Clinical trials: Preterm Neonate
Anemia
Umbilical Cord Blood Use For Admission Blood Tests of Very Low Birth Weight Preterm Neonates: A Multi-center Randomized Clinical Trial
The goal of this protocol is to establish a randomized clinical trial comparing the use of cord blood vs. infant blood with the primary outcome of comparing both the absolute hemoglobin concentration and the percent change in…
- Trial name
- NCT02103296
- Testing
- Drawing admission labs from cord blood, Drawing admission labs from infant blood
- Where
- 6 sites in United States
- Volunteers
- 80 people
- Sponsor
- Capt Alicia Prescott
Prematurity, Microbial Colonization
Microbiome Establishment in Preterm Infants
Our bodies are home to millions and millions of microbes (bacteria, fungi and viruses), that live in harmony with us without producing any negative (disease producing) effects.
- Trial name
- PIMENTO (NCT05803577)
- Where
- Ireland
- Volunteers
- 91 people
- Sponsor
- University College Cork
Bronchopulmonary Dysplasia
Safety and Efficacy of MSC-EVs in the Prevention of BPD in Extremely Preterm Infants
The phase 1/2 trial aims to evaluate the safety and efficacy of EXOB-001 consisting of extracellular vesicles derived from umbilical cord mesenchymal stromal cells in the prevention of bronchopulmonary dysplasia (BPD) in…
- Trial name
- EVENEW (NCT06279741)
- Testing
- Endotracheopulmonary Instillation, Suspension
- Where
- 8 sites in Belgium, Italy
- Volunteers
- 265 people
- Sponsor
- EXO Biologics S.A.
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
Premature Birth, Bronchopulmonary Dysplasia
Assessment of Lung Structure and Function of Infants Born Prematurely
The purpose of this study is to evaluate the growth of the lung and how easily gas can be taken up by the lung in healthy infants born at full term without any breathing problems and infants born prematurely.
- Conditions
- Premature Birth, Bronchopulmonary Dysplasia, Asthma
- Trial name
- NCT00422305
- Where
- United States
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Indiana University
Preterm Birth, Low Birth Weight
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Periodontal disease in pregnant women has been implicated as a potential risk factor for adverse pregnancy outcomes, including being born preterm, small-for-gestational age, and/or low birth weight.
- Conditions
- Preterm Birth, Low Birth Weight, Small Vulnerable Newborn, Small-for-gestational Age
- Trial name
- NCT07553286
- Testing
- A package of oral health interventions, including a daily antiseptic oral rinse (alcohol-free cetylpyridinium chloride (0.075%))
- Volunteers
- 2,280 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Bilirubin Encephalopathy
Bilirubin Neurotoxicity (BN) and Neurodevelopmental Impairment (NDI) in Extremely Preterm (EP) Infants: Avoidable by Reducing the Usual Intravenous Lipid (UL) Administration
The purpose of this study is to evaluate the effect of usual versus reduced lipid intake on unbound bilirubin levels, brainstem auditory evoked responses, and neurodevelopmental outcome at 2 years in extremely preterm infants.
- Trial name
- NCT04584983
- Testing
- usual prescribed intralipid (UL) regimen, restricted prescribed intralipid (RL) regimen
- Where
- United States
- Volunteers
- 134 people
- Sponsor
- The University of Texas Health Science Center, Houston
Pre-Eclampsia, Pre-Term
Vascular Inflammation and Anti-inflammatory Supplements After Adverse Pregnancy Outcomes
Women who had an adverse pregnancy outcome (APO), such as preeclampsia, preterm birth, or gestational diabetes, have a higher risk for heart disease.
- Conditions
- Pre-Eclampsia, Pre-Term, Intrauterine Growth Restriction, Hypertension in Pregnancy
- Trial name
- VIA (NCT04633551)
- Testing
- Anti-inflammatory supplement
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- University of South Carolina
Infant, Premature, Diseases, Motor Development
Standardized Infant NeuroDevelopmental Assessment (SINDA) in 0-24 Months Age in Turkey
This study aims to assess Turkish validity and reliability of Standardized Infant Neurodevelopmental Assessment and to spread its use for evaluation in early rehabilitation in our country.
- Trial name
- NCT04889027
- Testing
- Standardized Infant NeuroDevelopmental Assessment
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Ondokuz Mayıs University
Fetal Infection, Chorioamnionitis
Management of Prelabor Rupture of the Membranes at Term
Prolonged rupture of membranes has been associated with increased risk of chorioamnionitis and endometritis. In this study the investigators will investigate whether an early intervention to augment labor with oxytocin is…
- Conditions
- Fetal Infection, Chorioamnionitis, Endometritis, Cesarean Section Complications
- Trial name
- NCT04307069
- Testing
- Oxytocin
- Where
- Israel
- Volunteers
- 524 people
- Sponsor
- Rambam Health Care Campus
Premature Birth, Premature Infant
Growing Little PEAPODS Study
The goal of this clinical trial is to learn more about how the food and nutrition babies receive while in the Neonatal Intensive Care Unit (NICU) influences their ability to gain weight and fat-free mass, and their future growth…
- Conditions
- Premature Birth, Premature Infant, Premature, Intrauterine Growth Restriction
- Trial name
- NCT06226051
- Testing
- PEAPOD Infant Body Composition measuring device
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of Wisconsin, Madison
Pain
Neonatal Pain- and Distress Experiences and Later Pain Behavior of Former Preterm and Critically Ill Newborn Infants
Preterm and critically ill neonates experience many painful manipulations. The aim of the study is to evaluate the influence of these experiences and maternal deprivation on later pain behavior.
- Trial name
- NCT00926445
- Where
- Germany
- Volunteers
- 120 people
- Sponsor
- University of Cologne
Preterm Labor, Tobacco Use Disorder
Omega-3 Fatty Acids for Smoking Cessation in Pregnancy
Smoking is the most important modifiable risk factor for adverse pregnancy outcomes including preterm birth, neonatal death, and maternal complications.
- Trial name
- INFANTS (NCT04417595)
- Testing
- Fish Oil (Containing Omega-3 Acids), Olive Oil
- Where
- United States
- Volunteers
- 237 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University Medical Center
Cholestasis, Prematurity
Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants
Hypothesis to be Tested: Since the first description of intravenous alimentation over half a century ago, parenteral nutrition (PN) has become a common nutritional intervention for conditions characterized by inability to…
- Conditions
- Cholestasis, Prematurity, Gastroschisis, Intestinal Atresia
- Trial name
- NCT01062815
- Testing
- Parenteral Nutrition
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- University of Miami
Sleep
Earing Protectors Influence on Newborns Preterm Sleep Pattern
Preterm newborn sleep deprivation due to medical interventions and environmental characteristics of the Neonatal Intermediate Care Unit (NICU) can increase morbidity and developmental deleterious effects.
- Trial name
- NCT03373578
- Testing
- earmuffs
- Where
- Brazil
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Federal University of São Paulo
Intrapartum Fever, Chorioamnionitis
Antipyretic Treatment for Intrapartum Fever: Dipyrone vs Acetaminophen (RCT)
Chorioamnionitis, or intraamniotic infection, is a common condition affecting 2-5% of all term births. This condition poses well-recognized maternal and neonatal risks, and entails a series of clinical management decisions…
- Trial name
- PARADIP (NCT06950840)
- Testing
- Acetaminophen, dipyrone
- Where
- Israel
- Volunteers
- 140 people
- Sponsor
- Wolfson Medical Center
Pain, Preterm
The Nonpharmacological Methods in Reducing the Pain Caused by Orogastric Tube Insertion in Preterm Infants
According to the World Health Organization, preterm birth (from 20 to 37 gestation week) is a significant global health problem, as preterm infants represent an estimated 15 million infants per year worldwide.
- Conditions
- Pain, Preterm, Premature
- Trial name
- NCT04006743
- Testing
- The swaddling group, The expressed breast milk group, The facilitated tucking group
- Where
- Turkey (Türkiye)
- Volunteers
- 187 people
- Sponsor
- Akdeniz University
Preterm Delivery, Obstetrical Complications
Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial
This is a phase-III multi-center double-blind randomized clinical trial of 1,800 individuals with a history of prior preterm birth at less than 35 weeks gestation who are randomized to either 162 mg aspirin or 81 mg aspirin…
- Trial name
- ADEPT (NCT06980025)
- Testing
- 162mg Aspirin, 81mg Aspirin
- Where
- 14 sites in United States
- Volunteers
- 1,800 people, healthy volunteers welcome
- Sponsor
- The George Washington University Biostatistics Center
Bronchopulmonary Dysplasia, Death
Systemic Management in Extremely Preterm and Extremely Low Birth Weight Infants
to estimate incidences of major complications, such as bronchopulmonary dysplasia, death, and delivery room resuscitation among extremely preterm and extremely low birth weight infants in Northern China
- Trial name
- NCT06082414
- Testing
- no interventions
- Where
- China
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Peking University
PreTerm Neonate, Respiratory Distress Syndrome (RDS)
Neonatologist-Performed Lung Ultrasound (NPLUS) to Guide Respiratory Therapy
The goal of this cross-over clinical trial is to evaluate whether Neonatologist-Performed Lung Ultrasound (NPLUS) can be used in preterm babies on non-invasive breathing support to reduce the amount of oxygen they need.
- Trial name
- NCT06901206
- Testing
- Neonatologist performed lung ultrasound
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- Royal Hospital For Women