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Premature Birth clinical trials

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NCT ID: NCT06110364 Not yet recruiting - Clinical trials for Premature Ventricular Contraction

Vagal Nerve Stimulation as an Alternative Therapy for Premature Ventricular Contractions

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

Prospective randomized control pilot study

NCT ID: NCT06109285 Recruiting - Clinical trials for Retinopathy of Prematurity

Validation of i-ROP DL to Detect More Than Mild ROP

Start date: November 29, 2023
Phase: N/A
Study type: Interventional

In this study, the investigators aim to improve image acquisition and preprocessing pipeline for FDA application. Our previous research has used various methodologies to identify images to input into the algorithm. The investigators aim to evaluate the effect of image quality and field of view on the output of the device in addition to performing a precision study to evaluate the effect of different camera operators on image selection and device output. Additionally the investigators aim to assist conducting pivotal clinical study for assistive diagnosis. Based on two previous meetings with the FDA, the clinical study will test the following hypothesis: use of the i-ROP DL VSS improves the accuracy of plus disease diagnosis among clinicians performing telemedical review of images. The investigators also aim to assist in conducting pivotal clinical study of autonomous ROP screening. Preliminary data suggests that the i-ROP DL system could achieve 100% sensitivity for detection of severe ROP. The investigators will perform a clinical study to support a revised indication for use as an autonomous AI screening device. Output of the i-ROP DL system will be compared to masked telemedicine grading for identification of referral-warranted and treatment-requiring ROP.

NCT ID: NCT06105333 Recruiting - Preterm Clinical Trials

Fidgety Movements of Preterm Neonates Included in COSGOD III

Figdety_Ms
Start date: September 1, 2023
Phase:
Study type: Observational

The evidence on the effects of clinical care with cerebral NIRS (Near-infrared spectroscopy) monitoring on short term neurological outcome, displayed by fidgety movements between six to 20 weeks post term, are still uncertain. Two centers (Graz and Innsbruck), who participated in the COSGOD III trial, routinely performed GMA between 37+0 to 42+0 weeks of corrected age (writhing movements) and between six to 20 weeks post term (fidgety movements). Aim of the present study is therefore to assess in neonates, who were included into the COSGOD III trial, in a retrospective observational study routinely performed fidgety movements between six to 20 weeks of corrected age after discharge. The investigators hypothesise that the preterm neonates in the intervention group of the COSGOD III trial show better survival and short term neurological outcome, displayed by normal fidgety movements, compared to neonates in the control group.

NCT ID: NCT06103227 Not yet recruiting - Preterm Birth Clinical Trials

The Effect of Low Doses of Prednisone on the Prolongation of Pregnancy in Threatened Preterm Birth

Start date: December 1, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this clinical trial is to test the effect of low dose of prednisone in prevention of preterm labour in single pregnancies. The main question it aims to answer is does prednisone prolong singleton pregnancy in threatened preterm birth and reduce mortality and morbidity of newborns, without harmful consequences for mother and the foetus. Participants will be: - administered low dose of prednisone in a period of total 3 weeks on top of standard therapy - drown blood for standard laboratory tests - cervical swab and urine for urinoculture will be taken and - asked to sign Informed Consent Researcher will compare low dose of prednisone to standard therapy

NCT ID: NCT06102655 Recruiting - Clinical trials for Traditional Chinese Medicine

Effect and Mechanism of Jiajian Guishen Formulation on Premature Ovarian Insufficiency Based on Metabolomics

JJGS and POI
Start date: July 24, 2023
Phase: Early Phase 1
Study type: Interventional

1. Identify differential metabolites in POI patients. 2. Analysis of differential metabolites and their involved mechanism pathways.

NCT ID: NCT06101186 Completed - Preterm Birth Clinical Trials

The Effect of Nursing Counseling Perceived Stress, Coping and Birth Outcomes Among Pregnant Women

Start date: March 30, 2020
Phase: N/A
Study type: Interventional

Aim: The aim of this study is to determine the effect of the Pregnant Nursing Education and Counseling Program (HEGDAP), which is structured on the Neuman Systems Model, on the perception of stress, coping with stress and birth outcomes in pregnant women with preterm labor risk. Method: This study was conducted with 60 pregnant women at risk of preterm labor, including 30 experimental and 30 control, non-randomized double-blind pregnant women using pretest, interim follow-up and posttest. Data were collected using a personal information form, Perceived Stress in Risky Pregnancies Questionnaire, Ways of Coping with Stress Scale and Birth Outcomes Evaluation Form. Nursing counseling based on Neuman's System Model was applied to the intervention group. Data were evaluated using analysis methods such as t-test, chi-square, etc.

NCT ID: NCT06096961 Not yet recruiting - Premature Birth Clinical Trials

The Effect Of Baby Smell On The Amount Of Breast Milk, Salivary Cortisol Level And Mother Baby Attachment

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

The goal of this [type of study: randomized controlled clinical trial] is to [determine the effect of applying the scent of premature newborns who cannot be breastfed to the mother on the mother's milk amount, salivary cortisol level and mother-infant attachment.] in [mothers of premature babies]. The main question[s] it aims to answer are: - [Hypothesis 1: There is a difference in the amount of milk of the mother.] - [Hypothesis 2: There is a difference in the level of cortisol in the mother's saliva.] - [Hypothesis 3: There is a difference in terms of mother-baby attachment level.] Participants will [Participants will express milk and record the amount of milk.]. If there is a comparison group: Researchers will compare [control and experimental groups] to see if [difference in amount of milk, cortisol level, baby attachment].

NCT ID: NCT06082674 Completed - Premature Clinical Trials

Novel Low Cost Bubble CPAP as an Alternative Respiratory Support in Low Resource Setting

Start date: April 1, 2022
Phase: Phase 2
Study type: Interventional

This is a single-blind randomized controlled trial done in a Level III neonatal intensive care unit. Preterm newborns with RDS were randomized to receive oxygen therapy through bubble CPAP vs ventilator-derived CPAP. Differences in arterial blood gases, oxygen saturation, number of surfactant and CPAP failure rate between study groups were analyzed.

NCT ID: NCT06078618 Completed - Clinical trials for Premature Between 32 and 36 Weeks of Amenorrhoea

Place of Birth and Neonatal Health in Cases of Premature Birth Between 32 and 36 Weeks of Amenorrhoea

PREM3236
Start date: January 1, 2022
Phase:
Study type: Observational

Moderate and late premature babies (32-36 weeks of amenorrhoea) account for around 6% of births, but 20% of neonatal deaths. These children also have an increased risk of neonatal morbidity and long-term neurodevelopmental sequelae compared with full-term newborns. In the case of preterm birth, optimal antenatal, birth and postnatal management is necessary to prevent neonatal complications and mitigate longer-term consequences. However, we lack knowledge about the management of this at-risk population and the factors influencing their health. This knowledge is needed in the current context of unfavourable trends in neonatal health. Over the last ten years, neonatal and infant mortality has stagnated in France, with France falling behind other European countries. According to the latest European report, France ranks 22nd out of 33 countries. The causes of this stagnation are not well known, but many hypotheses have been put forward, including sub-optimal organisation of care.

NCT ID: NCT06076460 Recruiting - Clinical trials for Enteral Feeding Intolerance

Early Total Enteral Feeding Versus Convention Enteral Feeding in Preterm Infants 27-32 Weeks of Gestation

ETEFVsCEF
Start date: March 11, 2022
Phase: N/A
Study type: Interventional

The objective of the study is to compare the time of attainment of full enteral feeds in preterm neonates between 27-32 weeks of gestation started on early total enteral feeding (ETEF) with those started on conventional enteral feeding (CEF).