Clinical trials: Very Preterm Birth
Chronic Lung Disease of Prematurity, Bronchopulmonary Dysplasia
Relationship Between EIT and Respiratory Status in Very Preterm Infants
Electrical Impedance Tomography (EIT) is a non-invasive imaging technique that can measure lung function in real time. This study will follow premature infants to see if EIT can help predict which infants will be successful in…
- Conditions
- Chronic Lung Disease of Prematurity, Bronchopulmonary Dysplasia, Premature Lungs
- Trial name
- NCT06609135
- Testing
- Sentec LuMon Device (EIT system), Sentec Digital Monitoring System (transcutaneous CO2 monitor)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Lawrence Rhein
Newborn Complication, Premature
Between Urgency and Efficiency: Assessing the Feasibility of Implementing a Protocol for the Care of Extremely Premature and Very Low Birth Weight Infants During the First Hour of Life: GOLD Study
Premature newborns are a particularly vulnerable population, especially during the first hours of life as they adapt to life outside the womb.
- Trial name
- GOLD (NCT07461623)
- Testing
- Golden Hour protocol
- Sponsor
- Centre Hospitalier Universitaire de Nice
Premature Birth, Brain Injuries
Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants
This project is a Randomised Clinical Trial that includes a tactile-kinesthetic somatosensory stimulation or family centred education intervention with families of preterm infants at risk for sensori-motor disorders.
- Trial name
- NTM (NCT05542108)
- Testing
- Multisensory Stimulation and Family Education Group, Family Education Only Group (FEG)
- Where
- Italy
- Volunteers
- 24 people
- Sponsor
- University of Pisa
Neonatal Disease
Effect of DHA on Proinflammatory Cytokines Including Platelets Activating Factor (PAF) in Preterm Neonates
The purpose of this study is to determine whether docosahexaenoic acid is effective in the prevention or reducing severity of necrotizing enterocolitis in preterm/low birth weight neonates.Necrotizing enterocolitis (NEC) is the…
- Trial name
- NCT04746885
- Testing
- DHA
- Where
- Egypt
- Volunteers
- 80 people
- Sponsor
- Ain Shams University
Premature Infant
Calmer Brains in Very Preterm Infants
Very preterm infants in the neonatal intensive care unit (NICU) need lifesaving medical procedures which can be stressful and affect brain development.
- Trial name
- NCT07262385
- Testing
- Calmer
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- University of British Columbia
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
Preterm Infant, Growth
Using a New Human Milk Fortifier to Optimize Feeding
This study aims to compare the safety and efficacy of a new HMF and those of other HMF used before in very preterm infants.
- Trial name
- NCT04283799
- Testing
- A new human milk fortifier
- Where
- 7 sites in China
- Volunteers
- 276 people
- Sponsor
- Children's Hospital of Fudan University
Preterm Birth, Blood Transfusion Complication
Blood Warming in Preterm Infants to Decrease Hypothermia
Background/significance: Over 100,000 early preterm infants are born annually in the United States and suffer morbidity and mortality during hospitalization in a neonatal intensive care unit. One such condition is hypothermia.
- Conditions
- Preterm Birth, Blood Transfusion Complication, Hypothermia
- Trial name
- NCT05170633
- Testing
- Ranger blood warmer (3M Healthcare, Oakdale, Minnesota)
- Where
- United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- University of South Carolina
Cerebral Palsy, Infant, Newborn, Disease
Effectiveness of Family Collaborative Physiotherapy Programs With High-risk Infants
High risk infant is defined as infant with a negative history of environmental and biological factors, which can lead to neuromotor development problems.
- Conditions
- Cerebral Palsy, Infant, Newborn, Disease, Infant, Small for Gestational Age, Infant Asphyxia
- Trial name
- NCT04035291
- Testing
- exercise
- Where
- Turkey (Türkiye)
- Volunteers
- 63 people
- Sponsor
- Sanko University
PreTerm Neonate, Sedation for Invasive Mechanical Ventilation
Efficacy of Dexmedetomidine Versus Midazolam Sedation on Extubation Time in Mechanically Ventilated Preterm Infants
Very preterm neonates (born before 32 weeks' gestation) often require invasive mechanical ventilation (IMV) to manage respiratory insufficiency.
- Conditions
- PreTerm Neonate, Sedation for Invasive Mechanical Ventilation, Very Preterm Neonates With Sedation for Invasive Mechanical Ventilation
- Trial name
- DEXPRE (NCT06878703)
- Testing
- Midazolam, Dexmedetomidine
- Where
- France
- Volunteers
- 380 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Premature Infant
Cincinnati Infant Neurodevelopment Early Prediction Study (CINEPS)
The Early Prediction Study is a longitudinal population-based cohort study for very preterm infants ≤32 weeks gestational age. Preterm infants recruited from three greater Cincinnati and two Dayton area neonatal intensive care…
- Trial name
- NCT03345069
- Where
- United States
- Volunteers
- 393 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Respiratory Distress Syndrome
Minimally Invasive Surfactant Therapy Followed by CPAP (MISTCPAP) in Preterm Infants With RDS
There is a reducing incidence of pneumothorax, PIE and the combined outcome of death or BPD since the development of Surfactant therapy.
- Trial name
- MISTCPAP (NCT01723683)
- Testing
- Surfactant
- Where
- Taiwan
- Volunteers
- 60 people
- Sponsor
- China Medical University Hospital
Bronchopulmonary Dysplasia
Montelukast in Very Low Birthweight Infants
The purpose of this study is to determine the pharmacokinetics (PK) of montelukast (Singulair) in very low birth weight (VLBW) infants at risk for developing bronchopulmonary dysplasia (the need for supplemental oxygen).
- Trial name
- NCT00492102
- Testing
- Montelukast
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Prematurity, Speech Sound Disorder
Early Intervention in Very Preterm Children
The aim of the present study is to examine the effectiveness of a short, highly structured parent based speech intervention program on speech development in very preterm children with a Speech Sound Disorder (SSD) at 2 years of…
- Trial name
- NCT01352481
- Testing
- Early parent-based speech intervention program
- Where
- Netherlands
- Volunteers
- 25 people
- Sponsor
- Erasmus Medical Center
Enteral Nutrition, Born Very Premature
Prolonged Minimal Enteral Nutrition Versus Slowly Advancing Enteral Nutrition in Very Low Birth Weight Infants:
Recent studies showed the benefits of early initiation and advancement enteral feeds with daily increments in preterm infants on decreasing invasive infections and early achievement of full enteral feedings.
- Conditions
- Enteral Nutrition, Born Very Premature, Infant, Very Low Birth Weight
- Trial name
- NCT02913677
- Testing
- nutrition
- Where
- Turkey (Türkiye)
- Volunteers
- 199 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Apnea of Prematurity
Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study
Apnea of prematurity is a common condition that is usually treated with methylxanthines. Methylxanthines are adenosine receptor blockers that have powerful influences on the central nervous system.
- Trial name
- CAP-S (NCT01020357)
- Testing
- Caffeine citrate injection
- Where
- 4 sites in Australia, Canada
- Volunteers
- 201 people
- Sponsor
- McMaster University
Neonatal Sepsis, Early-Onset, Very Low Birth Weight Infant
IgM-Enriched Immunoglobulin for Neonatal Sepsis
This study compares giving prophylactic IgM enriched Intravenous Immunoglobulin (IVIG) with placebo in 1 hour after birth, in neonates with risk factors of Early-Onset Neonatal Sepsis (EONS).
- Conditions
- Neonatal Sepsis, Early-Onset, Very Low Birth Weight Infant, Inflammation, Infant, Newborn, Disease
- Trial name
- NCT04041765
- Testing
- IgM-enriched IVIG
- Volunteers
- 70 people
- Sponsor
- Fakultas Kedokteran Universitas Indonesia
Premature Birth
Follow-Up at 6 Years of a Cohort of Children Born Very Prematurely
Utilization of nitric oxide (NO) therapy has been related to a trend towards short term improvement in very premature infants. A two year follow-up of children treated soon after birth with NO in the neonatal period, suggests…
- Trial name
- NCT00390065
- Testing
- Nitric Oxide
- Where
- 2 sites in France
- Volunteers
- 108 people
- Sponsor
- Maternite Regionale Universitaire
Safety Issues, BPD - Bronchopulmonary Dysplasia
Autologous Cord Blood Cells for Prevention of BPD in Preterm
To study the effect of Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates
- Conditions
- Safety Issues, BPD - Bronchopulmonary Dysplasia, Neonatal Death
- Trial name
- NCT04311476
- Testing
- Autologous Umbilical Cord Blood Mononuclear Cells infusion Therapy, 0.9% Sodiun Chloride
- Where
- China
- Volunteers
- 62 people
- Sponsor
- yangjie
Ductus Arteriosus, Patent, Very Low Birth Weight Infants
Comparing Ibuprofen And Indomethacin For The Treatment Of The Patent Ductus Arteriosus in Very Premature Babies
The purpose of the study is to determine the safety and efficacy of ibuprofen, compared with indomethacin, in the treatment for the closure of the patent ductus arteriosus in premature babies born under 29 weeks gestation
- Trial name
- NCT00470743
- Testing
- Ibuprofen, Indomethacin
- Where
- Singapore
- Sponsor
- KK Women's and Children's Hospital