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Premature Birth clinical trials

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NCT ID: NCT06401083 Recruiting - Respiratory Failure Clinical Trials

The Effect of an Additional Pre-extubational Loading Dose of Caffeine-citrate

NEOKOFF22
Start date: December 21, 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to answer whether the use of a single loading dose (20 mg/kg) of caffeine citrate one hour before extubation has an impact on the success rate of extubation among preterm neonates. In addition, the investigators would like to assess the frequency of apneas and side effects of the intervention, as well as the development of NEC, BPD, IVH, PVL, and long-term neurodevelopmental outcomes in the investigated populations. According to institutional protocol, preterm infants born before the 32nd week of gestation receive a standard dose of caffeine citrate therapy. This covers a maintenance dose of 5-10 mg/kg of caffeine citrate administered intravenously once or twice daily after a loading dose of 20 mg/kg on the first day of life. In this trial, preterm infants born before the 32nd gestational week and who had been mechanically ventilated for at least 48 hours before planned extubation are planned to be randomly allocated into intervention and control groups. The intervention group will receive an additional loading dose of caffeine citrate 60 minutes before extubation. The control group will receive standard dosing regimens.

NCT ID: NCT06398912 Recruiting - Premature Birth Clinical Trials

Studying Newborns' Brain Activity in the NICU Through a Musical Intervention: the Role of Fundamental Frequency

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

This research project stands to the intersection of neonatology, neuroscience, and music based interventions (MBIs), exploring the impact of structured sound on the brain activity of premature newborns in Neonatal Intensive Care Units (NICU). It embarks on a pioneering investigation to decipher how variations in musical stimuli, particularly those that differ in human profiles (gender and kinship) and fundamental frequencies, affect the short-term electroencephalographic (EEG) footprint of these vulnerable infants. The project aims to uncover profound insights into the therapeutic potential of music within neonatal care, thereby advancing our understanding of neurodevelopmental interventions for premature infants.

NCT ID: NCT06395298 Recruiting - Dysphagia Clinical Trials

Effects of the Application of PIOMI in the Oral Feeding of Premature

PIOMI
Start date: February 13, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is assess whether the application of the premature oral motor intervention (PIOMI) combined with the Newborn Individualized Developmental Care and Assessment Program (NIDCAP), allows withdrawal of the external feeding device with guarantees of the patient's nutritional status, determining breastfeeding rates at hospital discharge and swallowing safety earlier than if only the care activity corresponding to the NIDCAP model is carried out, as well as the applicability of this standardised protocol in the neonatal intensive care unit of a tertiary hospital.

NCT ID: NCT06367881 Recruiting - Preterm Birth Clinical Trials

Assessment Of Dose-Dependent Immunomodulatory Effect Of Alveofact With or Without Steroisd In Neonatal RDS

Start date: August 18, 2022
Phase: Phase 1
Study type: Interventional

An Exploratory Randomized double-arm controlled trial to evaluate the immunomodulatory effect of low versus high dose of Alveofact with or without Budesonide.

NCT ID: NCT06362278 Recruiting - Clinical trials for Coronary Artery Disease

A Multi-omics Study of "Healthy" Premature CAD Patients

Start date: March 20, 2024
Phase:
Study type: Observational

The goal of this multi-center observational clinical trial is to investigate the genetic risk factors of patients with premature CAD and none traditional CAD risk factors through a multi-omics approach. The main questions it aims to answer are: - Genetic risk factors & metabolic fingerprints of patients with premature CAD and none traditional CAD risk factors remain unknown. - How to optimize current primary prevention strategy for this rare CAD subgroup?

NCT ID: NCT06353243 Recruiting - Preterm Birth Clinical Trials

Bilateral Infant Stimulation Study

BLISS
Start date: February 26, 2024
Phase: N/A
Study type: Interventional

This study will investigate stress that parents of children admitted to the neonatal intensive care unit (NICU) experience. Investigation of a novel intervention of using bilateral alternating stimulation to reduce parental stress and anxiety and increase bonding/attachment in NICU. Evaluate parental stress and feelings of bonding using surveys before and after the intervention. Intervention will be done at neonate's bedside while admitted to the NICU. Vital sign data will be collected as a marker of parent and neonate's stress response during the intervention.

NCT ID: NCT06345742 Recruiting - Preterm Clinical Trials

The Effect of Parental Participation on Newborn Comfort During Diaper Care

Start date: December 19, 2023
Phase: N/A
Study type: Interventional

It was aimed to determine the effect of parental participation on newborn comfort during diaper care practice in preterm infants. H1: Parental participation during infant diaper care practice in preterm infants has an effect on newborn comfort. H2: There is a difference in the effect of parent diaper care practice and the participation of the mother or father on newborn comfort in preterm infants. H3: There is a difference between the stress levels of parents before the application of infant diaper care in preterm infants.

NCT ID: NCT06345664 Recruiting - Preterm Birth Clinical Trials

Interdisciplinary E-health Based Follow-up of Preterm Born Children

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

The aim of the study is to assess mental and somatic symptoms of preterm born children at the ages of 2, 5 and 10 by a multidisciplinary team and to evaluate an app that screens for these symptoms. Furthermore, there will be an evaluation of an intervention by our multidisciplinary team that provides recommendations for further treatment and diagnostic procedures of the children.

NCT ID: NCT06340971 Recruiting - Premature Birth Clinical Trials

Air Pollution and Pregnancy

PTB
Start date: September 1, 2024
Phase:
Study type: Observational [Patient Registry]

We are an inter-disciplinary team of UK scientists with expertise in obstetrics, women's and child health, epidemiology, climate science, inflammation, computational modelling, machine learning and artificial intelligence. Together we have a long history with existing strengths underlying preterm birth research that crosses multiple disciplines and an excellent track record of publications and awards leading research in preterm birth. We aim to develop and validate a deep learning model to predict the risk of preterm birth and other adverse pregnancy outcomes using data from EPIC electronic health records at University College London Hospital Trust (UCLH) for a cohort of 18000 patients. We will obtain corresponding data on exposure to ambient pollution using non-identifiers for postcode (area) and date of delivery (month). The model will review the temporal sequence of events within a patient's medical history and current pregnancy, identifying significant interactions and will predict the risk of preterm birth. It will also determine the threshold and gestation at which pollution exposure has the greatest impact.

NCT ID: NCT06327152 Recruiting - Clinical trials for Apnea of Prematurity

Caffeine Use in the Management of Preterm Infants

Start date: February 22, 2024
Phase: Phase 2
Study type: Interventional

This study aims to assess whether extending the duration of caffeine therapy will help preterm infants achieve full oral feeding faster.