Clinical trials: VLBW - Very Low Birth Weight Infant
Infant, Newborn, Infant, Low Birth Weight
Physiologic Definition of Bronchopulmonary Dysplasia
This observational study was conducted to design and test a physiologic definition for bronchopulmonary dysplasia at 36 weeks of life.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- PhysiologicDef (NCT01223287)
- Where
- 21 sites in United States
- Volunteers
- 410 people
- Sponsor
- NICHD Neonatal Research Network
Extreme Prematurity, Extremely Low Birth Weight
RCT: The Effect of Held Position During Kangaroo Care on Physiological Parameters of Premature Infants
The goal of this superiority crossover randomised controlled trial is to investigate whether there is an optimal position at which to perform kangaroo mother care (KMC) in extremely preterm infants in the NICU.
- Conditions
- Extreme Prematurity, Extremely Low Birth Weight, Very Low Birth Weight Infant, Premature Birth
- Trial name
- NCT05686252
- Testing
- Held Position
- Where
- Ireland
- Volunteers
- 20 people
- Sponsor
- University College Cork
Psychomotor Impairment
Correlation Between Cerebral Oxygenation and Neurodevelopment in VLBW Preterm Infants.
The recent improvements in neonatal intensive care have led to a substantial increase in the survival rate of preterm infants; nevertheless, this population is still at high risk for long-term neurodevelopmental disabilities.
- Trial name
- NCT03104296
- Testing
- Griffiths Mental Development Scales
- Where
- Italy
- Volunteers
- 63 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Safety Issues, Tolerance
Safety and Tolerability of Lactoferrin/FOS in Very Low Birth Weight Infants
This study will examine the safety and tolerability of supplementation with bovine lactoferrin with fructo-oligosaccharide a simple sugar in very low birth weight infants.
- Conditions
- Safety Issues, Tolerance, Very Low Birth Weight Infant
- Trial name
- NCT03163212
- Testing
- Lactoferrin/FOS
- Volunteers
- 20 people
- Sponsor
- University of Virginia
Very Low Birth Weight Infant, Weight Gain
Effect of Milk Warming on the Very Low Birth Weight Infant
This study will compare if using a continuous milk warmer to warm breast milk compared to the standard method of warming breast milk in a hot water bath improves weight gain and feeding tolerance in infants born at 32 weeks…
- Conditions
- Very Low Birth Weight Infant, Weight Gain, Feeding Disorder Neonatal
- Trial name
- VLBW (NCT04282655)
- Testing
- Treatment Guardian Milk Warmer (Medela TM), Control
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- University of Oklahoma
Infant, Newborn, Infant, Low Birth Weight
Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2)
This pilot study is a randomized, placebo-controlled, clinical trial to measure changes in blood and urine levels of inositol in premature infants at high risk for retinopathy of prematurity (ROP) following repeated doses of…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- INS-2 (NCT01030575)
- Testing
- Inositol lower volume, Inositol mid-level volume, Inositol high volume
- Where
- 17 sites in United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Infant, Newborn, Infant, Low Birth Weight
Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure
This multicenter trial tested whether inhaled nitric oxide would reduce death or the need for oxygen in preterm infants (less than 34 weeks gestational age) with severe lung disease.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Preemie iNO (NCT00016523)
- Testing
- Inhaled nitric oxide
- Where
- 17 sites in United States
- Volunteers
- 420 people
- Sponsor
- NICHD Neonatal Research Network
Chronic Lung Disease
Genetic Variants and Susceptibility to Diseases of Prematurity in Very Low Birth-Weight Infants
The purpose of this study is to determine if sequence variations in genes involved in the development and function of vulnerable organs increases susceptibility to chronic lung disease (CLD) and other diseases affecting premature…
- Trial name
- CLD (NCT00710112)
- Testing
- gene variations
- Where
- United States
- Volunteers
- 1,100 people
- Sponsor
- Medical College of Wisconsin
Infant, Newborn, Infant, Low Birth Weight
Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis
This study will compare the effectiveness of two surgical procedures -laparotomy versus drainage - commonly used to treat necrotizing enterocolitis (NEC) or isolated intestinal perforations (IP) in extremely low birth weight…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NEST (NCT01029353)
- Testing
- Laparotomy, Drainage
- Where
- 22 sites in United States
- Volunteers
- 529 people
- Sponsor
- NICHD Neonatal Research Network
Feeding; Difficult, Newborn, Necrotizing Enterocolitis
A Multi-strain Synbiotic Versus a Multi-strain Probiotic in Premature Infants
The aims are to 1) compare two probiotic treatments (multi-strain synbiotic vs. multi-strain probiotic) on bifidobacteria fecal colonization counts at 1, 2, 3, and 4 weeks of life, 34 weeks corrected gestation age (CGA) ; 2)…
- Trial name
- NCT01337921
- Testing
- Multi-strain Probiotic
- Sponsor
- University of Nebraska
Low Birth Weight Infant
Platelet-activating Factor Acetylhydrolase (Paf-ah) Gene Expression
This is a prospective observational study to determine whether there is an association between the presence of platelet-activating factor acetylhydrolase (PAF-AH) gene polymorphisms and the development of chronic lung disease in…
- Trial name
- NCT00747240
- Where
- 2 sites in United States
- Volunteers
- 139 people
- Sponsor
- University of Utah
Extra Uterine Growth Restriction, Premature Infant Disease
Does Starting Feeds on the First Day of Life Help Premature Infants Reach Full Volume Feeds Sooner?
Feeding advancements in ELBW infants have evolved over decades. The fear of causing mortality and morbidity, notably NEC, have made providers cautious when advancing feeds.
- Conditions
- Extra Uterine Growth Restriction, Premature Infant Disease, VLBW - Very Low Birth Weight Infant
- Trial name
- NCT06731439
- Testing
- Starting feeds within 6 hours of life, Standard feeding protocol
- Where
- United States
- Volunteers
- 248 people
- Sponsor
- University of Tennessee
Other Preterm Infants, NEC
Probiotic Supplementation to Improve the GUT Microbiota of Very Low Birth Weight Preterm, a Pilot Study
This pilot trial is designed to investigate the benefits of the use of probiotics in GUT microbiota development and/or immunological biomarkers and how this can be related with the clinical status of very low birth weight…
- Trial name
- NCT02192996
- Testing
- Probiotic
- Where
- Spain
- Volunteers
- 5 people
- Sponsor
- Hospital Universitario La Paz
Very Low Birth Weight Infant
Clinical Outcomes of Ready-to-Use Parenteral Nutrition in Low Birth Weight Newborns in Colombia 2017-2023
The proposed study aims to assess the clinical outcomes of using ready-to-use parenteral nutrition, specifically Numeta G13E, compared to individualized parenteral nutrition in neonates with very low birth weight.
- Trial name
- NUMETA (NCT06200324)
- Testing
- Ready-to-Use Parenteral Nutrition
- Where
- Colombia
- Volunteers
- 284 people
- Sponsor
- Fundacion Clinica Valle del Lili
Infant, Newborn, Infant, Low Birth Weight
Observational Study of Surgical Treatment of Necrotizing Enterocolotis
The purposes of this study were: 1) to compare mortality and postoperative morbidities in extremely low birth weight (ELBW) infants who underwent initial laparotomy or drainage for necrotizing enterocolitis (NEC) or isolated…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NEC Surgery (NCT01223261)
- Where
- 17 sites in United States
- Volunteers
- 156 people
- Sponsor
- NICHD Neonatal Research Network
Bronchopulmonary Dysplasia, Very Low Birth Weight Infant
Work of Breathing in Premature Infants at Discharge
The purpose of this study is to compare how premature infants who required oxygen for at least 28 days during their time in the NICU (Neonatal Intensive Care Unit) breathe at discharge compared to premature infants who did not…
- Conditions
- Bronchopulmonary Dysplasia, Very Low Birth Weight Infant, Prematurity
- Trial name
- NCT03682575
- Testing
- Enrollment
- Where
- United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Christiana Care Health Services
Extubation Failure
Bubble Continuous Positive Airway Pressure (CPAP) With Conventional CPAP for Extubation in Preterm Infants
The objective of this study is to evaluate whether CPAP delivered by bubble CPAP resulted in a greater proportion of infants being successfully extubated when compared with management with ventilator derived CPAP.
- Trial name
- NCT00979433
- Testing
- Bubble CPAP, Conventional CPAP
- Where
- India
- Volunteers
- 32 people
- Sponsor
- All India Institute of Medical Sciences
Low-Birth-Weight Infant
Implementation Research of Kangaroo Mother Care in Rural Pakistan.
Pakistan has a high neonatal mortality rate (55/1000 live birth)(1) and each year more than 200,000 newborns die. In rural Pakistan, more than 50% deliveries occur at home and majority by unskilled birth attendants(2).
- Trial name
- KMC (NCT03545204)
- Testing
- Kangaroo Mother Care Package, Routine Standard Care
- Where
- 2 sites in Pakistan
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Aga Khan University
Extreme Prematurity,Extremely Low Birthweight, Extremely Low Birth Weight
Comparison of the Shukla and UN-1 Formulae in the Placement of the Umbilical Venous Catheter Among Neonates
Umbilical vein catheters (UVC) are commonly inserted in newborns especially neonates admitted to the Neonatal Intensive Care Unit (NICU).These catheters are used since 1959.
- Conditions
- Extreme Prematurity,Extremely Low Birthweight, Extremely Low Birth Weight, Very Low Birth Weight Infant, Neonatal Hypoglycemia
- Trial name
- NCT05022433
- Testing
- UVC insertion
- Where
- Singapore
- Volunteers
- 170 people
- Sponsor
- Singapore General Hospital
Very Low Birth Weight Infant, Respiratory Distress Syndrome in Premature Infant
Enteral Nutrition Tolerance And REspiratory Support (ENTARES)
This research study aims to evaluate the relation between non-invasive ventilation and feeding tolerance in preterms with respiratory distress syndrome (RDS).
- Conditions
- Very Low Birth Weight Infant, Respiratory Distress Syndrome in Premature Infant, Enteral Feeding Intolerance
- Trial name
- ENTARES (NCT03548324)
- Testing
- HHHFNC, NCPAP
- Where
- 13 sites in Italy
- Volunteers
- 280 people
- Sponsor
- University of Turin, Italy