Clinical trials: Very Preterm Infants
Babies Born Very Preterm
In-line Filtration to Reduce Systemic Inflammatory Response Syndrome in Babies Born Very prEtErm
While venous access is an essential part of caring for the preterm neonate potential severe adverse events, including contamination of fluids with bacteria, endotoxins and particulates could occur (Bethune 2001).
- Trial name
- FRISBEE (NCT02686060)
- Testing
- 0.2 micron positively charged PALL Corporation filters and 1.2 micro IV in-line filters used for lipid administration
- Where
- France
- Volunteers
- 160 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Extremely Premature Newborn (Born Before 32 Weeks' Gestation)
Description of Changes in NIRS as a Function of Ductus Arteriosus Status in Very Premature Babies Born Before 32 WG at the DIJON University Hospital
Monitoring patent ductus arteriosus is currently performed using echocardiography, an operator-dependent examination which requires holding the child on their back and which is potentially time-consuming.
- Trial name
- CAPNIRS (NCT06153771)
- Testing
- Collection of brain and kidney NIRS measurements, echocardiography
- Where
- France
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire Dijon
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
The goal of this clinical trial is to evaluate whether supplementing with pasteurized donor human milk (pHDM) or preterm formula (PTF) when own mother's milk (OMM) is insufficient can improve outcomes in very preterm infants born…
- Trial name
- NCT07045844
- Testing
- Pasteurized Donor Milk for Insufficient Breastfeeding, Preterm Formula for Insufficient Breastfeeding, Routine fortification
- Where
- 24 sites in China
- Volunteers
- 2,324 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
Preterm Birth, Very Preterm Infant
NICU-to-Home Dyadic Support for Very Preterm Infants and Families
This feasibility study will evaluate delivery of the Supporting Play Exploration and Early Development Intervention after neonatal intensive care unit discharge for very preterm infants and their families.
- Conditions
- Preterm Birth, Very Preterm Infant, Infant Development, Neonatal Intensive Care Unit
- Trial name
- MN-SPEEDI (NCT07820462)
- Testing
- Homebased SPEEDI, Telehealth SPEEDI
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- University of Minnesota
Very Premature Baby
Effects of a Multisensory Intervention Program on the Term Behavior of the Very Premature Baby
The growth and organization of the cerebral cortex is ensured by the oligodendrocyte-rich subplate, whose proper development depends on both subcortical structures and sensory experiences.
- Trial name
- PIVOT (NCT07903766)
- Testing
- Multisensory intervention program, Standard care
- Volunteers
- 144 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Breast Milk Fortifier Supplements, Premature
The Effect of Time to Start Breast Milk Fortifiers on Neonatal Outcomes in Very Low Birth Weight Premature Infants.
In the study, very low birth weight babies born in our hospital will be randomized in the closed envelope method, and breast milk fortifier will be started when 50 ml/kg/day breastfeeding volume is reached in one group, and…
- Trial name
- NCT05251441
- Testing
- Breast Milk Fortifier supplements
- Where
- Turkey (Türkiye)
- Volunteers
- 160 people
- Sponsor
- Ankara City Hospital Bilkent
Gastric Residual Volume, Preterm Infant
Routine Versus no Assessment of Gastric Residual Volumes in Preterm Infants
The practice of checking gastric residuals is not evidence based. The amount of gastric residual volume (GRV) does not correlate with either feeding intolerance or development of NEC.
- Conditions
- Gastric Residual Volume, Preterm Infant, Feeding Disorder Neonatal
- Trial name
- NCT04062851
- Testing
- No Gastric residual volume monitoring
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- AdventHealth
Psychomotor Impairment
Correlation Between Cerebral Oxygenation and Neurodevelopment in VLBW Preterm Infants.
The recent improvements in neonatal intensive care have led to a substantial increase in the survival rate of preterm infants; nevertheless, this population is still at high risk for long-term neurodevelopmental disabilities.
- Trial name
- NCT03104296
- Testing
- Griffiths Mental Development Scales
- Where
- Italy
- Volunteers
- 63 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Enteral Feeding Intolerance, Necrotizing Enterocolitis
Bovine Colostrum for Preterm Newborns
Feeding intolerance is a common problem in very preterm infants due to their immature digestive system. This intolerance extends the time to full enteral feeding and thereby also prolongs the time on parenteral nutrition (PN).
- Conditions
- Enteral Feeding Intolerance, Necrotizing Enterocolitis, Late-Onset Neonatal Sepsis
- Trial name
- PreColos-RCT (NCT03085277)
- Testing
- Bovine Colostrum, Preterm Formula
- Where
- 8 sites in China
- Volunteers
- 350 people
- Sponsor
- Per Torp Sangild
Hypotension, Very Low Birth Weight Infants
N-Terminal Pro-B-Type Natriuretic Peptide and Troponin Levels as Markers of Hemodynamic Stability in Very Low Birth Weight Infants During the First Days of Life
The primary objective is to test the hypothesis that there is an association between the hemodynamic status and the serum levels of NT-proBNP and cTnT in prematurely born infants.
- Conditions
- Hypotension, Very Low Birth Weight Infants, Ventricular Dysfunction, Prematurity
- Trial name
- NCT00425581
- Volunteers
- 100 people
- Sponsor
- Sheba Medical Center
Growth, Necrotizing Enterocolitis
Bovine Colostrum as a Fortifier Added to Human Milk for Preterm Infants
Very preterm infants (<32 weeks gestation) with very low birth weight (VLBW, <1500 g) show immaturity of organs and have high nutrient requirements forgrowth and development.
- Conditions
- Growth, Necrotizing Enterocolitis, Late-Onset Sepsis, Feeding Intolerance
- Trial name
- FortiColos (NCT03537365)
- Testing
- Bovine Colostrum (BC) / intervention group, FM85 / control group
- Where
- 7 sites in Denmark
- Volunteers
- 252 people
- Sponsor
- Per Torp Sangild
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
Infant, Newborn, Infant, Low Birth Weight
Generic Database of Very Low Birth Weight Infants
The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- GDB (NCT00063063)
- Testing
- No Intervention
- Where
- 31 sites in United States
- Volunteers
- 80,000 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Premature, Ductus Arteriosus, Patent
Urine NT-proBNP Levels and Echocardiographic Findings in Very Low Birth Weight (VLBW) Infants
The aim of the study is to evaluate urine NT-proBNP levels and new Echocardiographic Findings in VLBW infants. The investigators hypothesize that high urine NT-proBNP concentrations are associated with a hemodynamically…
- Conditions
- Infant, Premature, Ductus Arteriosus, Patent, Ventricular Function, Left
- Trial name
- NCT00799123
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Charite University, Berlin, Germany
Osteopenia of Prematurity
The Effect of Daily Exercise Program on Bone Mineral Density and Cortisol Level in Preterm Infants
ABSTRACT Objective: This randomized controlled double-blinded experimental study was carried out to determine the effects of daily exercise program on bone mineral density and cortisol level in preterm infants with very low birth…
- Trial name
- NCT03773679
- Testing
- Daily Exercise
- Volunteers
- 24 people
- Sponsor
- TC Erciyes University
Parenteral Nutrition-Associated Liver Disease
Low Dose Parenteral Fat for Prevention of Parenteral Nutrition Associated Cholestasis in Preterm Neonates
The goal of the study is to determine if parenteral nutrition-associated cholestasis (PNAC) is related to the amount of parenteral (intravenous) fat administered to premature babies until full enteral nutrition is achieved.
- Trial name
- NCT01050660
- Testing
- Intravenous fat emulsion, Restriction of intravenous fat emulsion to 1 gm/kg/d
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Yale University
Hyperbilirubinemia, Neonatal, Jaundice, Neonatal
Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight
This multi-center, randomized clinical trial compared different bilirubin levels as thresholds for timing of phototherapy in extremely low birth weight infants.
- Conditions
- Hyperbilirubinemia, Neonatal, Jaundice, Neonatal, Infant, Newborn, Infant, Low Birth Weight
- Trial name
- Phototherapy (NCT00114543)
- Testing
- Aggressive Phototherapy 501-750g, Aggressive Phototherapy 751-1000g, Conservative Phototherapy 501-750g
- Where
- 17 sites in United States
- Volunteers
- 1,974 people
- Sponsor
- NICHD Neonatal Research Network
Neonates and Preterm Infants, Infant Respiratory Distress Syndrome
Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minutes Versus 5 Minutes
Respiratory distress syndrome (RDS) is common in very preterm infants due to surfactant deficiency. Surfactant replacement therapy is lifesaving, and current guidelines recommend the less invasive surfactant administration (LISA)…
- Conditions
- Neonates and Preterm Infants, Infant Respiratory Distress Syndrome, Surfactant Deficiency Syndrome Neonatal, Surfactant
- Trial name
- SurfStab I (NCT07261787)
- Testing
- Poractant alfa (Curosurf®) - 1-minute administration, Poractant alfa (Curosurf®) - 5-minute administration
- Where
- Austria
- Volunteers
- 76 people
- Sponsor
- Medical University of Graz
Premature Birth
Cerebral Blood Flow Parameters and Neurobehavioral Development in Infants at Term Age
Although several studies have contrasted the hemodynamics of cerebral arteries using cranial Doppler ultrasound between full-term and preterm infants, the assessments were mostly conducted in the first days of life.
- Trial name
- NCT00676247
- Where
- Taiwan
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- National Taiwan University Hospital
Preterm Infants
Promoting Full Oral Feeding in Preterm Infants Less Than 30 Weeks Gestational Age
The investigators plan to use a new process to shorten the time of attaining full oral feeding in preterm infants less than 30 weeks gestational age.
- Trial name
- NCT04277806
- Testing
- New Oral feeding process
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Children's Hospital of Fudan University