Clinical trials: Very Preterm Birth
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
Infant, Premature, Leukomalacia, Periventricular
Recombinant Erythropoietin for Neuroprotection in Very Preterm Infants
Periventricular leukomalacia (PVL) is one of the most common brain injuries that occur in preterm infants. Inflammation, hypoxia-ischemia, free oxygen radical formation and excitotoxicity are all known pathogenic mechanisms that…
- Conditions
- Infant, Premature, Leukomalacia, Periventricular, Intraventricular Hemorrhage, Retinopathy of Prematurity
- Trial name
- NCT00910234
- Testing
- recombinant human erythropoietin (rhEpo), Normal saline
- Where
- Taiwan
- Volunteers
- 100 people
- Sponsor
- China Medical University Hospital
Premature; Infant
Comparing of High Flow Nasal Cannula Versus Cpap for Initial Respiratory Stabilisation of Very Premature Infants
Non-invasive continuous positive airway pressure (CPAP) stabilizes premature newborns, but its optimal pressure is unknown. High-flow nasal cannula (HFNC) is an alternative that minimizes trigeminal stimulation but lacks precise…
- Trial name
- SIMPLSAFE3 (NCT06543589)
- Testing
- High-flow-nasal-cannula
- Volunteers
- 443 people
- Sponsor
- Charles University, Czech Republic
Premature Birth
Continuity of Leg Movements in VLBW Premature Infants: From Spontaneous Kicking and Supported Stepping to Independent Walking
The purposes of this one-year follow-up study are twofold: (1) to prospectively examine the spontaneous kicking and the supported stepping movement in VLBW premature infants until attainment of independent walking; and (2) to…
- Trial name
- NCT00354783
- Volunteers
- 15 people
- Sponsor
- National Taiwan University Hospital
Prematurity; Extreme, Feeding Difficulties
Cot-side Suckometry and Oral Stimulation in Very Preterm Infants: A Pilot Study
Very preterm infants - born before 32 weeks' gestational age - commonly experience delayed transition to oral feeding due to immature suck-swallow-breathe coordination.
- Trial name
- STIMPREM (NCT07632066)
- Testing
- Bedside Suckometer, Structured Oral Stimulation Protocol
- Where
- France
- Volunteers
- 17 people
- Sponsor
- Hôpital de la Croix-Rousse
Premature Newborn
Conditions of Realization of the Echocardiography in Newborns
Experimental nociceptive stimulation of the fetus and neonate induces pulmonary artery vasoconstriction. The investigators assessed whether echocardiography for Ductus arteriosus screening may generate this hemodynamic response…
- Trial name
- NCT02893956
- Testing
- echocardiography with postural support, echocardiography with standard condition (usual)
- Where
- France
- Volunteers
- 30 people
- Sponsor
- University Hospital, Montpellier
Bronchopulmonary Dysplasia
Epidemiological Study for Bronchopulmonary Dysplasia (BPD) in China
This study will establish a nationwide cohort of very preterm infants in China, to investigate the epidemiological characteristics and short-term outcomes of BPD in different NICUs around the country.
- Trial name
- NCT03850457
- Testing
- No intervention
- Where
- China
- Volunteers
- 3,800 people
- Sponsor
- Children's Hospital of Fudan University
Infant, Newborn, Infant, Low Birth Weight
Delivery Room CPAP in Extremely Low Birth Weight Infants
This pilot study was designed to determine the feasibility of randomizing extremely low birth weight (ELBW) infants <28 weeks' gestation who required resuscitation to one of two resuscitation methods, either: (a) 100% oxygen by…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- DR-CPAP (NCT01223274)
- Testing
- CPAP/PEEP, Standard management practices
- Where
- 6 sites in United States
- Volunteers
- 104 people
- Sponsor
- NICHD Neonatal Research Network
Human Milk Fortification, Very Low Birth Weight Baby
Enrichment of Human Milk With Human and Bovine Milk-based Fortifiers for Very Preterm Infants: a Meta-analysis
Research has shown that provision of mother's milk is the optimal way to feed very low birthweight (VLBW) infants. Many infants will require a supplement to mother's milk, pasteurized donor human milk (PDHM) compared to preterm…
- Conditions
- Human Milk Fortification, Very Low Birth Weight Baby, Human Milk Nutrition, Human Milk Feeding
- Trial name
- NCT06870318
- Testing
- No intervention; Observational study
- Where
- 2 sites in Canada, Sweden
- Volunteers
- 355 people
- Sponsor
- The Hospital for Sick Children
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
Enterocolitis, Necrotizing
Probiotics Reduce Incidence of Necrotizing Enterocolitis for Very Low Birth Weight Infants
We investigate the efficacy of probiotics in reducing the incidence and severity of necrotizing enterocolitis (NEC) for very low birth weight (VLBW) infants.A prospective, masked, multi-center randomized control trial will be…
- Trial name
- NCT00540033
- Testing
- infloran
- Where
- Taiwan
- Volunteers
- 217 people, healthy volunteers welcome
- Sponsor
- China Medical University Hospital
Tissue Oxygenation
The Correlation Between Tissue Oxygenations Using NIRS and Clinical Outcomes in Very Preterm Infants.
With the development of neonatal critical medicine, the survival rate of premature infants has gradually increased, and the incidence of late complications has significantly decreased, but preterm delivery is still the main cause…
- Trial name
- TCBTOUNACOIVPI (NCT06483867)
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- The First Hospital of Jilin University
VLBW - Very Low Birth Weight Infant
Feeding Study in VLBW Premature Infants
A multi-center, single-blind, randomized, controlled, parallel-designed, prospective trial to compare growth between preterm infants fed one of three study human milk fortifiers added to human milk
- Trial name
- NCT05744193
- Testing
- Exempt Infant Formula
- Where
- 6 sites in United States
- Volunteers
- 22 people
- Sponsor
- Mead Johnson Nutrition
Feeding; Difficult, Newborn, Necrotizing Enterocolitis
A Multi-strain Synbiotic Versus a Multi-strain Probiotic in Premature Infants
The aims are to 1) compare two probiotic treatments (multi-strain synbiotic vs. multi-strain probiotic) on bifidobacteria fecal colonization counts at 1, 2, 3, and 4 weeks of life, 34 weeks corrected gestation age (CGA) ; 2)…
- Trial name
- NCT01337921
- Testing
- Multi-strain Probiotic
- Sponsor
- University of Nebraska
CHILDREN BORN VERY PRETERM AT SCHOOL-AGE
QUALITY OF LIFE OF CHILDREN BORN VERY PRETERM AT SCHOOL-AGE
AIMS The aims were 1) to describe the quality of life (QoL) of a cohort of children born very preterm (<28 weeks of gestation) aged 7 to 9 years; 2) to compare children's QoL to the QoL reported by a French general population of…
- Trial name
- NCT01675726
- Testing
- questionary on quality of life
- Where
- France
- Volunteers
- 350 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Gastric Tube Placement
Correct Gastric Tube Placement in Very Low Birth Weight Neonates
Gastric tube (GT) placement is a recurrent procedure in VLBW infants due to feeding impairment correlated with low birth weight.
- Trial name
- NCT04127773
- Testing
- oro gastric tube
- Where
- Italy
- Volunteers
- 220 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Very Low Birth Weight Infants, Premature Infants
Delayed Cord Clamping in Very Low Birth Weight Infants
The purpose of this study is to determine if there is a difference in neonatal outcomes with delayed umbilical cord clamping at 30 versus 60 seconds.
- Conditions
- Very Low Birth Weight Infants, Premature Infants, Intraventricular Hemorrhage
- Trial name
- DCC (NCT02337088)
- Testing
- Delayed cord clamping at 30 seconds, Delayed cord clamping at 60 seconds
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- University of Chicago