Clinical trials: Very Preterm Infants
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)
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
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
Retinopathy of Prematurity, Microbiome
The Analysis of Association of Retinopathy of Prematurity, Gut Microbiome Profile, and Systemic Inflammation
Study Aims 1. Understanding the gut microbiome profile in very low birth weight infants with or without ROP. The onset and aggravation of ROP and their relationship with gut microbiome will be examined. 2.
- Trial name
- NCT05144282
- Testing
- intravitreal injection of anti VEGF, laser photocoagulation
- Where
- Taiwan
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Chang Gung Memorial Hospital
Premature Baby 26 to 32 Weeks, Premature Babies
Effects of a Treatment Program Based on the Bobath Concept After Hospital Discharge in Children Born Very Preterm
INTRODUCTION: This project is presented as a continuation of the one approved in 2019 (Code: UALBIO2019/013). Early Intervention is defined as all interventions, including prevention, carried out with children aged 0-6 years…
- Conditions
- Premature Baby 26 to 32 Weeks, Premature Babies, Neurodevelopment Treatment, Neurodevelopment
- Trial name
- NCT07254780
- Testing
- Bobath, Early Intervention, Ordinary care
- Where
- Spain
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Universidad de Almeria
Pneumococcal Infections, Streptococcus Pneumoniae
Immunogenicity of PCV-7 Vaccine in VLBW Infants
Premature infants are at a high risk for pneumonia. The PCV-7 vaccine effectively prevents the invasive disease from Streptococcus pneumoniae in full-term infants, but was not thoroughly studied in premature infants.
- Conditions
- Pneumococcal Infections, Streptococcus Pneumoniae, Infant, Newborn, Infant, Low Birth Weight
- Trial name
- PCV-7 (NCT00273325)
- Where
- 10 sites in United States
- Volunteers
- 368 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Infant, Premature, Erythropoietin
High-Dose Erythropoietin in Extremely Premature Infants to Prevent/Attenuate Brain Injury: A Phase II Study
The highest risk for perinatal brain injury occurs among extremely premature infants who weigh less than 1250 grams at birth. Such perinatal brain injury is currently irreversible, associated with neurodevelopmental disability…
- Conditions
- Infant, Premature, Erythropoietin, Brain Injury, Intraventricular Hemorrhage
- Trial name
- NCT00589953
- Testing
- Erythropoietin
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Atlantic Health System
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
Retinopathy of Prematurity
Oral Propranolol Improve Retinopathy of Prematurity Outcomes in Very Preterm Infants
Retinopathy of prematurity (ROP) is a major cause of blindness and visual impairment in children in both developing and developed countries around the world.
- Trial name
- NCT02977000
- Testing
- Propranolol
- Where
- China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Huiqing Sun
Early-Onset Sepses, Neonatal, Periventricular Haemorrhage Neonatal
Zinc Supplementation on Very Low Birth Weight Infant
Premature birth is a major cause of neonatal death in addition to neonatal asphyxia and infections. Early in life, premature babies must get aggressive nutrition so that there is no extrauterine growth restriction (EUGR) in the…
- Conditions
- Early-Onset Sepses, Neonatal, Periventricular Haemorrhage Neonatal, Bronchopulmonary Dysplasia, Retinopathy of Prematurity
- Trial name
- NCT04050488
- Testing
- Zinc Sulfate
- Volunteers
- 364 people, healthy volunteers welcome
- Sponsor
- Fakultas Kedokteran Universitas Indonesia
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
Hypoglycemia in Newborn Infants
Gel for Early Hypoglycaemia Prevention in Preterm Infants
The GEHPPI study is a multicentre placebo controlled randomized controlled trial that aims to prevent early hypoglycaemia in preterm newborns born at ≤32 week's gestation.
- Trial name
- GEHPPI (NCT04353713)
- Testing
- 40% Dextrose Gel, 2% carboxymethylcellulose gel
- Where
- 5 sites in Czechia, Ireland
- Volunteers
- 534 people, healthy volunteers welcome
- Sponsor
- University College Dublin
Immunomodulation Effect
Effect of Autologous Cord Blood-mononuclear Cells Infusion on Immune Microenvironment in Infants Born Very Preterm in NICU
Multi-omics (analysis of peripheral blood immune cells subset, peripheral blood MNCs transcriptome, soluble inflammatory cytokine profile in blood and airway secretion, lung and gut microbiota, and the interaction) analysis was…
- Trial name
- NCT05087498
- Testing
- autologous cord blood mononuclear cells, normal saline
- Where
- China
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Guangdong Women and Children Hospital
Very Preterm Infant, Very Low Birth Weight Infants
The Use of Early Fortification in Preterm Infants
Very premature or very low birth weight (VLBW) infants are at risk of suboptimal growth after birth, making adequate nutrition essential.
- Trial name
- NCT07861984
- Testing
- Early Fortification, Standard Fortification
- Where
- Indonesia
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Universitas Indonesia
Preterm Birth
NICU-HEALTH (Hospital Exposures and Long-Term Health)
The purpose of this study is to evaluate the impact of environmental exposures during the NICU hospitalization on preterm infant development. The research team is interested in both chemical and non-chemical exposures.
- Trial name
- NCT01963065
- Where
- United States
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
Preterm Infant, Umbilical Cord Milking
Effect of Intact Umbilical Cord Milking on Neonatal and First Year Neurodevelopmental Outcomes in Very Preterm Infants.
The investigators hypothesise that intact umbilical cord milking (I-UCM) will reduce neonatal morbidity and improve long term neurodevelopmental outcome in very preterm infants.
- Trial name
- Cord-milking (NCT03200301)
- Testing
- Intact Umbilical Cord Milking
- Where
- India
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Jubilee Mission Medical College and Research Institute
Small for Gestational Age, Infant, Very Low Birth Weight
Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial.
Low-dose aspirin started in the first-trimester has been associated with a decrease of preeclampsia, fetal growth restriction and preterm birth in high-risk pregnancies.
- Conditions
- Small for Gestational Age, Infant, Very Low Birth Weight, Fetal Growth Retardation, Preeclampsia
- Trial name
- GAP (NCT02280031)
- Testing
- Acetylsalicylic Acid
- Where
- 2 sites in Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- CHU de Quebec-Universite Laval
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
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
Infant, Premature, Diseases, Infant Nutrition Disorders
Early Nutrition and Neurological Development of Very Preterm Infants
The main goal of this study is to determine the association between: the quantity of mother's milk and duration of breastfeeding the intake of polyunsaturated fatty acids and iron during hospitalization and the development of…
- Conditions
- Infant, Premature, Diseases, Infant Nutrition Disorders, Development; Delayed, Mental
- Trial name
- EPINUTRI (NCT01486173)
- Where
- France
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- Lapillonne, Alexandre, M.D.