Clinical trials: Very Preterm Infant
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
Respiratory Distress Syndrome in Premature Infant, Non-invasive Ventilation
Open Lung Strategy During Non-Invasive Respiratory Support of Very Preterm Infants in the Delivery Room
The opening and aeration of the lung is critical for a successful transition from fetal to neonatal life. Early nasal CPAP in the delivery room in spontaneously breathing premature babies with a gestational age of 30 weeks or…
- Conditions
- Respiratory Distress Syndrome in Premature Infant, Non-invasive Ventilation, Lung Injury
- Trial name
- OpenCPAP-DR (NCT05031650)
- Testing
- openCPAP, standardCPAP
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 145 people
- Sponsor
- Dokuz Eylul University
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
Infant, Premature, Nutrition, Enteral
Aspiration of Residual Gastric Contents
The primary purpose of this study is to determine nutrition outcomes and risks to gastrointestinal integrity and function of aspirating for routine gastric contents prior to each feeding in very low birth weight premature infants.
- Trial name
- NCT01863043
- Testing
- No aspiration of gastric contents, Routine aspiration of gastric contents
- Where
- United States
- Volunteers
- 146 people
- Sponsor
- University of Florida
Gastric Residual Volume, Preterm Infant
Routine Versus no Assessment of Gastric Residual Volumes in Preterm Infants
The practice of checking gastric residuals is not evidence based. The amount of gastric residual volume (GRV) does not correlate with either feeding intolerance or development of NEC.
- Conditions
- Gastric Residual Volume, Preterm Infant, Feeding Disorder Neonatal
- Trial name
- NCT04062851
- Testing
- No Gastric residual volume monitoring
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- AdventHealth
Preterm Infant, Birth, Preterm
Aeration, Breathing, Clamping Study 3
Delayed cord clamping (DCC) in preterm infants results in a decrease in mortality and a trend towards fewer intraventricular haemorrhages.
- Trial name
- ABC3 (NCT03808051)
- Testing
- Physiological-based cord clamping, Time-based cord clamping
- Where
- 10 sites in Netherlands
- Volunteers
- 689 people
- Sponsor
- Leiden University Medical Center
Very Preterm Maturity of Infant, Enteral Feeding Intolerance
Early Total Enteral Feeding Versus Convention Enteral Feeding in Preterm Infants 27-32 Weeks of Gestation
The objective of the study is to compare the time of attainment of full enteral feeds in preterm neonates between 27-32 weeks of gestation started on early total enteral feeding (ETEF) with those started on conventional enteral…
- Trial name
- ETEFVsCEF (NCT06076460)
- Testing
- Early Total Enteral Feeding, Conventional Enteral Feeding
- Where
- India
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- Lady Hardinge Medical College
Sleep
Body Movements Analysis During Sleep in Very Premature Infants
Sleep is a key factor for normal brain development of the newborn. However, it is poorly studied and little is known about its characterization, especially in premature infants.
- Trial name
- DODOPREMA (NCT03432182)
- Testing
- electroencephalography
- Where
- France
- Volunteers
- 68 people
- Sponsor
- Central Hospital, Nancy, France
Infant, Premature, Ductus Arteriosus, Patent
Urine NT-proBNP Levels and Echocardiographic Findings in Very Low Birth Weight (VLBW) Infants
The aim of the study is to evaluate urine NT-proBNP levels and new Echocardiographic Findings in VLBW infants. The investigators hypothesize that high urine NT-proBNP concentrations are associated with a hemodynamically…
- Conditions
- Infant, Premature, Ductus Arteriosus, Patent, Ventricular Function, Left
- Trial name
- NCT00799123
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Charite University, Berlin, Germany
Bronchopulmonary Dysplasia, Encephalomalacia
Randomized Trial of Hydrocortisone in Very Preterm High-Risk Infants
The purpose of this study is to determine whether treatment of very preterm infants at high-risk for lung and brain injury with low dose hydrocortisone results in improved pulmonary and neurologic outcomes.
- Conditions
- Bronchopulmonary Dysplasia, Encephalomalacia, Premature Birth
- Trial name
- NCT00167544
- Testing
- Hydrocortisone
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Nationwide Children's Hospital
Retinopathy of Prematurity
Pain Response During Examination for Retinopathy of Prematurity
Newborns infants equal or less than 1500 grams and/or equal and less than 32 weeks will have ophthalmologic examination for ROP at 6 weeks old.
- Trial name
- ROP (NCT00648687)
- Testing
- suck 12.5% dextrose in water 5 minutes before the procedure
- Where
- Brazil
- Volunteers
- 100 people
- Sponsor
- National Bioethics Commission of Brazil
Central Line Bloodstream Infections
The Effectiveness of Silver Alginate (Algidex) Patch in the Prevention of Central Line Infections in Very Low Birth Weight Infants
The purpose of this study is to determine whether silver alginate (Algidex) patch is effective in the prevention of central line infections in very low birth weight infants.
- Trial name
- NCT00964093
- Testing
- Silver Alginate
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Baylor Research Institute
Prematurity; Extreme, Feeding Difficulties
Cot-side Suckometry and Oral Stimulation in Very Preterm Infants: A Pilot Study
Very preterm infants - born before 32 weeks' gestational age - commonly experience delayed transition to oral feeding due to immature suck-swallow-breathe coordination.
- Trial name
- STIMPREM (NCT07632066)
- Testing
- Bedside Suckometer, Structured Oral Stimulation Protocol
- Where
- France
- Volunteers
- 17 people
- Sponsor
- Hôpital de la Croix-Rousse
Nasal Continuous Positive Airway Pressure,, Preterm Infants,
Early NCPAP Before Surfactant Treatment in Very Preterm Infants With RDS
We hypothesis a period of early NCPAP before surfactant treatment is effective for treating RDS and preventing BPD in very premature infants.
- Conditions
- Nasal Continuous Positive Airway Pressure,, Preterm Infants,, Surfactant Treatment,, Respiratory Distress Syndrome,
- Trial name
- NCT01996670
- Volunteers
- 683 people
- Sponsor
- Xiangya Hospital of Central South University
Infant, Newborn, Diseases, Infant, Extremely Low Birth Weight
Transfusion of Prematures Trial
The objective of the TOP trial is to determine whether higher hemoglobin thresholds for transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in the primary outcome of survival and rates of…
- Conditions
- Infant, Newborn, Diseases, Infant, Extremely Low Birth Weight, Infant, Small for Gestational Age, Bronchopulmonary Dysplasia (BPD)
- Trial name
- TOP (NCT01702805)
- Testing
- Liberal Cell Transfusion, Restricted red cell transfusion
- Where
- 20 sites in United States
- Volunteers
- 1,824 people
- Sponsor
- NICHD Neonatal Research Network
Intracranial Hemorrhage, Periventricular Leukomalacia
Does Erythropoietin Improve Outcome in Very Preterm Infants?
The main goal of this trial is to investigate whether early administration of human erythropoietin (EPO) in very preterm infants improves neurodevelopmental outcome at 24 months corrected age.
- Conditions
- Intracranial Hemorrhage, Periventricular Leukomalacia, Cerebral Palsy, Developmental Psychomotor Disorders
- Trial name
- NCT00413946
- Testing
- Recombinant human Erythropoietin, saline
- Where
- 5 sites in Switzerland
- Volunteers
- 420 people
- Sponsor
- Swiss Neonatal Network
Adrenal Insufficiency
Relative Adrenal Insufficiency in Preterm Very Low Birth Weight Infants With Shock
The objective of this study is to estimate the prevalence of relative adrenal insufficiency in preterm very low birth weight infants with and without shock.
- Trial name
- NCT00974337
- Where
- India
- Volunteers
- 39 people
- Sponsor
- All India Institute of Medical Sciences
Preterm Infant
Clinical Impact of Non-invasive Neurally Adjusted Ventilatory Assist in Very Preterm Infants
This is a prospective observational study investigating the impact of NIV-NAVA on short-term clinical outcomes and long-term neurodevelopment in very preterm infants.
- Trial name
- NCT06786039
- Testing
- Non-invasive NAVA
- Where
- 2 sites in South Korea
- Volunteers
- 80 people
- Sponsor
- Korea University Anam Hospital
Enteral Nutrition, Born Very Premature
Prolonged Minimal Enteral Nutrition Versus Slowly Advancing Enteral Nutrition in Very Low Birth Weight Infants:
Recent studies showed the benefits of early initiation and advancement enteral feeds with daily increments in preterm infants on decreasing invasive infections and early achievement of full enteral feedings.
- Conditions
- Enteral Nutrition, Born Very Premature, Infant, Very Low Birth Weight
- Trial name
- NCT02913677
- Testing
- nutrition
- Where
- Turkey (Türkiye)
- Volunteers
- 199 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Early Administration of Pulmonary Surfactant Guided by Lung Ultrasound Scores in Very Preterm Infants
Prospective, Non-Blinded, Randomized Controlled Trial on Early Administration of Pulmonary Surfactant Guided by Lung Ultrasound Scores in Very Preterm Infants.
Abstract Background: Bedside lung ultrasonography has been widely used in neonatal intensive care units (NICUs). Lung ultrasound scores (LUS) may predict the need for pulmonary surfactant (PS) application.
- Trial name
- NCT06491901
- Testing
- PS was given according to lung ultrasound score, PS was given according to clinical criteria
- Volunteers
- 60 people
- Sponsor
- Peking University Third Hospital