Clinical trials: Preterm Infant Nutrition
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
Premature Birth of Newborn, Malnutrition; Intrauterine or Fetal, Small-for-dates
The BabyGrow Longitudinal Study of Nutrition and Growth in Preterm Infants
This is a longitudinal, observational study on nutrition, growth and body composition in preterm infants. Aims to determine the adequacy of actual nutrient intake during the preterm period by investigating associations between…
- Trial name
- BabyGrow (NCT01881256)
- Volunteers
- 70 people
- Sponsor
- University College Cork
Preterm Infant Nutrition and Immune Function
Preterm Arginine INTake Study
The investigators will explore the effect of current intravenous feeding (parenteral nutrition (PN)) formulations on blood arginine levels and the genes that are involved in body nutrition and fighting infection in premature…
- Trial name
- PAINT (NCT02751437)
- Testing
- Arginine
- Where
- United Kingdom
- Volunteers
- 26 people
- Sponsor
- Liverpool Women's NHS Foundation Trust
Liver Disease
Half-life of Plasma Phytosterols in Very Low Birth Weight Preterm Infants With Parenteral Nutrition-associated Cholestasis
Parenteral nutrition-associated cholestasis (PNAC) is one of the most common complications resulting from administration of parenteral nutrition in neonates.
- Trial name
- NCT02947594
- Volunteers
- 37 people
- Sponsor
- Università Politecnica delle Marche
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
Prematurity, Light-For-Dates
Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants
In this proposed clinical trial, the investigators will randomize 80 very preterm (VPT) infants to receive either early (between day 4 and 7) or delayed (between day 10 and 14) fortification and determine if providing early…
- Conditions
- Prematurity, Light-For-Dates, Enteral Feeding Intolerance
- Trial name
- ENACT+ (NCT05525585)
- Testing
- Early HMF, Delayed HMF
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- University of Alabama at Birmingham
Premature; Infant, Light-for-dates, Enteral Feeding Intolerance
Exclusive Enteral Nutrition in Preterm Neonates
To test the hypothesis that early exclusive enteral nutrition with the minimal use of parenteral nutrition will improve preterm infants' nutritional outcomes when compared to delayed progression of enteral nutrition and prolonged…
- Trial name
- ENACT (NCT04337710)
- Testing
- Exclusive Enteral Nutrition, Progressive Enteral Nutrition
- Where
- United States
- Volunteers
- 102 people
- Sponsor
- University of Alabama at Birmingham
Growth, Body Composition
Effect of Target Fortified Human Milk on the Growth Quality of Very Preterm Infants (TargetFort)
It is reported that the standard method for fortification of human milk (HM) overestimates the energy and protein densities of HM (Macedo MHNP 2018), thus originating infant undernutrition (Macedo AJP 2018).
- Conditions
- Growth, Body Composition, Prematurity, Breast Milk Collection
- Trial name
- TargetFort (NCT04400396)
- Testing
- standard HM fortification, target HM fortification
- Where
- Portugal
- Volunteers
- 80 people
- Sponsor
- Centro Hospitalar de Lisboa Central
Postnatal Growth Disorder
Target Fortification of Breast Milk: How Often Breast Milk Needs to be Measured?
It has been observed that target fortification on different schedules leads to meal to meal variation. It changes the ratio of protein to energy and the percentage of carbohydrate to non-protein energy which may, affect growth.
- Trial name
- TFO2 (NCT02865941)
- Testing
- Fortification with modular protein, Fortification with modular carbohydrate, Fortification with modular fat
- Where
- Canada
- Volunteers
- 56 people
- Sponsor
- McMaster Children's Hospital
Hearing Loss, Mental Retardation
Postnatal HCMV Infection in Very Preterm Infants. Implications, Morbidity, Growth and Neurodevelopmental Outcomes.
The aim of this study is to investigate short and long term consequences from early postnatal HCMV infection transmitted via human milk in very preterm infants (birth weight < 1500 g or gestational age < 32 weeks).
- Conditions
- Hearing Loss, Mental Retardation, Microcephaly, Chorioretinitis
- Trial name
- NCT01151462
- Where
- Norway
- Sponsor
- Oslo University Hospital
Prematurity, Feeding Disorder Neonatal
Preterm Infants May Better Tolerate Warmer Feeds
Feeding intolerance is frequent among preterm infants in neonatal intensive care units (NICUs). Although there are many studies about enteral nutrition strategies and content in preterm infants, no evidence-based standards exist…
- Trial name
- Prematurity (NCT03743207)
- Testing
- Room temperature, Warmer temperature
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people
- Sponsor
- Ege University
Infant Malnutrition, Light-For-Dates With Signs of Fetal Malnutrition
Early DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
Growth-restricted very preterm infants (VPT) are born without adequate fat mass (FM) deposits and low docosahexaenoic acid (DHA) concentrations.
- Conditions
- Infant Malnutrition, Light-For-Dates With Signs of Fetal Malnutrition, Premature, Nutrition Disorder, Infant
- Trial name
- NCT06207071
- Testing
- DHA
- Where
- United States
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
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
Postpartum Depression, Lifestyle, Healthy
Nutrition and Physical Activity Intervention on Psychosocial Well-Being of Postpartum Mothers
This study aims to examine the effectiveness of nutrition and physical intervention to improve psychosocial well-being of postpartum mothers with preterm infants.
- Trial name
- NCT05444179
- Testing
- Mommies can Eat & Exercise with No Stress (MomEENS)
- Where
- Malaysia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Universiti Teknologi Mara
Premature Birth
Human Milk Fortifiers and Acid-Base Status
Double-blind randomized controlled trial to investigate the impact of two human milk fortifiers on acid-base status and longitudinal growth and weight gain in preterm infants.
- Trial name
- NCT00196482
- Testing
- changing of fortifier
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- University Medicine Greifswald
Preterm Birth
Enhanced Nutrition for Preterm Infants
The overall objective of the proposal is to demonstrate the feasibility of providing increased calories and protein in the first week of life to very low birth weight (VLBW) preterm infants.
- Trial name
- NCT03238768
- Testing
- Enhanced Intravenous Nutrition, Standard Intravenous Nutrition
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- University of Minnesota
Very Low Birth Weight Infant
Clinical Outcomes of Ready-to-Use Parenteral Nutrition in Low Birth Weight Newborns in Colombia 2017-2023
The proposed study aims to assess the clinical outcomes of using ready-to-use parenteral nutrition, specifically Numeta G13E, compared to individualized parenteral nutrition in neonates with very low birth weight.
- Trial name
- NUMETA (NCT06200324)
- Testing
- Ready-to-Use Parenteral Nutrition
- Where
- Colombia
- Volunteers
- 284 people
- Sponsor
- Fundacion Clinica Valle del Lili
Premature, Preterm Infant Health
Vitamin A Supplementation and Breast Milk Vitamin A Levels in Mothers of Preterm Infants
Preterm infants are at increased risk of vitamin A deficiency because they are born with low vitamin A stores and depend largely on breast milk to meet their nutritional needs.
- Conditions
- Premature, Preterm Infant Health, Vitamin A Deficiency, Human Milk
- Trial name
- VITAL (NCT07736768)
- Testing
- Oral multivitamin containing vitamin A
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Mississippi Medical Center
Infant, Premature
Consequences of Parenteral Nutrition Photoprotection on Oxidant Related Diseases Among Extremely Low Birth Weight Infants
The antioxidant system of very low birth weight infants is immature. This immaturity is implicated in the pathogenesis of diseases such as bronchopulmonary dysplasia or retinopathy.
- Trial name
- NCT00328419
- Testing
- photoprotected bags, tubing, syringes, standard tubing and bags
- Where
- France
- Volunteers
- 591 people
- Sponsor
- Hospices Civils de Lyon
Adiposity, Insulin Resistance
PREterM FOrmula Or Donor Breast Milk for Premature Babies
In order to address this crucial question, central to preterm newborn care, a multicentre United Kingdom (UK) -wide study randomising 4000 preterm babies would be necessary to achieve sufficient power to evaluate the impact on…
- Conditions
- Adiposity, Insulin Resistance, Metabolomic Profile, microRNA Profile
- Trial name
- PREMFOOD (NCT01686477)
- Testing
- Unfortified Human donor Milk used to make up any shortfall in mother's own milk, Fortified Human donor Milk used to make up any shortfall in mother's own milk, Preterm Formula used when there is a shortfall in mother's own milk
- Where
- United Kingdom
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Imperial College London