Clinical trials: Very Premature Baby
Infant, Newborn, Infant, Low Birth Weight
Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2)
This pilot study is a randomized, placebo-controlled, clinical trial to measure changes in blood and urine levels of inositol in premature infants at high risk for retinopathy of prematurity (ROP) following repeated doses of…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- INS-2 (NCT01030575)
- Testing
- Inositol lower volume, Inositol mid-level volume, Inositol high volume
- Where
- 17 sites in United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Premature Birth
Follow-Up of VLBW Infants With Chronic Lung Disease: Respiratory Health and Neurodevelopment
Although previous studies showed that preterm infants resolving from neonatal respiratory disease are more likely to exhibit respiratory illness, developmental disorders, impaired growth and cognitive limitations compared with…
- Trial name
- NCT00358891
- Where
- Taiwan
- Volunteers
- 98 people
- Sponsor
- National Taiwan University Hospital
Pulmonary Arterial Hypertension (PAH), Premature Infants
PNEUMOSTEM® for Improving Respiratory Outcomes in Very Premature Infants Diagnosed With Early Pulmonary Arterial Hypertension
The goal of this clinical trial is to evaluate the safety and potential efficacy of PNEUMOSTEM® for improving respiratory outcomes in very premature infants diagnosed with Early Pulmonary Arterial Hypertension.
- Trial name
- REVIVE-PH (NCT07368088)
- Testing
- PNEUMOSTEM®
- Where
- South Korea
- Volunteers
- 12 people
- Sponsor
- Samsung Medical Center
Partial Mineralocorticoid Deficiency
Impact of the Administration of Fludrocortisone in Very Premature Infants
Water and electrolytic homeostasis is remarkably controlled by the mineralocorticoid pathway (renin-angiotensin-aldosterone system acting on the renal tubule).
- Trial name
- MINIPREM (NCT03001089)
- Testing
- Oral Fludrocortisone (enteral)
- Where
- France
- Volunteers
- 66 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Infant, Newborn, Diseases, Other Preterm Infants
Surfactant Positive Airway Pressure and Pulse Oximetry Trial
This study compared the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24…
- Conditions
- Infant, Newborn, Diseases, Other Preterm Infants, Infant, Small for Gestational Age, Premature Birth
- Trial name
- SUPPORT (NCT00233324)
- Testing
- Surfactant, Continuous Positive Airway Pressure (CPAP), Supplemental oxygen with target saturation of 85 to 89%
- Where
- 22 sites in United States
- Volunteers
- 1,316 people
- Sponsor
- NICHD Neonatal Research Network
Respiratory Distress Syndrome (&Amp; [Hyaline Membrane Disease])
Early Surfactant Administration at FiO₂ >0.25 Under NIPPV for RDS in Very Preterm Infants
This multicenter randomized controlled trial investigates whether initiating pulmonary surfactant (PS) at a lower oxygen threshold (FiO₂ >0.25) during nasal intermittent positive pressure ventilation (NIPPV) for very preterm…
- Trial name
- NCT07100652
- Testing
- Threshold FiO₂
- Where
- China
- Volunteers
- 384 people
- Sponsor
- Jiulongpo No.1 People's Hospital
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
Neonatal, Pain Measurement
Assessment of the NIPE in Very Premature Infant Ventilated and Sedated in Neonatal Reanimation.
The Newborn Infant Parasympathetic Evaluation (NIPE) was developed as a method of analysis of the heart rate variability. The monitor gives a value between 0 (low value of the parasympathetic component) and 100 (high value of the…
- Conditions
- Neonatal, Pain Measurement, Reanimation
- Trial name
- NIPEpréma (NCT05223790)
- Testing
- Pain measurement during care procedures in neonatal reanimation
- Where
- France
- Volunteers
- 50 people
- Sponsor
- University Hospital, Lille
Very Preterm Infants, Zinc Deficiency
Higher and Standard Doses of Enteral Zinc Supplementation in Very Preterm Infants
The goal of this randomized clinical trial is to compare the effect of higher (10 mg per day) versus standard (1 mg per day) doses of zinc supplementation The main questions it aims to answer are: Growth velocities and delta…
- Trial name
- ZnVeryPT (NCT06219525)
- Testing
- Higher dose of enteral zinc, Standard dose of enteral zinc
- Where
- Thailand
- Volunteers
- 120 people
- Sponsor
- Prince of Songkla University
Infantile Hemangioma, Very Low Birth Weight Infants
Timolol for the Prevention of Proliferation of Infantile Hemangioma (TiPPIH Trial)
The purpose of this trial is to see if a topical beta blocker is effective in preventing the proliferation of infantile hemangioma.
- Trial name
- TiPPIH (NCT01434849)
- Testing
- topical 0.5% Timolol maleate
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Alice K. Gong
Infant, Premature, Diseases
Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants
The goal of this clinical trial is to learn if the multisensory early oral administration of human milk (M-MILK) intervention helps infants who are born younger than 32 weeks gestational age (very preterm infants).
- Trial name
- M-MILK RCT (NCT07216664)
- Testing
- Multisensory early oral administration of human milk
- Where
- 2 sites in United States
- Volunteers
- 125 people
- Sponsor
- Loyola University
Prematurity
Human Milk Cream as a Caloric Supplement in Pre-Term Infants
Human milk is commonly considered to have 20 calories per ounce (kcal/oz). However, studies show that up to 65% of human milk may be less than the expected 20 kcal/oz which can greatly affect an infant's growth.
- Trial name
- NCT01487928
- Testing
- Human Milk Cream
- Where
- 2 sites in United States
- Volunteers
- 78 people
- Sponsor
- Baylor College of Medicine
Respiratory Distress Syndrome in Premature Infants, Very Low Birth Weight Baby
Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation
This study hopes to determine whether nitric oxide along with oxygen during the first 20 minutes of life in infants needing help with breathing will reduce the percentage and total exposure to oxygen during that time frame.
- Trial name
- iNO (NCT01220687)
- Testing
- iNO, Nitrogen
- Where
- 2 sites in United States
- Volunteers
- 33 people
- Sponsor
- University of Oklahoma
Infant, Premature
Brain Volumes of Very Low Birth Weight Infants Measured by Cranial Ultrasonography
Neonatal cranial ultrasound (US) remains the method of choice to detect brain injury in high risk preterm infants on neonatal intensive care units (NICU).
- Trial name
- NCT02848755
- Testing
- Cranial ultrasonography
- Where
- Turkey (Türkiye)
- Volunteers
- 341 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
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
Nutrition of Preterm Infants
Early Total Enteral Feeding Versus Conventional Enteral Feeding in Stable Very Low Birth Weight Infants
The purpose of this study is to compare the effect of early total oral feeding versus conventional oral feeding in stable VLBW infants.
- Trial name
- NCT02187978
- Testing
- Early total enteral feeding (ETEF), Conventional enteral feeding (CEF)
- Where
- India
- Volunteers
- 180 people
- Sponsor
- Lady Hardinge Medical College
Infant, Premature, Diseases
Impact of Preterm Single Donor Milk in Very Low Birth Weight Infants
Human milk is the best source of enteral nutrition for the preterm infant. However during the infants first hours and days of life breastmilk from the own mother is usually not available.
- Trial name
- NCT02216292
- Testing
- Control Group, Preterm Single Donor Milk Group
- Where
- Austria
- Volunteers
- 300 people
- Sponsor
- Medical University of Vienna
Preterm Infant, Cerebral Palsy
Does Timing Matter? Supporting Play, Exploration, and Early Developmental Intervention
Infants born very preterm (≤28 weeks of gestation) are at high risk of having developmental disabilities including cerebral palsy, coordination impairments, attention deficit and learning disabilities.
- Trial name
- TimeSPEEDI2 (NCT03518736)
- Testing
- Supporting Play Exploration and Developmental Intervention (SPEEDI)
- Where
- 2 sites in United States
- Volunteers
- 85 people
- Sponsor
- University of Southern California
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
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