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Newborn Morbidity clinical trials

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NCT ID: NCT06466512 Not yet recruiting - Newborn Morbidity Clinical Trials

Feasibility of Introducing Midwifery-embodied Community Clinic Model

Start date: August 1, 2024
Phase: N/A
Study type: Interventional

Background (brief): 1. Burden: Maternal and neonatal mortality continue to be a serious public health problem in Bangladesh. Facility-based healthcare services reduce the probability of preventable causes of maternal and neonatal death. Community clinics (CCs) are located closer to the community than other healthcare facilities are. However, only 2.8% of all CCs are ready to provide antenatal care (ANC) and 2.4% of these facilities are ready to provide delivery services. Despite the wide acceptance of midwifery care for ANC and delivery services, they are posted only up to the Upazila Health Complexes and at selected Union Health and Family Welfare Centers. 2. Knowledge gap: There is a dearth of evidence on whether the utilisation of ANC, normal vaginal delivery, and postnatal care (PNC) services can be increased if midwives are assigned to CCs to provide these services. 3. Relevance: Midwives were trained to provide antenatal and postnatal care, conduct normal deliveries, and manage CC-specific pregnancy-related complications. Midwives are posted up to union-level facilities, and the Government of Bangladesh has a strategic plan to enable selective community clinics for normal delivery services in addition to antenatal and postnatal care. Hypothesis (if any): N/A Objectives: This study aims to assess the feasibility, adoption, acceptability, appropriateness, fidelity, coverage, and possible barriers and enablers of introducing Midwifery-embodied Community Clinic (MCC) model in selected community clinics of Bangladesh. Methods: We will implement a Midwifery-embodied Community Clinic (MCC) model in two CCs of the Baliakandi sub-district of Rajbari district. Trained midwives will provide ANC, select low-risk pregnant women, conduct their normal deliveries, and provide PNC services in CCs, while the CHCP will provide essential newborn care during NVD. High-risk mothers will be referred to the upper level of healthcare facilities for managment. In addition, counselling services will be provided to mothers by the Health Assistants and Family Welfare Assistants during their domiciliary visits. Transport services using the ambulances of the Upazila Health Complex will be integrated into the model to transport patients to the CCs and upper-level healthcare facilities in case of emergencies. Outcome measures/variables: The outcome measures will be feasibility, adoption, acceptability, appropriateness, fidelity, coverage, and possible barriers and enablers of the MCC model.

NCT ID: NCT06256406 Recruiting - Newborn Morbidity Clinical Trials

Effects of Confortable Environment, Kangaroo Care and Music Therapy in Newborns in Neonatal Intensive Care Unit

PRE-CARE
Start date: June 20, 2022
Phase: N/A
Study type: Interventional

Creating a comfortable environment, implementing kangaroo care, and incorporating music therapy are crucial interventions for newborns hospitalized in the Neonatal Intensive Care Unit (NICU). These strategies not only contribute to the physical well-being of the infants but also play a significant role in promoting their emotional and developmental health.

NCT ID: NCT06254651 Completed - Resuscitation Clinical Trials

Resuscitation Table Height for Face-mask Ventilation in Infants

ForTab
Start date: February 12, 2024
Phase: N/A
Study type: Interventional

Positive pressure ventilation (PPV) is the most important intervention in neonatal resuscitation. During PPV, it is important to hold the face-mask with care, as applying excessive pressure could cause injury to the infant, while insufficient pressure could be a contributor of mask leak and reduced effective ventilation. Application of positive pressure to face structures may trigger a vagally mediated reflex via the trigeminal nerve that innervates the skin of the face leading to apnoea and a decrease in heart rate (TCR, trigeminal-cardiac reflex). The force exerted by providers during neonatal ventilation to improve mask seal might result in pressure lesions and the elicitation of the trigeminal-cardiac reflex. The height of the resuscitation could influence the forces applied to the face and the quality of the procedure. Information about the applied forces in relation to the height of the resuscitation table is unknown.

NCT ID: NCT06213207 Recruiting - Newborn Morbidity Clinical Trials

Cluster Randomized Controlled Trial Applying Helping Baby Breathe in Nepal

SaLiN
Start date: February 18, 2024
Phase: N/A
Study type: Interventional

The cluster randomized controlled trial will be conducted in the selected health facilities/birthing centers of Sarlahi district in Nepal. Further from the selected health facilities. The investigators will assess the newborn in terms of their health outcomes. Characteristics related to the performance of skilled birth attendants will be measured prior to the intervention. After six months of the intervention, endline assessment will be conducted. The intervention unit are the health facilities which provide the services as birthing centers. The effectiveness of the intervention will be examined using generalized estimating equation against baseline vs. endline on skills performance of the health workers and newborn health outcomes. The study will be implied in the similar settings to improve the skill performance and newborn health outcomes in order to reduce neonatal mortality.

NCT ID: NCT06170892 Recruiting - Newborn Morbidity Clinical Trials

Kangaroo Position in Preterm Newborn Infants Under Oxygen Therapy

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

The kangaroo position, which is part of the Kangaroo Method strategy, is widely used in the Neonatal Intensive Care Unit and Neonatal Intermediate Care Units and aims to promote emotional bonding, cardiorespiratory, physiological and body temperature stability, in However, there is still little scientific evidence when it comes to newborns undergoing oxygen therapy. Identify, quantify and analyze the influence of the kangaroo position on the vital signs and respiratory comfort of preterm newborns using supplemental oxygen. To collect data, a physiotherapeutic assessment form suitable for clinical analysis was used. The newborns were placed in the kangaroo position in a single session, and the variables were identified before, during and after the application of the technique.

NCT ID: NCT06130488 Completed - Newborn Morbidity Clinical Trials

Implementation at Scale and Evaluation of KMC

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

The goal of this quasi-experimental study design is to look at feasibility and document the process and challenges of implementing KMC at scale in district Sanghar (Sindh) and Lasbella (Balochistan) . The main question it aims to answer are: - Does the KMC is feasible to be implemented in rural areas? - What is the process and challenges in implementing KMC in rural areas? - Pregnancy surveillance is going in the secondary level care hospitals and in its catchment population. Recruitment of babies is carried who are low birth weight (less than 2000grams). - Mothers taught to administer KMC by physician and nursing /LHV staff in the facility within first 6 hours after delivery and continue till the mother and baby are discharged by trained facility KMC management team. - After training and administration of KMC at facility for 72 hours, the mother and baby pair discharged and followed up at home by the team including project-based data collector and respective LHWs. - KMC Champions are in development for community mobilization and conducting sessions at village level. - We will compare pre and post intervention change in practices at facility level and at individual level of household and assess the KMC coverage.

NCT ID: NCT06081075 Recruiting - Genetic Disease Clinical Trials

Newborn Genomics Programme

Start date: January 15, 2024
Phase:
Study type: Observational

Genomic methods can significantly contribute to all facets of precision medicine, from diagnosis to prevention, therapeutic intervention, and management of acute and chronic illnesses. DNA based methods are already having a considerable impact across healthcare in fields that include: public health, infectious disease monitoring, acute and chronic disease, pharmacogenomics, prenatal testing and diagnosis, and therapeutic development. In this proposal, investigators are focusing on the application of genomic methods in precision medicine - specifically on rapid whole-genome sequencing of parents and children (i.e. a trio) for the identification of diseases that have genetic components. Goals Primary goal: is to provide safe rapid whole genome sequencing to Neonatal Intensive Care Unit/Pediatric Intensive Care Unit patients. Secondary goals: 1) Although several groups globally are implementing rapid sequencing of rare disease, these are predominantly in the research space, with many unanswered questions regarding the best way to implement them into a national healthcare system. Each country and their healthcare systems are unique, and valuable knowledge will be gained by implementing this process within a New Zealand context. As part of this the study will measure the impact on the individuals and families. 2) to expand the research team's understanding of non-coding disease-causing variants and methylation changes that contribute to severe disease in early life. Primary Aims 1. To incorporate long-read RNA sequencing data into the diagnostic rapid Whole Genome Sequencing pipeline to provide a direct measure of the functional outcome of the variants of clinical concern. 2. To measure the clinical utility of analysing non-coding variants in the diagnosis of critically ill children who do not have pathogenic, likely pathogenic, or variants of unknown significance for mendelian disorders. 3. To identify, in a real-world setting within the New Zealand health-care system, the clinical and economic effects of deploying rapid Whole Genome Sequencing-informed rapid precision medicine for critically ill children.

NCT ID: NCT05851222 Not yet recruiting - Acute Kidney Injury Clinical Trials

A Big Data Approach to Predict NEOnatal Acute Kidney Injury in Newborns expoSed to nephroTOxic Drugs (NeoAKI STOP)

NeoAKISTOP
Start date: August 1, 2023
Phase:
Study type: Observational

This observational retrospective study aims to learn about the incidence of acute kidney (AKI) injury in newborns in infants exposed to nephrotoxic drugs with a big data approach. The main question it aims to answer are: - Develop a model that can predict the occurrence of AKI in infants admitted to the NICU; - Identify the drug or combination of drugs associated with an increased risk of AKI. The group of infants exposed to drugs will be defined based on exposure for at least 1-day tone one or more therapies commonly used in the NICU. Once the AKI event has occurred, the observation of the trend of daily creatinine and diuresis values will be continued for the period covered by the study.

NCT ID: NCT05728307 Recruiting - Newborn Morbidity Clinical Trials

Post-market Observation of a Wireless Vital Sign Monitor for Hospitalized Newborns in Kenya

Start date: November 28, 2022
Phase:
Study type: Observational

The goal of this study is to measure the clinical impact and cost-effectiveness of a wireless vital signs monitor, neoGuard, for hospitalized newborns at a tertiary healthcare facility in Kenya. The main questions it aims to answer are: 1. Does the neoGuard vital signs monitor detect meaningful vital sign changes in hospitalized newborns? 2. Does the neoGuard vital signs monitor generate valid signals to trigger a timely response from nurses? 3. Is the neoGuard vital signs monitor associated with improved patient outcomes and lower mortality? 4. What is the cost-effectiveness of the neoGuard vital signs monitor in comparison to the standard-of-care monitoring system? Participants will be enrolled within the first 24 hours of admission and monitored for a period of 7 consecutive days or until they are discharged (whichever comes sooner). The study will consist of an intervention group and a comparison group. Researchers will compare nurses' response time to patients in distress, newborn complication rates and treatment outcomes between the two groups.

NCT ID: NCT05639309 Recruiting - Premature Birth Clinical Trials

Liver Regional Oxygen Saturation in Preterm Patent Ductus Arteriosus

Start date: January 13, 2023
Phase:
Study type: Observational

This study evaluates the usefulness of liver perfusion and oxygenation status using regional oxygen saturation (RSO2) values obtained via near-infrared spectroscopy in assessing the hemodynamical significance of patent ductus arteriosus in preterm infants.