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Premature Birth clinical trials

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NCT ID: NCT05359809 Completed - Stress Clinical Trials

Peripheral Intravenous Central Catheter Intervention in Preterm Infants

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

This study will be conducted to evaluate the effect of grasping reflex stimulation applied during peripheral intravenous central catheter (PIC) intervention on pain and stress in preterm infants receiving treatment and care in the neonatal intensive care unit.

NCT ID: NCT05352503 Completed - Anxiety Clinical Trials

The Effects of Making Pregnant Women With Preterm Birth Threat Watch Nature Images With Virtual Reality Goggles on the Levels of Stress, Anxiety, Attachment, and Care Satisfaction

Start date: April 5, 2022
Phase: N/A
Study type: Interventional

Virtual reality application, which is a non-pharmacological method, is used for different purposes in many different fields. One of the areas where virtual reality application is used is health services. Its use in the field of obstetrics is new. Virtual reality application is often in pregnancy; it is used to reduce pain, stress and anxiety levels, exercise training and train pregnant women to effectively manage their pain during childbirth. Although pregnancy is a normal physiological process, adverse situations may occur that can make every pregnancy risky. Threatened premature birth, which is called the onset of uterine contractions without cervical changes between the 20th and 37th weeks of pregnancy, is also among these risk groups. Pregnant women diagnosed with the threat of premature birth are usually treated by hospitalization. Psychological problems such as stress, fear and anxiety may develop in pregnant women who are on bed rest in the hospital. In these pregnant women, mother-infant attachment may also be adversely affected. Pregnant women who are hospitalized and taken to bed rest due to risky pregnancy need to be informed and supported by health personnel. The midwife's spending enough time with the pregnant woman, keeping in touch and meeting her needs increase satisfaction in terms of care. When the literature was examined, it was determined that pregnant women were satisfied with the virtual reality application and thus increased care satisfaction.

NCT ID: NCT05319834 Completed - Preterm Birth Clinical Trials

Comparative Study Between Vaginal Progesterone Alone or Combined With Aspirin in Prevention of Recurrent Preterm Birth

prematurity
Start date: April 1, 2022
Phase: Phase 4
Study type: Interventional

This is a double blinded randomized placebo controlled clinical trial to detect the efficacy and safety of vaginal progesterone alone or combined with aspirin in prevention of recurrent PTB.

NCT ID: NCT05310851 Completed - Preterm Clinical Trials

The Effect Of Oral Motor Stimulation And Nonnutritive Sucking To The Time Of Transition To Oral Nutrition In Preterm

Start date: January 10, 2021
Phase: N/A
Study type: Interventional

Oral feeding difficulty is one of the problems that preterm infants frequently experience due to poorly developed oral musculature. Sucking and swallowing are present in early fetal life, but sucking-swallowing and swallowing-respiratory coordination are respectively occurs after the 32 and 33-34 gestational week (GA). For this reason, although there are sucking movements in preterm babies with gestational weeks of 31 and below, oral feeding is difficult because adequate coordination cannot be achieved during sucking-swallowing and breathing. Until these structures develop, preterm babies are fed by gavage (nasogastric/orogastric route) in intensive care units. Gavage feeding causes many negativities such as preventing the advantages of oral nutrition and creating an entry route for infectious agents, and the discharge is also delayed. Thus, infants are exposed to adverse intensive care conditions for a longer period of time. For this reason, it is important to ensure the transition to full oral nutrition as soon as possible. There are various methods that facilitate the transition of infants to oral feeding. Pacifier and oral stimulation applications are some of them. Oral stimulation was first applied by Fucile et al (2002). It is a method consisting of a total of 15 minutes, in which therapeutic touches are made for 12 minutes before feeding, and in the last few minutes, non-nutritive sucking is applied. Later, Lessen thought that this intervention was longer than the fragile preterm babies with a small oral cavity and shortened the duration of the intervention and reformatted it. This intervention, called "Premature Infant Oral Motor Intervention (PIOMI)" (Preterm Infant Oral Motor Intervention), is a 5-minute application consisting of 3 minutes of massage and 2 minutes of non-nutritive sucking. In the literature review, a study comparing oral motor stimulation and pacifier method was reached. However, in this study, unlike our study, a pacifier was applied to one of the groups, a 12-minute stimulation to the second, and a 12-minute stimulation and pacifier to the third. In our study, there are 3 groups. one of the groups a pacifier will be applied to one group and a 5-minute oral stimulation program will be applied to the other group. The third group is the control group. The aim of the study is to evaluate the effect of pacifier and oral stimulation applied to preterm infants on the transition time to oral feeding.

NCT ID: NCT05263973 Completed - ROP Examination Clinical Trials

The Effect of Music on Pain, Comfort and Physiological Parameters During Prematurity Retinopathy Examination

Start date: March 10, 2022
Phase: N/A
Study type: Interventional

It is planned to determine the effect of music during Retinopathy of Prematurity (ROP) examination on pain, comfort and physiological parameters in preterm infants. This is single-center, randomized controlled trial, double blind, parallel. Hypotheses: H1: The music applied during the ROP examination has an effect on the Revised Premature Infant Pain Profile (PIPP-R) score of the preterm infant. H2: The music applied during the ROP examination has an effect on the Preterm Infant Comfort Scale (PMI) score of the preterm infant. H3: Music applied during the ROP examination has an effect on the physiological parameters (peak heart rate, O2 saturation) of the preterm infant. H4: The music applied during the ROP examination has an effect on the crying time of the preterm infant during the procedure. Method: The study will be performed with preterm infants (n=28) hospitalized in the neonatal intensive care unit of a tertiary hospital. Premature infants to be included in the study will be assigned to two study groups using the block randomization method created in the computer environment according to their gestational age, gender, birth weight. The data in the study were will be collected using the Questionaire Form for Preterm Newborns and Their Parents, Physiological Parameters Observation Form, Revised-Premature Infant Pain Profile (PIPP-R), Premature Infant Comfort Scale (PICS), Pulse Oximeter, Music CD, Music box, Video camera, decibel meter, tripod. Data will be collected by researcher ABÇ. Infants who meet the criteria for inclusion in the study will be selected from the infants who are planned to an ROP examination, and written and verbal consent will be obtained from the families by explaining the purpose of the study. Questionaire Form for Preterm Newborns and Their Parents will be obtained from the nurse observation form and patient files. Four minutes before the ROP, the infant will be monitored and physiological parameters will be recorded, and three minutes before the ROP, the experimental group will start to listen to music (Video recordings will be evaluated by three experts, PIPP-R and PICS). The music recording will continue to be played during the ROP examination for music group. No application will be made for the control group other than the clinical routines.

NCT ID: NCT05261503 Completed - Preterm Clinical Trials

Investigation of the Effectiveness of Environmental Enrichment-Based Intervention in Preterm Infants

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

The aim of this study is to investigate the effectiveness the HEP (Homeostasis-Enrichment-Plasticity) approach, which based upon the principles of enriched environment (EE) and ecological theories of development on preterm infants with developmental delay risk. Thirty-two preterm infants aged 4-10 months will be randomly divided into 2 groups as the HEP intervention group and the Traditional Physical Therapy (TPT) group. EE-based intervention will be applied to the HEP intervention group, and traditional physiotherapy will be applied to the TPT group for 12 weeks (24 sessions). The demographic information of the participants will be recorded. The motor and sensory functions of the infants will be evaluated with, the Peabody Developmental Motor Scales (PDMS-2) and the Test of Sensory Functions in Infants™ (TSFI™), respectively. Additionally, the anxiety status of the parents will be evaluated with the Beck Anxiety Inventory (BAI). All evaluations will be done twice, at the end and at the beginning of 12 weeks.

NCT ID: NCT05260424 Completed - Clinical trials for Respiratory Distress Syndrome, Newborn

Predictors for Nasal Intermittent Positive Pressure Ventilation Failure for Premature Infants With Respiratory Distress Syndrome

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

Non-invasive respiratory support methods have been widely used in premature babies with respiratory distress syndrome (RDS) which has changed the basic management of premature babies in the early period. According to the 2019 European Guidelines on RDS management, early nasal CPAP is recommended as first-line therapy in infants <30 weeks of age who are at risk of RDS who do not require mechanical ventilation (MV). However, some of the premature babies have faced non-invasive ventilation failure. Remarkably, infants who experience non-invasive ventilation failure are at increased risk of death, pneumothorax, intraventricular hemorrhage, and bronchopulmonary dysplasia (BPD), among other morbidities. In non-invasive ventilation failure, although demographic factors such as small gestational age, low birth weight, and male gender play a role, it has been suggested that surfactant deficiency may also play an important role. The most frequently reported risk factor in predicting non-invasive failure in studies is the fraction of inspiring oxygen during the first hours of life. In addition, positive end-expiratory airway pressure (PEEP) required for patient stabilization was found to be a potential predictor. However, there are still limited data to predict non-invasive ventilation failure. "Which newborns are at high risk for non-invasive ventilation failure?" and "When should the surfactant be applied?". The study is a single-center, prospective study to evaluate prognostic factors, and most importantly to define the FiO2 threshold, which is an indicator of possible non-invasive ventilation failure in infants supported with nasal intermittent positive pressure ventilation.

NCT ID: NCT05250102 Completed - Premature Birth Clinical Trials

Neonatal Pulse Oximetry Sensor Study

Start date: June 13, 2022
Phase: N/A
Study type: Interventional

To validate the SpO2 accuracy, bias, and precision of Medline's reprocessed pulse oximetry sensors as compared to SaO2 in arterial blood samples as assessed by CO-oximetry in neonates.

NCT ID: NCT05246150 Completed - Premature Birth Clinical Trials

NIRS Levels of Infants in Neonatal Intensive Care

Start date: March 1, 2019
Phase:
Study type: Observational [Patient Registry]

Aim: This study was conducted to determine the effect of nursing care practices on the Near Infrared Spectroscopy (NIRS) levels of premature infants in the neonatal intensive care unit (NICU). Materials and Method: This is a cross-sectional, analytical study. It was conducted over the period March 1 - April 26, 2019 in the Neonatal Intensive Care Unit (NICU) of Eskişehir Osmangazi University (ESOGU) Health Practices and Research Hospital. We did not calculate sample size, but included in the study, after the parents had been informed about the research, the entire universe of neonates in the NICU who matched the inclusion criteria during the period March 1 - April 26, 2019. The study was completed with 40 neonates. Data collection was performed with a "Descriptive Data Form," and a "Procedures Performed Chart." The data were evaluated with the IBM SPSS 24 package program.

NCT ID: NCT05230706 Completed - Preterm Infants Clinical Trials

Light/Dark Cycle Promotes Weight Gain in Preterm Infants

Start date: September 10, 2016
Phase: N/A
Study type: Interventional

The study focuses on the use of light/dark alternation as chronotherapy to prevent deterioration and reduce morbidity and mortality in premature patients, as well as favoring circadian alteration after birth, which should lead premature infants to a better evolution in life. NICU. With the hypothesis that exposure to light/dark cycles during hospitalization of preterm infants will decrease hospital stay. In addition, the light/dark cycle will allow a circadian organization of physiological variables such as salivary levels of cortisol and melatonin. To identify the benefits of the light/dark cycle in the clinical maturation of preterm newborn patients and early hospital discharge in preterm newborns.