Clinical trials: Birth Weight
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
Infant, Premature, Diseases, Infant, Small for Gestational Age
Optimizing Individual Nutrition in Preterm Very Low Birth Weight Infants
In preterm infants fed human milk, milk needs to be fortified to meet nutrient recommendations. Fortification can be 1) standard, 2) individualized (adjusted based on daily human milk nutrient analysis and milk volume), or 3)…
- Trial name
- NCT02372136
- Testing
- Individualized Nutrition, Optimized nutrition
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of Texas Southwestern Medical Center
Necrotizing Enterocolitis
STP206 for the Prevention of Necrotizing Enterocolitis (NEC)
This study is a sequential dose escalation study to assess the safety, tolerability, and preliminary NEC-preventative efficacy of two doses of STP206 versus control in very low birth weight and extremely low birth weight neonates.
- Trial name
- NCT01954017
- Testing
- STP206, Control
- Where
- 13 sites in United States
- Volunteers
- 103 people
- Sponsor
- Leadiant Biosciences, Inc.
Infant Mortality, Preterm Birth
Antenatal Micronutrient Supplementation and Infant Survival
The purpose of this community-based randomized trial is to examine whether a daily antenatal and postnatal multiple micronutrient supplement given to women will enhance newborn and infant survival and health and other birth…
- Conditions
- Infant Mortality, Preterm Birth, Low Birth Weight, Neonatal Mortality
- Trial name
- JiVitA-3 (NCT00860470)
- Testing
- Iron (27 mg) - folic acid (600 ug), Multiple micronutrient
- Where
- 2 sites in United States, Bangladesh
- Volunteers
- 44,567 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Infant Development, Infant,Premature
Movement-based Infant Intervention
The objective is to pilot test the effectiveness of an evidence-based intervention to promote positive neurodevelopmental outcomes in infants at risk for developmental delay.
- Conditions
- Infant Development, Infant,Premature, Infant, Very Low Birth Weight, Infant, Small for Gestational Age
- Trial name
- NCT03082313
- Testing
- Movement Intervention
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Southern California
Prematurity
Neurodevelopmental and Growth Outcomes of Early, Aggressive Protein Intake in Very Low Birthweight Infants
The purpose of this study is to determine whether providing increased protein to premature infants in the first week of life allows for better growth during the hospital stay and improved developmental outcomes by age 2.
- Trial name
- NCT01860573
- Testing
- Amino acids
- Where
- United States
- Volunteers
- 168 people
- Sponsor
- Women and Infants Hospital of Rhode Island
Staphylococcal Sepsis
Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight Neonates for Prevention of Staphylococcal Sepsis
Evaluate the safety, PK and efficacy comparing Pagibaximab Injection to placebo in preventing staphylococcal sepsis in very low birth weight infants.
- Trial name
- NCT00646399
- Testing
- Pagibaximab 50 mg/mL
- Where
- United States
- Volunteers
- 1,579 people, healthy volunteers welcome
- Sponsor
- Biosynexus Incorporated
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
Obesity
Mobile Integrated Care for Childhood Obesity
The goal of this clinical trial is to evaluate a new way of providing healthcare to children with an unhealthy weight. Families who participate will be assigned by chance to one of two groups.
- Trial name
- NCT05936385
- Testing
- Healthy Lifestyle, Standard of Care
- Where
- 3 sites in United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Nemours Children's Health System
Thromboembolism
Low Molecular Weight Heparin or no Treatment Following Cesarean Delivery
The aim of this study is to evaluate the feasibility of randomizing individuals to low molecular weight heparin (enoxaparin) or no treatment following cesarean delivery.
- Trial name
- NCT06118957
- Testing
- Enoxaparin
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- University of Utah
Infant, Newborn, Infant, Small for Gestational Age
Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
The Milk Trial seeks to determine the effect on neurodevelopmental outcomes at age 22-26 months of donor human milk as compared to preterm infant formula as the in-hospital diet for infants whose mothers choose not to provide…
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Extremely Low Birth Weight
- Trial name
- NCT01534481
- Testing
- Donor Milk, Preterm Formula
- Where
- 17 sites in United States
- Volunteers
- 483 people
- Sponsor
- NICHD Neonatal Research Network
Premature, Extremely Low Birth Weight Infants, Polyunsaturated Fatty Acid Levels
PUFA Supplementation in Premature Infants
The purpose of this study is to determine if buccal administration of a concentrated formulation of long-chain polyunsaturated fatty acids (LCPUFA) can help to maintain docosahexaenoic acid (DHA) levels in extremely low birth…
- Trial name
- NCT01955044
- Testing
- LCPUFA supplement
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Endeavor Health
Infant,Premature, Body Weight
Serial Assessment of Body Fat Accrual in Very Preterm Infants
Despite evidence that both rapid weight gain and excessive body fat accrual are associated with overweight and obesity, usual neonatal care of preterm infants does not include assessment of body fat accrual.
- Conditions
- Infant,Premature, Body Weight, Adiposity
- Trial name
- NCT03575897
- Testing
- Assessment of infant body composition
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Alabama at Birmingham
Infant, Low Birth Weight
Household Air Pollution and Health: A Multi-country LPG Intervention Trial
This study is a randomized controlled trial of liquefied petroleum gas (LPG) stove and fuel distribution in 3,200 households in four countries (India, Guatemala, Peru, and Rwanda).
- Trial name
- HAPIN (NCT02944682)
- Testing
- Liquefied petroleum gas (LPG) cookstove
- Where
- 4 sites in Guatemala, India and 2 more
- Volunteers
- 6,704 people
- Sponsor
- Emory University
Obesity
Remote Delivery of Weight Management for Adults With IDD
The purpose of this study is to compare different weight loss programs in people with IDD to see which program works better.
- Trial name
- NCT03291509
- Testing
- Video Conference Meetings, In-person Meetings, Enhanced Stop Light Diet
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of Kansas Medical Center
Apnea of Prematurity
A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants
The purpose of this study is to determine whether nasal intermittent positive pressure ventilation (NIPPV) reduces the need for endotracheal intubation in very low birth weight infants with persistent apnea who fail nasal…
- Trial name
- NCT03298035
- Testing
- NCPAP as mode for apnea prevention, NIPPV as rescue mode for apnea prevention
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- The University of Texas Health Science Center, Houston
Feeding; Difficult, Newborn, Growth Failure
Prophylactic Probiotics to Extremely Low Birth Weight Prematures
Mortality and incidence of severe complications is still high among extremely premature infants. Common causes of severe complications in this population are poor nutrition, necrotizing enterocolitis, and severe infections.
- Conditions
- Feeding; Difficult, Newborn, Growth Failure, Necrotizing Enterocolitis, Sepsis
- Trial name
- PROPEL (NCT01603368)
- Testing
- Lactobacillus reuteri
- Where
- 2 sites in Sweden
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- Ostergotland County Council, Sweden
Obesity, Labor Induction
Cervical Ripening for Obese Women: A Randomized, Comparative Effectiveness Trial
Obese pregnant women (BMI ≥ 30 kg/m2) are more likely than their normal-weight counterparts to require induction of labor because of increased rates of obstetric complications including pregnancy related hypertensive disorders…
- Conditions
- Obesity, Labor Induction, Cesarean Delivery
- Trial name
- CROWN (NCT02639429)
- Testing
- Vaginal Misoprostol, Foley Balloon + Vaginal Misoprostol
- Where
- United States
- Volunteers
- 236 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
Obesity, Obesity, Morbid
Increased Cefazolin During Cesarean Delivery in Obese Population
The purpose of this study is to determine whether an increased prophylactic dose (3 grams) of cefazolin at the time of cesarean delivery has superior coverage in adipose tissue than the current established dosing of 2 grams.
- Conditions
- Obesity, Obesity, Morbid, Pregnancy, Infection; Cesarean Section
- Trial name
- NCT02049944
- Testing
- Cefazolin
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- MemorialCare Health System
Pregnancy Related, Weight Gain, Maternal
Healthier At-home Meals for Expectant Mothers
This study is being done to test the feasibility, acceptability, and preliminary efficacy of a meal delivery intervention for managing gestational weight gain among pregnant women with overweight or obesity.
- Trial name
- Her HOME (NCT05605340)
- Testing
- Meal Delivery
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of Alabama at Birmingham