Clinical trials: Very Preterm Birth
Feeding; Difficult, Newborn, Necrotizing Enterocolitis
A Multi-strain Synbiotic Versus a Multi-strain Probiotic in Premature Infants
The aims are to 1) compare two probiotic treatments (multi-strain synbiotic vs. multi-strain probiotic) on bifidobacteria fecal colonization counts at 1, 2, 3, and 4 weeks of life, 34 weeks corrected gestation age (CGA) ; 2)…
- Trial name
- NCT01337921
- Testing
- Multi-strain Probiotic
- Sponsor
- University of Nebraska
Premature Infant, Work of Breathing
Work of Breathing and Kangaroo Mother Care
To compare work of breathing and oxygen saturation before, during, and after kangaroo mother care in preterm very low birth weight (VLBW) infants stable on non-invasive respiratory support.
- Conditions
- Premature Infant, Work of Breathing, Oxygen Saturation
- Trial name
- NCT03683316
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Christiana Care Health Services
Feeding Intolerance, Necrotizing Enterocolitis
Bovine Colostrum as a Human Milk Fortifier for Preterm Infants
Very preterm infants (<32 weeks gestation) show the immaturity of organs and have high nutrient requirements for growth and development.
- Conditions
- Feeding Intolerance, Necrotizing Enterocolitis, Postnatal Growth, Late-Onset Neonatal Sepsis
- Trial name
- FortiColos-Ⅱ (NCT03822104)
- Testing
- Bovine Colostrum, FM85
- Where
- 2 sites in China
- Volunteers
- 139 people
- Sponsor
- Per Torp Sangild
Immunomodulation Effect
Effect of Autologous Cord Blood-mononuclear Cells Infusion on Immune Microenvironment in Infants Born Very Preterm in NICU
Multi-omics (analysis of peripheral blood immune cells subset, peripheral blood MNCs transcriptome, soluble inflammatory cytokine profile in blood and airway secretion, lung and gut microbiota, and the interaction) analysis was…
- Trial name
- NCT05087498
- Testing
- autologous cord blood mononuclear cells, normal saline
- Where
- China
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Guangdong Women and Children Hospital
Vitamin A Deficiency, Vitamin D Deficiency
Effects of Fat-soluble Vitamins Supplementation on Common Complications and Neural Development in Very Low Birth Weight Infants
Vitamins A, D, and E play important roles in humans, such as vision function, immune function, bone metabolism, cell growth and differentiation and oxidation resistance.
- Conditions
- Vitamin A Deficiency, Vitamin D Deficiency, Vitamin E Deficiency, Very Low Birth Weight Infants
- Trial name
- NCT03876704
- Testing
- High dose of fat-Soluble Vitamin, Conventional dose of fat-Soluble Vitamin
- Where
- China
- Volunteers
- 120 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
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
Very Low Birthweight
Mother Sibling Interactions Following Very Low Birth Weight (VLBW) Infant Homecoming
The proposed study will explore longitudinally the impact of a very low birthweight (VLBW) infant on mother-sibling interactions and sibling adjustment.
- Trial name
- NCT01385254
- Where
- 2 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Duke University
Premature Infant, Breast Milk Expression
Growth and Nutritional Status of Very Low Birth Weight Infants Fed a High Protein Exclusive Human Milk Diet
The purpose of this two-arm investigation is to determine if growth patterns of very low birth weight infants (VLBW) (birth weight 750-1500 grams) fed human milk (maternal or donor) supplemented with a human milk-based fortifier…
- Trial name
- MedolacHMF (NCT03839173)
- Testing
- Human milk based human milk fortifier
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Augusta University
Bronchopulmonary Dysplasia
PREMILOC Trial to Prevent Bronchopulmonary Dysplasia in Very Preterm Neonates
There is increasing evidence linking a fetal and early neonatal systemic inflammatory response syndrome to the subsequent development of bronchopulmonary dysplasia (BPD) and white matter injury (WMI) in very preterm infants.
- Trial name
- PREMILOC (NCT00623740)
- Testing
- hydrocortisone
- Where
- France
- Volunteers
- 523 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Infant, Very Low Birth Weight, Lactation
Lactation Education Study in Mothers of Very Low Birth Weight Infants
This study will test the effectiveness of breast milk expression discharge instructions in digital video disc (DVD) format for home use by mothers of very low birth weight infants on the dose and duration of mother's breast milk…
- Trial name
- NCT01167517
- Testing
- Instructional digital video disc (DVD)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Wake Forest University Health Sciences
Infant, Newborn, Infant, Low Birth Weight
Inflammatory Cytokines Associated With Perinatal Brain Injury
This observational study assessed whether measurements of certain pro-inflammatory and anti-inflammatory cytokines in the blood (either singly or in combination) at birth and/or up to day of life 21 can predict cerebral palsy at…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Cytokines (NCT01035697)
- Where
- 18 sites in United States
- Volunteers
- 1,067 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Infection
Dynamics of the Microbiome in the Premature Infant
The purpose of the study is to describe the dynamics of the microbiome in the premature infant as a means to adapt the premature infant gut to affect better health outcomes.
- Trial name
- NCT02121938
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Duke University
Late-Onset Neonatal Sepsis, Extreme Prematurity
Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis
Fluid-unresponsive hypotension needing cardiotropic drug treatment is a serious complication in very preterm neonates with suspected late-onset sepsis (LOS; defined as culture positive or negative bloodstream infection or…
- Conditions
- Late-Onset Neonatal Sepsis, Extreme Prematurity, Neonatal Hypotension
- Trial name
- NCT05347238
- Testing
- Dopamine, Norepinephrine
- Where
- 22 sites in United States, Canada and 3 more
- Volunteers
- 550 people
- Sponsor
- Mount Sinai Hospital, Canada
Infant, Very Low Birth Weight
OptiMoM Kindergarten 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
- NCT02759809
- Testing
- Pasteurized donor human breastmilk, Preterm formula
- Where
- Canada
- Volunteers
- 158 people
- Sponsor
- The Hospital for Sick Children
Infant, Newborn, Infant, Low Birth Weight
Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia
This study tested whether Neonatal Intensive Care Unit (NICU) teams trained in benchmarking -- comparing care practices between different NICUs to see which practices prevent bronchopulmonary dysplasia (BPD) -- and quality…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Benchmarking (NCT00067613)
- Testing
- Benchmarking Management Practices, Standard Management Practices
- Where
- 17 sites in United States
- Volunteers
- 4,095 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Very Preterm Birth
Evaluation of a Sensory-tonic Stimulation on Development of Parent-infant Interactions and Social Cognition in Very Premature Children
Attachment is built primarily on the first interactions of the first 9 months of a baby's life. These first interactions and their effects of stress, pleasure and displeasure are retained to establish some of the baby's…
- Trial name
- CALIN (NCT04380051)
- Testing
- sensory-tonic stimulation, skin-to-skin contact
- Where
- France
- Volunteers
- 120 people
- Sponsor
- CHU de Reims
Very Preterm and Extremely Preterm Birth
Sodium and Milk Fortification Evaluation of Body Composition Among Very Preterm Infants
The goal of the trial is to learn if targeted sodium supplementation (including blood and urine sodium testing) versus standard milk fortification (including blood sodium testing) improves growth and body composition in very…
- Trial name
- SAFE (NCT07562997)
- Testing
- Urine sodium testing, Serum sodium testing, Milk fortification
- Where
- 3 sites in United States
- Volunteers
- 150 people
- Sponsor
- University of Washington
Patent Ductus Arteriosus
Feeding During Ibuprofen or Indomethacin Treatment of Preterm Infants
We hypothesize that feeding preterm infants while they receive indomethacin or ibuprofen therapy for treatment of a patent ductus arteriosus will decrease the incidence of feeding intolerance and shorten the time period that…
- Trial name
- NCT00728117
- Testing
- feeding, fasting
- Where
- 14 sites in United States
- Volunteers
- 177 people
- Sponsor
- University of California, San Francisco
Retinopathy of Prematurity, Microbiome
The Analysis of Association of Retinopathy of Prematurity, Gut Microbiome Profile, and Systemic Inflammation
Study Aims 1. Understanding the gut microbiome profile in very low birth weight infants with or without ROP. The onset and aggravation of ROP and their relationship with gut microbiome will be examined. 2.
- Trial name
- NCT05144282
- Testing
- intravitreal injection of anti VEGF, laser photocoagulation
- Where
- Taiwan
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Chang Gung Memorial Hospital
Meconium Ileus
Impact of Visceral Osteopathic Treatment on Meconium Evacuation in Preterm Infants
Timing of the first and last meconium stool is critical for oral feeding tolerance and proper gastrointestinal function. The time until premature infants pass their first meconium ranges from 1 hour to 27 days (median: 43 hours).
- Trial name
- NCT02140710
- Testing
- Osteopathic treatment
- Where
- Austria
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Medical University of Vienna