Clinical trials: Infant, Very Low Birth Weight
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
Very Low Birth Weight Infant
Individualized Fortification of Human Milk for Infants Born ≤ 1250 g (MaxiMoM-InForM)
Very low birth weight infants have increased nutritional needs. Extra nutrients are added to their human milk feeds to help improve their nutritional status, growth and neurodevelopment.
- Trial name
- NCT05308134
- Testing
- Standard fortification, Target fortification, BUN adjustable fortification
- Where
- 20 sites in Canada
- Volunteers
- 615 people
- Sponsor
- The Hospital for Sick Children
Low Birth Weight Infant
Nutrition, Growth and Development Among Very Preterm Infants
The main purpose of this study is to evaluate the effect of increased supply of energy, protein, vitamin A and the long chain polyunsaturated fatty acids docosahexaenoic acid and arachidonic acid on growth, brain maturation and…
- Trial name
- PRENU (NCT01103219)
- Testing
- Nutrition
- Where
- 3 sites in Norway
- Volunteers
- 50 people
- Sponsor
- University of Oslo
Very Low Birth Weight Infant, Very Preterm Maturity of Infant
USCOM Parameters in Preterm Infants: Reference Ranges
The goal of this observational study is to learn about the feasibility of hemodynamic measurement by the UltraSonic Cardiac Output Monitor (USCOM) in very preterm or very-low-birth-weight infants.
- Trial name
- NCT05961657
- Testing
- Hemodynamic measurements by USCOM
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- Fondazione IRCCS San Gerardo dei Tintori
Neurodevelopmental Outcomes
Single Patient Room Versus Open Bay in NICU
The NICU at the IWK Health Center in Halifax, Nova Scotia is embarking on a redevelopment project that will see its current open bay design converted to a single room care environment.
- Trial name
- NCT03867669
- Testing
- Open Bay Unit, Single patient room
- Where
- Canada
- Volunteers
- 160 people
- Sponsor
- IWK Health Centre
Infant, Very Low Birth Weight, Metabolic Syndrome, Protection Against
Growth, Risks of Allergy and Metabolic Syndrome in 6 Year Old Children Born Preterm Compared to Postdischarge Nutrition
This is a follow-up cohort study of 6 years old children born preterm in Denmark from 2004-2008, and at four different neonatal units. During hospitalisation they received breast milk with fortification.
- Conditions
- Infant, Very Low Birth Weight, Metabolic Syndrome, Protection Against, Allergy, Dietary Modification
- Trial name
- NCT02078687
- Testing
- Enfamil HM fortifier, Mead Johnson, Enfalac Premature Formula, Mead Johnson Nutritionals, Mothers own milk
- Where
- Denmark
- Volunteers
- 239 people
- Sponsor
- University of Southern Denmark
Low Birthweight Infant, Preterm
Exploring Minor Proteins and Peptides in Human Milk: a Proteomic Analysis Across Lactation Stages
Human milk (HM) is the optimal food source for the nutrition, growth, and development of newborns. The protein fraction of HM plays a crucial role in the healthy development of infants.
- Conditions
- Low Birthweight Infant, Preterm, Very Low Birth Weight Preterms
- Trial name
- PROTEOM-MILK (NCT06787963)
- Where
- 2 sites in Spain
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Maimónides Biomedical Research Institute of Córdoba
Necrotising Enterocolitis
The Efficacy of Symbiotic on Cytokines
The aim of this prospective double blinded randomised study is to investigate the efficacy of symbiotic preparation which contains lactobacillus casei, L. rhamnosus, L.
- Trial name
- NCT01899677
- Testing
- distilled water, symbiotic
- Where
- Turkey (Türkiye)
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Sepsis, Necrotising Enterocolitis Neonatal
Integrated Predictive Monitoring for Sepsis and Necrotizing Enterocolitis
Behind the scenes pilot trial in the computer lab involving chart review to use neonatal intensive care unit data to create computer models predicting sepsis and necrotizing enterocolitis in very small premature infants
- Trial name
- PREMO (K) (NCT07254559)
- Testing
- No Intervention: Observational Cohort
- Where
- United States
- Volunteers
- 144 people
- Sponsor
- University of Virginia
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
Respiratory Distress Syndrome
Effects of Volume Guarantee With Pressure Supported vs. Synchronized Intermittent Mandatory Ventilation in VLBW Infants
Studies in preterm infants have shown that adding volume guarantee (VG) to synchronized modes of ventilation is not only feasible but also advantageous for providing more constant and desirable mechanical breath size.
- Trial name
- NCT00295230
- Testing
- PSV+VG mode versus SIMV+VG mode
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Children's Hospitals and Clinics of Minnesota
Infant, Newborn, Infant, Low Birth Weight
Early-Onset Sepsis Surveillance Study
In this observational study, the NICHD Neonatal Research Network (NRN) is conducting surveillance of all infants born at NRN centers to identify all newborns who are diagnosed with early-onset sepsis (EOS) and/or meningitis.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- EOS (NCT00874367)
- Where
- 19 sites in United States
- Volunteers
- 615 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Hypotension, Very Low Birth Weight Infants
N-Terminal Pro-B-Type Natriuretic Peptide and Troponin Levels as Markers of Hemodynamic Stability in Very Low Birth Weight Infants During the First Days of Life
The primary objective is to test the hypothesis that there is an association between the hemodynamic status and the serum levels of NT-proBNP and cTnT in prematurely born infants.
- Conditions
- Hypotension, Very Low Birth Weight Infants, Ventricular Dysfunction, Prematurity
- Trial name
- NCT00425581
- Volunteers
- 100 people
- Sponsor
- Sheba Medical Center
Obstructive Sleep Apnea, Pregnancy Induced Hypertension
Sleep Quality in Pregnancy and Its Impact on Pregnancy Outcomes
Hypothesis:Sleep Disorders are very common during pregnancy but the their exact role in causation of pregnancy related disorders is yet to be determined.
- Conditions
- Obstructive Sleep Apnea, Pregnancy Induced Hypertension, High-Risk Pregnancy, Restless Leg Syndrome
- Trial name
- NCT02016638
- Testing
- Polysomnography and ambulatory blood pressure recording
- Where
- India
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- All India Institute of Medical Sciences
Infant, Newborn, Infant, Low Birth Weight
Cerebral Function Monitoring in Premature Infants
This observational study tests the feasibility of enrolling subjects and obtaining an amplitude-integrated electroencephalogram (aEEG) within the first 72 hours of life, a second aEEG recording between 72-168 hours of life, and…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NCT00873847
- Where
- 8 sites in United States
- Volunteers
- 102 people
- Sponsor
- NICHD Neonatal Research Network
Neonatal Staphylococcal Sepsis
Safety and Pharmacokinetics Study in VLBW Neonates With BSYX-A110
"Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose Escalating, Safety and Pharmacokinetics Study in Very Low Birth Weight Neonates of Four Doses of BSYX-A110 for the Prevention of S.
- Trial name
- N002 (NCT00631878)
- Testing
- Pagibaximab (formerly BSYX-A110)
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Biosynexus Incorporated
Infant, Very Low Birth Weight
L-arginine Concentrations and CPS Polymorphisms in VLBW Infants
Plasma L-arginine concentrations are decreased in premature infants with necrotizing enterocolitis (NEC). A carbamoyl-phosphate synthetase 1 (CPS1) polymorphism has been correlated with low plasma concentrations of L-arginine in…
- Trial name
- NCT00554866
- Testing
- blood sample and buccal swab sample
- Where
- 4 sites in Italy, Netherlands and 1 more
- Volunteers
- 477 people
- Sponsor
- Maastricht University Medical Center
NIDCAP
Application of the Best Evidence of Neonatal Individualized Developmental Care Assessment Program (NIDCAP) in Very Low Birth Weight Infant (VLBWI)
In order to help THE GROWTH and development of VLBWI in Neonatal Intensive Care Unit (NICU) and reduce the interference of external environment to them, we summarized the best evidence of NIDCAP care, and applied the evidence to…
- Trial name
- NCT05166720
- Testing
- NIDCAP care
- Where
- China
- Volunteers
- 14 people
- Sponsor
- Children's Hospital of Fudan University
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
Olive Oil Adverse Reaction, Nursing Caries
Effect of Enteral Olive Oil Supplement On Weight Gain and Development of Some Complications in Preterm
Objective: The objective of the present research is to compare the nutritional status, weight gain, length of hospital stay, and development of some complications in very low birth-weight (VLBW) infants who received and did not…
- Conditions
- Olive Oil Adverse Reaction, Nursing Caries, Enteral and Supplement Feeds Adverse Reaction, Preterm
- Trial name
- NCT05815849
- Testing
- Olive oil
- Where
- Turkey (Türkiye)
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Kocaeli University