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Infants 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: NCT03716882 Completed - Infants Clinical Trials

Acoustic Structures Crying of Infants From 1 to 4 Months and Their Signification

LongCRY
Start date: October 16, 2018
Phase:
Study type: Observational

Crying is a survival mechanism for babies and their almost exclusive means of expression until the age of 4 months. Babies 'cry is mostly related to pain, a feeling of hunger, discomfort or separation following the departure of a parent around. Crying is a complex but essential means of communication and information between a baby and his parents that raises the question of their meaning. The cry phenomenon consists of complex acoustic signals produced by the vocal cords and filtered by the vocal tract. The vibrations frequency determines the fundamental frequency, itself responsible for the perception of the cry tone (pitch). The frequency spectrum of a cry is modified during the passage through the upper airways forming broad bands called "resonance frequency" or "formants". From the specificity of a crying sequence, it is possible to extract dynamic information and relate it to the perception that the adult has of it. Thus dynamic crying is often perceived by the adult as an imminent need of the baby. Some studies have shown that a child's crying may change according to his degree of discomfort, suggesting that crying was a "graduated signal" whose frequency and timbre could vary along a continuum. These changes would explain why adult listeners would be able to dissociate crying babies of different intensities. Conversely, an inappropriate response to crying could gradually generate disorders of the relationship between the baby and the parent. However, despite their potential neuro-ethological interest, knowledge of information transmitted by babies's cry remains superficial. This could be related to the relatively obsolete techniques of recording or due to the lack of objective physiological data on babies 'cry. Finally, the perception and reactions of adults when they hear crying babies are not fully understood.

NCT ID: NCT03327415 Completed - Infants Clinical Trials

Nutri-Bébé 2013 Survey on Food Consumption of Infants and Young Children

NBB2013
Start date: January 3, 2013
Phase: N/A
Study type: Observational

The Nutri-Bébé 2013 survey is an observational cross-sectional study aiming to update food consumption, practices and nutrient intakes in children under 3 years of age in metropolitan France.

NCT ID: NCT03047876 Not yet recruiting - Infants Clinical Trials

Brain Vascular Reactivity to Hypothermic Circulatory Arrest With Antegrade Cerebral Perfusion During Aortic Arch Surgery

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

Many neonates and infants who undergo complex cardiac surgery are affected by neurological developmental delays. Whilst catastrophic events are immediately identifiable from clinical examination or by macro changes on MRI or CT scans, smaller changes are often not immediately visible or detected. This is an observational pilot study examining brain vascular reaction to hypothermic circulatory arrest with antegrade cerebral perfusion and neuro-protection techniques during aortic arch surgery in neonates and infants. A combination of duplex ultrasound and transcranial doppler will be used to record in-depth information on the cerebrovascular changes that occur during the entire length of the surgical procedure and during the early postoperative period. The proposed techniques and equipment are non-invasive and are in use clinically to evaluate brain perfusion in a similar age group. During aortic arch surgery, the patient's body and brain temperature is reduced to values between 18 and 24 degrees centigrade in order to decrease metabolic demand that provides a form of metabolic protection. However, there is no consensus within the clinical community regarding the optimal temperature at which to perform surgery. Moreover, in order to improve cerebral perfusion, the brain is perfused via the right internal carotid artery with cold blood. At Alder Hey Children Hospital, this surgery is undertaken by the three surgeons but, due to clinical preference, differs in relation to the temperature at which surgery is undertaken. This provides the opportunity to observe the impact of different temperatures on cerebral vascular reactivity in neonates and young infants The arguments for future comparisons and a larger randomised study will be made based on the information gained from this observational study.

NCT ID: NCT02119104 Completed - Infants Clinical Trials

Prevenar (13v) Infant Drug Use Investigation

Start date: March 2014
Phase: N/A
Study type: Observational

The purpose of this study is to investigate post marketing use and safety of Prevnar ( 13v) in infants vaccinated for the first time at the age of 2 months, inclusive, to 7 months, exclusive.

NCT ID: NCT02069522 Terminated - Infants Clinical Trials

Healthy Term Infants Fed Milk-Based Formulas

Start date: February 2014
Phase: N/A
Study type: Interventional

This is a prospective, double blind, crossover study in healthy infants randomized to one of two study formulas. The trial will consist of two 21 day study feeding periods separated by a study washout period.

NCT ID: NCT01953562 Withdrawn - Infants Clinical Trials

Positioning and the Spontaneous Breathing Test in Neonates

Start date: October 2013
Phase: N/A
Study type: Observational

The spontaneous breathing test (SBT) is routinely performed on all intubated patients in the NICU who are potential candidates for extubation from mechanical ventilatory support. For all parents who consent, the routine SBT will be performed on all infants. In addition to the routine SBT the following will occur: 1. work of breathing indices: obtained non-invasively through respiratory inductive plethysmography (RIP). 2. Performing the SBT in the prone position, in addition to the routine position (supine).

NCT ID: NCT01664234 Completed - Difficult Airway Clinical Trials

Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children

Start date: January 1, 2012
Phase: N/A
Study type: Interventional

Infants (0-1 yr.) with anticipated difficult airways will be enrolled in the study. Specifically, we will include infants with cleft palate, Pierre Robin, Treacher Collins, trisomy 21, or similar congenital malformations. Patients with American Society of Anesthesiologists physical status scores ≥3 will be excluded, as will those with congenital heart disease and left-to-right shunting. Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq. Randomization (1:1) will be based on computer-generated codes with random block sizes and stratified by hospital; allocation will be concealed and provided to clinicians via a secure web site that will be accessed shortly before induction of anesthesia.

NCT ID: NCT01575184 Recruiting - Infants Clinical Trials

Effect of Shoulder Traction on Size and Relative Position of Internal Jugular Vein to Carotid Artery

Start date: August 2011
Phase: N/A
Study type: Interventional

Internal jugular vein (IJV) catheterization is frequently performed in infants undergoing major surgery. Although it has been suggested that head rotation increases the degree of overlapping between IJV and carotid artery (CA), IJV catheterization without head rotation is extremely difficult in infants. The aim of the present study is to evaluate whether the caudo-lateral traction of the ipsilateral arm can decrease the degree of overlapping between IJV and CA in infants during head rotation.