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Very Low Birth Weight Infant clinical trials

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NCT ID: NCT05406804 Completed - Clinical trials for Very Low Birth Weight Infant

Olfactory Stimulation for Very Low Birth Weight Infants

Start date: July 1, 2020
Phase: N/A
Study type: Interventional

This is a RCT study examining whether odor administration to mothers of very low birth weight infants promotes stabilization of vital signs compared with common nursing care. This study used breast milk olfactory stimuli familiar and liked by premature infants to understand the effects of olfactory stimuli on the physiological indicators of very low birth weight infants, the effect on the time of complete enteral nutrition, and the effects on growth and development of very low birth weight infants.

NCT ID: NCT05399667 Active, not recruiting - Preterm Birth Clinical Trials

Assessment of Body Composition in Premature Children Submitted to an Early Stimulation Program

Start date: January 31, 2020
Phase:
Study type: Observational

This is a cross-sectional study of a randomized clinical trial to investigate nutritional aspects of pre-scholar aged children born preterm submitted to an early stimulation program versus conventional care program. The preterm-born children participated in the project entitle "Early Intervention Program for Preterm Infants and Their Parents: establishing the impact at 18 Months Corrected Age" (NCT02835612), which performed a continuous early stimulation in very and extremely preterm infant's families in their first 12 to 18 months. In the present study, preterm born children currently with 3 to 6 years old and their mothers (or legal guardian) are once more invited to a one-day visit for a nutritional and clinical evaluation at the Clinical Research Center of Hospital de Clínicas de Porto Alegre/Brazil. In the consultation, preterm born children and theirs mothers are submitted to the following exams: body composition by electrical bioimpedance, clinical and physical evaluation, anthropometric measurements, and children's eating habits, eating behavior and parental educational style in food through specific questionnaires. Moreover, this study will also investigate a group of pre-scholar health children born at term to obtain reference values for variables analysed. The goal with these findings is to determine if an early stimulation program could present a positive impact in anthropometric outcomes and nutritional aspects in this more vulnerable preterm born population.

NCT ID: NCT05308134 Recruiting - Clinical trials for Very Low Birth Weight Infant

Individualized Fortification of Human Milk for Infants Born ≤ 1250 g (MaxiMoM-InForM)

Start date: November 11, 2021
Phase: N/A
Study type: Interventional

Very low birth weight infants have increased nutritional needs. Extra nutrients are added to their human milk feeds to help improve their nutritional status, growth and neurodevelopment. Standard fortification of human milk is routine in most neonatal units in North America, but despite the added nutrients, infants are often discharged from hospitals with poor growth, and their neurodevelopment remains suboptimal. Two individualized fortification methods, target and BUN adjustable, have been proposed to improve the nutrient supply to infants. However, there is currently insufficient evidence to support the implementation of individualized fortification or one method over the other. Therefore, this study will randomly assign very low birth weight infants to receive feeds fortified according to standard, target or BUN adjustable fortification methods until 36 weeks gestational age or hospital discharge whichever occurs first. Feedings will be prepared in milk preparation rooms to ensure caregivers and outcomes assessor remain blinded to feeding allocation. Growth, morbidities, and nutrient intakes will be determined throughout hospitalization and skinfolds assessed at 36 weeks. At 4 months CA, growth and body composition will be determined by air displacement plethysmography and processing speed by electroencephalography on a subset of infants. Neurodevelopment will be assessed using the Bayley Scales of Infant and Toddler Development, at 18-24 months CA.

NCT ID: NCT05274386 Recruiting - Clinical trials for Very Low Birth Weight Infant

Evaluation of the Impact of SpO2 Averaging Time on Performance of an Automatic FiO2 Control System: a Randomized Study

Start date: February 17, 2022
Phase: N/A
Study type: Interventional

The aim of the study is to determine the preferred oximeter averaging setting during automated control of FiO2 (A-FiO2) in infants receiving respiratory support and supplemental oxygen.

NCT ID: NCT05192668 Completed - Clinical trials for Very Low Birth Weight Infant

The Setting and Effect Evaluation of QT in NICU

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

In order to create a better environment for growth and development for very low birth weight infants(VLBWIs), investigators introduce quiet time, which is an intervention method that reduces environmental noise in the ward and centralizes medical and nursing operations. By analyzing the weight gain of VLBWIs in the intervention group and the control group during hospitalization, the effect of setting a quiet time in the NICU on improving the growth and development of VLBWIs is evaluated.

NCT ID: NCT05022433 Completed - Clinical trials for Very Low Birth Weight Infant

Comparison of the Shukla and UN-1 Formulae in the Placement of the Umbilical Venous Catheter Among Neonates

Start date: June 6, 2019
Phase:
Study type: Observational

Umbilical vein catheters (UVC) are commonly inserted in newborns especially neonates admitted to the Neonatal Intensive Care Unit (NICU).These catheters are used since 1959. It is a suitable method for parenteral nutrition access and medications administration. Despite the benefits of the UVC, its potential complications must be considered. Thus, it is vital to determine the appropriate penetration length of the UVC.

NCT ID: NCT04982133 Completed - Preterm Clinical Trials

Weight Gain in Extremely Premature Infant With Targeted Versus Adjusted Fortification

FORTIN
Start date: April 19, 2021
Phase: N/A
Study type: Interventional

Investigation about the effect on weight gain in extremely low birth weight preterm with individualized fortification, according to human milk analysis versus fortification adjusted according to urea serum concentration.

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: NCT04542096 Recruiting - Respiratory Failure Clinical Trials

Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT

Start date: September 29, 2020
Phase:
Study type: Observational

Electric Impedance Tomography (EIT) is a lung monitoring technique based on the injection of small currents and voltage measurements using electrodes on the skin surface generating cross-sectional images representing impedance change in a slice of the thorax. It is a real time, radiation free, non-invasive and portable. Neonatal respiratory distress syndrome (RDS) is a respiratory disorder resulting from immaturity of the lung structure and lack of surfactant. It is one the most common conditions in premature infants. Many of these infants require either invasive or non-invasive respiratory support. The goal of the study is to investigate the dynamic changes in pulmonary aeration during assisted breathing in very low birthweight preterm infants using pulmonary electrical impedance tomography. Currently most widely used methods to assess respiratory lung function are either invasive and/or indirect (ABG, pulse oximetry, transcutaneous pCO2 measurement), lacks temporal resolution (lung ultrasound) or emit ionizing radiation (CT). EIT provides information on regional lung aeration without the aforementioned shortcomings.

NCT ID: NCT04497012 Recruiting - Clinical trials for Very Low Birth Weight Infant

Iron Supplementation and Intestinal Health

Start date: November 17, 2020
Phase: Phase 4
Study type: Interventional

This is a randomized double-blinded study of enteral iron supplementation in Very Low Birth Weight infants. The subjects will be randomized into low dose (2 mg/kg/day) and high dose (6 mg/kg/day) of daily iron supplementation. The primary outcomes are intestinal health including microbiome, inflammation, and barrier function.