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Birth Weight clinical trials

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NCT ID: NCT06266455 Not yet recruiting - Clinical trials for Very Low Birth Weight Infant

Individualized Nutrition to Optimize Preterm Infant Growth and Neurodevelopment

THRIVE
Start date: February 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06246032 Active, not recruiting - Preterm Clinical Trials

Impact of Modified Feeding Protocol on Neonatal Outcomes

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

The goal of this clinical trial is to compare modified feeding protocol and current feeding protocol on neonatal outcomes in preterm infants who born with weight less than 2kg. The main questions it aims to answer are: - Is Modified feeding protocol will decrease the duration of parenteral nutrition and length of hospital stay? - Is Modified feeding protocol feasible, efficient, and safe in preterm infants? Participants will undergo the modified feeding protocol since birth until discharge.

NCT ID: NCT06217913 Not yet recruiting - Birth Weight Clinical Trials

Effects of Monitoring Blood Pressure During Pregnancy

Start date: December 1, 2024
Phase: N/A
Study type: Interventional

In this study, at least 400 women with high-risk of pregnancy hypertension will use a wearable device to monitor the blood pressure during gestational age from 12 weeks to 28weeks. The observed outcomes including maternal and offspring. Participants were from three hospital including Shanghai Xinhua Hospital, Jiaxing Maternal and Child Health Hospital and Peking University Third Hospital. Pregnant women were randomly divided into control group (routine delivery examination group) and intervention group (routine delivery examination group + use of wearable blood pressure monitoring device group), 200 cases each.

NCT ID: NCT06212427 Recruiting - Premature Infant Clinical Trials

Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs)

Start date: November 20, 2023
Phase: N/A
Study type: Interventional

The goal of this post-market study is to describe the effect of a liquid supplement containing 2 specific human milk oligosaccharides (HMOs), 2'-fucosyllactose [2'FL] and lacto-N-neotetraose [LNnT], on feeding tolerance, growth, and adverse events of special interest in preterm infants in a real-world setting.

NCT ID: NCT06207994 Recruiting - Clinical trials for Very Low Birth Weight Infant

PRICO: OPTI Target Range

POSTR
Start date: February 20, 2024
Phase: N/A
Study type: Interventional

The aim of the study is to determine if a narrower SpO2 Target Range setting automated control of FiO2 (A-FiO2) is more effective than a wider SpO2 Target Range

NCT ID: NCT06200324 Completed - Clinical trials for Very Low Birth Weight Infant

Clinical Outcomes of Ready-to-Use Parenteral Nutrition in Low Birth Weight Newborns in Colombia 2017-2023

NUMETA
Start date: March 1, 2017
Phase:
Study type: Observational

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. Conducted in a level 4 neonatal intensive care unit from March 2017 to March 2023, the study focuses on growth parameters (weight, head circumference, height), growth velocity, and the incidence of complications. The retrospective open-cohort observational design involves a sample of 284 infants, 142 in each group, considering a 95% confidence level and 80% power. The study addresses the need for a local evaluation of the efficacy of ready-to-use parenteral nutrition in this vulnerable population.

NCT ID: NCT06198881 Active, not recruiting - Birth Weight Clinical Trials

Association Between Labor Induction and Birth Weight in Cases of Fetal Macrosomia: The MACROMODA Cohort Study

MACROMODA
Start date: October 1, 2023
Phase:
Study type: Observational

The rising prevalence fof fetal macrosomia represents a significant challenge in obstetrics, affecting both maternal and neonatal outcomes. Such challenges include complications like perineal tears and postpartum hemorrhage. Concurrently, the frequency of labor induction practices on the rise, yet the implications for neonatal weight are inadequately understood. To address this gap, our study aims to evaluate the association between labor induction and neontal birth weight through a population-based cohort study. The findings have the potential to inform more accurate clinical guidelines, thereby enhancing the quality of maternity care.

NCT ID: NCT06157684 Recruiting - Clinical trials for Gestational Diabetes

Timing of Ambulation and Infant Birth Weight in Gestational Diabetes

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

This is a randomized controlled trial to assess the effect of routine exercise counseling compared to the recommendation for postprandial ambulation on infant birthweight among pregnant people with gestational diabetes mellitus. The primary outcome is birthweight percentile for gestational age at delivery. Secondary outcomes include feasibility and acceptability, need for metformin or insulin for glycemic control, mode of delivery, neonatal hypoglycemia. Participants will be counseled to either complete 20 minutes of walking after meals, or be counseled with routine exercise counseling of 30 minutes of low-impact 5x a week. Their activity will be tracked by "FitBit" pedometers and uploaded via bluetooth to a database for review. They will continue to receive routine obstetric and diabetes care.

NCT ID: NCT06125860 Recruiting - Preterm Birth Clinical Trials

BEP Targeting Strategies in Ethiopia

BEP
Start date: August 7, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized effectiveness study is to evaluate the different targeting strategies for the delivery of balanced energy and protein (BEP) supplements among pregnant women in Addis Ababa, Ethiopia. The main goals of the study are to: 1) determine the effectiveness of two individual-based antenatal BEP targeting strategies for preventing adverse pregnancy outcomes; 2) compare the cost-effectiveness of the universal BEP provision with two individual-based targeting strategies for preventing adverse pregnancy outcomes; and 3) generate implementation evidence regarding the feasibility and acceptability of different antenatal BEP targeting strategies. Pregnant women will be enrolled during pregnancy, assigned to different strategies of BEP supplementation, and followed from pregnancy through six weeks postpartum to evaluate the impacts of different BEP targeting strategies on pregnancy, maternal, and child outcomes.

NCT ID: NCT06082414 Completed - Clinical trials for Bronchopulmonary Dysplasia

Systemic Management in Extremely Preterm and Extremely Low Birth Weight Infants

Start date: January 30, 2019
Phase:
Study type: Observational

to estimate incidences of major complications, such as bronchopulmonary dysplasia, death, and delivery room resuscitation among extremely preterm and extremely low birth weight infants in Northern China