Clinical trials: Very Preterm Infants
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
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
Vitamin B-12 Deficiency
THE B-BABIES STUDY: An Observational Study of Group B Vitamins in Preterm Infants
Infancy may be associated with a risk of micronutrient depletion due to the high demands of rapid growth. This is particularly true when preterm birth occurs, as the period before term exhibits the highest rate of bodily growth…
- Trial name
- B-BABIES (NCT07163962)
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant
Optimizing Nutrition and Milk (Opti-NuM) Project
Early nutrition critically influences growth, neurodevelopment and morbidity among infants born of very low birth weight (VLBW), but current one-size-fits-all feeding regimes do not optimally support these vulnerable infants.
- Conditions
- Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant, Nutritional Requirements, Human Milk Fortification
- Trial name
- Opti-NuM (NCT06870981)
- Testing
- Opti-NuM is an observational secondary use of data/samples study, the investigators will analyze information and specimens from the MaxiMoM platform RCTs. No interventions form part of this study.
- Where
- 6 sites in United States, Canada
- Volunteers
- 1,100 people
- Sponsor
- The Hospital for Sick Children
Premature Infant
Erythropoietin Protects Very Preterm Infants Against Necrotizing Enterocolitis
This study evaluates the effect of repeated low-dose erythropoietin (EPO) treatment on necrotizing enterocolitis (NEC) in very preterm infants. Half of participants will receive EPO, while the other half will receive a placebo.
- Trial name
- NCT03919500
- Testing
- EPO, Normal saline
- Where
- China
- Volunteers
- 1,285 people
- Sponsor
- Zhengzhou University
Infant, Very Low Birth Weight, Growth Failure
Preterm Infants on Early Solid Foods
Introduction: Preterm infants with a birth weight less than 1500 grams have special nutritional needs in comparison to full-term neonates.
- Trial name
- PIES-Project (NCT01809548)
- Testing
- Early intervention group, Late intervention group
- Where
- Austria
- Volunteers
- 177 people
- Sponsor
- Medical University of Vienna