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Premature Birth clinical trials

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NCT ID: NCT05844345 Recruiting - Nasal Injury Clinical Trials

The Effect of Hydrocolloid Tape and Facial Massage in Premature Infants During Noninvasive Mechanical Ventilation

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

The aim of this study is to assess the effect of nasal injury prevention interventions (NIPI) (hydrocolloid tape and facial massage) on nasal septum injury, stress and comfort of premature neonates (28-35 weeks gestation) receiving non-invasive mechanical ventilation (NIMV) support.

NCT ID: NCT05843266 Recruiting - Prematurity Clinical Trials

Early Childhood Attention Battery in Preterm Children

Start date: February 1, 2022
Phase:
Study type: Observational [Patient Registry]

The aims of this project are: 1. To explore, using the ECAB, if and in which measure the attentional abilities of young preterm children are different from term peers, whom reference data are already published27. 2. To correlate the ECAB results with the "Conner's Teacher, Rating Scale- Revised e Conner's Parent Rating Scale", one of the available diagnostic interview that helps to identify signs of Attention Deficit Hyperactivity Disorder (ADHD) in young children, at the age of 6 years and over. 3. To study individual trajectories of attention pattern and development during age.

NCT ID: NCT05841121 Recruiting - Preterm Birth Clinical Trials

Antenatal Dexamethasone for Late Preterm Deliveries

Start date: August 25, 2023
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to compare dexamethasone in late preterm deliveries. The main questions it aims to answer are: Does antenatal dexamethasone reduce the need for respiratory support in late preterm infants? Does antenatal dexamethasone reduce neonatal morbidities and mortality? Does antenatal dexamethasone reduce admission to Neonatal Intensive Care Unit and length of hospital stay? Participants will be allocated into 2 groups: intervention with dexamethasone IM and control (standard care). Investigators will compare these two groups to see if antenatal dexamethasone reduces the need for respiratory support in late preterm infants, neonatal morbidities and mortality, admission to NICU and length of hospital stay.

NCT ID: NCT05837390 Recruiting - Preterm Birth Clinical Trials

Can Cervical Stiffness in the Second Trimester Predict Preterm Birth in High-Risk Singleton Pregnancies?

PRECISION
Start date: July 6, 2023
Phase:
Study type: Observational

Preterm birth (PTB), defined as delivery before 37 weeks gestation, is a common complication of pregnancy and affects up to 1 in 10 women in the UK. PTB is the leading cause of neonatal mortality and morbidity with babies born earliest being at the greatest risk. Identifying women at high risk of having a PTB and offering treatments and intervention to try and prevent this outcome is a huge priority in clinical practice and in government policy. The PRECISION study will explore the use of a new antenatal test of cervical stiffness to try and improve the recognition of women who may deliver early. Current clinical practice involves measurement of cervical length (CL) and fetal fibronectin in women known to be high risk for PTB. However recent research suggests these methods could be improved upon and we may be able to recognise women at risk more reliably and at an earlier stage in the pregnancy if we use cervical stiffness assessments. A licensed, CE-marked, vacuum-aspiration device called the Pregnolia system has been developed to give quantitative cervical stiffness index scores during pregnancy. This study will directly compare cervical length measurements and fetal fibronectin results with cervical stiffness, using the Pregnolia system, during the second trimester in women known to be high risk for preterm birth. The investigators will aim to explore the best possible predictive tool kit bundle for PTB using any combination of these assessments.

NCT ID: NCT05835817 Recruiting - Premature Clinical Trials

Magnetoencephalography by Optical Pumping Magnetometer

MEG OPM
Start date: May 2023
Phase: N/A
Study type: Interventional

MagnetoEncephaloGraphy (MEG) is a method of recording brain activity with high temporal resolution and good spatial resolution, compared to current recording techniques such as ElectroEncephaloGraphy (EEG). The main limitation of MEG is its cost due to the sensors used, the Super Quantum Interference Devices (SQUID). These require a complex infrastructure from an instrumentation point of view to operate, requiring liquid helium, most often at a loss, at increasing cost. Optical Pumping Magnetometers (OPM) type sensors represent a promising alternative to SQUIDs sensors, especially since they do not require helium cooling. The purpose of this project is to Identify biomarkers in Magnetoencephalography of normal brain development in healthy adults, premature and term newborns from "a priori" obtained by the classical technique of High Resolution EEG performed.

NCT ID: NCT05835765 Enrolling by invitation - Premature Birth Clinical Trials

Use of Dynamic Elastometric Body in Preterm Newborns

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

The goal of this prospective pilot study is to test the use of dynamic elastomeric body in a population of preterm newborns with hyperexcitability syndrome. The main questions it aims to answer are: - To evaluate the effectiveness of the body in elasto-compressive material (FLEXA) in addition to standard care; - To evaluate how the use of dynamic elastomeric body promote postural containment, reduce hyperexcitability (tremor and crying), improve the organization of movement and reduce respiratory distress. Participants will be given to routine clinical evaluations that are part of the standard of care of the premature infant admitted to Neonatology. The clinical evaluation shall consist of: - Hammersmith neonatal neurological examination; - Neonatal Intensive Care Unit Network Neurobehavioural Scale (NNNS); - General Movement's (GM's) - Goal Attainment Scaling (GAS) Researchers will compare a study group that will be subjected to treatment with the body in elasto-compressive material and a control group without using the body in elasto-compressive material.

NCT ID: NCT05835700 Completed - Clinical trials for Gasdermin D Levels in Preterm Labor

The Relationship Between Serum Gasdermin-D Levels and Pyroptosis and Preterm Labor

Start date: July 15, 2021
Phase: N/A
Study type: Interventional

In this study, the investigators aimed to investigate the relationship between Gasdermin D levels measured from the maternal serum of patients diagnosed with preterm labor and spontaneous preterm labor in pregnant women.

NCT ID: NCT05830955 Completed - Clinical trials for Postpartum Depression

The Effect of Lullaby and Breastmilk Smell on Preterm Newborns

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

The goal of this clinical trial is to investigate the effect of live lullaby from mother voice, and breast milk smell on pyhsiological parameters, comfort and maternal attachment levels of preterm newborns who are between 35-37 weeks of gestation at the time of the study and the level of pospartum depression of mothers. The main hypothesis are: H0: The live lullaby from mother voice and breast milk smell have no effects on pyhsiological parameters, comfort and maternal attachment levels of preterm newborns H1: The live lullaby from mother voice has effects on pyhsiological parameters, comfort and maternal attachment levels of preterm newborns H2: The breast milk smell has effects on pyhsiological parameters, comfort and maternal attachment levels of preterm newborns H3: There is differences between the live lullaby from mother voice and the breast milk smell interventions in terms of preterm newborns' physiological parameters, comfort and maternal attachment levels. H4: The postpartum depression level of mothers in experimental groups (lullaby group and breast milk group) is lower than the control group. Participants will be in three groups according to the interventions. The preterm newborns who are going to listen a live lullaby from their mothers' voice will be the first group (Lullaby group). The preterms in the second group (Breast milk group) are going to smell their mothers' breast milk. The preterms in the third group (Control group) are going to recieve rutin nursing care interventions.

NCT ID: NCT05827679 Completed - Clinical trials for Digestive System Disease

Creation and Validation of a Clinical Evaluation Scale for Abdominal Condition of the Premature (ECAP)

ECAP
Start date: March 15, 2023
Phase:
Study type: Observational

Every year in France, 60,000 children are born prematurely (before 37 weeks of amenorrhea), and present an immaturity of their various systems, in particular the digestive system. This can result in feeding intolerance, which is expressed by abdominal distension, regurgitation or vomiting, irregular transit and abdominal discomfort. This feeding intolerance influences the length of hospitalization and can lead to necrotising enterocolitis, a major complication. In the Neonatal Intensive Care Units of Clermont-Ferrand hospital center, abdominal massages have been performed by physiotherapists for several years in order to improve the condition of the digestive system. However, the indication for abdominal massage is very dependent on the caregivers in charge of the newborn and the evaluation of the abdominal condition remains subjective with a great variability between examiners. Thus, some newborns will receive massage multiple times a day while others will not. Developmental care is essential for these premature infants, especially to avoid over-stimulation. It is important not to add care, such as massage, if it is not needed. It is therefore essential to properly assess the digestive status of premature babies in order to determine whether they have feeding intolerance and whether they require treatment with abdominal massage. To date, the investigators have not found measurable criteria or existing scales that can describe the digestive status of newborns. The main objective of the study is therefore to create and validate a clinical assessment scale for the abdominal status of preterm infants.

NCT ID: NCT05827250 Recruiting - Premature Birth Clinical Trials

Vibroacoustic Study of Lung Development in Newborn Infants

Start date: February 13, 2023
Phase:
Study type: Observational

Investigators hypothesize that premature newborns with poor cardiopulmonary performance have higher morbidities and poorer physical and cognitive developmental outcomes. Investigators further hypothesize that audible sounds combined with novel inaudible vibrations above and below human perception interpreted with transparent and auditable AI algorithms can detect and identify early gas and fluid movement anomalies not uncovered by conventional tools in an non-invasive, easy, fast, and low cost examination.