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Newborn Morbidity clinical trials

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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: 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: NCT04985227 Completed - Newborn Morbidity Clinical Trials

Impact of Home Weight Tele-monitoring on the Number of Office Visits in the First Six Weeks of Life in Infants.

Start date: August 9, 2021
Phase: N/A
Study type: Interventional

Currently American Academy of Pediatrics (AAP) Bright Futures Guideline recommends 2 visits for all healthy term newborn infants in the first 6 weeks of life, first at 3-5 days of life and the second at around a month. However, compliant parents of infants are known to get at least 1-2 extra visits due to primary care provider's concern about appropriate weight gain. These weight check visits as they take up extra time, car gas, parking charges, loss of work time and paying for childcare during the visits. Clinic resources are also unnecessarily utilized. Remote home monitoring of infant weights with the use of technology could reduce the need for office visits and improve efficiency on the provider side, enhance parental satisfaction and decrease transmission of viruses in the winter season. The main objective is to monitor the daily weight of term infants born at 37 completed weeks of greater, discharged from the newborn nursery, remotely through the electronic medical record by the primary care provider and to reduce any extra visit in the first six weeks of life. Using block randomization, the infants will be assigned to either group A, where no home telemonitoring of weight will take place or group B, where the parent will be provided with a weighing scale. The parent will enter the weight into the MyChart application on the smartphone or on the computer which will be tracked by the pediatrician. The pediatrician will take the decision whether to bring the infant in for a weight check visit based on the weight information. If the weight gain is satisfactory, the pediatrician will see the patient at around 1 month of age per recommendation and the parents will stop the weight checks at that time. The sample size required was 16 on each arm (total 32) which has been increased to 20 each arm to account for technical problems and/or loss to follow up.

NCT ID: NCT04925908 Completed - Covid19 Clinical Trials

Exclusive Breastfeeding in Infants of Mothers Infected With Novel Coronavirus

Start date: June 1, 2021
Phase:
Study type: Observational

COVID-19 pandemic emerges an issue for breastfeeding.Earlier in pandemic mothers who had COVID-19 were separated from their babies due to insufficient data but this approach was abandoned due to the lack of transmission via breastmilk.However, where mothers with COVID-19 are cohorted in the same room, they still have to be isolated from their babies following the birth.Investigators aimed to evaluate rate of exclusive breastfeeding(EB) within first 6 months among mothers who were isolated from their babies due to COVID-19.

NCT ID: NCT04785183 Completed - Oxidative Stress Clinical Trials

Antioxidant Effects of Melatonin in Preterm

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

Preterm infants are at risk of free radical mediated diseases from oxidative stress (OS) injury. Melatonin (MEL) is a powerful antioxidant and scavenger of free radicals. In preterm neonates, melatonin deficiency has been reported. Several studies tested the efficacy of melatonin to counteract oxidative damage in diseases of newborns such as chronic lung disease, perinatal brain injury, necrotizing enterocolitis, retinopathy of prematurity and sepsis, giving promising results. In these studies, the dosages of melatonin varied over a wide range. The present study was designed to test the hypothesis that oral administration of melatonin reduced OS and consequentially, the occurrence of intraventricular haemorrhage (IVH), necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP) and bronchopulmonary dysplasia (BPD) in preterm newborns.

NCT ID: NCT04734002 Completed - Clinical trials for Surgery--Complications

Neonatal Surgery Intensive Care Unit: Hacettepe Experience

NSICUHE
Start date: January 1, 2020
Phase:
Study type: Observational [Patient Registry]

Background: Surgical treatment in the neonatal period mostly consists of congenital anomalies. Due to the different characteristics of newborns, the practice of monitoring this group of patients by neonatal specialists in neonatal intensive care units is increasingly common in the world and in our country. In our hospital, neonatal surgery intensive care unit model has been applied for about six years. Objectives: This study was aimed at examining the data gathered from the neonatal surgery intensive care unit we created at Ihsan Dogramaci Children's Hospital and the contribution of this model toward improving the health of newborns with surgical problems. Methods: The file records of newborns admitted to the neonatal and neonatal surgery intensive care units which operate on two separate floors at Ihsan Dogramaci Children's Hospital were retrospectively analyzed for the period January 2014 to December 2019. The information of the patients was recorded retrospectively for the study period with the information obtained from the hospital database. The investigators believe that the neonatal surgery intensive care unit model should become widespread in Turkey. As there is a paucity of information concerning this subject in the literature worldwide and in our country, through this study the investigators wanted to draw attention to the subject by sharing our own experience working at İhsan Dogramaci Children's Hospital.

NCT ID: NCT04634981 Completed - Clinical trials for Anesthesia; Adverse Effect

Does the Mode of Anesthesia Affect the Feto-maternal Outcome in Category-1 Caesarean Section

Start date: August 12, 2020
Phase:
Study type: Observational

Spinal anesthesia (SA) has become the standard technique in elective cesarean section (CS) as it results in less maternal and neonatal morbidity than general anesthesia (GA) (Grade-A recommendation, NICE). For women requiring emergency CS, rapid sequence general anesthesia (RSGA) is commonly used because this technique is faster to perform than SA. Though several randomized trials have compared the maternal and fetal outcome between these two anesthetic techniques, the studies with respect to category 1 CS (emergent conditions that hold immediate threat to life of the woman or fetus) are limited.

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: NCT04323397 Completed - Clinical trials for Noninvasive Ventilation

Nasal HFOV Versus Nasal SIPPV in Neonate Following Extubation: RCT Crossover Study

nHFOnSIPPV
Start date: July 1, 2020
Phase: N/A
Study type: Interventional

Mechanical ventilation was introduced to treat respiratory failure in preterm infants or sick neonates then improvements in survival (1,2). However, the complications from short or long term use of ventilation can result in unintended harm or burden (e.g., air leak syndrome, pneumonia, bronchopulmonary dysplasia, neurological injury, retinopathy of prematurity) (3,4). To reduce these risks, clinicians should aggressive extubated neonates as early as possible. Respiratory (focus on blood gas as well as partial pressure CO2 [pCO2]) or extubation (focus on clinical condition as well as reintubation) failure was worrisome in pediatrician and parents if the neonate was reintubated owing to complete recovery of lung disease or inadequate respiratory drive. Non-invasive ventilation (NIV) was supported for primary respiratory support (initial mode before endotracheal intubation) or post-extubation. Nasal continuous positive airway pressure (nCPAP) was familiar to NIV mode in neonatal respiratory support. Nowadays, the new NIV modalities are nasal intermittent synchronized positive pressure ventilation (nSIPPV) and nasal high frequency oscillation (nHFO). To increase the likelihood of nCPAP success, other new modalities of NIV may be interesting. From theory, nSIPPV and nHFO combines peak inspiratory pressure (PIP) with synchrony and high-frequency oscillations without synchrony above CPAP, respectively. From meta-analysis, nSIPPV and nHFO were statistically significant superior than nCPAP both respiratory and extubation failure in neonate (5,6). The aim of our study was to investigate the efficacy of nHFOV and nSIPPV for CO2 clearance and reintubation rate after extubated neonates. The investigators hypothesized that nHFOV mode would improve CO2 clearance better than nSIPPV mode.