Clinical trials: Very Preterm Birth
Infant, Very Low Birth Weight
Liquid Preterm Formula Versus Powdered Human Milk Fortifier in VLBW Infants
This study aims to compare the short-term effects on growth and feeding tolerance of a liquid high calorie formula added to human milk versus powdered human milk fortifier in small preterm infants.
- Trial name
- NCT00760942
- Testing
- Similac special care 30, Similac human milk fortifier
- Where
- United States
- Volunteers
- 84 people
- Sponsor
- University of Oklahoma
Preterm, Premature
Effects of Kinesiotaping on Respiratory Muscles in Very Preterm Infants
This study aimed to evaluate the effects of kinesio taping on blood gas parameters, respiratory rate, heart rate, oxygen saturation, and pressure limits in preterm infants with RDS who are on NIV.
- Conditions
- Preterm, Premature, Infant, Newborn, Diseases, Respiratory Distress Syndrome
- Trial name
- NCT06285669
- Testing
- kinesiotaping application
- Where
- Turkey (Türkiye)
- Volunteers
- 26 people
- Sponsor
- Ondokuz Mayıs University
Nosocomial Infection, Necrotizing Enterocolitis
Effect of Oral Probiotic Supplementation on The Rate of Hospital Acquired Infection and Necrotizing Enterocolitis in Preterm Very Low Birth Weight Infants
The purpose of this study is to determine whether oral probiotic supplementation could reduce the incidence of nosocomial infections in preterm infants.
- Trial name
- NCT01340469
- Testing
- probiotics
- Where
- Thailand
- Volunteers
- 160 people
- Sponsor
- King Chulalongkorn Memorial Hospital
Very Preterm Children With Dysexecutive Disorders
Quality of Life of Very Preterm Children With Dysexecutive Disorders at Elementary School Age During the Confinement-deconfinement Period of Covid-19 Pandemic
Since March 2020, a new HCoV, SARS-Cov2, originating in China, has been spreading around the world. As of 13 may 2020, almost 4.2 million cases of infections and 292 000 died were reported worldwide (140 000 infection cases and…
- Trial name
- GPE-QolVID (NCT04696679)
- Testing
- Patient Quality of life assessment, Control group Quality of life assessment
- Where
- France
- Volunteers
- 170 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Infant, Very Low Birth Weight
L-arginine Concentrations and CPS Polymorphisms in VLBW Infants
Plasma L-arginine concentrations are decreased in premature infants with necrotizing enterocolitis (NEC). A carbamoyl-phosphate synthetase 1 (CPS1) polymorphism has been correlated with low plasma concentrations of L-arginine in…
- Trial name
- NCT00554866
- Testing
- blood sample and buccal swab sample
- Where
- 4 sites in Italy, Netherlands and 1 more
- Volunteers
- 477 people
- Sponsor
- Maastricht University Medical Center
Preterm Birth, Periventricular Leukomalacia
Neuroprotection by Magnesium Sulfate Given to Women at Risk of Very Preterm Birth
Magnesium is neuroprotective in neonatal animal models of acquired hypoxic-ischemic and/or inflammatory cerebral lesions. It is associated with a significant reduction of perinatal death and cerebral palsy in some observational…
- Conditions
- Preterm Birth, Periventricular Leukomalacia, Brain Ischemia, Intracranial Hemorrhages
- Trial name
- NCT00120588
- Testing
- magnesium
- Where
- France
- Volunteers
- 700 people
- Sponsor
- University Hospital, Rouen
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
Plasma Concentration
Effect Partial Digested Triglycerides on Supply Long-chain Fatty Acids to Very Preterm Newborns
Main objective: To determine the bioavailability of long-chain fatty acids in very preterm newborns after administering a supplement from the first days of life until 36 weeks postmenstrual age compared to children who did not…
- Trial name
- DHA-CIAL (NCT07311382)
- Testing
- Measure long-chain fatty acids in plasma after administration of a supplement from the first days of life until 36 weeks postmenstrual age
- Where
- Spain
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Hospital Universitario La Paz
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