Clinical trials: Low-Birth-Weight Infant
Preterm Infant, Very Low Birth Weight Infant
Lactoferrin Infant Feeding Trial - LIFT_Canada
This is a multicentre, phase III, 2-arm, masked randomized controlled trial. The primary hypothesis is that oral bovine lactoferrin (bLF), through its antimicrobial, antioxidant and anti-inflammatory properties, will reduce the…
- Conditions
- Preterm Infant, Very Low Birth Weight Infant, Morbidity;Newborn
- Trial name
- NCT03367013
- Testing
- Bovine Lactoferrin, No Bovine Lactoferrin added
- Where
- 9 sites in Canada
- Volunteers
- 453 people
- Sponsor
- Dr. Elizabeth Asztalos
Body Composition
Growth and Body Composition in Preterm Infants
Growth is traditionally used as a prognostic measure after admission to a neonatal intensive care unit (NICU). Quality of neonatal intensive care is one of the factors determining the health and quality of life for those that…
- Trial name
- Crescer (NCT00875251)
- Testing
- body composition
- Where
- 2 sites in Brazil
- Volunteers
- 60 people
- Sponsor
- Oswaldo Cruz Foundation
Infant, Low Birth Weight, Anemia
Erythropoietin Treatment in Extremely Low Birth Weight Infants
Objective: To investigate whether recombinant EPO reduces the need for transfusion in extremely low birth weight (ELBW) infants and to determine the optimal time for treatment.
- Trial name
- EPO (NCT00593801)
- Testing
- epoetin beta
- Where
- Germany
- Volunteers
- 219 people
- Sponsor
- Charite University, Berlin, Germany
Respiratory Distress Syndrome in Premature Infants, Very Low Birth Weight Baby
Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation
This study hopes to determine whether nitric oxide along with oxygen during the first 20 minutes of life in infants needing help with breathing will reduce the percentage and total exposure to oxygen during that time frame.
- Trial name
- iNO (NCT01220687)
- Testing
- iNO, Nitrogen
- Where
- 2 sites in United States
- Volunteers
- 33 people
- Sponsor
- University of Oklahoma
Infant Development, Sensory Disorder
The Prechtl's General Movement Assessment, Hammersmith Infant Neurological Examination and Sensory Profile-2
In the Neonatal Intensive Care Unit (NICU), infants encounter many sensory stimuli (excessive noise, bright lights, painful medical applications, etc.) that are not present in the uterus.
- Conditions
- Infant Development, Sensory Disorder, Sensory Processing Disorder, Motor Delay
- Trial name
- highrisk (NCT05217199)
- Testing
- Measurements
- Where
- Turkey (Türkiye)
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Kahramanmaras Sutcu Imam University
ELBW - Extremely Low Birth Weight Infant, IVH- Intraventricular Hemorrhage
The Impact of Continuous Transcutaneous CO2 (TCCO2) Monitoring in Extremely Low Birth Weight (ELBW) Infants
An observational study comparing outcomes of Extremely Low Birth Weight (ELBW) infants that were monitored with non-invasive Transcutaneous CO2 (TCCO2) monitor to infants that were not monitored by TCCO2 monitor.
- Trial name
- NCT03477708
- Where
- Israel
- Volunteers
- 166 people
- Sponsor
- Rambam Health Care Campus
Parenteral Nutrition-Associated Liver Disease
Low Dose Parenteral Fat for Prevention of Parenteral Nutrition Associated Cholestasis in Preterm Neonates
The goal of the study is to determine if parenteral nutrition-associated cholestasis (PNAC) is related to the amount of parenteral (intravenous) fat administered to premature babies until full enteral nutrition is achieved.
- Trial name
- NCT01050660
- Testing
- Intravenous fat emulsion, Restriction of intravenous fat emulsion to 1 gm/kg/d
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Yale University
Infant, Newborn, Infant, Low Birth Weight
Dexamethasone Therapy in VLBW Infants at Risk of CLD
Infants who are on breathing support are often treated with steroids (dexamethasone); however, the best timing of therapy is not known.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Dexamethasone (NCT00011362)
- Testing
- Dexamethasone Early, Dexamethasone Late
- Where
- 13 sites in United States
- Volunteers
- 371 people
- Sponsor
- NICHD Neonatal Research Network
Extremely Low Birth Weight Infants
Post-Extubation Assessment of Clinical Stability in ELBW Infants
This is an observational, proof-of-concept, feasibility study that aims to evaluate the feasibility of a monitoring system that integrates clinical data, high-resolution waveforms from the bedside monitor, regional oxygenation…
- Trial name
- PEACE (NCT06037083)
- Testing
- Oxygen saturation probe, Near infrared spectroscopy sensors, Electrical impedance tomography
- Where
- 2 sites in Canada
- Volunteers
- 20 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Prematurity, Low Birth Weight
Paternal Involvement in Nursing Guidance and Breastfeeding Self-Efficacy in Mothers of High-Risk Newborns
This study aims to evaluate whether a structured nursing guidance program that increases fathers' participation in the care of hospitalized high-risk newborns improves maternal outcomes compared with routine nursing care.
- Conditions
- Prematurity, Low Birth Weight, Respiratory Distress Syndrome, Newborn, Neonatal Hyperbilirubinemia
- Trial name
- NCT07834008
- Testing
- step-by-step parent education, active father participation in breastfeeding support
- Where
- Taiwan
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Taipei Medical University Shuang Ho Hospital
Malaria, Sexually Transmitted Diseases
Gestational Sulfadoxine-pyrimethamine and Azithromycin Treatment to Prevent Preterm Birth
The purpose of this study is to examine whether treatment of pregnant Malawian women with repeated doses of sulfadoxine-pyrimethamine and azithromycin antibiotics will prevent preterm deliveries and result in other health…
- Conditions
- Malaria, Sexually Transmitted Diseases, Preterm Birth, Pregnancy
- Trial name
- NCT00131235
- Testing
- Sulfadoxine-pyrimethamine treatment twice during pregnancy, Sulfadoxine-pyrimethamine at 4-week intervals, Sulfadoxine-pyrimethamine every 4 weeks + azithromycin twice
- Where
- Malawi
- Volunteers
- 1,320 people, healthy volunteers welcome
- Sponsor
- Tampere University
Extremely Low Birthweight Infant, Continuous Tracheal Gas Insufflation
Ventilation of the Extremely Premature Infants Optimized by Dead Space Washout
The Continuous Tracheal Gas Insufflation (CTGI) is a ventilation option of conventional mechanical ventilation that is used to reduce or even eliminate the dead space caused by respiratory prostheses.
- Conditions
- Extremely Low Birthweight Infant, Continuous Tracheal Gas Insufflation, Medical Device, Lung Protection
- Trial name
- Volem (NCT06334523)
- Testing
- Ventilation with Dead Space Washout via Continuous Tracheal Gas Insufflation (CTGI)
- Where
- 4 sites in France
- Volunteers
- 144 people
- Sponsor
- Centre Hospitalier Intercommunal Creteil
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
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, 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
Premature Infant, Breast Milk Expression
Growth and Nutritional Status of Very Low Birth Weight Infants Fed a High Protein Exclusive Human Milk Diet
The purpose of this two-arm investigation is to determine if growth patterns of very low birth weight infants (VLBW) (birth weight 750-1500 grams) fed human milk (maternal or donor) supplemented with a human milk-based fortifier…
- Trial name
- MedolacHMF (NCT03839173)
- Testing
- Human milk based human milk fortifier
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Augusta University
Diarrhea, Respiratory Infection
Impact of Zinc Supplementation in Low Birth Weight Infants on Severe Morbidity, Mortality and Zinc Status: A Randomized Controlled Trial
There are currently no interventions available to substantially reduce the incidence of low birth weight (LBW) apart from increasing the age at marriage, maternal iron supplementation and possibly improved energy intakes.
- Conditions
- Diarrhea, Respiratory Infection, Low Birth Weight
- Trial name
- NCT00272142
- Testing
- Zinc
- Where
- India
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Society for Applied Studies
Growth Failure, CLABSI - Central Line Associated Bloodstream Infection
The Effect of Early Versus Standard Central Line Removal on Growth of Very Low Birth Weight Premature Infants
This study compares two different regimens of a central line removal in respect to weight at 36 weeks postmenstrual age in very low birth weight (VLBW) preterm infants.
- Trial name
- NCT03730883
- Testing
- Central line removal at 100ml/kg/day., Central line removal at 140ml/kg/day.
- Where
- 4 sites in Poland
- Volunteers
- 214 people
- Sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, Poland
Preterm
Early Childhood (2-year) Outcomes Among Former VLBW From the ReDiMOM Trial
The goal of this study is to determine the long-term outcomes associated with an economic intervention that was provided to encourage mother's of very premature infants to provide mother's own milk.
- Trial name
- NCT07702318
- Where
- United States
- Volunteers
- 275 people
- Sponsor
- Rush University Medical Center
Prematurity
Preterm Donor Human Milk Supplementation of Mother's Own Milk in VLBW Infants
This prospective randomized controlled trial aims to investigate whether feeding very low birth weight (VLBW) infants with Mother's own milk (MOM) supplemented with either preterm (PDM) or term donor milk (TDM), when MOM is…
- Trial name
- NCT05675397
- Testing
- donor human milk
- Where
- 2 sites in Greece
- Volunteers
- 200 people
- Sponsor
- National and Kapodistrian University of Athens