Clinical trials: Preterm Infant Nutrition, open to volunteers
Premature Birth, Premature Infant
Growing Little PEAPODS Study
The goal of this clinical trial is to learn more about how the food and nutrition babies receive while in the Neonatal Intensive Care Unit (NICU) influences their ability to gain weight and fat-free mass, and their future growth…
- Conditions
- Premature Birth, Premature Infant, Premature, Intrauterine Growth Restriction
- Trial name
- NCT06226051
- Testing
- PEAPOD Infant Body Composition measuring device
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of Wisconsin, Madison
Bronchopulmonary Dysplasia (BPD)
Enteral Lipid Supplementation and Bronchoplumonary Dysplasia of Premature Infants
The Impact of Omega-3 (DHA - Docosahexaenoic Acid) and Omega-6 (ARA - Arachidonic Acid) Supplementation on the Development of Bronchopulmonary Dysplasia in Extremely and Very Preterm Infants (24-29 weeks of gestational age).
- Trial name
- PRELUDE (NCT07652684)
- Testing
- Enteral supplementation with ARA and DHA (in a 2:1 ratio) in addition to standard care and feeding, Standard care and feeding
- Where
- Greece
- Volunteers
- 74 people
- Sponsor
- Aristotle University Of Thessaloniki
Prematurity
Preterm Donor Human Milk Supplementation of Mother's Own Milk in VLBW Infants
This prospective randomized controlled trial aims to investigate whether feeding very low birth weight (VLBW) infants with Mother's own milk (MOM) supplemented with either preterm (PDM) or term donor milk (TDM), when MOM is…
- Trial name
- NCT05675397
- Testing
- donor human milk
- Where
- 2 sites in Greece
- Volunteers
- 200 people
- Sponsor
- National and Kapodistrian University of Athens
Premature
Metabolic Mechanisms Induced by Enteral DHA and ARA Supplementation in Preterm Infants
A comprehensive analysis of the impact of exogenous enteral DHA and ARA supplementation on lipid metabolism including the production of downstream derived mediators and how this impacts important biological pathways such as…
- Trial name
- NCT05380401
- Testing
- Enfamil® DHA & ARA Supplement for Special Dietary Use
- Where
- 7 sites in United States
- Volunteers
- 328 people
- Sponsor
- The University of Texas Health Science Center at San Antonio
Preterm Infants
Protocol-driven Nutrition in Preterm Infants
The project is a national, prospective, multicenter, interventional pilot project focused on protocol-driven nutrition in preterm infants in the Czech republic.
- Trial name
- NCT07364500
- Testing
- Nutrition plan supported by advanced clinical nutrition software
- Where
- 5 sites in Czechia
- Volunteers
- 400 people
- Sponsor
- Institute of Health Information and Statistics of the Czech Republic
Newborn; Vitality, Nursing Caries
Effect of Intranasal Breast Milk Administration in Preterm Infants
The aim of the study was to investigate the effect of intranasal breast milk administration on cerebral oxygenation level, vital signs and time to full oral feeding in preterm infants.
- Conditions
- Newborn; Vitality, Nursing Caries, Breast Feeding
- Trial name
- NCT06706115
- Testing
- Intranasal human breast milk
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Selcuk University
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
Health Problems in Pregnancy, Pregnancy Outcomes
Peking University Birth Cohort in Weifang (PKUBC-WF)
The PKUBC-WF is a prospective cohort study carried out in Weifang city of Shandong, China. The primary aim of this study is to investigate the short-term and long-term effects of pre-pregnant and prenatal exposure on maternal and…
- Conditions
- Health Problems in Pregnancy, Pregnancy Outcomes, Gestational Diabetes, Gestational Hypertension
- Trial name
- NCT06234332
- Testing
- No Interventions
- Where
- China
- Volunteers
- 2,800 people, healthy volunteers welcome
- Sponsor
- Peking University
Nutrition Intervention, Quality Improvement
Optimizing Early Nutrition Management of Extremely and/or Very Preterm Infants
A clinical quality improvement bundle on early nutrition supplementation is developed to improving the clinical outcomes (including growth, organ function, and neurodevelopment outcomes) of extremely and/or very preterm infants.
- Conditions
- Nutrition Intervention, Quality Improvement, Preterm Infant
- Trial name
- NCT07538999
- Testing
- A nutritional improving bundle for the intervention group, Routine nutritional strategies for the control group
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Children's Hospital of Fudan University
Extreme Prematurity, Anemia of Prematurity
Folic Acid Supplementation to Reduce Anemia in Extremely Preterm Infants
Anemia of Prematurity (AOP) is very common in extremely preterm infants and often leads to blood transfusions. Folic acid, essential for growth and DNA synthesis, is deficient in premature infants.
- Trial name
- FASCINATE (NCT06220461)
- Testing
- Folic acid
- Where
- Canada
- Volunteers
- 90 people
- Sponsor
- University of Calgary
Vitamin D Deficiency, Osteopenia of Prematurity
The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants.
The aim of this study will be to assess the effectiveness of monitored vit D supplementation in a population of preterm infants and to identify whether the proper vit D supplementation in preterm infants can reduce the incidence…
- Conditions
- Vitamin D Deficiency, Osteopenia of Prematurity, Nephrolithiasis, Metabolic Bone Disease
- Trial name
- HIDVID (NCT06199102)
- Testing
- cholecalciferol/ Devikap
- Where
- Poland
- Volunteers
- 130 people
- Sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, Poland
Neonatal İntensive Care, Nutrition With A Chronobiological Approach
The Effect of PIOMI and Chronobiological Nutrition on Readiness for Feeding, Full Transition to Oral Feeding and Body Weight
This is a randomized controlled experimental study evaluating the effects of oral motor intervention and chronobiological approach to feeding model applied to preterm infants on feeding readiness, transition to total oral feeding…
- Conditions
- Neonatal İntensive Care, Nutrition With A Chronobiological Approach, Readiness For Feding, Body Weight
- Trial name
- PIOMI (NCT07306793)
- Testing
- PIOMI study group, Nutrition Study Group with a Chronobiological Approach, Control group
- Where
- Turkey (Türkiye)
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Aydin Adnan Menderes University
Trace Aluminum Ions in Parenteral Nutrition
Portable Detection, Assessment, and Control of Trace Aluminum Ions in Parenteral Nutrition Formulations for Preterm Infants
The research team will develop a series of multivalent nanozyme materials (MOF@Arg@His) to construct a sensing platform with dual-mode colorimetric and fluorescent responses, thereby markedly improving the sensitivity and…
- Trial name
- PN-Al POCT (NCT07646925)
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Han Tongyan
Prematurity; Extreme, Failure to Thrive in Newborn
Targeted Fortification of Donor Breast Milk in Preterm Infants
This study is a randomized controlled trial comparing standard fortification of donor breast milk to targeted fortification of donor breast milk in preterm infants.
- Conditions
- Prematurity; Extreme, Failure to Thrive in Newborn, Growth Retardation, Growth Failure
- Trial name
- NCT04294368
- Testing
- Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid, Similac Liquid Protein Fortifier, Nestle Microlipid
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Columbia University
Preterm Infant Health, Premature Babies
Human Milk Concentrating Device to Optimize Mother's Own Milk
This study is a randomized, non-inferiority clinical trial evaluating a human milk concentration (HMC) device in preterm infants.
- Trial name
- NEOMOM (NCT07576972)
- Testing
- Human Milk Concentration Device, Standard of Care Fortified Feeding
- Where
- United States
- Volunteers
- 310 people
- Sponsor
- Mother's Milk is Best
Cardiac Abnormalities, Nutrient Intake
Early Nutrition and Heart Structure and Function in Preterm Infants During the First Year of Life
Preterm infants are babies born before 37 completed weeks of pregnancy. Early nutrition is important for their growth and development, and it may also be associated with how their heart develops and functions during infancy.
- Trial name
- NCT07892209
- Testing
- echocardiography
- Volunteers
- 80 people
- Sponsor
- Assiut University
Very Preterm Maturity of Infant, Very Low Birth Weight Infant
Individualized Nutrition to Optimize Preterm Infant Growth and Neurodevelopment
Human milk has several well-established benefits but does not adequately meet the increased nutritional demands of the growing preterm infant, necessitating additional nutrient supplementation in a process known as fortification.
- Trial name
- THRIVE (NCT06266455)
- Testing
- Standardized Fortification, Adjustable Fortification
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Children's National Research Institute
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
Preterm Birth, Preeclampsia
The ROOT Study: Scaling the 'Standard of Care Plus' Obstetric Nutrition Model to Optimize Maternal and Infant Health
The 'Standard of Care Plus' ('PLUS') model in the ROOT Study consists of analyzing select micronutrient and gene variants of pregnant females to construct trimester-specific and personalized nutrition and lifestyle…
- Conditions
- Preterm Birth, Preeclampsia, Gestational Diabetes Mellitus (GDM), Small for Gestational Age (SGA)
- Trial name
- ROOT (NCT07559773)
- Testing
- 'Standard of Care PLUS'
- Volunteers
- 500 people
- Sponsor
- GrowBaby Life Project
Extreme Prematurity, Enteral Nutrition
High-energy Human Milk Diets in the First Two Weeks After Birth to Reduce BPD in Extremely Preterm Infants
This Phase II, parallel-group, masked, randomized clinical trial aims to evaluate whether a DHA/ARA-enriched, fortified human milk diet administered during the first 14 days of life reduces respiratory morbidity and improves lung…
- Conditions
- Extreme Prematurity, Enteral Nutrition, Bronchopulmonary Dysplasia
- Trial name
- MEND-BPD (NCT07307612)
- Testing
- High-energy group, Standard-energy group
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Alabama at Birmingham