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Very Low Birth Weight Infant clinical trials

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NCT ID: NCT06433674 Not yet recruiting - Clinical trials for Nutritional Deficiency

Enteral Zinc Supplementation in Very Low Birth Weight Infants

Start date: June 1, 2024
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT05806684 Not yet recruiting - Premature Clinical Trials

Hyperbilirubinemia and Retinopathy of Prematurity in Preterm Infants: a Retrospective Study.

biliROP
Start date: May 1, 2023
Phase:
Study type: Observational

The goal of this retrospective observational study is to [learn about the correlation between hyperbilirubinemia and retinopathy of prematurity in preterm infants. The main question it aims to answer are: • To evaluate the possible effect of neonatal jaundice linked to the presumed protective antioxidant action of bilirubin on the development of ROP, compared to a control group which, although presenting ROP, did not develop jaundice.

NCT ID: NCT05483231 Not yet recruiting - Clinical trials for Very Low Birth Weight Infant

The Effect of Family Integrated Care on Melatonin Level in Very Low Birth Weight Infants

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

This study will explore the effect of Family integrated care (FICare) on the level of melatonin and other clinical outcomes in very low birth weight infants (VLBWIs) by integrating families into the neonatal intensive care unit (NICU) care team and participating in the daily care of VLBWIs, as well as the influence of FIcare on parents' outcomes.

NCT ID: NCT05461404 Not yet recruiting - Clinical trials for Very Low Birth Weight Infant

Emollient Therapy for Premature Infants in Zimbabwe

Start date: August 1, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the efficacy of topical emollient treatments in improving neonatal growth and mortality rates.

NCT ID: NCT04640805 Not yet recruiting - Growth Failure Clinical Trials

Targeted Fortification of Pasteurized Donor Human Milk

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

This randomized controlled trial aims to evaluate a modified targeted fortification method of pasteurized donor human milk (PDHM) in very low birth weight infants (VLBWs). Pools of PDHM will be analyzed for macronutrient content using the Miris Human Milk Analyzer. The control arm will receive standard of care, which is PDHM without additional protein fortification. The intervention arm will receive PDHM with a fat content of 3.8g/dL or more, with additional protein fortification of 0.67g/dL. Primary outcome will be rate of malnutrition at hospital discharge or 37 weeks, whichever earlier. Secondary outcomes include body composition, feed tolerance, and morbidity outcomes.

NCT ID: NCT04041765 Not yet recruiting - Inflammation Clinical Trials

IgM-Enriched Immunoglobulin for Neonatal Sepsis

Start date: September 2019
Phase: Phase 3
Study type: Interventional

This study compares giving prophylactic IgM enriched Intravenous Immunoglobulin (IVIG) with placebo in 1 hour after birth, in neonates with risk factors of Early-Onset Neonatal Sepsis (EONS). In addition to the intervention, standard regimen antibiotics are also given within 1 hour. The IVIG is given for 3 days and primary and secondary outcomes will be collected. Risk factors are both from maternal and neonate origin.

NCT ID: NCT03163212 Not yet recruiting - Safety Issues Clinical Trials

Safety and Tolerability of Lactoferrin/FOS in Very Low Birth Weight Infants

Start date: June 2017
Phase: Early Phase 1
Study type: Interventional

This study will examine the safety and tolerability of supplementation with bovine lactoferrin with fructo-oligosaccharide a simple sugar in very low birth weight infants. Lactoferrin is a major whey protein in mother's milk and plays a role in promoting a mature and healthy gut. It also has antimicrobial and immunomodulation activities.