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Premature Birth clinical trials

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NCT ID: NCT05120843 Completed - Depression Clinical Trials

Testing Feasibility of Care Coordination and Motivational Interviewing for Women With a Recent Preterm Birth

Start date: February 3, 2022
Phase: N/A
Study type: Interventional

This study continues an adaptation of care coordination to address the needs of women after preterm birth. This is a small single arm open trial designed to test intervention implementation and refine the intervention before ongoing feasibility testing.

NCT ID: NCT05116670 Completed - Morality Clinical Trials

Comparison of Care Practices, Mortality and Morbidity of Very Preterm Infants Between Two Tertiary Centers in Northwest and South of China

Start date: October 15, 2021
Phase:
Study type: Observational

Care practices, mortality and morbidity of very premature infants from two different tertiary centers were collected and compared, in order to discover areas for improvement where these two newborn centers can learn from each other.

NCT ID: NCT05114096 Recruiting - Preterm Birth Clinical Trials

Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS)

SNACS
Start date: July 20, 2023
Phase: Phase 4
Study type: Interventional

Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities in preterm infants, such as respiratory distress syndrome. The standard of care for pregnant people at risk of preterm birth includes 2 doses of Celestone (for a total of 24 mg in Canada, or 22.8 mg in Australia) to accelerate fetal lung maturity. The investigators plan to conduct a randomized controlled trial to determine whether half the usual dose (12 mg in Canada, or 11.4 mg in Australia) of Celestone is non-inferior to the standard double doses.

NCT ID: NCT05110599 Terminated - Anxiety Clinical Trials

Bryophyllum Pinnatum Treatment of Anxiety Related to Signs of Preterm Birth

Start date: July 12, 2022
Phase: Phase 2
Study type: Interventional

The present IIT (Investigator-Initiated Trial) study is a prospective, randomised, placebo-controlled, double blind trial. Women hospitalised with signs of preterm birth can be recruited for the study. Participants will take study medication for 2 weeks (or until birth) and fill out a questionnaire at 3 time points (at baseline, after 1 week and after 2 weeks) to assess state of anxiety and sleep quality. Furthermore, information regarding adverse events and the further course of the pregnancy are recorded.

NCT ID: NCT05107713 Completed - Clinical trials for Evaluation of Preterm NAVA Catheter Placement

Positioning of EDI Catheter In Premature Infants

PIPI
Start date: November 1, 2021
Phase:
Study type: Observational

Nasogastric (NG) and orogastric (OG) feeding tubes have a high incidence of malpositioning, occurring in up to 59% of preterm infants (Lopes 2019). Ideally, the tip of the feeding tube (including the orifices) should be located within the body of the stomach. Malpositioning of the feeding tube can be classified as (i) being "too far out" where the tip of the catheter is located in the esophagus above the gastro-esophageal junction, potentially resulting in reflux, aspiration, apnea or (ii) being inserted "too far in" where the tip is located in the pylorus or the duodenum, leading to malabsorption of nutrients, diarrhea, and poor weight gain. Feeding tubes can also be found "curled up" inside the stomach (Quandt 2009) as much as 35% of the time. As well, one cannot ignore the risk of perforation, where the incidence has been reported to be 1.1% in extremely low birth weight (ELBW) infants (<1000g) (n = 7/646) (Thanhaeuser M, 2019); of note: perforations occurred on the third day of life (range days 2-14) not during initial feeding tube placement. In 2008, a modified feeding tube was introduced to the market (Maquet Critical Care AB), which contains sensors placed in its wall, 13 mm above the feeding orifices, used for measuring the electrical activity of the diaphragm (Edi) during spontaneous breathing. The Edi signal is then used to neurally control mechanical ventilation, or for neural monitoring of the breathing pattern (Sinderby 1999; Beck 2016). The so-called "Edi catheter" comes with the manufacturer's recommended insertion measurements and verification window. In the Servo-I, the insertion distance is provided by a formula on the catheter packaging. In the Servo-U and Servo-n, the calculation for predicted insertion is provided by a tool in the ventilator. There is no available, published data upon which the manufacturer's recommendations were based. It is possible that obtaining appropriate positioning of the Edi catheter - based on a pattern of electrical signals from the sensors - could reduce the incidence of malposition. This proposed study is observational, and non-interventional. The purpose is to verify the position of a neurally guided, clinically-placed, Edi catheter using radiography (Ellett 2011). We will also record physical measurements and weights of the babies in order to validate previously described methods of predicting insertion length. The x-rays will be taken with "near-simultaneous" screenshots of the Edi catheter positioning window.

NCT ID: NCT05100212 Recruiting - Clinical trials for Retinopathy of Prematurity

umBilical Or Adult Donor Red Blood Cells in Extremely Low Gestational Age Neonates and Retinopathy of Prematurity (BORN)

BORN
Start date: December 1, 2021
Phase: Phase 2
Study type: Interventional

Extremely low gestational age neonates (ELGAN, i.e., born before 28 gestation weeks) are among the most heavily transfused pediatric patients. In this clinical setting, repeated red blood cell (RBC) transfusions independently predict a poor outcome, with a higher risk for mortality and morbidity. Recent studies from our own and other groups highlighted a close association between low levels of fetal hemoglobin (HbF) and severity of retinopathy of prematurity (ROP) and bronchopulmonary dysplasia (BPD), two disabilities that frequently complicate preterm birth. This association is not surprising, considering that 1) preterm neonates have a highly immature antioxidant reserve and both ROP and BPD rely on the oxidative damage as underlying mechanism; 2) in comparison with HbA, HbF is endowed with higher oxygen affinity, greater redox potential, higher tetrameric stability, and higher ability to generate unbound nitric oxide, all functions potentially protective in presence of an oxidative challenge; 3) in normal prenatal life, developing organ and tissues are exposed exclusively to HbF until last weeks of gestation; 4) in preterm neonates, the switch of the synthesis from HbF to HbA occurs around their due date, i.e., several weeks after the premature birth; 5) when preterm neonates receive transfusions, their tissues are abruptly exposed to high levels of HbA. We have recently run a pilot trial demonstrating as a proof-of-concept that transfusing cord blood red blood cell concentrates (CB-RBC) effectively prevents or restrains the HbF loss consequent to adult donor standard transfusions (A-RBC). This study explores the hypothesis that transfusing CB-RBCs instead of A-RBC may lower the incidence of severe ROP in ELGANs needing transfusions.

NCT ID: NCT05099588 Completed - Clinical trials for Retinopathy of Prematurity

The Incidence of Treatment-requiring Retinopathy of Prematurity in Greece

GR-ROP
Start date: June 1, 2020
Phase:
Study type: Observational

A prospective observational study of the incidence of treatment-requiring ROP (TR-ROP), at a national level, in Greece.

NCT ID: NCT05095285 Completed - Premature Clinical Trials

Pain and Comfort During Endotracheal Suction in Premature Neonates

Start date: July 1, 2019
Phase: N/A
Study type: Interventional

Most of the preterm babies in neonatal units are followed up with invasive mechanical ventilation support. For this reason, endotracheal suction is needed repeatedly in preterm babies in order to open the airway obstruction caused by secretions and to maintain the airway patency. Endotracheal aspiration, which is one of the invasive procedures in which pain is felt most in newborns, is performed by nurses. Endotracheal suction, which causes pain and discomfort in intensive care units, negatively affects the comfort of patients. Studies emphasize that comfort is an indicator of pain and stress, and the comfort scale is also used in pain and distress assessments. Effective pain management and the development of pain-related care standards to reduce pain in preterm newborn infants improve clinical and neurodevelopmental outcomes. For this reason, it is necessary to reduce the pain that has an effect on the development of preterm babies. In pediatric nursing, studies on non-pharmacological methods have increased in recent years in order to increase the comfort of infants and reduce pain and stress, especially during painful and stressful procedures in infants followed in neonatal intensive care units. When the literature is examined, there are few studies measuring the effectiveness of non-pharmacological methods used in reducing pain due to endotracheal suction. There are differences in the effectiveness of the methods applied in the existing studies. Therefore, more observation, research and scientific studies by neonatal nurses are needed to reduce the pain associated with endotracheal suction in preterm newborns. In this study, swaddling and oropharyngeal colostrum, which are two non-pharmacological methods, will be applied during endotracheal suction to preterm newborns receiving invasive mechanical ventilation support. This experimental study was planned to determine the effect of these two non-pharmacological methods on procedural pain and comfort and to contribute to evidence-based nursing practices.

NCT ID: NCT05087511 Completed - Preterm Birth Clinical Trials

The Effect Of Risk Factors Considered Together With Preterm Birth History on Development

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

This thesis was planned to examine the effects of risk factors seen with a history of preterm birth on sensory and motor development in preschool children. A total of 48 children, 24 with only a history of preterm birth and 24 with additional risk factors for preterm birth, were included in the study.

NCT ID: NCT05087238 Completed - Clinical trials for Ventricular Premature Complexes

CBT for Premature Ventricular Contractions

PVC-CBT
Start date: January 14, 2021
Phase: N/A
Study type: Interventional

The purpose of the present interdisciplinary research program is to develop and evaluate a disease-specific cognitive behavior therapy (CBT) protocol to increase quality of life (QoL) and reduce symptom burden in patients with Premature Ventricular Contractions (PVC).