Clinical trials: Low Birth Weight Infants
Respiratory Distress Syndrome, Newborn
LISA Catheter With Marked vs. Unmarked Tip in Extremely Low Birth Weight Infants With RDS
This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA catheter with a marked tip vs.
- Trial name
- NCT05399628
- Testing
- Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter, Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter
- Where
- Italy
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University Hospital Padova
Osteopenia of Prematurity
The Effect of Physical Activity on Bone Mineralization and Immune System in Very Low Birth Weight Infants
Studies have demonstrated that brief (5-10 min a day) passive range-of-motion exercise is beneficial for bone development in very low birth weight (VLBW) preterm infants.
- Trial name
- NCT01042639
- Testing
- passive physical activity
- Where
- Israel
- Volunteers
- 45 people
- Sponsor
- Meir Medical Center
Apnea of Prematurity
Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study
Apnea of prematurity is a common condition that is usually treated with methylxanthines. Methylxanthines are adenosine receptor blockers that have powerful influences on the central nervous system.
- Trial name
- CAP-S (NCT01020357)
- Testing
- Caffeine citrate injection
- Where
- 4 sites in Australia, Canada
- Volunteers
- 201 people
- Sponsor
- McMaster University
Neonatal Mortality
Ghana Newborn Home Visits Neonatal Mortality Trial
Introduction: Just under four million infants die each year before reaching one month of age; neonatal deaths now account for 38% of the 10.8 million deaths among children younger than 5 years of age.
- Trial name
- Newhints (NCT00623337)
- Testing
- Home visits
- Where
- Ghana
- Volunteers
- 15,000 people
- Sponsor
- London School of Hygiene and Tropical Medicine
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
Surgical Procedures, Infant, Newborn
Neonatal Non-Invasive Hemoglobin Determination
The purpose of this study is to evaluate hemoglobin (Hgb) measurement by Masimo-developed pulse co-oximetry in pediatric patients weighing less than 3 kilograms (Kg).
- Conditions
- Surgical Procedures, Infant, Newborn, Infant, Low Birth Weight
- Trial name
- NCT01335919
- Sponsor
- Children's Hospital of Philadelphia
Infant, Premature, Erythropoietin
High-Dose Erythropoietin in Extremely Premature Infants to Prevent/Attenuate Brain Injury: A Phase II Study
The highest risk for perinatal brain injury occurs among extremely premature infants who weigh less than 1250 grams at birth. Such perinatal brain injury is currently irreversible, associated with neurodevelopmental disability…
- Conditions
- Infant, Premature, Erythropoietin, Brain Injury, Intraventricular Hemorrhage
- Trial name
- NCT00589953
- Testing
- Erythropoietin
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Atlantic Health System
Respiratory Distress Syndrome, Preterm Birth
LISA vs INSURE in Extremely Low Birth Weight Infants. A Manikin Study
This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA vs. INSURE in a manikin simulating an extremely low birth weight infant.
- Conditions
- Respiratory Distress Syndrome, Preterm Birth, Surfactant Deficiency Syndrome Neonatal
- Trial name
- NCT04944108
- Testing
- LISA approach, Insure approach
- Where
- 2 sites in Italy
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- University Hospital Padova
Patent Ductus Arteriosus
Paracetamol Versus Ibuprofen for PDA Closure
Comparison between the safety and efficacy of oral paracetamol and oral ibuprofen in treatment of Patent Ductus Arteriosus (PDA) in premature infants
- Trial name
- NCT03265782
- Testing
- ibuprofen, paracetamol
- Volunteers
- 30 people
- Sponsor
- Ain Shams University
Preterm Infants, Respiratory Distress Syndrome
Diaphragm Electrical Activity of Preterm Infants on nCPAP With Binasal Prongs Versus RAM Cannula
Preterm babies have immature lungs and frequent pauses in their breathing which often necessitates breathing support. Nasal Continuous Positive Airway Pressure (nCPAP) is one of the most commonly used tools, but the standard…
- Conditions
- Preterm Infants, Respiratory Distress Syndrome, CPAP, RAM Cannula
- Trial name
- NCT03121781
- Testing
- respiratory support- interface
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- Sunnybrook Health Sciences Centre
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
Body Temperature, Oxygen Saturation
Can Kangarooing Small Babies on the Back of a Mother Keep Them Warm and Stable
The purpose of this study was to assess the effectiveness of Kangarooing small babies on the back of a mother
- Conditions
- Body Temperature, Oxygen Saturation, Heart Rate, Respiratory Rate
- Trial name
- NCT04346498
- Testing
- Chest-to-back
- Where
- Ethiopia
- Volunteers
- 50 people
- Sponsor
- SISAY GERE
Hypotension, Very Low Birth Weight Infants
N-Terminal Pro-B-Type Natriuretic Peptide and Troponin Levels as Markers of Hemodynamic Stability in Very Low Birth Weight Infants During the First Days of Life
The primary objective is to test the hypothesis that there is an association between the hemodynamic status and the serum levels of NT-proBNP and cTnT in prematurely born infants.
- Conditions
- Hypotension, Very Low Birth Weight Infants, Ventricular Dysfunction, Prematurity
- Trial name
- NCT00425581
- Volunteers
- 100 people
- Sponsor
- Sheba Medical Center
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
Infant, Very Low Birth Weight, Neonatal Hypoglycemia
Continuous Glucose Monitoring and Preterm Infants
Neonatal hypoglycemia is associated with brain injury and impaired neurodevelopment outcomes in very low birth weight infants (VLBWI).
- Trial name
- CGM&VLBWI (NCT02583776)
- Testing
- Unblinded - CGM, Blinded - CGM
- Where
- 3 sites in United States, Italy
- Volunteers
- 50 people
- Sponsor
- University Hospital Padova
Transfusion, Feeding During Transfusion
Withholding Feeds During Red Blood Cell Transfusion and TRAGI
Necrotising enterocolitis (NEC) is a devastating picture that all the neonatologists are afraid of facing during the follow up of newborns.
- Conditions
- Transfusion, Feeding During Transfusion, Transfusion Related Acute Gut Injury, Necrotising Enterocolitis
- Trial name
- Tx-TRAGI (NCT02132819)
- Testing
- Withholding feeds, feeding during transfusion
- Where
- Turkey (Türkiye)
- Volunteers
- 150 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Prematurity
Early DHA Supplementation in Very Low Birth Weight Infants
This clinical trial will evaluate the effects of giving supplements of PUFA to premature infants.
- Trial name
- NCT03192839
- Testing
- Low dose PUFA, High dose PUFA
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Mead Johnson Nutrition
Infant, Very Low Birth Weight, Metabolic Syndrome, Protection Against
Growth, Risks of Allergy and Metabolic Syndrome in 6 Year Old Children Born Preterm Compared to Postdischarge Nutrition
This is a follow-up cohort study of 6 years old children born preterm in Denmark from 2004-2008, and at four different neonatal units. During hospitalisation they received breast milk with fortification.
- Conditions
- Infant, Very Low Birth Weight, Metabolic Syndrome, Protection Against, Allergy, Dietary Modification
- Trial name
- NCT02078687
- Testing
- Enfamil HM fortifier, Mead Johnson, Enfalac Premature Formula, Mead Johnson Nutritionals, Mothers own milk
- Where
- Denmark
- Volunteers
- 239 people
- Sponsor
- University of Southern Denmark
Early-Onset Sepses, Neonatal, Periventricular Haemorrhage Neonatal
Zinc Supplementation on Very Low Birth Weight Infant
Premature birth is a major cause of neonatal death in addition to neonatal asphyxia and infections. Early in life, premature babies must get aggressive nutrition so that there is no extrauterine growth restriction (EUGR) in the…
- Conditions
- Early-Onset Sepses, Neonatal, Periventricular Haemorrhage Neonatal, Bronchopulmonary Dysplasia, Retinopathy of Prematurity
- Trial name
- NCT04050488
- Testing
- Zinc Sulfate
- Volunteers
- 364 people, healthy volunteers welcome
- Sponsor
- Fakultas Kedokteran Universitas Indonesia
Premature Infants, Very Low Birth Weight Infants
The Video System to Provide a Developmental Training Guide for Preterm Infants
This study aimed to establish a systematic developmental training guide protocol for parent-centered early intervention and verify the concept and feasibility of a video system for parent-centered in-home developmental therapy…
- Trial name
- NCT06965842
- Testing
- Parent-centered developmental training
- Where
- South Korea
- Volunteers
- 12 people
- Sponsor
- Seoul National University Hospital