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Premature Birth 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: NCT06265740 Not yet recruiting - Premature Birth Clinical Trials

Early Diagnosis of Premature Births by Analysis of the Vaginal Microbiota

PREMABIOTE
Start date: March 2024
Phase: N/A
Study type: Interventional

Objectives: to assess the relevance of the "RiboTaxa" algorithm coupled with neural network learning based on analysis of vaginal microbiota metagenomic sequencing data for predicting prematurity in an identified at-risk population. Study description: Longitudinal follow-up of a cohort of pregnant women, with collection of biological samples, and a posteriori case-control comparison based on the occurrence of an event (premature birth).

NCT ID: NCT06263127 Not yet recruiting - Preterm Infants Clinical Trials

Sensory Motor Interventions on Preterm Infants

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

Preterm infants experiencing bottle feeding difficulties will be included in this study. Two distinct interventions, oral stimulation (OS) and infant massage (IM), will be administered in this study. The objective of this clinical trial is to compare the effectiveness of these two approaches, either individually or in combination, in improving the feeding performance and development of participants.

NCT ID: NCT06262308 Not yet recruiting - Clinical trials for Preterm Birth Complication

Emotional Support for Women Experiencing PPROM

Start date: March 2024
Phase: N/A
Study type: Interventional

Preterm Prelabour Rupture of the Membranes is a pregnancy complication affecting 3% of all pregnancies. Outcomes for both the mother and baby are variable including: preterm delivery, fetal infection, cord prolapse, abruption as well as maternal sepsis and even maternal death. The outcomes are not only variable but the stress and uncertainty can be over a protracted period of time. This is a pilot study that aims to provide personalised psychological intervention at the time of PPROM based on Cognitive Behavioural Principles to see whether this improves psychological outcomes for women.

NCT ID: NCT06259604 Not yet recruiting - Preterm Birth Clinical Trials

Preterm Infant Oral Motor Intervention (PIOMI)

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

The purpose of this research; The aim of this study is to examine the effects of oral motor intervention (PIOMI) and combined kangaroo care applied to preterm babies on weight gain, oral feeding skills, transition to full oral feeding and discharge time.

NCT ID: NCT06246864 Not yet recruiting - Clinical trials for Neonatal Skin Conditions

Evaluation of the Effects on the Skin of Different Materials Used in Orogastric Tube Detection in Premature Babies

Start date: February 5, 2024
Phase: N/A
Study type: Interventional

While medical adhesives provide fixation of devices and catheters in neonatal intensive care, they can cause disruption of skin integrity when removed. Therefore, when detecting medical devices, it is important to choose products that will not harm babies' skin and to use different occlusive dressings (polymer foams, hydrogel dressings, hydrocolloid dressings). This study aims to compare the effectiveness of different types of patches (Hydrocolloid dressing and Hypoallergenic Flexible Patch) used in the detection of oragastric catheter (OG) in preterm babies hospitalized in the neonatal intensive care unit in preventing skin damage.

NCT ID: NCT06240715 Not yet recruiting - Preterm Clinical Trials

Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries- PreTerm

CORDMILK-PT
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The goal of this multicenter, cluster-randomized, crossover trial is to determine if umbilical cord milking compared to early cord clamping will reduce in-hospital mortality in non-vigorous preterm infants born between 30 weeks and 34 weeks of gestation.

NCT ID: NCT06234332 Not yet recruiting - Obesity Clinical Trials

Peking University Birth Cohort in Weifang (PKUBC-WF)

Start date: February 1, 2024
Phase:
Study type: Observational

The PKUBC-WF is a prospective cohort study carried out in Weifang city of Shandong, China. The primary aim of this study is to investigate the short-term and long-term effects of pre-pregnant and prenatal exposure on maternal and child health. Data are collected regarding environmental, nutritional and lifestyle exposures as well as short-term and long-term health outcomes of mothers and their children from birth to before 18 years old. Biological samples including peripheral blood, urine, placenta, umbilical cord, cord blood, and faeces are also collected.

NCT ID: NCT06226051 Not yet recruiting - Premature Birth Clinical Trials

Growing Little PEAPODS Study

Start date: June 2024
Phase:
Study type: Observational

The goal of this clinical trial is to learn more about how the food and nutrition babies receive while in the Neonatal Intensive Care Unit (NICU) influences their ability to gain weight and fat-free mass, and their future growth and development. Participants will: - have body growth measurements collected using the PEAPOD device - have nutritional information collected, and - be followed for neurodevelopmental outcomes Participants can expect to be in the study for 36 months.

NCT ID: NCT06220461 Not yet recruiting - Extreme Prematurity Clinical Trials

Folic Acid Supplementation to Reduce Anemia in Extremely Preterm Infants

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

Anemia of Prematurity (AOP) is very common in extremely preterm infants and often leads to blood transfusions. Folic acid, essential for growth and DNA synthesis, is deficient in premature infants. Despite the adoption of folic acid supplementation, evidence supporting its effectiveness in preventing AOP remains scarce. Recommendations for folic acid intake exceed what's naturally found in breast milk, particularly for extremely low birthweight infants. Practices regarding folic acid supplementation vary widely, prompting the need for research. The FACINATE trial aims to determine if additional folic acid supplementation improves hemoglobin levels and reduces late blood transfusions in extremely preterm infants, a question not addressed in current literature.