Clinical trials: Very Preterm Infant
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
Preterm, Very Low Birth Weight Infant
Weight Gain in Extremely Premature Infant With Targeted Versus Adjusted Fortification
Investigation about the effect on weight gain in extremely low birth weight preterm with individualized fortification, according to human milk analysis versus fortification adjusted according to urea serum concentration.
- Conditions
- Preterm, Very Low Birth Weight Infant, Feeding, Breast, Food, Fortified
- Trial name
- FORTIN (NCT04982133)
- Testing
- Protein supplementation based on plasma urea concentration every other week or human milk analysis on experiment
- Where
- Spain
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hospital Universitario La Paz
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
Respiratory Distress Syndrome, Newborn
Feasibility Study of Placement and Surfactant Administration Through a Preterm Size Laryngeal Mask Airway in Very Low Birth Weight Neonates With Respiratory Distress Syndrome
Surfactant administration via a supraglottic airway device or laryngeal mask airway (SALSA) is a minimally invasive method of instilling surfactant in the trachea during spontaneous breathing and after applying nasal continuous…
- Trial name
- NCT06606444
- Testing
- Surfactant Administration Through Laryngeal or Supraglottic Airways
- Where
- Vietnam
- Volunteers
- 45 people
- Sponsor
- Karolinska Institutet
Preterm Infant
Clinical Impact of Non-invasive Neurally Adjusted Ventilatory Assist in Very Preterm Infants
This is a prospective observational study investigating the impact of NIV-NAVA on short-term clinical outcomes and long-term neurodevelopment in very preterm infants.
- Trial name
- NCT06786039
- Testing
- Non-invasive NAVA
- Where
- 2 sites in South Korea
- Volunteers
- 80 people
- Sponsor
- Korea University Anam Hospital
Late Onset Neonatal Sepsis, Necrotizing Enterocolitis
Effects of Oral Probiotic Supplementation on the Clinical Status of Very-low-birth-weight Preterm Neonates.
The purpose of this study was to evaluate the safety of a probiotic foodstuff and its influence on emergence and development of natural intestinal flora and the clinical status of premature very low birth weight neonates.
- Conditions
- Late Onset Neonatal Sepsis, Necrotizing Enterocolitis, Infant, Very Low Birth Weight
- Trial name
- NCT02073214
- Testing
- Probiotic
- Volunteers
- 182 people
- Sponsor
- IBSS Biomed S.A.
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
Bronchopulmonary Dysplasia, Child Development
Maternal Omega-3 Supplementation to Reduce Bronchopulmonary Dysplasia
The aim of this randomized controlled trial is to determine whether docosahexaenoic acid (or DHA, an omega-3 lipid) supplementation in lactating mothers providing breast-milk to their infant born below 29 0/7 weeks of gestational…
- Conditions
- Bronchopulmonary Dysplasia, Child Development, Neonatal and Perinatal Conditions
- Trial name
- MOBYDIck (NCT02371460)
- Testing
- DHA-rich algal oil
- Where
- 16 sites in Canada
- Volunteers
- 461 people
- Sponsor
- CHU de Quebec-Universite Laval
Retinopathy of Prematurity
Pain Response During Examination for Retinopathy of Prematurity
Newborns infants equal or less than 1500 grams and/or equal and less than 32 weeks will have ophthalmologic examination for ROP at 6 weeks old.
- Trial name
- ROP (NCT00648687)
- Testing
- suck 12.5% dextrose in water 5 minutes before the procedure
- Where
- Brazil
- Volunteers
- 100 people
- Sponsor
- National Bioethics Commission of Brazil
Skin to Skin, Premature Newborns
Skin-to-skin Contact During the Transfer From the Delivery Room to the Neonatal Intensive Care Unit: Impact on Very Preterm Infants and Their Parents
Developmental care are recognized as a standard of care for preterm infants in neonatal intensive care units. Regular skin-to skin contacts during the neonatal stay show short and long-term beneficial effects on preterm infants…
- Trial name
- TRANSPAPNEO (NCT05820386)
- Testing
- Skin-to-skin Contact (SSC), Incubator
- Where
- 4 sites in France
- Volunteers
- 118 people
- Sponsor
- University Hospital, Tours
Infant; Premature, Light-For-Dates
Nephrocalcinosis in Very Low Birth Weight Infants
Extremely premature children benefit from specific follow-up that requires high nutritional intake and the use of specific therapies that expose them to the risk of nephrocalcinosis.
- Trial name
- NCT04860583
- Testing
- Renal ultrasound
- Volunteers
- 265 people
- Sponsor
- Hospices Civils de Lyon
Respiratory Infections
Role of Human Milk Bank in the Protection of Severe Respiratory Disease in Very Low Birth Weight Premature Infants
Acute respiratory infections are the leading cause of hospitalization in premature infants worldwide. Severity rates are particularly high in developing countries.
- Trial name
- NCT01390753
- Testing
- Human donor milk
- Where
- Argentina
- Volunteers
- 300 people
- Sponsor
- Fundacion Infant
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
Infant Development
Differences Between the Bayley-II and the Bayley-III in Very Preterm Infants at 2 Years
The objective of this randomized study is to test the hypothesis that scores on the Bayley Scales of Infant Development-III (Bayley-III) are higher than scores on the Bayley Scales of Infant Development-II (BSID-II) in the same…
- Trial name
- NCT01373177
- Testing
- Bayley Scales of Infant Development-II, Bayley Scales of Infant Development-III
- Where
- United States
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Philadelphia
Oral Disorders
Acquisition of Full Oral Feeding and Further Oral Disorders in Extremely Preterm Infants
Extremely premature infants (born before 29 weeks) frequently present oral disorders. The management of these patients require assisted ventilation, enteral nutrition, and intensive daily care (procedural pain, exposure to pain…
- Trial name
- ORAPREM (NCT06648083)
- Testing
- Food autonomy
- Where
- France
- Volunteers
- 170 people
- Sponsor
- Hospices Civils de Lyon
Severe Intra-uterine Growth Restriction, Preterm Birth
Impact of Early and Severe Fetal Growth Restriction on Neurodevelopmental Outcomes in Preterm Infants
Very early onset intra uterine growth restriction (IUGR) affects 5-10% of pregnancies and is the second leading cause of perinatal mortality.
- Conditions
- Severe Intra-uterine Growth Restriction, Preterm Birth, Neurodevelopmental Disorders, Placental Insufficiency
- Trial name
- NCT05381272
- Volunteers
- 20 people
- Sponsor
- Central Hospital, Nancy, France
Infant Respiratory Distress Syndrome, Respiratory Insufficiency
Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study
The purpose of this study is to test whether application of high frequency ventilation through a nasal tube can lower blood carbon dioxide levels in stable preterm infants.
- Conditions
- Infant Respiratory Distress Syndrome, Respiratory Insufficiency, Apnea of Prematurity
- Trial name
- NCT00296231
- Testing
- Nasal high frequency ventilation
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Tarah T Colaizy
Infant, Newborn, Infant, Low Birth Weight
Dexamethasone Therapy in VLBW Infants at Risk of CLD
Infants who are on breathing support are often treated with steroids (dexamethasone); however, the best timing of therapy is not known.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Dexamethasone (NCT00011362)
- Testing
- Dexamethasone Early, Dexamethasone Late
- Where
- 13 sites in United States
- Volunteers
- 371 people
- Sponsor
- NICHD Neonatal Research Network
Respiratory Insufficiency of Prematurity
Canadian Oxygen Trial (COT)
Study Question: In infants who are born at gestational ages of 23 0/7 to 27 6/7 weeks, does lowering the concentration of supplemental oxygen to target an arterial oxygen saturation by pulse oximetry (SpO2)of 85-89% compared with…
- Trial name
- COT (NCT00637169)
- Testing
- Titration of oxygen therapy
- Where
- 23 sites in United States, Argentina and 4 more
- Volunteers
- 1,201 people
- Sponsor
- McMaster University
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