Clinical trials: Low; Birthweight
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
Sepsis, Necrotising Enterocolitis Neonatal
Integrated Predictive Monitoring for Sepsis and Necrotizing Enterocolitis
Behind the scenes pilot trial in the computer lab involving chart review to use neonatal intensive care unit data to create computer models predicting sepsis and necrotizing enterocolitis in very small premature infants
- Trial name
- PREMO (K) (NCT07254559)
- Testing
- No Intervention: Observational Cohort
- Where
- United States
- Volunteers
- 144 people
- Sponsor
- University of Virginia
LBW, Preterm
Effects of Kangaroo Mother Care Among Low Birth Weight (LBW) and Preterm Infants
Hypothermia, infections ,and ineffective breastfeeding are some of the commonest causes of deaths among premature and low birth weight LBW infants.
- Trial name
- KMC (NCT01776281)
- Testing
- Kangaroo Mother Care, Standard Care
- Where
- Pakistan
- Volunteers
- 82 people
- Sponsor
- Aga Khan University
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
Infant, Extremely Low Birth Weight, Lung Diseases, Obstructive
Growth, Health and Development in Children Born Extremely Preterm
Background: In a national Norwegian cohort of children born before 28 weeks gestation or with a birth weight less than 1000 g born in 1999 and 2000, 372 survived.
- Conditions
- Infant, Extremely Low Birth Weight, Lung Diseases, Obstructive, Disorder of Bone Density and Structure, Unspecified, Cognition Disorders
- Trial name
- PEP11 (NCT01150071)
- Where
- 2 sites in Norway
- Volunteers
- 232 people
- Sponsor
- University of Bergen
Low Birth Weight, Infant Mortality
Antenatal Micronutrient Supplementation and Birth Weight
The purpose of this study was to determine the effects of providing supplements containing alternative combinations of micronutrients during pregnancy on birth weight and other infant and maternal health and nutritional outcomes…
- Conditions
- Low Birth Weight, Infant Mortality, Pregnancy, Nutritional Status
- Trial name
- NCT00115271
- Testing
- Nutritional supplements
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Neonatal Sepsis, Necrotizing Enterocolitis
Bovine Lactoferrin and Neonatal Survival in Low Birth Weight Babies.
Pakistan has the third highest number of neonatal deaths worldwide. During the last two decades (1990-2013), neonatal mortality rate in the country has declined by only 1.0% per year.
- Trial name
- NCT03431558
- Testing
- bLF (Bovine lactoferrin)
- Where
- Pakistan
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Aga Khan University
Respiratory Distress Syndrome, Newborn, Premature Birth
SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.
SURFAXIN® (lucinactant) treatment will be examined in very low birth weight infants to prevent development of chronic lung disease, commonly known as bronchopulmonary dysplasia (BPD), in premature infants who have required…
- Conditions
- Respiratory Distress Syndrome, Newborn, Premature Birth, Bronchopulmonary Dysplasia
- Trial name
- NCT00215540
- Testing
- Lucinactant 175 mg/kg, Lucinactant 90 mg/kg
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Windtree Therapeutics
Prematurity Complications
Gut Permeability and Microbiome in Preterm Infants
NEC, a life-threatening, GI emergency characterized by increased IP, affects approximately 7 to 10% of preterm neonates, and typically occurs within 7 to 14 days of birth with mortality as high as 30-50%.
- Trial name
- NCT07667049
- Testing
- measurement of intestinal permeability
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Maryland, Baltimore
PDA, Low; Birthweight, Extremely (999 Grams or Less)
The Efficacy of Implementing a Treatment Algorithm in Managing Patent Ductus Arteriosus (PDA) in the Extremely Low Birth Weight Neonatal Population.
To evaluate whether utilizing a standardized patent ductus arteriosus (PDA) treatment algorithm in managing ELBW (extremely low birth weight) neonates ≤1000 grams (g) improves clinical outcomes and helps prevent undesirable side…
- Trial name
- NCT04379843
- Where
- 2 sites in United States
- Volunteers
- 208 people, healthy volunteers welcome
- Sponsor
- Pediatrix
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
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
Premature Birth, Extreme Prematurity
The Pilot Experimental Study of the Neuroprotective Effects of Exosomes in Extremely Low Birth Weight Infants
To study the safety and efficacy of intranasal administration of exosomes derived from mesenchymal stromal cells on long-term neurodevelopmental outcome in extremely low birth weight infants born at gestational age 25/0-27/6…
- Conditions
- Premature Birth, Extreme Prematurity, Preterm Intraventricular Hemorrhage, Hypoxia-Ischemia, Cerebral
- Trial name
- NCT05490173
- Testing
- Exosomes derived from mesenchymal stromal cells (MSCs)
- Where
- Russia
- Volunteers
- 10 people
- Sponsor
- Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
Preterm Infants
Very Low Birth Weight Preterm Infant Bundled Care in the NICU
The purpose of this study is to explore the impact of bundling nursing care activities on the overall health of Very Low Birthweight (VLBW) preterm infants who receive bundled care in a Level IV Neonatal Intensive Care Unit…
- Trial name
- NCT03370757
- Testing
- 3-hour bundled care, 6-hour bundled care
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Duke 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
Low; Birthweight, Breast Feeding, Exclusive
Indonesia After Discharge LBW Infant HMF Supplementation Study
Low birth weight (LBW) infant (1800-2449 gram) will be given the new human milk fortifier (HMF) which contains protein, lipid, carbohydrate and micronutrients after discharge.
- Conditions
- Low; Birthweight, Breast Feeding, Exclusive, Gestational Age and Weight Conditions
- Trial name
- DAHLIA (NCT04954807)
- Testing
- human milk fortified
- Where
- 4 sites in Indonesia
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- Universitas Indonesia
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - MHSB
This study evaluates the use of a NICU clinical integration system (Dashboard and accessories) in improving the quality of care delivered, patient health outcomes, and parent and clinician satisfaction.
- Conditions
- Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less), Neonatal Infection, Satisfaction
- Trial name
- NCT03673579
- Testing
- NICU Dashboard
- Where
- United States
- Sponsor
- Philips Healthcare
Stunting, Low Birth Weight
Evidence Generation Related to Stunting Prevention in Balochistan
The World Food Programme (WFP) has signed MoU with Planning and Development Department of Balochistan in collaboration with Nutrition Cell and National Programme for Family Planning and Primary Health Care, Balochistan for the…
- Conditions
- Stunting, Low Birth Weight, Anemia in Pregnancy
- Trial name
- NCT03689218
- Testing
- Maamta (Nutritious Food Supplement), Wawamum (Lipid-Based Nutrient Supplement)
- Where
- 2 sites in Pakistan
- Volunteers
- 2,180 people, healthy volunteers welcome
- Sponsor
- Aga Khan University
Weight Gain
"Impact of Kangaroo Mother Care Plus Massage Therapy on Growth of Preterm Low Birth Weight Infants at Discharge"
Kangaroo mother care plus massage therapy will lead to improved growth of preterm low birth weight infants at discharge.
- Trial name
- NCT05640297
- Testing
- KMC with Massage therapy
- Where
- Bangladesh
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Noninvasive Ventilation, Low Birth Weight
Noninvasive NAVA Versus NIPPV in Low Birthweight Premature Infants
The investigator hypothesizes that in very low birth weight infants who require respiratory support via noninvasive ventilation, that synchronizing the ventilator breath with the baby's breath using neurally adjusted ventilatory…
- Trial name
- NCT03137225
- Testing
- Neurally Adjusted Ventilatory Assist, Nasal Intermittent Positive Pressure Ventilation
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Virginia Commonwealth University