Clinical trials: Very Low Birthweight Infants
Necrotizing Enterocolitis, Death
The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing Enterocolitis
The purpose of this study is to investigate the efficacy and its mechanisms of oral mixture probiotics in preventing necrotizing enterocolitis among the preterm very low birth weight infants.
- Trial name
- NCT02552706
- Testing
- probiotics, glucose solution
- Where
- 4 sites in China
- Volunteers
- 270 people
- Sponsor
- Shenzhen Bao'an Maternal and Child Health Hospital
Morbidity;Infant
Survival and nEonatal outComes of veRy Low Birth wEight Infants in Türkiye: Turkish Neonatal Society SECRETS-TR Study
The aim of this multi-center study was to evaluate the mortality rate and early neonatal outcomes of very low birth weight (VLBW) infants hospitalized in neonatal intensive care units (NICUs) in Türkiye.
- Trial name
- TNS-SECRETS (NCT06543524)
- Testing
- Care of premature infants
- Where
- Turkey (Türkiye)
- Volunteers
- 3,150 people
- Sponsor
- Başakşehir Çam & Sakura City Hospital
Small for Gestational Age, Infant, Very Low Birth Weight
Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial.
Low-dose aspirin started in the first-trimester has been associated with a decrease of preeclampsia, fetal growth restriction and preterm birth in high-risk pregnancies.
- Conditions
- Small for Gestational Age, Infant, Very Low Birth Weight, Fetal Growth Retardation, Preeclampsia
- Trial name
- GAP (NCT02280031)
- Testing
- Acetylsalicylic Acid
- Where
- 2 sites in Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- CHU de Quebec-Universite Laval
Growth Retardation
The Effects of Time Points to Cease Parenteral Nutrition and IGF-1 on Very Low Birth Weight Infants
This study aims to estimate short-term and long-term effects of time points to cease parenteral nutrition on very preterm infants, such as growth; to estimate the role of insulin-like growth factor 1 in the growth.
- Trial name
- NCT06071403
- Testing
- (enteral feeding volume/ total fluid volume)*100%
- Where
- China
- Volunteers
- 416 people, healthy volunteers welcome
- Sponsor
- Peking University
Infant Respiratory Distress Syndrome, Respiratory Insufficiency
Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study
The purpose of this study is to test whether application of high frequency ventilation through a nasal tube can lower blood carbon dioxide levels in stable preterm infants.
- Conditions
- Infant Respiratory Distress Syndrome, Respiratory Insufficiency, Apnea of Prematurity
- Trial name
- NCT00296231
- Testing
- Nasal high frequency ventilation
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Tarah T Colaizy
Preterm Infant, Early-Onset Neonatal Sepsis
Utility of Placental/Umbilical Cord Blood in Early Onset Neonatal Sepsis in Very Low Birth Weight Infants
This study evaluates the utility of placental/umbilical cord blood (PUCB) to perform the baseline workup testing for EONS in Very Low Birth Weight Infants: CBC (Complete Blood Count) with differential, Immature/Total ratio (I/T…
- Conditions
- Preterm Infant, Early-Onset Neonatal Sepsis, Umbilical Cord
- Trial name
- NCT03694613
- Testing
- Placental/Umbilical Cord Blood sample
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- The University of Texas Medical Branch, Galveston
Fungal Infections Systemic
Oral Nystatin Prophylaxis to Prevent Systemic Fungal Infection in Very Low Birth Weight Preterm Infants
This study determines the effectiveness of oral nystatin as prophylaxis in order to prevent systemic fungal infection in very low birth weight preterm neonates.
- Trial name
- NCT03390374
- Testing
- Nystatin Oral
- Volunteers
- 95 people
- Sponsor
- Dr Cipto Mangunkusumo General Hospital
Infant, Newborn, Infant, Small for Gestational Age
Hydrocortisone for BPD
The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life.
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Infant, Premature
- Trial name
- NCT01353313
- Testing
- Hydrocortisone
- Where
- 20 sites in United States
- Volunteers
- 800 people
- Sponsor
- NICHD Neonatal Research Network
Very Low Birth Weight Infant, Very Preterm Maturity of Infant
CGM Use in Preterm Infants
Preterm infants (gestational age (GA) at birth < 31 weeks) admitted to the University of Minnesota Masonic Children's Hospital NICU will have a Dexcom G6 sensor Continuous Glucose Monitor (CGM) placed shortly after consent and…
- Conditions
- Very Low Birth Weight Infant, Very Preterm Maturity of Infant, Hyperglycemia
- Trial name
- NCT05436925
- Testing
- Dexcom G6 sensor Continuous Glucose Monitor (CGM)
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Minnesota
NIDCAP
Application of the Best Evidence of Neonatal Individualized Developmental Care Assessment Program (NIDCAP) in Very Low Birth Weight Infant (VLBWI)
In order to help THE GROWTH and development of VLBWI in Neonatal Intensive Care Unit (NICU) and reduce the interference of external environment to them, we summarized the best evidence of NIDCAP care, and applied the evidence to…
- Trial name
- NCT05166720
- Testing
- NIDCAP care
- Where
- China
- Volunteers
- 14 people
- Sponsor
- Children's Hospital of Fudan University
Infant, Very Low Birth Weight
Oropharyngeal Administration of Colostrum to Very Low Birth Weight Infants
The purpose of this study is to explore the effects of Oropharyngeal administration of colostrum to very low birth weight infants on sIgA and lactoferrin, in order to explore the protect immune function of colostrum to very low…
- Trial name
- NCT02389478
- Testing
- Oropharyngeal administration of colostrums, Oropharyngeal administration of Normal saline
- Volunteers
- 64 people
- Sponsor
- Children's Hospital of Fudan University
Premature Birth
Continuity of Leg Movements in VLBW Premature Infants: From Spontaneous Kicking and Supported Stepping to Independent Walking
The purposes of this one-year follow-up study are twofold: (1) to prospectively examine the spontaneous kicking and the supported stepping movement in VLBW premature infants until attainment of independent walking; and (2) to…
- Trial name
- NCT00354783
- Volunteers
- 15 people
- Sponsor
- National Taiwan University Hospital
Very Preterm Maturity of Infant, The Risk Factors for Improving the Prognosis of VLBW Infants
Analyses of Anemia in Very Low Birth Weight (VLBW) Infants.
To study and analyze the association of the severity of anemia with neonatal morbidity and the risk factors of anemia in ealry life (less than 3 days of life) among the very low birth weight (VLBW) infants.
- Trial name
- NCT05949788
- Testing
- No intervention
- Where
- China
- Volunteers
- 146 people
- Sponsor
- Shenzhen Bao'an Maternal and Child Health Hospital
Plagiocephaly
Premie Pouch to Manage Deformational Plagiocephaly in Very Low Birth Weight Infants
This pilot project proposes to develop and test a new device to manage (defined as resolving, prohibiting, inhibiting or preventing) the development of Deformational Plagiocephaly (DP) in prematurely born infants weighing < 1…
- Trial name
- NCT03184441
- Testing
- Premie Pouch
- Where
- 3 sites in United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
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
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
Necrotising Enterocolitis
The Efficacy of Symbiotic on Cytokines
The aim of this prospective double blinded randomised study is to investigate the efficacy of symbiotic preparation which contains lactobacillus casei, L. rhamnosus, L.
- Trial name
- NCT01899677
- Testing
- distilled water, symbiotic
- Where
- Turkey (Türkiye)
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training 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
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
Infant, Premature
Brain Volumes of Very Low Birth Weight Infants Measured by Cranial Ultrasonography
Neonatal cranial ultrasound (US) remains the method of choice to detect brain injury in high risk preterm infants on neonatal intensive care units (NICU).
- Trial name
- NCT02848755
- Testing
- Cranial ultrasonography
- Where
- Turkey (Türkiye)
- Volunteers
- 341 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital