Clinical trials: Low Birth Weight Infant
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
Preterm Birth, Very Low Birth Weight Infant
Assessment of Body Composition in Premature Children Submitted to an Early Stimulation Program
This is a cross-sectional study of a randomized clinical trial to investigate nutritional aspects of pre-scholar aged children born preterm submitted to an early stimulation program versus conventional care program.
- Conditions
- Preterm Birth, Very Low Birth Weight Infant, Early Intervention, Parent-Child Relations
- Trial name
- NCT05399667
- Testing
- Early stimulation, Conventional care
- Where
- Brazil
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Hospital de Clinicas de Porto Alegre
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
Infant, Low Birth Weight
Preventing Linear Growth Faltering Among Low Birth Weight Infants in Bangladesh
Low birth weight (LBW) infants are particularly vulnerable to frequent infections and consequent morbidity resulting in sub-optimal breastfeeding, limited ingestion of complementary foods and ultimately micronutrient deficiencies…
- Trial name
- NCT01455636
- Testing
- Hand Sanitizer, Improved Micronutrient Powder, No hand sanitizer
- Where
- 2 sites in Bangladesh, Canada
- Volunteers
- 467 people
- Sponsor
- The Hospital for Sick Children
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
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
Inadequate; Pulmonary Ventilation, Newborn, Infant, Very Low Birth Weight
Nasal Noninvasive NAVA in the Very Low Birth Weight Infant
The purpose of this study is to determine if a new type of mechanical ventilation, or breathing machine (called neurally adjusted ventilatory assist or NAVA), will provide additional support to infants who were born prematurely.
- Trial name
- NCT01785563
- Testing
- Nasal NIV-NAVA
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Tarah T Colaizy
Human Milk Fortification, Very Low Birth Weight Baby
Enrichment of Human Milk With Human and Bovine Milk-based Fortifiers for Very Preterm Infants: a Meta-analysis
Research has shown that provision of mother's milk is the optimal way to feed very low birthweight (VLBW) infants. Many infants will require a supplement to mother's milk, pasteurized donor human milk (PDHM) compared to preterm…
- Conditions
- Human Milk Fortification, Very Low Birth Weight Baby, Human Milk Nutrition, Human Milk Feeding
- Trial name
- NCT06870318
- Testing
- No intervention; Observational study
- Where
- 2 sites in Canada, Sweden
- Volunteers
- 355 people
- Sponsor
- The Hospital for Sick Children
Preterm Infants, Infant, Low Birth Weight
Effects of Early Yakson Touch and Kinesthetic Stimulation on the Development of High Risk Neonates
The role of physiotherapy interventions in treatment of high risk infants has not been established even after a number of studies.
- Trial name
- YTKS (NCT02815904)
- Testing
- Yakson touch, Conventional handling, Kinesthetic stimulation
- Where
- India
- Volunteers
- 28 people
- Sponsor
- Asir John Samuel
Periodontal Diseases, Premature Birth
Prevention of Pre-Term Birth by Treatment of Periodontal Disease
The aim of the study is to investigate, in an Australian population of pregnant women, whether the treatment of periodontal disease during pregnancy prevents pre-term birth and other complications of pregnancy.
- Conditions
- Periodontal Diseases, Premature Birth, Pre-Eclampsia
- Trial name
- NCT00133926
- Testing
- Treatment of periodontal disease
- Where
- Australia
- Volunteers
- 1,094 people
- Sponsor
- King Edward Memorial Hospital
Cerebral Palsy, Infant, Newborn, Disease
Effectiveness of Family Collaborative Physiotherapy Programs With High-risk Infants
High risk infant is defined as infant with a negative history of environmental and biological factors, which can lead to neuromotor development problems.
- Conditions
- Cerebral Palsy, Infant, Newborn, Disease, Infant, Small for Gestational Age, Infant Asphyxia
- Trial name
- NCT04035291
- Testing
- exercise
- Where
- Turkey (Türkiye)
- Volunteers
- 63 people
- Sponsor
- Sanko University
Thrombocytopenia, Neonatal
Neonatal Platelet Transfusion Threshold Trial
The objective of the NeoPlaTT trial is to test whether, among extremely preterm infants born at 23 0/7 to 26 6/7 weeks' gestation, a lower platelet transfusion threshold, compared to a higher threshold, improves survival without…
- Conditions
- Thrombocytopenia, Neonatal, Platelet Transfusion, Infant, Newborn, Diseases
- Trial name
- NeoPlaTT (NCT06676904)
- Testing
- Higher Platelet Transfusion Threshold, Lower Platelet Transfusion Threshold
- Where
- 20 sites in United States
- Volunteers
- 2,433 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Low-Birth-Weight Infant, Tuberculosis
IMPAACT P1106: Pharmacokinetic Characteristics of Antiretrovirals and Tuberculosis Medicines in Low Birth Weight Infants
P1106 is Phase IV prospective pharmacokinetic (PK) study of low birth weight infants who are receiving or will be receiving as part of clinical care nevirapine (NVP) prophylaxis, tuberculosis (TB) prophylaxis or treatment and/or…
- Conditions
- Low-Birth-Weight Infant, Tuberculosis, HIV
- Trial name
- NCT02383849
- Where
- 2 sites in South Africa
- Volunteers
- 124 people
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Venous Thromboembolism, Postpartum Period
The PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity
The goal of the PARTUM trial is to determine if taking low-dose aspirin daily for 6 weeks after delivery is similar (non-inferior) to usual care low-molecular-weight heparin injections to prevent venous thromboembolism (VTE…
- Conditions
- Venous Thromboembolism, Postpartum Period, Aspirin, Low Molecular Weight Heparin
- Trial name
- NCT06494878
- Testing
- Aspirin, Low-molecular-weight heparin
- Where
- 12 sites in Belgium, Canada and 5 more
- Volunteers
- 8,805 people
- Sponsor
- University of Calgary
Low Birthweight, Pre-Term
Low-birthweight Infant Feeding Exploration
Globally, 15% of all babies, amounting to 20 million infants each year, are born low birthweight (LBW), defined less than 2500 grams (5.5 lbs).
- Trial name
- LIFE (NCT04002908)
- Where
- 3 sites in India, Malawi and 1 more
- Volunteers
- 3,188 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
Very Low Birth Weight Infant
The Setting and Effect Evaluation of QT in NICU
In order to create a better environment for growth and development for very low birth weight infants(VLBWIs), investigators introduce quiet time, which is an intervention method that reduces environmental noise in the ward and…
- Trial name
- NCT05192668
- Testing
- Quiet time care
- Where
- China
- Volunteers
- 124 people
- Sponsor
- Children's Hospital of Fudan University
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
Preterm Birth
Human Milk in Preterm Infants
Current NICU protocol introduces human milk fortifier at 8 days of feeding. This study will introduce human milk fortifier at day 1. The primary outcome is the effect on growth velocity at 28 days and 36 weeks post menstrual age.
- Trial name
- NCT05228535
- Testing
- Human milk fortifier
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Augusta University
Infant, Premature, Nutrition, Enteral
Aspiration of Residual Gastric Contents
The primary purpose of this study is to determine nutrition outcomes and risks to gastrointestinal integrity and function of aspirating for routine gastric contents prior to each feeding in very low birth weight premature infants.
- Trial name
- NCT01863043
- Testing
- No aspiration of gastric contents, Routine aspiration of gastric contents
- Where
- United States
- Volunteers
- 146 people
- Sponsor
- University of Florida
Necrotizing Enterocolitis, Very Low Birth Weight Infants
Splanchnic Oxygenation After the First Enteral Feed in Preterm Infants: Prediction of Feeding Tolerance.
Enteral nutrition of preterm and intrauterine growth-restricted (IUGR) infants is still a challenge for neonatologists. Due to the immaturity of the gastrointestinal tract, preterm infants are at high risk of developing feeding…
- Trial name
- NIRS-SO (NCT02383264)
- Where
- Italy
- Volunteers
- 61 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna