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Newborn clinical trials

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NCT ID: NCT04218929 Completed - Newborn Clinical Trials

Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants

Start date: December 10, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate that a new infant formula for term infants supports age-appropriate growth. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. In this randomized, controlled trial (RCT), healthy, term, formula-fed (FF) infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants (CF) or the study formula for term infants (SF) for 16 weeks. A reference group of human milk-fed infants will also be enrolled. The primary efficacy objective is to compare the growth of infants randomized to the study infant formula (SF) versus growth of infants randomized to the standard commercial infant formula (CF).

NCT ID: NCT04033874 Recruiting - Newborn Clinical Trials

The Efficacy of Non-pharmacological Interventions on Pain Levels, Crying Times and Voice Decibels in Newborns

Start date: July 10, 2019
Phase: N/A
Study type: Interventional

This study aimed to investigate and compare the effects of different non-pharmacological interventions (kangaroo care, holding on mother's lap, white noise listening, ambient sound listening) on newborns' crying times, voice decibels and pain levels during heel-stick procedure

NCT ID: NCT03969459 Completed - Microbiota Clinical Trials

Impact of Exposure to Persistent Organic Pollutants During Pregnancy on the Composition of Breast Milk and Consequences on the Newborn

PESTIMICOBLAIT
Start date: May 28, 2019
Phase:
Study type: Observational

Epidemiological studies link early exposure to persistent organic pollutants (POPs) with health consequences in the newborn. Experimental studies have shown the impact of POPs on the gut microbiota. This project aims to characterize the POPs content in breast milk in an exposed population and to evaluate the impact on breast milk composition and intestinal microbiota establishment in the newborn. The health consequences will be evaluated by the clinical follow-up of the newborn.

NCT ID: NCT03931707 Recruiting - Newborn Clinical Trials

The China Neonatal Genomes Project

CNGP
Start date: August 8, 2016
Phase:
Study type: Observational

The project will carry out the genetic testing of 100000 neonates in the next 5 years. The aim of the project is to construct the Chinese neonatal genome database, establish the genetic testing standard of neonatal genetic diseases, and promote the industrialization of neonatal genetic disease gene testing, improve the training system for genetic counseling.

NCT ID: NCT03920748 Completed - Newborn Clinical Trials

Evaluation of the Relationship Between Airway Measurements and Laryngoscopic View in Newborn and Infants

Start date: July 10, 2018
Phase:
Study type: Observational [Patient Registry]

Background and Aim: The overall incidence of difficult laryngoscopy in pediatric anesthesia is lower than in adults, but this risk is higher in patients younger than one year of age. In the last decade, different measurements have been used to obtain difficult laryngoscopy markers in children. In this study, we aimed to evaluate the relationship between the airway measurements (some performed by using ultrasonography (USG)) and the difficult laryngoscopic view in neonates and infants. Design: This is a prospective, single blinded, observational study. The number of patients was calculated as follows: A sample of 12 from the positive group (difficult laryngoscopy group) and 96 from the negative group (easy laryngoscopy group) achieve 80% power to detect a difference of 0.25 between the area under the ROC curve (AUC) under the null hypothesis of 0.50 and an AUC under the alternative hypothesis of 0,75 using a two-sided z-test at a significance level of 0.05. Methods: All patients which is newborn and infant age group undergoing elective surgery requiring intubation under general anesthesia are assessed. Patients' age, body mass index (BMI), thyromental distance, mandibula length, the distance between the lip corner and ipsilateral ear tragus, and the transverse length (measured by hand sign-middle-ring fingers adjacent side by side) measurements are recorded. In thyromental distance measurement, "thyroid notch" are determined by USG. The laryngoscopic view is graded by a different experienced anaesthetist who is blinded to the airway measurements. Statistical analysis: Receiver operating characteristic (ROC) curves are used to determine the best cut-off point for distance variables in the separation of difficult and easy laryngoscopy groups. Sensitivity, selectivity, positive predictive value and negative predictive values of lengths are calculated according to determined cut point.The difference between the two groups in terms of qualitative variables are evaluated by chi-square or Fisher's exact test. The normal distribution of the numerical variables are examined with the Shapiro-Wilk test. The difference between the two groups in terms of numerical variables are investigated by Mann Whitney U test. Values of p <0.05 are considered as statistically significant.

NCT ID: NCT03818139 Completed - Ultrasonography Clinical Trials

Performance of Lung Ultrasonography for Endotracheal Tube Positioning in Neonates

ECHOSI
Start date: January 30, 2019
Phase:
Study type: Observational

Lung Ultrasonography (US) has been shown to be effective for verifying endotracheal tube (ETT) position in adults and children but has been less studied in neonates. The aim of this study is to evaluate the performance of lung US in determining correct ETT position in neonates, in comparison with X Ray

NCT ID: NCT03690804 Completed - Newborn Clinical Trials

Assessment of Autonomic Co-regulation Between Newborn and Parent During Kangaroo Care Sessions in Neonatal Intensive Care Units

Co-PAP
Start date: September 19, 2018
Phase: N/A
Study type: Interventional

Mother-infant separation, as a result of hospitalization, leads to stress and anxiety for both parent and infant, lowers feelings of maternal competency and corrupts bonding process. Kangaroo Care (KC), is as a widespread procedure in which the naked newborn is placed on the parent's bare chest. KC is known to enhance neonatal outcome by improving temperature regulation, cardiorespiratory stability or psychomotor development. It also promotes mother-infant interactions and enhances parental psychological well-being. Heart rate variability (HRV) analysis is a non-invasive tool able to consider autonomic nervous system activity. Previous studies have shown that pleasant feelings are associated with an increase of high frequencies variations index (HFnu index) reflecting a prevalence of parasympathetic activity. This one can be assess by a new monitor called NIPĪ£ (Neonatal index of parasympathetic activity) in newborns and ANI (Analgesic nociception index) in adults can provide a comfort index by quantifying the parasympathetic tone. The investigators hypothesize that kangaroo care could induce an autonomic co-regulation between newborn and parent by increasing parasympathetic activity. The study will involve 40 preterm or term newborns and their parent, performing a one hour kangaroo care session in intensive unit and neonatal intensive care unit from hospital of Saint-Etienne (France).

NCT ID: NCT03630575 Not yet recruiting - Newborn Clinical Trials

Study of Psychoactive Substances in Newborns' Hair Whose Mothers Were Treated and Followed at the Nice University Hospital - New Born Hair Study

NBHS
Start date: September 1, 2018
Phase: N/A
Study type: Interventional

Hair toxicological analysis is nowadays a complementary technique to blood and urinary analyses because it allows a better detection of xenobiotics in time. The detection of xenobiotics is expressed in hours in blood and in days in urines; it is several months in the hair. So, hair makes it possible to establish a retrospective timetable of consumption and exposure to xenobiotics. In newborns, hair has different morphological characteristics than adults' hair. It is thinner, more porous and the development phases are not the same. Nevertheless, it is recognized that the absorption mechanisms of xenobiotics in newborns' hair are similar to those of adults. On the other hand, some difficulties of interpretation and discernment are observed between in utero exposure and environmental exposure after birth. It is interesting to have data to estimate the absorption of psychoactive substances in newborns' hair following an utero exposure. The main objective of this project is to study the mechanisms of incorporation of psychoactive substances administered to the mothers during pregnancy in newborns' hair.

NCT ID: NCT03560999 Active, not recruiting - Newborn Clinical Trials

Non-Anesthetized Plexus Technique for Infant (BPBP) MRI Evaluation

NAPTIME
Start date: March 11, 2017
Phase:
Study type: Observational

The investigators are studying the ability of a novel rapid magnetic resonance imaging (MRI) protocol to provide more accurate and earlier information about whether an infant with brachial plexus birth palsy will require nerve surgery.

NCT ID: NCT03553134 Completed - Newborn Clinical Trials

Descriptive Study of Brain Velocity in Transcranial Doppler in Newborns Over 35 Weeks of Gestational Age in the Maternity Ward

VELOCITE
Start date: April 19, 2018
Phase:
Study type: Observational

There are significant variations in blood circulation at birth with the transition from fetal to permanent circulation. These variations are particularly impacted by the closure of the arterial canal within the first 48 hours of life. Blood circulation velocity values within the cerebral arteries have been well documented in newborns and infants a few days old. However, the initial values of these velocities and their variations during the first hours of life are not well known. The objective of this study is to describe the evolution of brain circulation at birth in newborns over 35 weeks of gestational age and to investigate the effect of arterial canal closure on brain circulation.