopulmonary Dysplasia, NEC - Necrotizing Enterocolitis
Targeted vs Standard Fortification of Breast Milk
BACKGROUND: Human milk (HM) is recommended for all very low birth infants (VLBW)). Breast-milk is highly variable in nutrient content, failing to meet the nutritional demands of VLBW.
- Conditions
- BPD - Bronchopulmonary Dysplasia, NEC - Necrotizing Enterocolitis, Weight Gain, VLBW - Very Low Birth Weight Infant
- Trial name
- NCT03775785
- Testing
- Tailored enteral nutrition
- Where
- 2 sites in Poland
- Volunteers
- 200 people
- Sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, Poland
Patent Ductus Arteriosus
Comparative Study of Efficacy and Safety of Oral Ibuprofen and Intravenous Ibuprofen in Closure of Patent Ductus Arteriosus in Very Low Birth Weight Infants
it is a prospective randomized simple-blinded pilot trial with the principal aim to compare efficacy and tolerance between oral ibuprofen and intravenous ibuprofen in early curative closure of PDA in very low birth weight…
- Trial name
- NCT00642330
- Testing
- oral ibuprofen, intravenous ibuprofen
- Where
- Tunisia
- Volunteers
- 62 people
- Sponsor
- Hopital La Rabta
Gut Microbiota, Metabolites
Targeting Gut Microbiota and Metabolites for Very Preterm Infants Through Oropharyngeal Administration of Colostrum
Background: Oropharyngeal administration of colostrum (OAC) has an immune stimulating effect on oropharyngeal-associated lymphoid tissue, and can also promote the maturation of the gastrointestinal tract.
- Trial name
- NCT05481866
- Testing
- Oropharyngeal administration of colostrum, Oropharyngeal administration of sterile water
- Where
- China
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Shenzhen People's Hospital
Feeding Intolerance
Glycerin Suppositories for Treatment of Feeding Intolerance in Preterm Infants
Feeding intolerance is a common problem in preterm infants.
- Trial name
- NCT02149407
- Testing
- Glycerin, Rectal stimulation, Control
- Where
- 2 sites in Saudi Arabia
- Volunteers
- 230 people
- Sponsor
- King Saud Medical City
Mechanical Ventilation, Retinal Disease
Cpap at Delivery Room for Preterm Infants
The objective of the study is to determine if CPAP applied within less than 15 min of life in the DR reduces the necessity of mechanical ventilation and surfactant during the first 5 days of life.
- Conditions
- Mechanical Ventilation, Retinal Disease, Death, Respiratory Tract Disease
- Trial name
- CPAP-DR (NCT01024361)
- Testing
- CPAP
- Volunteers
- 200 people
- Sponsor
- University of Sao Paulo
Infant, Very Low Birth Weight
Evaluation of Prolact-Plus Human Milk Fortifier
Prolacta Bioscience has developed the first purely human fortifier, Prolact-Plus, that can provide a source of many of the required nutrients for premature, newborn infants, particularly protein and calories.
- Trial name
- NCT00486590
- Testing
- Prolact-Plus Human Milk Fortifier
- Where
- 4 sites in United States
- Volunteers
- 105 people
- Sponsor
- Prolacta Bioscience
Other Preterm Infants, Transitory Neonatal Electrolyte Disturbance
Clinical Tolerance of Numeta 13%
Numeta G13% is a triple chamber bag including amino acids plus electrolytes, glucose and lipids, dedicated for parenteral nutrition in preterm newborn infants when oral/enteral nutrition is not possible, insufficient or contra…
- Conditions
- Other Preterm Infants, Transitory Neonatal Electrolyte Disturbance, Disorder of Mineral Metabolism, Failure to Thrive
- Trial name
- BAXTERULG2 (NCT01772927)
- Testing
- Parenteral Nutrition
- Where
- Belgium
- Volunteers
- 30 people
- Sponsor
- University of Liege
Bronchopulmonary Dysplasia (BPD), Prematurity
Oral Vitamin A Supplementation for Prevention of Bronchopulmonary Dysplasia in Preterm Infants
Bronchopulmonary dysplasia (BPD) remains a major complication of very low birth weight (VLBW) preterm infants. Vitamin A is essential for lung development and epithelial integrity, and deficiency has been associated with an…
- Conditions
- Bronchopulmonary Dysplasia (BPD), Prematurity, Very Low Birth Weight
- Trial name
- VITA-BPD (NCT07577180)
- Testing
- Vitamin A
- Where
- Turkey (Türkiye)
- Volunteers
- 209 people
- Sponsor
- Erhan Calisici
Very Preterm Maturity of Infant
Prematurity at the Limit of Viability
Advancements in perinatal care have significantly improved the survival of extremely premature infants, establishing a viability threshold below 25 weeks' gestational age (GA).
- Trial name
- PRELIVIA (NCT06391476)
- Testing
- Study of the evolution of a cohort of children born between 22 and 25 weeks gestational age
- Where
- France
- Volunteers
- 300 people
- Sponsor
- Hospices Civils de Lyon
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
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
Morality, Morbidity;Newborn
Comparison of Care Practices, Mortality and Morbidity of Very Preterm Infants Between Two Tertiary Centers in Northwest and South of China
Care practices, mortality and morbidity of very premature infants from two different tertiary centers were collected and compared, in order to discover areas for improvement where these two newborn centers can learn from each…
- Conditions
- Morality, Morbidity;Newborn, Very Preterm Maturity of Infant
- Trial name
- NCT05116670
- Where
- China
- Volunteers
- 807 people
- Sponsor
- Nanjing Medical University
Premature Infants
Effect of Erythropoietin on Neurodevelopmental Outcomes in Very Preterm Infants With Intraventricular Hemorrhage
Erythropoietin (EPO) has been shown to be neurotrophic and neuroprotective in several animal models and some clinical studies. Our hypothesis is that EPO could improve long-term neurological outcomes in very preterm infants with…
- Trial name
- NCT03914690
- Testing
- Erythropoietin, Normal saline
- Where
- China
- Volunteers
- 316 people
- Sponsor
- Zhengzhou University