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Infant, Newborn, Diseases clinical trials

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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: NCT04074824 Recruiting - Clinical trials for Necrotizing Enterocolitis

A Genome-Wide Association Study for Neonatal Diseases

Start date: September 1, 2018
Phase:
Study type: Observational

This is an observational study to identify genetic risks for neonatal diseases, necrotizing enterocolitis (NEC) using genome-wide association study (GWAS) and enterotype investigation. We hypothesize that specific genetic factors and microbiome could predispose preterm neonates for the development of NEC.

NCT ID: NCT04073342 Not yet recruiting - Neonatal Disease Clinical Trials

Intestinal Genes Expression Associated With Necrotizing Enterocolitis

Start date: January 1, 2020
Phase:
Study type: Observational

In recent days, necrotizing enterocolitis is one of the most common and devastating problem in preterm infants. Therefore, it became a high growing research topic in the last decade. The development of medical care increases the survival of preterm babies and consequently increase the number of cases with this serious problem. A systematic review shows the incidence of necrotizing enterocolitis is about 2-7% in babies less than 32weeks gestation and 5-22% in baby's birth weight less than 1000gram.

NCT ID: NCT04041765 Not yet recruiting - Inflammation Clinical Trials

IgM-Enriched Immunoglobulin for Neonatal Sepsis

Start date: September 2019
Phase: Phase 3
Study type: Interventional

This study compares giving prophylactic IgM enriched Intravenous Immunoglobulin (IVIG) with placebo in 1 hour after birth, in neonates with risk factors of Early-Onset Neonatal Sepsis (EONS). In addition to the intervention, standard regimen antibiotics are also given within 1 hour. The IVIG is given for 3 days and primary and secondary outcomes will be collected. Risk factors are both from maternal and neonate origin.

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).