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Newborn Complication clinical trials

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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: NCT05537389 Recruiting - Clinical trials for Catheter Complications

Intravenous Neonatal Central Access Safety Trial

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

Particulate contamination due to infusion therapy (administration of parenteral nutrition and medications) carries a potential health risk for infants in neonatal intensive care units (NICU). In-line filtration is increasingly used in critically-ill infants but its benefits, by preventing micro-particle infusion in neonates, remain to be demonstrated. In-line filters in the intravenous administration sets prevent the infusion of particles, which may reduce infectious complications.

NCT ID: NCT04781361 Completed - Fluid Therapy Clinical Trials

Comparison of the Isotonic and Hypotonic Intravenous Maintenance Fluids In Term Newborns: Neofluid Study

NEOFLUID
Start date: December 30, 2020
Phase:
Study type: Observational

Considering the physiological changes in fluid and electrolyte balance and providing proper support are one of the important aspects of neonatal intensive care. Maintenance intravenous fluids are designed to maintain homeostasis when a patient is unable to uptake required water, electrolytes, and energy. Hypotonic fluids are still the most commonly prescribed IV fluids for pediatric hospitalized patients. However, previous studies, including children older than one month of age revealed that traditionally used hypotonic fluids may lead to hyponatremia. Because of the absence of evidence-based data, there is currently no clear consensus on the optimal composition of maintenance intravenous fluid therapy in newborns, leading to wide practice variation. The National Clinical Guideline Center (NICE) 2015 recommends the use of isotonic fluids in term newborn infants and some newborn centers has begun to use isotonic fluids since guidelines recommendations. Since the publication of the NICE guideline, no studies have addressed this topic. In this prospective, observational , multicentric study, conventional hypotonic fluids containing sodium chloride (NaCl) < 130 mmol/L compared with isotonic fluids (containing NaCl between 131-154 mmol/L) in terms of the risk of hyponatremia, hypernatremia, plasma sodium (pNa) level change, treatment morbidities, hospitalization duration and mortality.

NCT ID: NCT04606589 Completed - Newborn Morbidity Clinical Trials

Feasibility Study Evaluating the Efficacy of a Wireless Vital Signs Monitor for Critically Ill Newborns in Kenya

Start date: February 1, 2021
Phase: Early Phase 1
Study type: Interventional

The neoGuard device is a 4-in-1 wearable vital signs monitor designed to continuously measure temperature, pulse rate (PR), respiratory rate (RR) and blood oxygen saturation (SpO2) in newborns. In this study, researchers will evaluate the feasibility of the neoGuard device at two rural health facilities in Western Kenya and assess the preliminary efficacy of the technology in improving health outcomes for newborns. This is a pre/post intervention study. The standard-of-care arm (n=223) will be enrolled between 20 Oct - 20 Nov, 2020 and the neoGuard intervention arm (n=223) will be enrolled between 1 - 31 Dec, 2020.

NCT ID: NCT04422041 Completed - Newborn Clinical Trials

Comparison of Early Versus Very Early Postnatal Discharge on Hospital Readmissions in Newborns

Start date: July 1, 2016
Phase: N/A
Study type: Interventional

This study compared hospital readmission and complications between very early discharge and early discharge in healthy newborn patients.

NCT ID: NCT04207658 Completed - Prevention Clinical Trials

The Effects Of Pushing Techniques During Second Stage Of Labour On Maternal and Newborn Health

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

Purpose :To determine the impact of directed Valsalva's's versus spontaneous pushing techniques during second stage of labour on postpartum maternal fatigue. . Methods: The control group participants have an onset of spontaneous pushing when the cervical dilatation was 6cm while the directed pushing group carried out the Valsalva's manoeuvre.The data of the study are obtained by utilizing Baseline Obstetric Data Form and Visual Analogue Fatigue Scale (VAFS). The investigators have done postpartum tests on perineal tear, hemorrhagia, haemoglobin level, vital findings, blood pH, pO2 and pCO2, and lactate level for the mother while the neonatal tests of APGAR score for 1st and 5th minutes, umbilical artery blood pH, pO2 and pCO2 levels are done for the newborn.

NCT ID: NCT04154618 Recruiting - Clinical trials for Newborn Complication

Continuous Vital Sign Monitoring in Newborns

Start date: February 18, 2020
Phase:
Study type: Observational

This study evaluates the feasibility and usability of continuous wireless vital sign monitoring of well newborns during their birth hospitalization.

NCT ID: NCT04014504 Completed - Hearing Loss Clinical Trials

Pethidine Analgesia and Neonatal Hearing Screening Test

Start date: January 1, 2017
Phase:
Study type: Observational

Neonatal hearing screening may fail due to some perinatal and neonatal factors. It is well known that false positivity in newborn hearing screening increases cost and maternal anxiety and anxiety. There is still widespread concern about the use of opoid analgesics to relieve pain during labor. The aim of this study was to determine the effects of pethidine administered during labor on neonatal hearing screening test false positivity rates.

NCT ID: NCT03751787 Completed - Clinical trials for Newborn Complication

Cranial Osteopathy in Functional Disorders of the Newborn

Start date: September 2009
Phase: N/A
Study type: Interventional

To evaluate, from the maternity stay, the interest of the cranial osteopathy in the reduction of the hyper irritability of the newborn and the improvement of the postural abnormalities