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Premature Birth clinical trials

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NCT ID: NCT06464042 Recruiting - Clinical trials for Myocardial Infarction

Influence of Air Quality on the Development and Progression of Premature Coronary Artery Disease

AIRHEART
Start date: May 23, 2024
Phase:
Study type: Observational

The new global guidelines from the World Health Organization on air quality provide evidence of the damage that air pollution inflicts on human health at even lower concentrations than previously thought. Different studies have shown an increase in the incidence of coronary artery disease (CAD) in young people in recent decades. The main objective of this project is to study the impact of environmental pollutants on the premature manifestation of CAD from different epidemiological approaches and their impact on the evolution of these patients with a gender perspective. It is a retrospective analytical case-control study nested in a cohort of patients ≤40 years old with a clinical history of CAD including: ST-segment elevation myocardial infarction, non-ST-segment elevation acute coronary syndrome, unstable angina, stable angina or silent angina according to the international classification of diseases.

NCT ID: NCT06463652 Not yet recruiting - Preterm Birth Clinical Trials

Cerclage With Progesterone Versus Progesterone Only in Singleton Pregnancies

RESILIENT
Start date: June 2024
Phase: N/A
Study type: Interventional

This study compares the effectiveness of cervical cerclage with vaginal progesterone to vaginal progesterone only for the prevention of preterm birth in women with a singleton pregnancy and a short cervical length. Participants will be randomly assigned in a 1:1 ratio to receive cerclage plus progesterone or progesterone only.

NCT ID: NCT06462638 Not yet recruiting - Preterm Birth Clinical Trials

COntact RElationship in Neonatal Intensive Care Unit

CORE in NICU
Start date: November 1, 2024
Phase:
Study type: Observational

The present research project aims to explore the value that contact relationships between caregivers and the preterm infant may have in terms of promoting developmental and maturational processes,by attending to the neurobehavioral states of the infant in response to maternal and paternal voice. The study is aimed at furthering the still underdeveloped knowledge regarding the possible effects of the paternal voice on the neurobehavioral states of the preterm infant in the crib, comparing them with the effects of exposure to the maternal voice and the voice of a familiar but non-parental figure, such as the NICU nurse. These behavioral states will also be observed as a function of the psychological condition of the parents, investigating the presence of a possible postpartum depressive condition and/or anxiety of the mother and symptomatology attributable to perinatal affective disorders in the fathers, which are often overlooked; and again, the neurobehavioral responses of the infants will be correlated with the neurophysiological responses of the parents/nurses who interact with them through voice and touch. The research aims to have a direct impact on both parents and health care personnel: in addition to questionnaires dedicated to screening parents for perinatal psychological disorders, artificial intelligence systems will be used to intercept possible postpartum depression early by recording the maternal voice, enabling the activation of a psychological support intervention and reducing the negative impact that a postpartum depression has on the early mother-child relationship. In addition, information on parent-child interactive modalities will be able to further guide the intake of assignment and particularly the accompaniment of parents during the time of hospitalization.

NCT ID: NCT06461975 Completed - Clinical trials for Retinopathy of Prematurity

Effect of Benoxinate Hydrochloride Eye Drops on The Premature Infant Pain Profile Score During Retinopathy of Prematurity Screening

Start date: January 1, 2023
Phase: Phase 3
Study type: Interventional

Aims: To evaluate the effects of topical Benoxinate HCL eye drops on the Premature Infant Pain Profile (PIPP) scores in infants undergoing Retinopathy of Prematurity (ROP) screening. Methods: A randomized prospective double-masked cross-over trial was conducted on preterm infants screened for ROP at least twice. Dilated fundus examination was done in Group A infants using the tear substitute eye drops and the second using the Benoxinate HCL drops and the reversed order of drops for Group B. Video recording of the pulse oximeter monitor, the face and the body of the infant were analyzed by a single neonatology consultant for Premature Infant Pain Profile (PIPP) scoring 1 minute before, during the examination of the first eye, 1 minute and 5 minutes after the conclusion of the examination of the second eye. The sound of the ophthalmologist on the video recordings indicating the time of the lid speculum insertion, the shining of the indirect ophthalmoscope light without indentation and the scleral indentation would aid in assessing the differences of the PIPP indicators during each step of the examination.

NCT ID: NCT06461429 Not yet recruiting - Preterm Birth Clinical Trials

PLatform for Adaptive Trials In Perinatal UnitS - [Core Protocol]

PLATIPUS
Start date: February 1, 2025
Phase: N/A
Study type: Interventional

PLATIPUS is an adaptive platform trial aimed at improving the health of infants born preterm (before 37 weeks' gestation). PLATIPUS will compare how different treatments and care provided to pregnant women and people at risk of preterm birth and infants born preterm affect infant health. The main questions PLATIPUS aims to answer are: 1. What effect/s do different treatments/care provided to pregnant women and people at risk of preterm birth have on the health of their infants? (Pregnancy domains) 2. What effect/s do different treatments/care given to infants born preterm have on their health ? (Neonatal domains). This registration record relates to the PLATIPUS Core (or 'master') protocol which provides guidance for the overall running of the trial. Additional appendices will outline the aims, questions, treatments, and activities for each separate research question (domain). Each Domain-Specific Appendix will be registered separately on ClinicalTrials.gov and will link to this record.

NCT ID: NCT06458582 Completed - Premature; Infant Clinical Trials

High Flow Nasal Cannula Is Appropriate Alternative for Stabilization of Very Premature Infants: A Prospective Observational Study

SIMPLSAFE
Start date: February 1, 2021
Phase: N/A
Study type: Interventional

A prospective observational study evaluates the safety and efficacy of using High-Flow Nasal Cannula to stabilize very preterm infants immediately after birth. Following placental transfusion, high flow nasal cannula at 8 l/min is administered along with intermittent tactile stimulation. Criteria for switching to other interventions like continuous positive airway pressure or positive pressure ventilation are set for cases of persistent bradycardia or low SpO2.

NCT ID: NCT06455631 Not yet recruiting - Pain Clinical Trials

The Effect of Non-pharmacological Methods on Pain

Start date: August 10, 2024
Phase: N/A
Study type: Interventional

The research will be conducted using a randomized controlled experimental method.The preterm newborns included in the study will be randomized into three groups using the sealed envelope method. In the facilitated tucking position + oral breast milk group, preterm newborns will be placed in the facilitated tucking position 15 minutes before tape removal and given oral breast milk 2 minutes before. This position will be maintained until 2 minutes after tape removal. Preterm newborns in the kangaroo care + oral breast milk group will undergo kangaroo care 15 minutes before tape removal and receive oral breast milk 2 minutes before. Kangaroo care allows mother-baby interaction but no feeding. In the control group, newborns will undergo routine nesting with gentle touch and verbal comfort provided if they cry.This study is designed to evaluate the effect of the fetal position, oral breast milk administration, and kangaroo care on pain during tape removal in preterm newborns.

NCT ID: NCT06452524 Completed - Myopia Clinical Trials

Prematurity and Ophthalmological Changes

Start date: September 1, 2021
Phase:
Study type: Observational [Patient Registry]

Ophthalmological differences in school-aged children with and without a history of retinopathy of prematurity

NCT ID: NCT06451406 Completed - Hyaluronic Acid Clinical Trials

Hyaluronic Acid Injection in the Glans Penis Versus Selective Serotonin Reuptake Inhibitors for Lifelong Premature

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

The aim of this study was to compare the effectiveness and safety of selective serotonin reuptake inhibitors (dapoxetine) and hyaluronic acid gel injection in the glans penis for lifelong premature.

NCT ID: NCT06443788 Recruiting - Clinical trials for Preterm Premature Rupture of Membrane

Trans-perineal Ultrasound in Assessment of PPROMs

Start date: February 15, 2024
Phase: N/A
Study type: Interventional

Accurate and timely diagnosis of preterm pre-labor rupture of membranes (PPROM) is important to prevent adverse maternal and fetal outcomes. Following a history of PPROM, physical examination should be performed in a way that minimizes the risk of infection using a speculum. This is important to confirm the diagnosis by visualizing the amniotic fluid passing from the cervical canal or pooling in the vagina. In addition to examining the cervix to assess its dilatation and effacement and look for umbilical cord prolapse or fetal prolapse. However, Pelvic exam is one of the most common anxiety provoking medical procedures that's why this study aims at using the transperineal ultrasound as a non-invasive, accurate, cost effective, applicable and readily available tool in assessment of PPROM with less patient anxiety and fear.