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Intraventricular Hemorrhage clinical trials

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NCT ID: NCT05311228 Completed - Clinical trials for Bronchopulmonary Dysplasia

The Efect of Azithromicyn on Bronchopulmonary Displasia in Extremely Preterm and Very Preterm Infant

Start date: June 8, 2021
Phase: Phase 4
Study type: Interventional

This study was to see the effectiveness of azithromycin in preventing the incidence of bronchopulmonary dysphasia in extremely preterm and very premature infants. Inclusion criteria were infants with a gestational age of 25-31 weeks 6 days who experienced respiratory distress and their families had agreed to participate in the study, then randomized. The intervention was in the form of giving azithromycin in the intervention group and no intervention was carried out in the control group and then followed up to 36 weeks PMA

NCT ID: NCT04077333 Completed - Clinical trials for Bronchopulmonary Dysplasia

MISA to NRDS:a Multicenter Study in China

Start date: July 1, 2017
Phase: N/A
Study type: Interventional

BACKGROUND Treatment of neonatal respiratory distress syndrome with exogenous surfactant and mechanical ventilation made millions of preterm infants survived in neonatal intensive care unit (NICU). Endotracheal intubation surfactant administration is related to invasive intubation and short periods of positive pressure ventilation and implies the risk of lung injury. Continuous positive airway pressure (CPAP) or NIPPV (Non-invasive positive pressure ventilation) with surfactant but without intubation may work synergistically. This randomized trial investigated a minimal invasive surfactant administration (MISA). To test the hypothesis that MISA increases survival without bronchopulmonary dysplasia (BPD) at 36 weeks' gestational age in very low birth weight infants. DESIGN, SETTING, AND PARTICIPANTS The Minimal Invasive Surfactant Administration (MISA) was a multicenter, randomized, clinical, parallel-group study conducted between July 1st, 2017, and November 30, 2018, in 8 level III neonatal intensive care units in Beijing, Tianjin, and Hebei province, China. The final follow-up date was March 30, 2019. Participants enrolled spontaneously breathing preterm infants born between 26.1 and 31.9 weeks' gestational age with signs of respiratory distress syndrome. In an intention-to-treat design, infants were randomly assigned to receive surfactant (Calf pulmonary surfactant, Double-Crane Pharmaceutical Co., China) either via a 5Fr nasogastric tube during CPAP/NIPPV-assisted spontaneous breathing (minimal invasive surfactant administration group, MISA group) or after conventional endotracheal intubation during mechanical ventilation (endotracheal intubation surfactant administration group, EISA group). INTERVENTION MISA via a 5Fr nasogastric tube with an ophthalmic surgery straight forceps.

NCT ID: NCT03452722 Completed - Brain Injuries Clinical Trials

Neuroinflammatory Response in Patients With ICH and IVH Treated With rtPA

Start date: June 1, 2011
Phase:
Study type: Observational

This study compares the neuroinflammatory response in patients with hypertensive ICH associated with IVH treated with intraventriculary applied rtPA, and the control group. The inflammatory mediator concentration is analyzed in local cerebrospinal liquor.

NCT ID: NCT03230032 Completed - Thrombosis Clinical Trials

Pacifier Activated Device and Mother's Voice in Infants at High-risk for Cerebral Palsy

Start date: June 9, 2017
Phase: N/A
Study type: Interventional

The study seeks to determine the efficacy of non-nutritive suck (NNS) training using a pacifier-activated device (PAM) with mothers' voice to condition suck-strength and rhythmicity, in improving the feeding and developmental outcomes of infants at high-risk for CP.

NCT ID: NCT03153150 Completed - Atrial Fibrillation Clinical Trials

Start or STop Anticoagulants Randomised Trial (SoSTART)

SoSTART
Start date: March 28, 2018
Phase: Phase 3
Study type: Interventional

Primary research question: For adults surviving spontaneous (non-traumatic) symptomatic intracranial haemorrhage with persistent/paroxysmal atrial fibrillation/flutter (AF), does starting full treatment dose oral anticoagulation (OAC) result in a beneficial net reduction of all serious vascular events compared with not starting OAC? Trial design: Investigator-led, multicentre, randomised, open, assessor-masked, parallel group, clinical trial of investigational medicinal product (CTIMP) prescribing strategies. Investigators plan for a pilot phase, followed by a safety phase.

NCT ID: NCT03110887 Completed - Clinical trials for Intraventricular Hemorrhage

Monitoring Outcome in Neonatal Thrombocytopenia

MONET
Start date: November 20, 2015
Phase: N/A
Study type: Observational

Rationale: Approximately 10% of neonates admitted to neonatal intensive care units develop a major hemorrhage. In an attempt to avert this severe complication various preventive measures have been implemented. One of these is the transfusion of platelets to premature neonates with low platelet counts. However, this practice is not supported by scientific evidence. Most neonates with low platelet counts never experience a major bleeding and platelet transfusions may carry risks of volume overload or infection. Therefore, it is important to treat only those patients that truly benefit from this intervention. We urgently need a scientifically based tool to predict which premature neonates are at risk for major bleeding. A few prediction models do exist, but these only allow assessment of bleeding risk at baseline, and do not correct for changes in clinical status during the admission period. We believe that adding this feature to our prediction model will significantly improve our ability to predict bleeding. The prediction model will also be helpful in developing individualized transfusion guidelines as it helps us to predict which neonates would benefit from prophylactic platelet transfusions. Main objective: to develop a dynamic prediction model for bleeding in preterm neonates with low platelet counts. Study design: retrospective observational cohort study. Study population: neonates with a gestational age at birth of < 34 weeks admitted to a neonatal intensive care unit (NICU), with a thrombocyte count of less than 50x109/L will be included. Assessments: only data generated through standard care will be collected. This includes platelet counts, cerebral ultrasounds, information about bleeding and transfusions, and multiple clinical variables. Main study endpoint: major bleeding during admission Statistical analyses: dynamic prediction model using landmarking.

NCT ID: NCT02784821 Completed - Clinical trials for Bronchopulmonary Dysplasia

Antibiotic "Dysbiosis" in Preterm Infants

Start date: January 16, 2017
Phase: Phase 2
Study type: Interventional

Prolonged antibiotic use in preterm neonates has significant consequences on the developing intestinal microbiome, metabolome and host response, predisposing the neonate to various major morbidities, including necrotizing enterocolitis (NEC), late-onset sepsis, bronchopulmonary dysplasia (BPD), and mortality. The hypothesis is that early and prolonged antibiotic use in preterm neonates has significant consequences on the developing intestinal microbiome, metabolome and host response, predisposing the neonate to various major morbidities. It is possible that the effect of this widespread antibiotic use outweighs the potential benefits. This study will randomize preterm infants born at less than 33 weeks gestation to either pre-emptive antibiotics or no-pre-emptive antibiotics. The purpose of this research is to evaluate the risks and benefits of current practice to determine optimal levels of antibiotic use that protects the babies from infection with minimal effect on the microbiome and subsequent adverse outcomes related to overuse of antibiotics.

NCT ID: NCT02400697 Completed - Sepsis Clinical Trials

Placental Transfusion Project for Preterm Infants

Start date: September 2014
Phase: N/A
Study type: Observational

The American College of Obstetrics and Gynecology, American Academy of Pediatrics and the World Health Organization have recently published recommendations related to placental transfusions in preterm infants. This project will review outcomes of preterm infants following a quality improvement implementation process in several delivery centers in Indiana. Centers involved in this project are also part of the Indiana Vermont Oxford Network (IRB#1003-84). Data is recorded for that network and the investigators site will be reviewing that data every 3 months from infants who have completed the Vermont Oxford Network collection. This project will specifically look at the incidence of intraventricular hemorrhage, necrotizing entercolitis, periventricular leukomalacia, sepsis and death following the implementation of the ACOG recommendations.

NCT ID: NCT02231411 Completed - Clinical trials for Intraventricular Hemorrhage

Neonatal Resuscitation With Intact Cord

NRIC
Start date: August 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to examine whether providing ventilation during delayed umbilical cord clamping provides greater placental transfusion and improved hemodynamic transition at birth.

NCT ID: NCT02221219 Completed - Brain Injury Clinical Trials

Effects of Delayed Cord Clamp and/or Indomethacin on Preterm Infant Brain Injury

Start date: August 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) are brain lesions that commonly occur in preterm infants and are well-recognized major contributors to long-term brain injury and related disabilities later in life. Despite its prevalence, long term consequences, and enormous medical and social costs, mechanisms of IVH and optimal strategies to prevent or treat its occurrence are poorly defined, especially for extremely premature infants. Only one medical therapy, prophylactic indomethacin during the first 3 days of life, has been shown to prevent or decrease the severity of IVH in preterm infants, but its use is limited by toxic side effects and debatable effects on long-term outcomes. Several small studies and case reports suggest that delayed umbilical cord-clamping (DCC) may also decrease the incidence of IVH in premature infants, but thus far these trials have indomethacin treatment mixed within their cord clamping protocols. The investigators are conducting a randomized, blinded investigation of 4 treatment groups: 1) Control (no intervention); 2) DCC alone; 3) Prophylactic indomethacin alone; 4) Combination of DCC/indomethacin, with respect to survival, IVH or PVL incidence and severity, neurodevelopmental outcomes, and relevant mechanistic effects. With the steady rise in extreme prematurity births and clear links of IVH to long-term disabilities there is a need to improve care for these patients. This multi- disciplinary project addresses an important medical problem for an understudied patient population, where the current practice has clear limitations.