Clinical trials: Low; Birthweight
Newborn Complication, Premature
Between Urgency and Efficiency: Assessing the Feasibility of Implementing a Protocol for the Care of Extremely Premature and Very Low Birth Weight Infants During the First Hour of Life: GOLD Study
Premature newborns are a particularly vulnerable population, especially during the first hours of life as they adapt to life outside the womb.
- Trial name
- GOLD (NCT07461623)
- Testing
- Golden Hour protocol
- Sponsor
- Centre Hospitalier Universitaire de Nice
Meconium Ileus, Very Low Birth Weight Infant
Impact of Oral Application of Gastrografin on the Meconium Evacuation in Very Low Birth Weight Infants
Gastrografin is a radiopaque contrast agent for the gastrointestinal tract (GIT) which can be applied orally or rectally. In neonatal intensive care, Gastrografin is used to detect otherwise radiologically invisible perforations…
- Trial name
- NCT01515696
- Testing
- Gastrografin, Sterile water
- Volunteers
- 96 people
- Sponsor
- Nadja Haiden,MD
Prematurity, Low Birth Weight
Supplementation With Lactoferrin in Preterm Newborns
The main objective of the study is to evaluate the antioxidant effect of lactoferrin and its ability to reduce free radicals related diseases in the newborn.
- Trial name
- lactoprenew (NCT01172236)
- Testing
- Lactoferrin
- Volunteers
- 1,300 people
- Sponsor
- University of Siena
Adrenal Insufficiency
Relative Adrenal Insufficiency in Preterm Very Low Birth Weight Infants With Shock
The objective of this study is to estimate the prevalence of relative adrenal insufficiency in preterm very low birth weight infants with and without shock.
- Trial name
- NCT00974337
- Where
- India
- Volunteers
- 39 people
- Sponsor
- All India Institute of Medical Sciences
Intervention
Effect of Developmental Care on Very Low Birth Weight Infants
The goal of this clinical trial is to learn if developmental care works when implemented in very low birth weight infants. The main questions it aims to answer are: Does developmental care shorten the length of hospital stay in…
- Trial name
- NCT06515574
- Testing
- developmental care
- Where
- 2 sites in China
- Volunteers
- 1,600 people
- Sponsor
- Children's Hospital of Fudan University
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
Iron Deficiency, Anemia of Prematurity
Neurodevelopment After Early Iron Supplementation
Background: Iron deficiency in early childhood may impair neurodevelopment. Aim: To examine whether early iron supplementation improved neurodevelopment in preterm infants.
- Conditions
- Iron Deficiency, Anemia of Prematurity, Neurodevelopmental Delay
- Trial name
- NCT00457990
- Testing
- Oral administration of ferrous sulphate
- Where
- Germany
- Volunteers
- 204 people
- Sponsor
- University of Ulm
NAFLD
Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals
The investigators will conduct a proof-of-principle 4-weeks low-calorie diet (LCD) intervention study in low birth weight (LBW) subjects and normal birth weight (NBW) controls with documented (MR scan) liver fat content equal to…
- Trial name
- NCT05842850
- Testing
- Caloric restriction intervention, No intervention
- Where
- 2 sites in Denmark
- Volunteers
- 8 people
- Sponsor
- Steno Diabetes Center Copenhagen
Bronchopulmonary Dysplasia, Necrotizing Enterocolitis
Effects of Delayed Cord Clamping in Very Low Birth Weight Infants
The purpose of this study was to see if a brief delay in cord clamping for 30 to 45 seconds would result in higher hematocrit levels, fewer transfusions, healthier lungs, and better motor function at 40 wks and 7 months of age.
- Conditions
- Bronchopulmonary Dysplasia, Necrotizing Enterocolitis, Intraventricular Hemorrhage, Late Onset Neonatal Sepsis
- Trial name
- NCT00840983
- Testing
- delayed cord clamping
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- University of Rhode Island
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
Anticandidal Property of Saccharomyces Boulardii on Very Low Birth Weight Infants
Comparison of Saccharomyces Boulardii and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants
Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Saccharomyces boulardii was shown to reduce candida colonization.
- Trial name
- NCT01411748
- Testing
- Reflor, mikostatin
- Where
- Turkey (Türkiye)
- Volunteers
- 140 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Prone Positioning, Bronchopulmonary Dysplasia
Prone Versus Supine Positioning and the Impact on Bronchopulmonary Dysplasia in Very Low Birth Weight Infants.
In this pilot study, the investigator team aims to evaluate whether standardized prone positioning compared to usual positioning improves moderate to severe bronchopulmonary dysplasia (BPD) rates as assessed at 36 weeks post…
- Trial name
- NCT04890158
- Testing
- Prone positioning for a total of 6 hours daily
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Montefiore Medical Center
Staphylococcal Sepsis
Safety and Pharmacokinetics Study in Adults for the Prevention of S. Epidermidis Infection in Low Birth Weight Infants
The purpose of this Phase 1 study is to evaluate the safety and pharmacokinetics of BSYX-A110 in a small number of healthy adult volunteers.
- Trial name
- NCT00636285
- Testing
- BSYX-A110
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Biosynexus Incorporated
Infant, Extremely Low Birth Weight, Feeding Behavior
Somatosensory Modulation of Salivary Gene Expression and Oral Feeding in Preterm Infants
Two innovative approaches, pulsatile orocutaneous entrainment of non-nutritive suck via orosensory entrainment (NTrainer) device technology and serial salivary gene expression analyses, will be merged to examine the relation…
- Trial name
- NCT02696343
- Testing
- NTrainer
- Where
- 4 sites in United States
- Volunteers
- 121 people
- Sponsor
- University of Nebraska Lincoln
Very Low Birth Weight Infant, Placental Transfusion
Extrauterine Placental Transfusion In Neonatal Resuscitation Of Very Low Birth Weight Infants
To investigate the effect of extrauterine placental transfusion (EPT) compared to delayed cord clamping (DCC) on the mean hematokrit on the first day of life in very low birth weight infants (VLBW) born by caesarian section.
- Conditions
- Very Low Birth Weight Infant, Placental Transfusion, Anemia
- Trial name
- EXPLAIN (NCT03916159)
- Testing
- Extrauterine placental transfusion (Intervention group), Delayed cord clamping (Control group)
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Universitätsklinikum Köln
Preterm Birth, Low Birth Weight
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Periodontal disease in pregnant women has been implicated as a potential risk factor for adverse pregnancy outcomes, including being born preterm, small-for-gestational age, and/or low birth weight.
- Conditions
- Preterm Birth, Low Birth Weight, Small Vulnerable Newborn, Small-for-gestational Age
- Trial name
- NCT07553286
- Testing
- A package of oral health interventions, including a daily antiseptic oral rinse (alcohol-free cetylpyridinium chloride (0.075%))
- Volunteers
- 2,280 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Cytomegalovirus Disease
TT-CMV Observational Birth Cohort Study
The spread of viruses through transfusions is the cause of serious illness and death in recipients whose immune systems are unable to fight infection.
- Trial name
- TT-CMV (NCT00907686)
- Where
- 3 sites in United States
- Volunteers
- 600 people
- Sponsor
- Emory University
Breast Milk, Premature Infant
Individualized Fortification of Breast Milk
Objectives: To compare the effects of two different methods of individualized protein fortification of breast milk on the early growth of VLBW preterm infants.
- Trial name
- NCT03324126
- Volunteers
- 32 people
- Sponsor
- Ozgul Bulut
Necrotizing Enterocolitis, Very Low Birth Weight Infants
Splanchnic Oxygenation After the First Enteral Feed in Preterm Infants: Prediction of Feeding Tolerance.
Enteral nutrition of preterm and intrauterine growth-restricted (IUGR) infants is still a challenge for neonatologists. Due to the immaturity of the gastrointestinal tract, preterm infants are at high risk of developing feeding…
- Trial name
- NIRS-SO (NCT02383264)
- Where
- Italy
- Volunteers
- 61 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Infant, Newborn, Infant, Low Birth Weight
Development of Standards for the New Ballard Maturation Score
The primary purpose of this study was to evaluate the accuracy of gestational age (GA) estimates by using the New Ballard Score (NBS) in newborns 24 to 27 weeks GA with accurate obstetric estimates of GA.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Ballard (NCT01203449)
- Where
- 11 sites in United States
- Volunteers
- 1,090 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network