Clinical trials: VLBW - Very Low Birth Weight Infant
Cholestasis
Cholestasis in Extreme Low Birth Weight Infants (ELBW)
Parenteral nutrition associated liver disease (PNALD) in preterm neonates is characterized by early occurrence of intrahepatic cholestasis (parenteral nutrition associated cholestasis (PNAC).
- Trial name
- NCT01164878
- Volunteers
- 122 people
- Sponsor
- Medical University of Vienna
Infant, Newborn, Infant, Low Birth Weight
Inflammatory Cytokines Associated With Perinatal Brain Injury
This observational study assessed whether measurements of certain pro-inflammatory and anti-inflammatory cytokines in the blood (either singly or in combination) at birth and/or up to day of life 21 can predict cerebral palsy at…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Cytokines (NCT01035697)
- Where
- 18 sites in United States
- Volunteers
- 1,067 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Very Low Birth Weight Infant
Olfactory Stimulation for Very Low Birth Weight Infants
This is a RCT study examining whether odor administration to mothers of very low birth weight infants promotes stabilization of vital signs compared with common nursing care.
- Trial name
- NCT05406804
- Testing
- Olfactory stimulation, Routine nursing care
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Children's Hospital of Fudan University
Very Low Birth Weight Infant
Individualized Fortification of Human Milk for Infants Born ≤ 1250 g (MaxiMoM-InForM)
Very low birth weight infants have increased nutritional needs. Extra nutrients are added to their human milk feeds to help improve their nutritional status, growth and neurodevelopment.
- Trial name
- NCT05308134
- Testing
- Standard fortification, Target fortification, BUN adjustable fortification
- Where
- 20 sites in Canada
- Volunteers
- 615 people
- Sponsor
- The Hospital for Sick Children
Late-Onset Neonatal Sepsis
Clinical Impact of Donor Milk Pasteurized by HTST Treatment in Preterm Infants
Randomized double-blind clinical trial to compare the incidence of microbiological proven late onset sepsis in extremely preterm infants (<1000 grams) that are supplemented with donor milk pasteurized by High Temperature Short…
- Trial name
- NCT04424667
- Testing
- donor milk
- Where
- 2 sites in Spain
- Volunteers
- 211 people
- Sponsor
- Carmen Rosa Pallas
Low Birth Weight Infant
Nutrition, Growth and Development Among Very Preterm Infants
The main purpose of this study is to evaluate the effect of increased supply of energy, protein, vitamin A and the long chain polyunsaturated fatty acids docosahexaenoic acid and arachidonic acid on growth, brain maturation and…
- Trial name
- PRENU (NCT01103219)
- Testing
- Nutrition
- Where
- 3 sites in Norway
- Volunteers
- 50 people
- Sponsor
- University of Oslo
Very Low Birth Weight Infant, Very Preterm Maturity of Infant
USCOM Parameters in Preterm Infants: Reference Ranges
The goal of this observational study is to learn about the feasibility of hemodynamic measurement by the UltraSonic Cardiac Output Monitor (USCOM) in very preterm or very-low-birth-weight infants.
- Trial name
- NCT05961657
- Testing
- Hemodynamic measurements by USCOM
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- Fondazione IRCCS San Gerardo dei Tintori
Infant, Newborn, Infant, Small for Gestational Age
Vitamin E for Extremely Preterm Infants
The purpose of this pilot trial is to test the safety and efficacy of administering one dose of vitamin E, via a tube into the stomach, to extremely preterm infants (less than 27 weeks gestation and less than 1000 grams birth…
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Infant, Premature
- Trial name
- NCT01193270
- Testing
- Vitamin E
- Where
- 16 sites in United States
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Respiratory Distress Syndrome
Effects of Volume Guarantee With Pressure Supported vs. Synchronized Intermittent Mandatory Ventilation in VLBW Infants
Studies in preterm infants have shown that adding volume guarantee (VG) to synchronized modes of ventilation is not only feasible but also advantageous for providing more constant and desirable mechanical breath size.
- Trial name
- NCT00295230
- Testing
- PSV+VG mode versus SIMV+VG mode
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Children's Hospitals and Clinics of Minnesota
Infant, Newborn, Infant, Low Birth Weight
Early-Onset Sepsis Surveillance Study
In this observational study, the NICHD Neonatal Research Network (NRN) is conducting surveillance of all infants born at NRN centers to identify all newborns who are diagnosed with early-onset sepsis (EOS) and/or meningitis.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- EOS (NCT00874367)
- Where
- 19 sites in United States
- Volunteers
- 615 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Infant, Newborn, Infant, Low Birth Weight
Cerebral Function Monitoring in Premature Infants
This observational study tests the feasibility of enrolling subjects and obtaining an amplitude-integrated electroencephalogram (aEEG) within the first 72 hours of life, a second aEEG recording between 72-168 hours of life, and…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NCT00873847
- Where
- 8 sites in United States
- Volunteers
- 102 people
- Sponsor
- NICHD Neonatal Research Network
Neonatal Staphylococcal Sepsis
Safety and Pharmacokinetics Study in VLBW Neonates With BSYX-A110
"Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose Escalating, Safety and Pharmacokinetics Study in Very Low Birth Weight Neonates of Four Doses of BSYX-A110 for the Prevention of S.
- Trial name
- N002 (NCT00631878)
- Testing
- Pagibaximab (formerly BSYX-A110)
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Biosynexus Incorporated
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
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
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
RDS - Infants, RDS of Prematurity
Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT
Electric Impedance Tomography (EIT) is a lung monitoring technique based on the injection of small currents and voltage measurements using electrodes on the skin surface generating cross-sectional images representing impedance…
- Conditions
- RDS - Infants, RDS of Prematurity, Respiratory Failure, Prematurity
- Trial name
- NCT04542096
- Testing
- Lung electrical impedance tomography monitoring
- Where
- Lithuania
- Volunteers
- 72 people
- Sponsor
- Vilnius University
Neonatal Sepsis, Early-Onset, Very Low Birth Weight Infant
IgM-Enriched Immunoglobulin for Neonatal Sepsis
This study compares giving prophylactic IgM enriched Intravenous Immunoglobulin (IVIG) with placebo in 1 hour after birth, in neonates with risk factors of Early-Onset Neonatal Sepsis (EONS).
- Conditions
- Neonatal Sepsis, Early-Onset, Very Low Birth Weight Infant, Inflammation, Infant, Newborn, Disease
- Trial name
- NCT04041765
- Testing
- IgM-enriched IVIG
- Volunteers
- 70 people
- Sponsor
- Fakultas Kedokteran Universitas Indonesia
Low Birth Weight Infant, Enteral Nutrition
Oral Versus Intravenous Rehydration for Prevention of Dehydration in Premature Babies, During the First Days of Life.
This prospective randomised study comparing administration of a hypo-osmolar oral hydration solution with the classical hydration via IV (intravenous) infusion in premature infants of more than 32 weeks GA (gestational age) aims…
- Trial name
- SROPREMA (NCT00715000)
- Testing
- Oral rehydration therapy, classical hydration via intravenous infusion
- Where
- France
- Volunteers
- 49 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Very Low Birth Weight Infant, Premature Infants
Pilot Trial Investigating Every Other Day Dosing of Oral Iron in Premature Infants (IQONic)
Study focuses on determining if daily versus every-other-day (EOD) oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks post-menstrual age in premature neonates
- Conditions
- Very Low Birth Weight Infant, Premature Infants, Anemia of Prematurity, Iron Deficiency, Anaemia in Children
- Trial name
- NCT06555315
- Testing
- 6 mg/kg of oral iron as ferrous sulfate administered every other day., 6 mg/kg of oral iron as ferrous sulfate administered every day.
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- CHRISTUS Health
Very Low Birth Weight Infant
The Effect of Family Integrated Care on Melatonin Level in Very Low Birth Weight Infants
This study will explore the effect of Family integrated care (FICare) on the level of melatonin and other clinical outcomes in very low birth weight infants (VLBWIs) by integrating families into the neonatal intensive care unit…
- Trial name
- NCT05483231
- Testing
- Family integrated care intervention group, Routine nursing care group
- Where
- China
- Volunteers
- 64 people
- Sponsor
- Children's Hospital of Fudan University