Very Low Birth Weight Infant

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Review clinical trials related to Very Low Birth Weight Infant. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

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. In U.S. neonatal intensive care units (NICUs), human milk is primarily supplemented using standardized fortification, in which a multicomponent fortifier is added to human milk to achieve assumed nutrient content based on standard milk reference values. However, this method does not account for the significant variability in human milk composition or in preterm infant metabolism, and up to half of all very premature infants experience poor growth and malnutrition using current nutritional practices. Poor postnatal growth has adverse implications for the developing preterm brain and long-term neurodevelopment. Recent advances allow for individualized methods of human milk fortification, including adjustable and targeted fortification. Adjustable fortification uses laboratory markers of protein metabolism (BUN level) to estimate an infant's protein requirements. In targeted fortification, a milk sample is analyzed to determine its specific macronutrient and energy content, with additional macronutrient supplementation provided as needed to achieve goal values. Emerging data suggest that both methods are safe and effective for improving growth, however information on their comparable efficacy and neurodevelopmental implications are lacking, particularly using advanced quantitative brain MRI (qMRI) techniques. Through this prospective, randomized-controlled trial, the investigators will compare the impact of individualized human milk fortification on somatic growth and neurodevelopment in preterm infants. Infants will be randomized to receive one of three nutritional interventions: standardized (control group), adjustable, or targeted human milk fortification. Infants will undergo their assigned nutritional intervention until term-equivalent age or discharge home, whichever is achieved first. Brain qMRI will be performed at term-corrected age, and neurodevelopmental follow-up will be performed through 5 years of age.

Participants needed: 150
Trial details
Age: Up to 4Biological sex: AllType: InterventionalSponsor: Children's National Research InstituteUpdated: Jul 11, 2025Locations: 1
Eligibility criteria

Birth gestational age (GA) of ≤32 weeks [+3]

Formula feeding prior to 36 weeks PMA or discharge home (whichever achieved firs... [+2]

Status: Recruiting

Swiss Neonatal Network & Follow-up Group

The chief aim of the Swiss Neonatal Network \& Follow-Up Group (SwissNeoNet) is to maintain and / or improve the quality and safety of medical care for high-risk newborn infants and their families in Switzerland through a coordinated program of research, education and collaborative audit. In support of its aim, SwissNeoNet hosts the official medical quality register for the Swiss level III and level IIB units. Participation for these units is mandatory according to the intercantonal declaration for Highly Specialized Medicine (HSM) of September 22, 2011 and the Society's Standards for Levels of Neonatal Care in Switzerland.

Participants needed: 1,000
Trial details
Age: 0-28Biological sex: AllType: ObservationalSponsor: Swiss Neonatal NetworkUpdated: Jun 29, 2025Locations: 1Duration: 6 Years
Eligibility criteria

Not listed

Status: Recruiting

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

Participants needed: 100
Trial details
Age: 26-32Biological sex: AllType: InterventionalSponsor: CHRISTUS HealthUpdated: Aug 15, 2024Locations: 1
Eligibility criteria

Children (Minor < 18 years of age) [+4]

Status: Not yet recruiting

Enteral Zinc Supplementation in Very Low Birth Weight Infants

The goal of this clinical trial is to observe for changes in rate of weight gain in the very low birth weight (VLBW) infants by adding an enteral Zinc supplement of 1 mg/kg/day of elemental zinc. The main question it aims to answer: • Does an enteral Zinc supplement of 1 mg/kg/day increase rate of weight gain in VLBW infants Researches will compare the experimental group to a placebo group to see if there is a statistical difference in rate of weight gain between the two groups * Once the participants have reached 100 ml/kg/day of enteral feeds. The participants will be randomized to one of two groups. The treatment group will receive \~1 mg/kg/day of elemental enteral Zinc, and the control group to receive similar amount of enteral sterile water put in a colored syringe. The Zinc Supplement would be Zinc Sulfate. The primary team would otherwise be managing the patient's feeding using our hospital's feeding protocol. As long as the patient is tolerating 100 ml/kg/day of enteral feeds, the Zinc Supplement will continue until 36 weeks postmenstrual age (PMA) or hospital discharge, whichever comes first. * The participants will have three Zinc levels measured: once prior to Zinc Supplementation, once at around the four week mark, and once at the completion of therapy.

Participants needed: 50
Trial details
Phase: Phase 3Age: 25-36Biological sex: AllType: InterventionalSponsor: University of TennesseeUpdated: Jun 6, 2024
Eligibility criteria

Birth weight < 1500 grams [+2]

Major congenital malformations especially anomaly of the GI tract [+3]