Clinical trials: Birth Weight
Low-Birth-Weight Infant
Implementation Research of Kangaroo Mother Care in Rural Pakistan.
Pakistan has a high neonatal mortality rate (55/1000 live birth)(1) and each year more than 200,000 newborns die. In rural Pakistan, more than 50% deliveries occur at home and majority by unskilled birth attendants(2).
- Trial name
- KMC (NCT03545204)
- Testing
- Kangaroo Mother Care Package, Routine Standard Care
- Where
- 2 sites in Pakistan
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Aga Khan University
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
Low Birth Weight
DarDar Nutrition Study in HIV Breastfeeding Women
This study being conducted in Dar es Salaam, Tanzania, to determine if a protein-calorie supplementation (PCS) and micronutrient supplement (MNS) will have an impact on health outcomes for HIV-infected pregnant women and their…
- Trial name
- DarDar2B (NCT01461863)
- Testing
- Porridge protein calorie supplement, multivitamin
- Where
- Tanzania
- Volunteers
- 96 people
- Sponsor
- Dartmouth-Hitchcock 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.
Weight, Birth, Premature Birth
Effects of Olfactory and Gustatory Stimulus on the Nutrition of Premature Babies
The objective of this clinical trial is to test the effects of olfactory and taste stimulation with milk or water in premature newborns with a gestational age between 28 and 32 weeks.
- Trial name
- NCT06305052
- Testing
- Milk, Water
- Where
- Brazil
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Professor Fernando Figueira Integral Medicine Institute
Premature Birth
Three-Part Program for Parents With Premature Infants
This study evaluated the efficacy of a comprehensive, three-part program for parents of premature infants. This program was designed to improve development in preterm children and includes an educational video, tests to evaluate…
- Trial name
- NCT00056680
- Testing
- Psychoeducational video, Infant massage, Brazelton Neonatal Behavioral Assessment Scale
- Where
- 5 sites in United States
- Volunteers
- 173 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Anemia of Prematurity, Very Low Birth Weight Infant
Iron Supplementation and Intestinal Health
This is a randomized double-blinded study of enteral iron supplementation in Very Low Birth Weight infants. The subjects will be randomized into low dose (2 mg/kg/day) and high dose (6 mg/kg/day) of daily iron supplementation.
- Trial name
- NCT04497012
- Testing
- 2mg/kg/day Iron Sulfate, 6 mg/kg/day Iron Sulfate
- Where
- United States
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- University of South Florida
Weight
Energy Expenditure Assessment of Premature Infants
The goal of this study is verify if the energy expenditure in preterm infant fed with human milk is different from preterm formula.
- Trial name
- NCT00769509
- Testing
- energy expenditure in preterm fed with preterm formula, assessment of energy expenditure
- Where
- Brazil
- Volunteers
- 25 people
- Sponsor
- Oswaldo Cruz Foundation
Very Low Birth Weight Infant, Growth Failure
Targeted Fortification of Pasteurized Donor Human Milk
This randomized controlled trial aims to evaluate a modified targeted fortification method of pasteurized donor human milk (PDHM) in very low birth weight infants (VLBWs).
- Conditions
- Very Low Birth Weight Infant, Growth Failure, Donor Breast Milk
- Trial name
- NCT04640805
- Testing
- Protein supplementation, Analysis with Miris Human Milk Analyzer
- Where
- Singapore
- Volunteers
- 61 people
- Sponsor
- KK Women's and Children's Hospital
Low Birth Weight Infants
The Influence by Dietary Human Milk Oligosaccharide in Low Birth Weight Infants
This study aims to investigate the concentration of various growth factors and cytokines in blood, and to examine the gut microbiota of low birth weight infants fed with formulas with or without Human Milk Oligosaccharide (HMO)…
- Trial name
- NCT05203900
- Testing
- Infant formula with Human Milk Oligosaccharide, Infant formula without Human Milk Oligosaccharide
- Where
- Thailand
- Volunteers
- 60 people
- Sponsor
- Meiji Co., Ltd.
Metabolic Bone Disease, Osteopenia
A Study to Assess Metabolic Bone Disease of Prematurity Using an Acoustic Method
The goal of this project is to develop a new noninvasive ultrasound based technique, called vibro-acoustic analysis (VAA), for evaluation of infant bone health with particular application in assessment of bone health in premature…
- Conditions
- Metabolic Bone Disease, Osteopenia, Neonatal Rickets
- Trial name
- NCT04752098
- Testing
- Vibro-acoustic analysis (VAA), based on ultrasound radiation force
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Mayo Clinic
Low Birth Weight Baby, Very Low Birth Weight Baby
Home-based Interventional Program on Low Birth Weight Baby Care
The goal of this interventional study is to evaluate whether a home-based interventional program for mothers can improve their knowledge and performance in caring for their low birth weight baby at home.
- Trial name
- (HBEP-LBWC) (NCT07482904)
- Testing
- Home-based Interventional group
- Where
- Iraq
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Chawarwan Saleem Abdullah
Premature Birth, Low Birth Weight
Pilot Trial of CenteringPregnancy With Mindfulness Skills
In the U.S., rates of preterm birth and low birth weight have increased over the past 30 years. Poor birth outcomes are especially high among racial/ethnic minority populations.
- Conditions
- Premature Birth, Low Birth Weight, Postpartum Depression
- Trial name
- NCT01646463
- Testing
- CenteringPregnancy, CenteringPregnancy with Mindfulness Skills
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Low-Birth-Weight
Impact of Promoting Community Initiated Kangaroo Mother Care (KMC) for Low Birth Weight Infants
This study is being conducted to assess the impact of promoting community initiated Kangaroo Mother Care (ciKMC) for low birth weight babies on post enrolment neonatal mortality and mortality post enrolment upto 6 months of age.
- Trial name
- KMC-LBW (NCT02653534)
- Testing
- Kangaroo Mother Care
- Where
- India
- Volunteers
- 8,402 people, healthy volunteers welcome
- Sponsor
- Society for Applied Studies
Prematurity
Lactase-Assisted Control Trial On Weight GAin in INfants.
Lactose, a disaccharide that includes the monosaccharides glucose and galactose, is the main carbohydrate found exclusively in mammalian milk.
- Trial name
- LACTOGAIN (NCT07150884)
- Testing
- Lactase
- Where
- Greece
- Volunteers
- 100 people
- Sponsor
- Aristotle University Of Thessaloniki
Infant, Newborn, Infant, Low Birth Weight
Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome
The purpose of this study is to compare the efficacy of two surfactants, Exosurf Neonatal (Burroughs Wellcome Co.) and Survanta (Ross Laboratories), for the treatment of neonatal respiratory distress syndrome.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Surfactant 1 (NCT01203358)
- Testing
- Exosurf, Survanta
- Where
- 13 sites in United States
- Volunteers
- 617 people
- Sponsor
- NICHD Neonatal Research Network
Overweight or Obesity
NDPP-NextGen: A Clinical Trial to Reduce Intergenerational Obesity and Diabetes Risks
The goal of this clinical trial is to test an enhanced version of the National Diabetes Prevention Program (NDPP-NextGen) that is tailored to young women in childbearing years.
- Trial name
- NCT05674799
- Testing
- NDPP-NextGen
- Where
- United States
- Volunteers
- 403 people, healthy volunteers welcome
- Sponsor
- Wake Forest University Health Sciences
Birth Outcomes, Stunting
Uganda Birth Cohort Study
The UBC was a USAID-funded longitudinal prospective cohort study of pregnant women (n= 5030) aged 15-49 years from rural North and South-Western regions of Uganda, conducted between 2014 and 2016.
- Conditions
- Birth Outcomes, Stunting, Wasting, Anemia
- Trial name
- UBC (NCT04233944)
- Where
- United States
- Volunteers
- 5,044 people
- Sponsor
- Tufts University
Body Mass Index 25 or Greater, BRCA1 Gene Mutation
Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members
This pilot clinical trial studies different types of energy balance interventions to see how well they work in increasing the physical activity levels of breast cancer gene-positive patients, Lynch syndrome-positive patients…
- Conditions
- Body Mass Index 25 or Greater, BRCA1 Gene Mutation, BRCA2 Gene Mutation, Breast Carcinoma
- Trial name
- NCT02194387
- Testing
- Dietary Intervention, Internet-Based Intervention, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 337 people, healthy volunteers welcome
- Sponsor
- M.D. Anderson Cancer Center
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