Clinical trials: Very Preterm Infant
Very Low Birth Weight Infant, Premature Infants
Pilot Trial Investigating Every Other Day Dosing of Oral Iron in Premature Infants (IQONic)
Study focuses on determining if daily versus every-other-day (EOD) oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks post-menstrual age in premature neonates
- Conditions
- Very Low Birth Weight Infant, Premature Infants, Anemia of Prematurity, Iron Deficiency, Anaemia in Children
- Trial name
- NCT06555315
- Testing
- 6 mg/kg of oral iron as ferrous sulfate administered every other day., 6 mg/kg of oral iron as ferrous sulfate administered every day.
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- CHRISTUS Health
Postnatal Growth Restriction
Impact of Hindmilk on Weight Gain Among Moderate to Very Preterm Infants in Zambia
The primary hypothesis is that very preterm infants between 28 0/7 to 31 6/7 weeks with a birth weight from 1000-1999 grams allocated to the HV breastmilk group (200-240 mL/kg/day) until hospital discharge or 40 weeks'…
- Trial name
- NCT05403684
- Testing
- High-volume breastmilk
- Where
- Zambia
- Volunteers
- 214 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Influenza
Study of Live, Attenuated Influenza Vaccination in Preterm and Full-Term Infants
Severe influenza respiratory disease is increasingly recognized in children. Influenza hospitalization rates in high-risk infants, such as premature infants, are increased some five-fold over rates in other children.
- Trial name
- NCT01194297
- Testing
- Live attenuated influenza vaccine, Inactivated influenza vaccine
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Preterm Birth
Interdisciplinary E-health Based Follow-up of Preterm Born Children
The aim of the study is to assess mental and somatic symptoms of preterm born children at the ages of 2, 5 and 10 by a multidisciplinary team and to evaluate an app that screens for these symptoms.
- Trial name
- NeoUp (NCT06345664)
- Testing
- Diagnostics and intervention recommendations
- Where
- Germany
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- University Hospital Tuebingen
Small for Gestational Age, Infant, Very Low Birth Weight
Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial.
Low-dose aspirin started in the first-trimester has been associated with a decrease of preeclampsia, fetal growth restriction and preterm birth in high-risk pregnancies.
- Conditions
- Small for Gestational Age, Infant, Very Low Birth Weight, Fetal Growth Retardation, Preeclampsia
- Trial name
- GAP (NCT02280031)
- Testing
- Acetylsalicylic Acid
- Where
- 2 sites in Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- CHU de Quebec-Universite Laval
Pneumococcal Infections, Streptococcus Pneumoniae
Immunogenicity of PCV-7 Vaccine in VLBW Infants
Premature infants are at a high risk for pneumonia. The PCV-7 vaccine effectively prevents the invasive disease from Streptococcus pneumoniae in full-term infants, but was not thoroughly studied in premature infants.
- Conditions
- Pneumococcal Infections, Streptococcus Pneumoniae, Infant, Newborn, Infant, Low Birth Weight
- Trial name
- PCV-7 (NCT00273325)
- Where
- 10 sites in United States
- Volunteers
- 368 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Premature Baby 26 to 32 Weeks, Premature Babies
Effects of a Treatment Program Based on the Bobath Concept After Hospital Discharge in Children Born Very Preterm
INTRODUCTION: This project is presented as a continuation of the one approved in 2019 (Code: UALBIO2019/013). Early Intervention is defined as all interventions, including prevention, carried out with children aged 0-6 years…
- Conditions
- Premature Baby 26 to 32 Weeks, Premature Babies, Neurodevelopment Treatment, Neurodevelopment
- Trial name
- NCT07254780
- Testing
- Bobath, Early Intervention, Ordinary care
- Where
- Spain
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Universidad de Almeria
Infant, Newborn, Infant, Low Birth Weight
Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection
A controlled clinical trial was conducted at eight participating centers between January 1, 1988, and March 31, 1991. Patients were randomly assigned to an intravenous immune globulin group or a control group.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- IVIG (NCT01203345)
- Testing
- IVIG
- Where
- 8 sites in United States
- Volunteers
- 2,416 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Necrotizing Enterocolitis
Role of Probiotics for Prevention of NEC in Preterm VLBW Infants
This prospective randomized double-blind control trial is carrying out in the neonatal unit of Sylhet MAG Osmani Medical College Hospital, Sylhet between July 2012 to December 2015 with the diagnosis of preterm (<33 weeks…
- Trial name
- Probiotics (NCT02650869)
- Testing
- Probiotics, Breast milk
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Sylhet M.A.G.Osmani Medical College
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
Weight Gain Preterm
Strategy to Minimize In-hospital Malnutrition in Premature Babies
Adequate nutrition is important for preventing malnutrition in the postnatal period and thus optimize growth and development of children born prematurely.
- Trial name
- SPN (NCT01217164)
- Testing
- no intervention
- Where
- Brazil
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Hospital Universitario Pedro Ernesto
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
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
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
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
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
Anemia of Prematurity, Very Low Birth Weight Infant
Iron Supplementation and Intestinal Health
This is a randomized double-blinded study of enteral iron supplementation in Very Low Birth Weight infants. The subjects will be randomized into low dose (2 mg/kg/day) and high dose (6 mg/kg/day) of daily iron supplementation.
- Trial name
- NCT04497012
- Testing
- 2mg/kg/day Iron Sulfate, 6 mg/kg/day Iron Sulfate
- Where
- United States
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- University of South Florida
Very Preterm Infants
Feeding the Preterm Gut Microbiota - Impact of Infant-feeding on Preterm Gut Microbiota Development
Preterm infants are especially vulnerable to gut microbiota disruption and dysbiosis since their early gut microbiota is less abundant and diverse.
- Trial name
- FEEDMI (NCT03663556)
- Testing
- Infant-feeding
- Where
- 2 sites in Portugal
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Universidade do Porto
Very Preterm Infant, Very Low Birthweight
LIFT-UP: Randomized Controlled Trial of Fortification of Human Milk
The goal of the LIFT-UP randomized controlled trial is to evaluate the efficacy of feeding routinely and fortified human milk using a standardized clinical protocol to very low birthweight (VLBW) or very preterm (VPT) infants in…
- Trial name
- LIFT-UP RCT (NCT06765863)
- Testing
- Human Milk Fortifier, Volume targets
- Where
- 4 sites in India
- Volunteers
- 776 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)