Clinical trials: Very Low Birthweight Infants
Apnea of Prematurity
Caffeine for Apnea of Prematurity (CAP)
At least 5 of every 1000 live-born babies are very premature and weigh only 500 to 1250 grams at birth. Approximately 30-40% of these high-risk infants either die or survive with lasting disabilities.
- Trial name
- NCT00182312
- Testing
- Caffeine citrate injection
- Where
- 34 sites in United States, Australia and 7 more
- Volunteers
- 2,000 people
- Sponsor
- McMaster University
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
Premature Infant
Effects Of Not Measuring Gastric Residual Content On Feeding Tolerance In Premature Infants iNFANTS
Omitting evaluation of gastric residual contents prior to feeding very premature infants will increase the feeding intake at 2 weeks, and total caloric intake and growth by 3 weeks, as well as decrease the time required for…
- Trial name
- NCT01965769
- Testing
- No gastric residual evaluation
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- University of Florida
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
Nosocomial Infection, Necrotizing Enterocolitis
Effect of Oral Probiotic Supplementation on The Rate of Hospital Acquired Infection and Necrotizing Enterocolitis in Preterm Very Low Birth Weight Infants
The purpose of this study is to determine whether oral probiotic supplementation could reduce the incidence of nosocomial infections in preterm infants.
- Trial name
- NCT01340469
- Testing
- probiotics
- Where
- Thailand
- Volunteers
- 160 people
- Sponsor
- King Chulalongkorn Memorial Hospital
Infant, Very Low Birth Weight
OptiMoM Grows Up: 5.5-year Follow-up of the OptiMoM Fortifier Study
In Canada, the leading cause of long-term disability in children is being born at very low birth weight (VLBW). To help improve outcomes, nutrition is a modifiable aspect of infant care.
- Trial name
- NCT04308902
- Testing
- VLBW, Term-born Comparison
- Where
- Canada
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- The Hospital for Sick Children
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
Extreme Prematurity, Extremely Low Birth Weight
RCT: The Effect of Held Position During Kangaroo Care on Physiological Parameters of Premature Infants
The goal of this superiority crossover randomised controlled trial is to investigate whether there is an optimal position at which to perform kangaroo mother care (KMC) in extremely preterm infants in the NICU.
- Conditions
- Extreme Prematurity, Extremely Low Birth Weight, Very Low Birth Weight Infant, Premature Birth
- Trial name
- NCT05686252
- Testing
- Held Position
- Where
- Ireland
- Volunteers
- 20 people
- Sponsor
- University College Cork
Premature Birth, Infant, Very Low Birth Weight
The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia
This study is multicentered, prospective, randomized, opened, parallel, intervention study. The aim of this study is to evaluate the efficacy and safety of Montelukast sodium in the prevention of bronchopulmonary dysplasia (BPD)…
- Conditions
- Premature Birth, Infant, Very Low Birth Weight, Bronchopulmonary Dysplasia
- Trial name
- BPD (NCT01717625)
- Testing
- Montelukast
- Where
- South Korea
- Volunteers
- 72 people
- Sponsor
- Ajou University School of Medicine
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
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
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, Newborn, Infant, Low Birth Weight
Delayed Cord Clamping in VLBW Infants
This study tested the feasibility of conducting a randomized controlled trial to vary the timing that doctors clamp the umbilical cord after birth in extremely low birthweight infants.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NCT01222364
- Testing
- Standard Cord Clamping, Delayed Cord Clamping
- Where
- 4 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Respiratory Distress Syndrome
Extubation Readiness Study in Very Low Birthweight Infants
The objective of this study is to determine whether use of the spontaneous breathing trial allows for earlier successful extubation of very low birth weight (VLBW) infants who are intubated for >48 hours and have not yet been…
- Trial name
- NCT01471431
- Testing
- spontaneous breathing trial
- Where
- 2 sites in United States
- Volunteers
- 81 people
- Sponsor
- University of Pennsylvania
Central Line Bloodstream Infections
The Effectiveness of Silver Alginate (Algidex) Patch in the Prevention of Central Line Infections in Very Low Birth Weight Infants
The purpose of this study is to determine whether silver alginate (Algidex) patch is effective in the prevention of central line infections in very low birth weight infants.
- Trial name
- NCT00964093
- Testing
- Silver Alginate
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Baylor Research Institute
Hyperglycaemia
Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates
Very low birthweight neonates commonly develop high blood sugar levels. There is an association between high blood sugar levels and poorer short term outcomes but it is not known whether the high sugar level itself actually…
- Trial name
- NCT01419873
- Testing
- Actrapid Human Insulin
- Where
- New Zealand
- Volunteers
- 30 people
- Sponsor
- Christchurch Women's Hospital
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, Low Birth Weight
A Randomized Clinical Trial on Supplementation of DHA and AA to Preterm Infants
A randomized, double-blind trial of docosahexaenoic and arachidonic acid supplementation in breast-fed preterm infants Background: Docosahexaenoic acid (DHA) and arachidonic acid (AA) are essential for preterm infants.
- Trial name
- NCT00226187
- Testing
- Supplement of fatty acid (DHA and AA)
- Where
- Norway
- Volunteers
- 140 people
- Sponsor
- University of Oslo
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)
Very Low Birth Weight Infant
Pharmacokinetic Study of Fluconazole in Premature Infants
The purpose of this study is to investigate the pharmacokinetics of fluconazole which is used as prophylaxis of invasive fungal infection in premature infants.
- Trial name
- NCT01683760
- Testing
- Fluconazole
- Where
- South Korea
- Volunteers
- 80 people
- Sponsor
- Seoul National University Hospital