Clinical trials: Low-Birth-Weight
Respiratory Distress Syndrome In Premature Infants
Safety and Efficacy Study of the Draeger Babylog VN500 Device in HFOV Mode in VLBW Neonates
The purpose of this study is to determine the safety and effectiveness of the Babylog VN500 in high frequency oscillatory ventilation (HFOV) mode as a method for treating very low birth weight (VLBW) neonates requiring invasive…
- Trial name
- NCT02445040
- Testing
- Babylog VN500 in HFOV Mode
- Where
- 14 sites in United States
- Volunteers
- 225 people
- Sponsor
- Draeger Medical Systems, Inc.
Patent Ductus Arteriosus
Feeding During Ibuprofen or Indomethacin Treatment of Preterm Infants
We hypothesize that feeding preterm infants while they receive indomethacin or ibuprofen therapy for treatment of a patent ductus arteriosus will decrease the incidence of feeding intolerance and shorten the time period that…
- Trial name
- NCT00728117
- Testing
- feeding, fasting
- Where
- 14 sites in United States
- Volunteers
- 177 people
- Sponsor
- University of California, San Francisco
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
Other Preterm Infants
Effects of Infant Formula on the Growth and Tolerance in Preterm/Low Birth Weight Infants
This is a two stage open-label, single-arm, multicenter and observational study.
- Trial name
- NCT02073071
- Testing
- Preterm infant formula per standard of care
- Where
- 10 sites in China
- Volunteers
- 139 people
- Sponsor
- Abbott Nutrition
Maternal Micronutrient Status, Pregnancy
Multiple Micronutrient Versus Iron-Folic Acid Supplementation in Pregnant Women in Indonesia
Micronutrient deficiencies during pregnancy may affect the mother's nutritional status and the baby's growth. This study compared two types of daily supplements for pregnant women: a multiple micronutrient supplement and an iron…
- Conditions
- Maternal Micronutrient Status, Pregnancy, Low Birth Weight, Maternal Anemia
- Trial name
- NCT07725549
- Testing
- Multiple micronutrient supplementation, Iron and Folic Acid Supplementation
- Where
- Indonesia
- Volunteers
- 66 people
- Sponsor
- Indonesia Timur University
Very Preterm Maturity of Infant, Very Low Birth Weight Infant
Individualized Nutrition to Optimize Preterm Infant Growth and Neurodevelopment
Human milk has several well-established benefits but does not adequately meet the increased nutritional demands of the growing preterm infant, necessitating additional nutrient supplementation in a process known as fortification.
- Trial name
- THRIVE (NCT06266455)
- Testing
- Standardized Fortification, Adjustable Fortification
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Children's National Research Institute
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
Low Birth Weight
Synthesis of Glutathione From Low Birth Weight Newborn Babies
The aim of the study is to determine mechanisms leading to glutathione deficiency in low birth weight newborn babies. Compared to full term neonates, depletion in this population may be due to a decreased synthesis rate or to an…
- Trial name
- glutathione (NCT00607061)
- Testing
- Blood sample collection
- Where
- France
- Volunteers
- 35 people
- Sponsor
- Nantes University Hospital
Extremely Low Birth Weight Infants, Respiratory Distress Syndrome, Newborn
LUS AT BIRTH IN INFANTS BORN BEFORE 26 WEEKS
All infants born before 26 weeks born in a hospital included in the registry will receive a LU at birth, before the first dose of surfactant. We will register as well the length of IMV, NIV or the need of IMV in the whole sample.
- Trial name
- MINI-LUS (NCT06394583)
- Testing
- Lung ultrasound
- Volunteers
- 150 people
- Sponsor
- Andaluz Health Service
Mortality, Morbidity
Sex-Differential Health Interventions In Low-Birth-Weight Infants
Our group has consistently found that the major interventions to reduce morbidity and mortality in low-income countries have sex-differential effects.
- Conditions
- Mortality, Morbidity, Growth, Neonatal Mortality
- Trial name
- NCT00625482
- Testing
- OPV, OPV plus BCG
- Where
- Guinea-Bissau
- Sponsor
- Bandim Health Project
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, Low Birth Weight
Effect of Kangaroo Baby Massage on Mother-infant Interaction at Home
The objective of this randomized clinical trial will determine the effectiveness of nursing intervention (Kangaroo Baby Massage) on the interaction between mothers and premature, low birth weight infants at home The dyad mother…
- Conditions
- Premature, Low Birth Weight, Mother-Infant Interaction, Gain, Weight
- Trial name
- KBM (NCT04908332)
- Testing
- Kangaroo Baby Massage
- Where
- Colombia
- Volunteers
- 68 people
- Sponsor
- Universidad Nacional de Colombia
Breast Milk Expression
Early Initiation of Milk Expression in Mothers of Very Low Birth Weight Infants
Compelling evidence exists that breast milk helps protect very premature infants from prematurity-specific morbidities. Unfortunately, mothers of premature infants often exhibit delayed lactogenesis stage II (when the milk "comes…
- Trial name
- NCT01892085
- Testing
- Early initiation, Intermediate expression, Late initiation
- Where
- United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- University of Florida
Hypothermia
Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part III
The overall hypothesis is that plastic bags used in combination with WHO thermoregulation care will reduce the incidence of hypothermia in preterm/low birth weight and full term infants when compared to routine WHO…
- Trial name
- NCT01604434
- Testing
- Incubator-torso bag, Incubator-no plastic bag
- Where
- Zambia
- Sponsor
- University of Alabama at Birmingham
Nosocomial Infection, Necrotizing Enterocolitis
Effect of Oral Probiotic Supplementation on The Rate of Hospital Acquired Infection and Necrotizing Enterocolitis in Preterm Very Low Birth Weight Infants
The purpose of this study is to determine whether oral probiotic supplementation could reduce the incidence of nosocomial infections in preterm infants.
- Trial name
- NCT01340469
- Testing
- probiotics
- Where
- Thailand
- Volunteers
- 160 people
- Sponsor
- King Chulalongkorn Memorial Hospital
Adolescents, Anemia
Effect of Micronutrients and Life Skills Education on the Health and Nutrition of Adolescent and Young Women in Pakistan
The primary aims of this study are: 1) To evaluate the impact of supplementation with multiple micronutrients (MMN) from preconception and life skills education among women 15-18.9 years of age at enrolment on the prevalence of…
- Conditions
- Adolescents, Anemia, Pregnancy, Empowerment
- Trial name
- NCT03287882
- Testing
- Multiple micronutrients (UNIMMAP composition), Life skills based education
- Where
- Pakistan
- Volunteers
- 25,447 people, healthy volunteers welcome
- Sponsor
- Aga Khan University
Premature; Infant, Light-for-dates
Cue-based Tactile Stimulation and Infant Stress Reactivity
The present study is an examination of cue-directed tactile stimulation (CTDS), administered by mothers and NICU nurses, on infant and maternal stress reactivity, infant immune system functioning, maternal parenting cognitions…
- Trial name
- NCT01121523
- Testing
- Cue directed tactile stimulation
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Penn State University
Respiratory Distress Syndrome
Early CPAP in Respiratory Distress Syndrome
The purpose of this study is to establish if a strategy of EBCPAP application in a subgroup of VLBWI, 800 to 1500g birthweight, decreases the need for mechanical ventilation in this group, without affecting mortality.
- Trial name
- NCT00368680
- Testing
- Early Bubble CPAP
- Where
- 14 sites in Argentina, Chile and 3 more
- Volunteers
- 256 people
- Sponsor
- Pontificia Universidad Catolica de Chile
Pregnancy, Premature Birth
Development of a Nationally Scalable Model of Group Prenatal Care to Improve Birth Outcomes: "Expect With Me"
This study addresses the intractable challenges of adverse birth outcomes, including preterm delivery and low birthweight, by proposing the development, implementation and evaluation of a model of group prenatal care that could…
- Conditions
- Pregnancy, Premature Birth, Infant, Low Birth Weight, Postpartum Period
- Trial name
- NCT02169024
- Testing
- Expect With Me group prenatal care, Standard individual prenatal care
- Where
- 2 sites in United States
- Volunteers
- 2,402 people, healthy volunteers welcome
- Sponsor
- Yale University
Infant, Newborn, Diseases, Other Preterm Infants
Surfactant Positive Airway Pressure and Pulse Oximetry Trial
This study compared the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24…
- Conditions
- Infant, Newborn, Diseases, Other Preterm Infants, Infant, Small for Gestational Age, Premature Birth
- Trial name
- SUPPORT (NCT00233324)
- Testing
- Surfactant, Continuous Positive Airway Pressure (CPAP), Supplemental oxygen with target saturation of 85 to 89%
- Where
- 22 sites in United States
- Volunteers
- 1,316 people
- Sponsor
- NICHD Neonatal Research Network