Clinical trials: Birth Weight
Infant, Newborn, Infant, Low Birth Weight
Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2)
This pilot study is a randomized, placebo-controlled, clinical trial to measure changes in blood and urine levels of inositol in premature infants at high risk for retinopathy of prematurity (ROP) following repeated doses of…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- INS-2 (NCT01030575)
- Testing
- Inositol lower volume, Inositol mid-level volume, Inositol high volume
- Where
- 17 sites in United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Intraventricular Hemorrhage (IVH), Bleeding in the Brain
Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial
The purpose of this multicenter trial is to determine if indomethacin prevents bleeding in the brain of very low birth weight preterm infants.
- Conditions
- Intraventricular Hemorrhage (IVH), Bleeding in the Brain, Prematurity, Very Low Birth Weight Infants
- Trial name
- NCT00033917
- Testing
- indomethacin
- Where
- 3 sites in United States
- Volunteers
- 630 people, healthy volunteers welcome
- Sponsor
- Yale University
Obesity; Familial, Pregnancy Related
Maternal Metabolic and Molecular Changes Induced by Preconception Weight Loss and Their Effects on Birth Outcomes
Our hypothesis is that aggressive preconception weight loss in obese women will improve the metabolic health of the mother and the intrauterine environment.
- Trial name
- NCT03244722
- Testing
- Very-low energy Diet (VLED), Standard of care (SOC)
- Where
- United States
- Volunteers
- 147 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Preterm Birth, Low Birth Weight <2500 Grams
Reducing Preterm Births in Underserved Pregnant Women
Timely screening and management of modifiable conditions can reduce preterm births, yet providing effective prenatal risk management systems to meet the unique needs of medically underserved populations is complex.
- Conditions
- Preterm Birth, Low Birth Weight <2500 Grams, Verylow Birthweight <1500 Grams
- Trial name
- NCT01344616
- Testing
- lifestyle support
- Where
- United States
- Volunteers
- 482 people, healthy volunteers welcome
- Sponsor
- PHCC LP
Preterm Birth, Health Care Utilization
Testing Feasibility of Care Coordination and Motivational Interviewing for Women With a Recent Preterm Birth
This study continues an adaptation of care coordination to address the needs of women after preterm birth. This is a small single arm open trial designed to test intervention implementation and refine the intervention before…
- Conditions
- Preterm Birth, Health Care Utilization, Tobacco Use, Contraceptive Usage
- Trial name
- NCT05120843
- Testing
- Care coordination and motivational interviewing
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Philadelphia
Obesity, Lifestyle-related Condition
Lifestyle Intervention in Preparation for Pregnancy (LIPP)
Studies evaluating lifestyle intervention in obese women during pregnancy have reported limited success in decreasing excessive gestational weight gain, and have failed to achieve the key outcome of breaking the obesity cycle and…
- Conditions
- Obesity, Lifestyle-related Condition, Macrosomia, Fetal
- Trial name
- NCT03146156
- Testing
- Lifestyle Intervention
- Where
- 4 sites in United States
- Volunteers
- 143 people, healthy volunteers welcome
- Sponsor
- Tufts Medical Center
Obesity
A Study to Evaluate the Effect of the Experimental GLP-1 Drug PF-07081532 on Blood Levels of Common Birth Control Pills, and Drugs Omeprazole and Midazolam, and Effect of GLP-1 Drug Semaglutide on Midazolam Blood Levels in Healthy Adults With Weight in the Obesity Range
Two different groups of healthy volunteers will be chronically treated with GLP-1 drugs PF-07081532 or alternatively Semaglutide.
- Trial name
- NCT05671653
- Testing
- PF-07081532, Semaglutide
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Pfizer
Plagiocephaly
Premie Pouch to Manage Deformational Plagiocephaly in Very Low Birth Weight Infants
This pilot project proposes to develop and test a new device to manage (defined as resolving, prohibiting, inhibiting or preventing) the development of Deformational Plagiocephaly (DP) in prematurely born infants weighing < 1…
- Trial name
- NCT03184441
- Testing
- Premie Pouch
- Where
- 3 sites in United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
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
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
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
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
Sleep, Pregnancy
Ghana PrenaBelt Trial: A Positional Therapy Device to Reduce Still-Birth
Every day in Ghana, 47 babies are stillborn (SB) and 232 babies are born with low birth-weight (LBW) - many of whom will die in infancy or suffer lifelong consequences.
- Conditions
- Sleep, Pregnancy, Stillbirth, Infant, Low Birth Weight
- Trial name
- NCT02379728
- Testing
- PrenaBelt, Body Position Sensor
- Where
- Ghana
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Allan Kember
Obesity, Morbid, Spinal Anesthesia
ED90 for Hyperbaric Bupivacaine in Super Obese Parturients
The aim of this study is to determine the ED90 of hyperbaric intrathecal bupivacaine for the super obese population undergoing cesarean section under a combined spinal epidural technique.
- Conditions
- Obesity, Morbid, Spinal Anesthesia, Cesarean Delivery
- Trial name
- NCT03781388
- Testing
- Bupivacaine
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Duke University
Obesity
Evaluation of an Enhanced Delivery Model for Go NAPSACC
This study will compare the effectiveness and cost of Basic and Enhanced delivery models for Go NAPSACC on child care centers' use of evidence-based nutrition and physical activity practices.
- Trial name
- NCT03938103
- Testing
- Enhanced Go NAPSACC, Basic Go NAPSACC
- Where
- 2 sites in United States
- Volunteers
- 364 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Infant, Small for Gestational Age, Infant, Low Birth Weight
KBTH-GIRHL Healthy Birth Weight Study: A Cross-Section
This study was designed and conducted in an effort to establish a comparison group for the Ghana PrenaBelt Trial (NTC02379728). The Ghana PrenaBelt Trial examined the effect, on birth weight, of a belt-like device to help…
- Conditions
- Infant, Small for Gestational Age, Infant, Low Birth Weight, Pregnancy, Sleep
- Trial name
- KBTH-HBWS (NCT03062228)
- Where
- Ghana
- Volunteers
- 162 people, healthy volunteers welcome
- Sponsor
- IWK Health Centre