Clinical trials: Very Low Birth Weight
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)
Apnea of Prematurity
A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants
The purpose of this study is to determine whether nasal intermittent positive pressure ventilation (NIPPV) reduces the need for endotracheal intubation in very low birth weight infants with persistent apnea who fail nasal…
- Trial name
- NCT03298035
- Testing
- NCPAP as mode for apnea prevention, NIPPV as rescue mode for apnea prevention
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- The University of Texas Health Science Center, Houston
BPD - Bronchopulmonary Dysplasia, NEC - Necrotizing Enterocolitis
Targeted vs Standard Fortification of Breast Milk
BACKGROUND: Human milk (HM) is recommended for all very low birth infants (VLBW)). Breast-milk is highly variable in nutrient content, failing to meet the nutritional demands of VLBW.
- Conditions
- BPD - Bronchopulmonary Dysplasia, NEC - Necrotizing Enterocolitis, Weight Gain, VLBW - Very Low Birth Weight Infant
- Trial name
- NCT03775785
- Testing
- Tailored enteral nutrition
- Where
- 2 sites in Poland
- Volunteers
- 200 people
- Sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, Poland
Patent Ductus Arteriosus
Comparative Study of Efficacy and Safety of Oral Ibuprofen and Intravenous Ibuprofen in Closure of Patent Ductus Arteriosus in Very Low Birth Weight Infants
it is a prospective randomized simple-blinded pilot trial with the principal aim to compare efficacy and tolerance between oral ibuprofen and intravenous ibuprofen in early curative closure of PDA in very low birth weight…
- Trial name
- NCT00642330
- Testing
- oral ibuprofen, intravenous ibuprofen
- Where
- Tunisia
- Volunteers
- 62 people
- Sponsor
- Hopital La Rabta
Feeding Intolerance
Glycerin Suppositories for Treatment of Feeding Intolerance in Preterm Infants
Feeding intolerance is a common problem in preterm infants.
- Trial name
- NCT02149407
- Testing
- Glycerin, Rectal stimulation, Control
- Where
- 2 sites in Saudi Arabia
- Volunteers
- 230 people
- Sponsor
- King Saud Medical City
Mechanical Ventilation, Retinal Disease
Cpap at Delivery Room for Preterm Infants
The objective of the study is to determine if CPAP applied within less than 15 min of life in the DR reduces the necessity of mechanical ventilation and surfactant during the first 5 days of life.
- Conditions
- Mechanical Ventilation, Retinal Disease, Death, Respiratory Tract Disease
- Trial name
- CPAP-DR (NCT01024361)
- Testing
- CPAP
- Volunteers
- 200 people
- Sponsor
- University of Sao Paulo
Infant, Very Low Birth Weight
Evaluation of Prolact-Plus Human Milk Fortifier
Prolacta Bioscience has developed the first purely human fortifier, Prolact-Plus, that can provide a source of many of the required nutrients for premature, newborn infants, particularly protein and calories.
- Trial name
- NCT00486590
- Testing
- Prolact-Plus Human Milk Fortifier
- Where
- 4 sites in United States
- Volunteers
- 105 people
- Sponsor
- Prolacta Bioscience
Other Preterm Infants, Transitory Neonatal Electrolyte Disturbance
Clinical Tolerance of Numeta 13%
Numeta G13% is a triple chamber bag including amino acids plus electrolytes, glucose and lipids, dedicated for parenteral nutrition in preterm newborn infants when oral/enteral nutrition is not possible, insufficient or contra…
- Conditions
- Other Preterm Infants, Transitory Neonatal Electrolyte Disturbance, Disorder of Mineral Metabolism, Failure to Thrive
- Trial name
- BAXTERULG2 (NCT01772927)
- Testing
- Parenteral Nutrition
- Where
- Belgium
- Volunteers
- 30 people
- Sponsor
- University of Liege
Bronchopulmonary Dysplasia (BPD), Prematurity
Oral Vitamin A Supplementation for Prevention of Bronchopulmonary Dysplasia in Preterm Infants
Bronchopulmonary dysplasia (BPD) remains a major complication of very low birth weight (VLBW) preterm infants. Vitamin A is essential for lung development and epithelial integrity, and deficiency has been associated with an…
- Conditions
- Bronchopulmonary Dysplasia (BPD), Prematurity, Very Low Birth Weight
- Trial name
- VITA-BPD (NCT07577180)
- Testing
- Vitamin A
- Where
- Turkey (Türkiye)
- Volunteers
- 209 people
- Sponsor
- Erhan Calisici
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
Respiratory Distress Syndrome, Newborn
Diaphragm Electrical Activity of Preterm Infants on nCPAP Versus NIHFV
Preterm babies have immature lungs and frequent pauses in their breathing which often necessitates breathing support. Nasal Continuous Positive Airway Pressure (nCPAP) is one of the most commonly used tools, but does not always…
- Trial name
- NCT02267018
- Testing
- Drager VN500 Ventilator
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- Sunnybrook Health Sciences Centre
Ductus Arteriosus, Patent
Patent Ductus Arteriosus (PDA) Screening Trial
The ductus arteriosus directs blood away from the pulmonary circulation and toward the systemic circulation during fetal life, then closes after birth.
- Trial name
- NCT01031316
- Testing
- Nondisclosure of screening echocardiogram results, Disclosure of screening echocardiogram results
- Where
- 2 sites in United States
- Volunteers
- 88 people
- Sponsor
- University of Pennsylvania
Infant, Very Low Birth Weight, Calcium Deficiency
Identifying Vitamin D Deficiency in Very Low Birth Weight Infant (VLBW) Infants Part 2
This study is to determine the amount of vitamin D required for a very low birth weight infant to reach vitamin D sufficiency and achieve optimal calcium health and bone growth.
- Conditions
- Infant, Very Low Birth Weight, Calcium Deficiency, Vitamin D Deficiency
- Trial name
- NCT01363167
- Testing
- 400 IU Cholecalciferol- Vitamin D Daily
- Where
- 2 sites in United States
- Volunteers
- 68 people
- Sponsor
- Medical University of South Carolina
Premature Birth, Late-onset Invasive Infection
Speed of Increasing Milk Feeds Trial
Survival of preterm infants has increased greatly over the years, so a major aim now is to improve the long term outlook for these babies and to avoid serious complications.
- Conditions
- Premature Birth, Late-onset Invasive Infection, Necrotizing Enterocolitis
- Trial name
- SIFT (NCT01727609)
- Testing
- Milk feed (breast milk or formula milk)
- Where
- 57 sites in Ireland, United Kingdom
- Volunteers
- 2,804 people
- Sponsor
- University of Oxford
Very Low Birth Weight Infants
Comparison of Lactobacillus Reuteri 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. Lactobacillus reuteri was shown to reduce candida colonization.
- Trial name
- NCT01531192
- Testing
- Lactobacillus reuteri, Nystatin
- Where
- Turkey (Türkiye)
- Volunteers
- 300 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Meconium Obstruction of Prematurity
Intestinal Fatty Acid Binding Protein in Very Low Birth Weight Infants With Meconium Obstruction
Urinary intestinal fatty acid binding protein (i-FABP), a marker of intestinal mucosal cell damage, has recently been proposed as a clinically useful measure in the early detection of necrotizing enterocolitis (NEC).
- Trial name
- NCT02864446
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Seoul National University Hospital
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
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
Preterm Infants, Post Traumatic Stress Disorder
Developmental Outcomes of Extreme Prematurity, 5-15 Years Postpartum
The purpose of this study is to assess the emotional well being of mothers to preterm infants with ELBW 5-15 years after the birth. Post-traumatic symptoms and parental stress levels will be taken into consideration.
- Conditions
- Preterm Infants, Post Traumatic Stress Disorder, Emotional Stress, Infant, Very Low Birth Weight
- Trial name
- NCT01430832
- Where
- Israel
- Volunteers
- 95 people
- Sponsor
- Sheba Medical Center
Liver Diseases
Half-life of Plasma Phytosterols in Preterm Infants on Parenteral Nutrition
The purpose of this study is to determine plasma phytosterols half-lives in preterm infants who received intravenous soy oil-based lipid emulsions.
- Trial name
- NCT02758834
- Volunteers
- 45 people
- Sponsor
- Università Politecnica delle Marche