Clinical trials: Very Preterm Infant
Postnatal Growth Restriction
Impact of Hindmilk on Weight Gain Among Moderate to Very Preterm Infants in Zambia
The primary hypothesis is that very preterm infants between 28 0/7 to 31 6/7 weeks with a birth weight from 1000-1999 grams allocated to the HV breastmilk group (200-240 mL/kg/day) until hospital discharge or 40 weeks'…
- Trial name
- NCT05403684
- Testing
- High-volume breastmilk
- Where
- Zambia
- Volunteers
- 214 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Preterm, Very Low Birth Weight Infant
Weight Gain in Extremely Premature Infant With Targeted Versus Adjusted Fortification
Investigation about the effect on weight gain in extremely low birth weight preterm with individualized fortification, according to human milk analysis versus fortification adjusted according to urea serum concentration.
- Conditions
- Preterm, Very Low Birth Weight Infant, Feeding, Breast, Food, Fortified
- Trial name
- FORTIN (NCT04982133)
- Testing
- Protein supplementation based on plasma urea concentration every other week or human milk analysis on experiment
- Where
- Spain
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hospital Universitario La Paz
Prematurity, Very Preterm Maturity of Infant
Sleep in SNOO Smart Sleeper Bassinet in Preterm Infants
The goal of this clinical trial is to compare sleeping in a SNOO Smart Sleeper bassinet (SNOO) with sleeping in traditional bassinet conditions in premature infants. The main questions it aims to answer are: 1.
- Trial name
- NCT05711927
- Testing
- SNOO Smart Sleeper, Traditional bassinet
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Columbia University
Infant, Newborn, Infant, Low Birth Weight
Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection
A controlled clinical trial was conducted at eight participating centers between January 1, 1988, and March 31, 1991. Patients were randomly assigned to an intravenous immune globulin group or a control group.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- IVIG (NCT01203345)
- Testing
- IVIG
- Where
- 8 sites in United States
- Volunteers
- 2,416 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Very Low Birth Weight Infant
Emollient Therapy for Premature Infants in Zimbabwe
The purpose of this study is to assess the efficacy of topical emollient treatments in improving neonatal growth and mortality rates.
- Trial name
- NCT05461404
- Testing
- Topical Emollient Therapy
- Where
- Zimbabwe
- Volunteers
- 520 people, healthy volunteers welcome
- Sponsor
- Stanford University
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
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
Infant Malnutrition, Light-For-Dates With Signs of Fetal Malnutrition
Early DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
Growth-restricted very preterm infants (VPT) are born without adequate fat mass (FM) deposits and low docosahexaenoic acid (DHA) concentrations.
- Conditions
- Infant Malnutrition, Light-For-Dates With Signs of Fetal Malnutrition, Premature, Nutrition Disorder, Infant
- Trial name
- NCT06207071
- Testing
- DHA
- Where
- United States
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
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
Premature Birth
Theory of Mind in Preschool Children, School Children, Youths and Adults Born Preterm or Full-term
This study tests preschoolers, school children, youths and young adults, who were born preterm or full-term, in their theory of mind abilities.
- Trial name
- NCT02628015
- Where
- Germany
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- University of Bonn
Very Low Birth Weight Infants
Cognitive and Behavioral Outcomes of School-aged Children Who Were Born Preterm
This study evaluates the cognitive and behavioral outcomes including image findings of school-aged children who were born preterm compared with who were born term gestational age.
- Trial name
- NCT02741934
- Where
- South Korea
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Very Preterm Maturity of Infant, Enteral Feeding Intolerance
Early Total Enteral Feeding Versus Convention Enteral Feeding in Preterm Infants 27-32 Weeks of Gestation
The objective of the study is to compare the time of attainment of full enteral feeds in preterm neonates between 27-32 weeks of gestation started on early total enteral feeding (ETEF) with those started on conventional enteral…
- Trial name
- ETEFVsCEF (NCT06076460)
- Testing
- Early Total Enteral Feeding, Conventional Enteral Feeding
- Where
- India
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- Lady Hardinge Medical College
Infant Development, Sensory Disorder
The Prechtl's General Movement Assessment, Hammersmith Infant Neurological Examination and Sensory Profile-2
In the Neonatal Intensive Care Unit (NICU), infants encounter many sensory stimuli (excessive noise, bright lights, painful medical applications, etc.) that are not present in the uterus.
- Conditions
- Infant Development, Sensory Disorder, Sensory Processing Disorder, Motor Delay
- Trial name
- highrisk (NCT05217199)
- Testing
- Measurements
- Where
- Turkey (Türkiye)
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Kahramanmaras Sutcu Imam University
Infant Development
Differences Between the Bayley-II and the Bayley-III in Very Preterm Infants at 2 Years
The objective of this randomized study is to test the hypothesis that scores on the Bayley Scales of Infant Development-III (Bayley-III) are higher than scores on the Bayley Scales of Infant Development-II (BSID-II) in the same…
- Trial name
- NCT01373177
- Testing
- Bayley Scales of Infant Development-II, Bayley Scales of Infant Development-III
- Where
- United States
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Philadelphia
Gut Microbiota, Metabolites
Targeting Gut Microbiota and Metabolites for Very Preterm Infants Through Oropharyngeal Administration of Colostrum
Background: Oropharyngeal administration of colostrum (OAC) has an immune stimulating effect on oropharyngeal-associated lymphoid tissue, and can also promote the maturation of the gastrointestinal tract.
- Trial name
- NCT05481866
- Testing
- Oropharyngeal administration of colostrum, Oropharyngeal administration of sterile water
- Where
- China
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Shenzhen People's Hospital
Infant, Newborn, Infant, Small for Gestational Age
Vitamin E for Extremely Preterm Infants
The purpose of this pilot trial is to test the safety and efficacy of administering one dose of vitamin E, via a tube into the stomach, to extremely preterm infants (less than 27 weeks gestation and less than 1000 grams birth…
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Infant, Premature
- Trial name
- NCT01193270
- Testing
- Vitamin E
- Where
- 16 sites in United States
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Infant, Newborn, Infant, Low Birth Weight
The Effects of Erythropoietin (EPO) on the Transfusion Requirements of Very Low Birth Weight Infants
This study tested the safety and efficacy of transfusing erythropoietin (Epo) and iron in infants of <1,250g birth weight. For infants 401-1,000g birth weight, we tested whether early erythropoietin (Epo) and iron therapy would…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- EPO (NCT01203514)
- Testing
- Erythropoietin
- Where
- 9 sites in United States
- Volunteers
- 318 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
Very Preterm Infant, Very Low Birthweight
LIFT-UP: Randomized Controlled Trial of Fortification of Human Milk
The goal of the LIFT-UP randomized controlled trial is to evaluate the efficacy of feeding routinely and fortified human milk using a standardized clinical protocol to very low birthweight (VLBW) or very preterm (VPT) infants in…
- Trial name
- LIFT-UP RCT (NCT06765863)
- Testing
- Human Milk Fortifier, Volume targets
- Where
- 4 sites in India
- Volunteers
- 776 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
Necrotizing Enterocolitis
Probiotics in the Management of Necrotizing Enterocolitis in HIV-exposed Premature Infants
A randomized, double blind, placebo controlled clinical trial was conducted in the neonatal high care unit of Tygerberg Children's Hospital (TBCH) Cape Town, South Africa for the period July 2011 to August 2012.
- Trial name
- NCT01868737
- Testing
- Probiotic
- Where
- South Africa
- Volunteers
- 184 people, healthy volunteers welcome
- Sponsor
- University of Stellenbosch