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Infant, Newborn, Diseases clinical trials

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NCT ID: NCT04309162 Completed - Neonatal Disorder Clinical Trials

Soft Tissue Therapy in Managing Procedural Pain Among Neonates.

Start date: August 3, 2020
Phase: N/A
Study type: Interventional

Effect of Soft tissue Therapy in managing Procedural Pain among neonates admitted in neonatal intensive care unit. This study focuses on the Procedural pain management with the help of Soft tissue manipulation which includes various techniques like stroking, petrissage manipulations.

NCT ID: NCT04271995 Completed - Neonatal Disorder Clinical Trials

Gastric Lipase Enhanced Nasogastric Tube Study in Neonates

Start date: March 2, 2020
Phase:
Study type: Observational

The newborn infants who are sick and those who are born prior to due date (preterm) are admitted to the neonatal unit. These babies are unable to feed through their mouth, so a special tube is passed through their nose to the stomach, nasogastric (NG) tube) to provide milk feeds. The bedside nurse inserts the tube and then aspirate some of the fluid from the stomach. As the stomach normally produce acid, these aspirate is then tested on a colour coded paper strip to check if the fluid is acidic. However, on many occasions this test is not very clear. This could be due to misplacement of the tube or the stomach in a newborn not being able to produce enough acid. This then leads to re-siting of another tube and following the same procedure. Sometimes the clinical team may like to do an X Ray to check the position of the tube resulting in unnecessary exposure to radiation. The study will use a special chemical added to the currently existing paper test strip which the investigators believe will enhance the capability of detecting the correct position of the NG tube. This idea has been tested in adults and found to have increased the sensitivity of the test strip significantly. Based on the adult study the study will require to test 233 babies to see if this increases the sensitivity of correct NG tube placement. Parents of all babies who requires an NG tube for milk feeds will be approached and after appropriate consent could be recruited to the study. Babies who are clinically very unstable, moribund and those with diagnosis of bowel obstruction will be excluded from the study.

NCT ID: NCT04259008 Completed - Clinical trials for Infant, Newborn, Disease

Safety of Manganese Restriction in Neonatal Parenteral Nutrition

Start date: June 11, 2020
Phase: Phase 4
Study type: Interventional

Participants will be <= 32 weeks gestational age (GA) neonates randomized to parenteral nutrition (PN) prepared with standard dose trace elements or to PN prepared with standard trace elements minus manganese.

NCT ID: NCT04234152 Completed - Lung Diseases Clinical Trials

Complete Shielding of Multivitamins to Reduce Toxic Peroxides in the Parenteral Nutrition: A Pilot Study

C-SMART-PN
Start date: November 23, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to examine if a new and simple method involving complete photo-protection of multivitamins only (since sampling through infusion) will result in a significant reduction of peroxide contamination of parenteral nutrition compared to standard method of parenteral nutrition preparation and infusion in extremely preterm infants.

NCT ID: NCT04222907 Completed - Clinical trials for Streptococcal Infection Group B as Cause of Diseases Classified Elsewhere (Diagnosis)

The Relationship Between GBS Screening in Pregnant Women Insured in Maccabi Healthcare Services (MHS) and Early-onset Neonatal Disease in Israel

Start date: January 1, 2015
Phase:
Study type: Observational [Patient Registry]

Determination of GBS colonization rates in Pregnant Women insured with Maccabi Health Services, Doctors' Compliance Rates for Referral for Testing, test execution rates, and Early-onset GBS Disease (EOGBSD) Rates in Israel. Determine the relationship between conducting a GBS test in pregnant women and EOGBSD in Israel.

NCT ID: NCT04076189 Completed - Clinical trials for Infant, Newborn, Disease

Time of Positive Pressure Ventilation in Non-vigorous Infants Born Through Meconium-stained Amniotic Fluid

MASTIME
Start date: September 16, 2019
Phase: N/A
Study type: Interventional

Background: Meconium stained amniotic fluid (MSAF) complicates 3 to 14% of pregnancies, causing meconium aspiration syndrome (MAS) in 5-10% of neonates born. Due to lack of evidence of benefits of endotracheal suctioning at birth in non-vigorous infants, recent neonatal resuscitation guidelines do not recommend it as a routine and they suggest to start ventilation within the first minute of life, which may be critical to reverse asphyxia and stabilize the neonate. There are concerns regarding the safety and efficacy of this change in practice because it is not based on large randomized controlled trials. Besides that, the delay in the beginning of the PPV in these babies has not been previously explored. Objective: to compare the time of PPV initiation between performing immediate laryngoscopy with intubation and suctioning and performing immediate PPV without intubation in a manikin. Methods: Level III NICU consultants, residents, and fellows trained in advanced airway management will be randomly assigned to AB arm (endotracheal suction, followed by the procedure without endotracheal suction) and to BA arm (reverse sequence), with a washout period of 6 hour. During each simulation, an external observer will record the time of PPV initiation. The primary outcome measure will be the time of PPV initiation in the endotracheal suction arm compared to the control arm.

NCT ID: NCT04035291 Completed - Cerebral Palsy Clinical Trials

Effectiveness of Family Collaborative Physiotherapy Programs With High-risk Infants

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

High risk infant is defined as infant with a negative history of environmental and biological factors, which can lead to neuromotor development problems. It is a heterogeneous group of premature infants born under thirty-seven weeks of age, with infants with low birth weight, term or developmental retardation for various reasons. Therefore, preterm infants with low birth weight can survive with a neurological sequelae such as cerebral palsy (CP), epilepsy, hearing and vision loss, mental retardation, speech and speech problems, and learning difficulties. The clinical diagnosis of CP, which can be observed in high-risk infants, is based on the combination of some neurological and clinical signs. High-risk of infant follow-up programs provide guidance for the treatment of neurodevelopmental delays and deterioration in terms of early development. Three methods with the best predictable validity that can determine CP before the adjusted age of 5-month is Magnetic Resonance Imaging (MRI), Prechtl's Assessment of General Movements (GMs), Hammersmith Infant Neurological Evaluation. In recent years, the diagnosis of high-risk of CP can be detected at 3 months with predictive validity and reliability by evaluating the quality of GMs. GMs are now considered the gold standard for early detection of CP because of its high sensitivity and specificity than MRI, cranial US and neurological evaluations. It was also found that cognitive or language skills may be inadequate in school age in patients with inadequate movement character and in the same postural patterns according to age, although GMs are normal. So new clinical care guidelines and new intervention research for infants with CP under the age of 2, needed to have been shown. High-risk infants who are thought to have developmental disorders need early intervention, but it is not yet known which interventions are more effective. In the literature, although interventions are generally shown to have a greater impact on cognitive development, their contribution to motor development cannot be fully demonstrated. The effectiveness of physiotherapy programs in the diagnosis and treatment of CP has not been clarified in the past years as a silent period. Therefore, studies involving early physiotherapy programs are needed in infants at high risk for CP.

NCT ID: NCT04034719 Completed - Clinical trials for Infant, Newborn, Disease

Benefit of Scarf Support on Skin-to-skin Time and Portage in Neonatology and at Home

PAPSE
Start date: October 8, 2019
Phase: N/A
Study type: Interventional

Carrying (or kangaroo carrying) is known to reduce neonatal and child morbidity and mortality and improves the quality of survival of premature and term children during the most fragile growth period, the first thousand days of life. Carrying is also a growing brain protection technique and becomes a routine of care in all neonatal units around the world. In University hospital of Saint-Etienne, the developmental care program has been developed since 2002 in all neonatology units and advocates the practice of skin-to-skin carrying between the parent (father or mother) and his baby, from the time of the hospitalization. Professionals in units who have long been thinking about the concept of attachment and the benefits of skin-to-skin, wish to validate the use of the wearing scarf as a tool for the practice of skin -in-skin in neonatology then back home by performing a randomized monocentric prospective longitudinal study.

NCT ID: NCT03985501 Completed - Sickle Cell Disease Clinical Trials

DREPAMASSE Study - Evaluation of a Newborn Screening for Sickle Cell Disease by Tandem Mass Spectrometry

DREPAMASSE
Start date: March 16, 2021
Phase:
Study type: Observational

Three methods are actually used in newborn screening for sickle cell disease (SCD) in France: isoelectric focusing, high performance liquid chromatography and capillary electrophoresis. New technologies are currently under development such as Matrix Assisted Laser Desorption Ionisation - Time of Flight (MALDI-TOF) and tandem mass spectrometry (MS/MS) using the SpOtOn Diagnostics Reagent Kit available in United Kingdom only. Zentech company (Liège, Belgium) is developing a package for SCD newborn screening using MS/MS technology. The main objective of the present study will be to compare this new technique with the technique actually used in the hospital center of Lille (sub-contractor for SCD newborn screening of Lyon) and the haemoglobin analysis to test its accuracy (sensitivity and specificity).

NCT ID: NCT03956511 Completed - Clinical trials for Infant, Newborn, Diseases

Integrated Prediction of Extubation Outcome by the Spontaneous Breathing Trial in Newborn Infants

Start date: February 2016
Phase:
Study type: Observational

Prolonged mechanical ventilation (MV) is associated with significant adverse effects in newborn infants and clinicians aim at its minimum possible duration. Failed extubation and need for reintubation is common and further prolongs the duration of MV. Hence, accurate prediction of readiness for extubation would incur a considerable reduction in respiratory morbidity. The Spontaneous breathing Trial (SBT) involves placing the infant on endotracheal continuous positive airway pressure for five minutes with continuous monitoring of heart rate and oxygen saturation levels. The infant would pass the test if there is no hypoxia or bradycardia during the trial. A successful SBT might predict successful extubation. The respiratory muscles play a crucial role in successful extubation. One simple way to quantify respiratory muscle function is the rate of relaxation of the inspiratory muscles that can be depicted by the rate of the decline of the airway pressure signal following a spontaneous breath. The hypothesis of the investigator is that respiratory muscle function assessment using the rate of relaxation of the inspiratory muscles during a SBT can accurately predict extubation outcomes either independently or in conjunction with the outcome of the SBT and the variability of the respiratory parameters during the SBT. This could increase the predicting accuracy of extubation outcomes and thus reduce re-intubation associated respiratory morbidity.