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Prematurity clinical trials

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NCT ID: NCT06420531 Not yet recruiting - Prematurity Clinical Trials

Optimizing Human Milk Intake for Growth and Gut Health in Very Preterm Infants

Start date: April 2025
Phase: N/A
Study type: Interventional

The goal of this multi-center randomized, parallel group trial is to determine the effect of human milk diets ranging between 180 and 200 mL/kg/day on the body composition outcomes of moderately preterm infants born between 27 and 31 weeks of gestation.

NCT ID: NCT06026163 Not yet recruiting - Prematurity Clinical Trials

Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress

CAT/LPT
Start date: October 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Use of caffeine citrate in late-preterm infants with respiratory distress is questionable. Oliphant and colleagues found in a recently published study that caffeine therapy use in late-preterm infants at a loading dose of 20 and 40 mg/kg and maintenance dose of 10 and 20 mg/kg/day reduces the incidence of intermittent hypoxia events by 61 and 67% respectively. The investigators hypothesized that caffeine will improve respiratory drive, prevent apnea, shorten the hospital stay and improve arousal state in late preterm infants. The investigators aim to study the effect of caffeine citrate on late preterm babies as regard duration of respiratory support, duration of hospital stay, respiratory morbidity, incidence and frequency of apnea.

NCT ID: NCT05989438 Not yet recruiting - Prematurity Clinical Trials

Different Intervention Models of Premature Infants Based on the ICF Biopsychosocial Model

Start date: August 15, 2023
Phase: N/A
Study type: Interventional

Prematurity is an important risk factor for delayed neuropsychomotor development. The main objective of this study is to analyze the impact of different intervention models on the neuropsychomotor development of premature babies based on the ICF biopsychosocial model.

NCT ID: NCT05694611 Not yet recruiting - Prematurity Clinical Trials

Preterm Neonates Brain Ultrasound With CEUS and Elastography

Start date: May 2023
Phase: Phase 3
Study type: Interventional

The aim of the study is to investigate levels of brain perfusion and elasticity in preterm neonates when they reach the estimated due date and to compare the data with magnetic resonance imaging at term. Contrast enhanced ultrasound (sulphur hexafluoride) and ultrasound-assisted elastography will be used to evaluate the state of brain perfusion with ultrasound. Different appropriate imaging sequences will be used regarding MRI, including asl-perfusion. Neonates recruited from the Neonatal Intensive Care Unit (NICU) of Turku University Hospital will be recruited.

NCT ID: NCT05065385 Not yet recruiting - Prematurity Clinical Trials

The EveryPrem Project: Evaluating the INTER-NDA for Standardized Neurodevelopmental Screening at 2 Years of Age for Children Born Preterm.

EveryPrem
Start date: November 1, 2021
Phase:
Study type: Observational

Neurodevelopmental follow-up of infants at high-risk such as preterm born is necessary in order to early detect impairments and early start a supportive/therapeutic intervention. Valid tools should be available for screening infants with developmental problems even where resources are limited. Such screening would ensure an adequate medical care during and after hospital discharge as well as evidence-based parental pre- and postnatal counselling. While in Switzerland, these tools are specifically needed for the neurodevelopmental surveillance of moderate to late pretem born infants, in low- and mid-income countries, they are needed to monitor the whole population of preterm born infants. To fill this important gap, the present study aims to determine whether it is feasible to extend neurodevelopmental screening (currently offered to only a very small part of children born preterm), by using a new cost-effective neurodevelopmental assessment, the INTERGROWTH-21st Neurodevelopment Assessment (INTER-NDA, www.inter-nda.com Assessment) at age 2 years.

NCT ID: NCT04869709 Not yet recruiting - Prematurity Clinical Trials

Late Preterm Corticosteroids and Neonatal Hypoglycemia

Start date: July 2021
Phase: Phase 4
Study type: Interventional

This is a prospective randomized controlled trial investigating the timing of betamethasone administration in late preterm infants in relation to delivery and impact on neonatal hypoglycemia. Previous data has shown that neonatal hypoglycemia is increased in late preterm infants that were exposed to antenatal corticosteroids. The investigators hypothesize that the timing of steroid administration may impact the development of neonatal hypoglycemia.

NCT ID: NCT04862377 Not yet recruiting - Clinical trials for Bronchopulmonary Dysplasia

Intratracheal Budesonide With Surfactant to Prevent Bronchopulmmonary Dysplasia.

BuS
Start date: October 1, 2021
Phase: Phase 3
Study type: Interventional

This study is designed to determine whether intratracheal administration of budesonide combined with surfactant, as compared to surfactant alone, will modify ecographic (lung ultrasound score) and biological markers (IL-6 concentration in respiratory secretions) at 7 days of life in preterm infants ≤32 weeks of gestational age (GA).

NCT ID: NCT04852094 Not yet recruiting - Prematurity Clinical Trials

Family-centered Round in Neonatology

VINCI
Start date: September 1, 2021
Phase:
Study type: Observational

The family-centered care is based on dignity and respect, information sharing, collaboration and participation in care and decision-making. In a neonatal unit, the medical round by the attending physician is an important moment for shairing information with the medical and nursing staff and for the decision making process. In France, parents are rarely actively involved in the medical round. The aim of this study is to plan the implantation of the Family-centered round in a neonatal department using the 6 steps of the "Intervention mapping": 1/needs assessment; 2/ performance and change objectives; 3/ theory-based framework; Curriculum development; 5- adoption and implementation; 6- evaluation and dissemination

NCT ID: NCT04549727 Not yet recruiting - Prematurity Clinical Trials

Development and Use of a Tissue and Human Enteroid Biorepository to Study the Pathophysiology of NEC

Start date: November 1, 2020
Phase:
Study type: Observational

Despite a greater understanding of NEC physiopathology, modest progress has been done in terms of intervention and prevention of the disease over the past three decades, being the mortality rate unchanged. Investigators intend to leverage our knowledge and technical expertise developed with fetal enteroids to further investigate the processes leading to NEC by deriving and performing functional studies on human intestinal enteroids generated from intestinal resection for therapeutic reasons in NEC and non-NEC patients 1. Generate a tissue biorepository composed of: enteroids and other lamina propria cells 2. Comparative studies of the gene expression profile of tissue, epithelial enteroids and underlying lamina propria of NEC, non-NEC, hypoxic and non-hypoxic infants 3. In vitro functional studies for the evaluation of critical factors in NEC pathophysiology 4. In vitro functional studies to identify the activation of processes leading to intestinal epithelium necroptosis and/or apoptosis in bacteria challenged and hypoxic conditions 5. Correlative studies of the impact of perinatal variables on the intestinal barrier functionality at baseline and challenged with pathogens 6. In vitro comparison of the intestinal barrier functionality in infants complicated by condition of prenatal hypoxia versus non hypoxic infants 7. Validation the NEC enteroids as an in vitro model for the identification of treatments and prevention of NEC

NCT ID: NCT03121196 Not yet recruiting - Clinical trials for Gestational Diabetes

Social Deprivation and Pregnancy

Start date: May 2017
Phase: N/A
Study type: Observational

Social deprivation during pregnancy is associated to adverse perinatal outcomes. However, prenatal screening of social deprivation by reliable measurement is not performed. Prevalence of social deprivation is yet underestimated during pregnancy and vulnerable women are not being provided optimal prenatal care. Our aim is to validate EPICES score during pregnancy.