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Newborn clinical trials

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NCT ID: NCT02374281 Completed - Newborn Clinical Trials

Autonomic Nervous System Reactivity of the Newborn After a Nociceptive Stress: Interest of Sucrose and Non-nutritive Sucking

BBSUCROSE
Start date: December 2014
Phase: Phase 3
Study type: Interventional

The management of the pain is a constant care concern in neonatal and maternity units. Many studies show an interest in the use of sugar solutions to reduce nociception during painful events in infants. However, these studies are based mainly on behavioral observation of the newborn but intrinsic mechanisms of analgesic power are not clearly understood for sucrose solutions. Our hypothesis is that the analgesic mechanism of sucrose solutions in infants involves a subcortical reactivity notably by action via the brain stem. To explore the intensity of pain and evaluate the subcortical activity, we will use 1) the analysis of heart rate variability (frequency indices whose HFnu) as a peripheral witness of subcortical functioning of the autonomic nervous system 2) electroacoustic analysis of the intensity of crying baby, 3) a composite pain score (DAN score).

NCT ID: NCT01891201 Completed - Breastfeeding Clinical Trials

Intrapartum Oxytocin Administration Affects Primitive Neonatal Reflexes

Start date: March 2011
Phase: N/A
Study type: Observational [Patient Registry]

The aim of this study was to assess whether administration of oxytocin intrapartum (Oxt) has any effect on Neonatal Primitive Reflexes (RNP) and if dose dependent. The secondary objective is to assess the effects on exclusive breastfeeding at 3 months

NCT ID: NCT01732978 Completed - Newborn Clinical Trials

Are Parents Privileged Listeners Their Baby ?

BABIES_CRY
Start date: September 2012
Phase: N/A
Study type: Interventional

The crying baby is a sound signal including information relating to this individual identity or related to its physiological or motivational state. The objective of the study is to determine the implementation of the recognition of individual tone of the baby by his parents and acoustic modulation of the baby based on parental response. The detailed study of the acoustic structure of crying and analysis of parental perception will determine the dynamics during the first weeks of life of this recognition, and the influence of factors such as parental presence, or breastfeeding . For this study is organized in three stages: first, the recording of the baby's crying Secondly, a listening test parental soundtracks and third analysis of the acoustic structure of crying and parental response.

NCT ID: NCT01604460 Completed - Hypothermia Clinical Trials

Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part V

Start date: June 2012
Phase: Phase 4
Study type: Interventional

The overall hypothesis is that plastic bags used in combination with WHO thermoregulation care will reduce the incidence of hypothermia in preterm/low birth weight and full term infants when compared to routine WHO thermoregulation care alone. Part V is comparing standard WHO thermoregulation practices plus use of a plastic torso wrap to no plastic torso wrap in full term infants from resuscitation to one hour after birth.

NCT ID: NCT01427985 Completed - Intubation Clinical Trials

Influence of Premedication Protocols for Neonatal Endotracheal Intubation on Cerebral Oxygenation

Start date: June 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to examine the influence of premedication drugs Atropin, Fentanyl and Mivacurium and of endotracheal intubation on cerebral oxygenation and cardiac output in term and preterm newborn infants. Two different protocols of premedication are compared.

NCT ID: NCT01212419 Completed - Surgery Clinical Trials

SWC on aEEG in Post-surgical Neonates on Morphine and Midazolam

Start date: March 2009
Phase: N/A
Study type: Observational

Objectives: Sleep characteristics have been used for prediction of neuro-developmental outcome. The aim of our study was to evaluate the influence of morphine and midazolam on the development of SWC in newborns > 32 weeks' gestational age after major non-cardiac surgery. Study design: This prospective aEEG study included infants > 32+0 weeks' gestation admitted to the Neonatal Intensive Care Unit at The Royal Children's Hospital in Melbourne who were undergoing major non-cardiac surgery. The BrainZ Monitor (BRM2, Version 8.0, BrainZ Instruments, New Zealand) was applied post-operatively. The time of onset and quality of SWC and the maximum levels of morphine and midazolam as predictors of time to SWC were then assessed. Results: Forty-seven eligible infants were included. Emergence of SWC was observed at a mean of 13 hours post-surgery. The maximum dose of morphine or midazolam was not predictive of time to SWC. Conclusions: Despite high doses of continuous infusions of morphine and midazolam SWC was observed on aEEG in neonates > 32 weeks' gestational age soon after major non-cardiac surgery. The main type of aEEG background pattern was not affected by the maximum dose of either morphine or midazolam. Abnormalities in aEEG in post-surgical patients are not always drug related.

NCT ID: NCT01176162 Completed - Newborn Clinical Trials

Aldosterone Resistance in Preterm Infants

PREMALDO
Start date: January 2010
Phase: N/A
Study type: Observational

In the neonatal period, the human kidney is characterized by a functional immaturity responsible for an impaired ability to regulate water and sodium homeostasis, which is exacerbated by prematurity. This altered sodium handling could be related to a partial renal aldosterone resistance. Renal sodium reabsorption and potassium excretion are mainly controlled by aldosterone, after binding to the mineralocorticoid receptor (MR). The investigators have analyzed MR expression throughout human and mouse renal development, and the investigators found a weak MR expression at birth. The investigators have conducted a pilot study in full-term newborns, which confirmed a partial neonatal aldosterone resistance. This study also highlighted that urinary aldosterone is the best index to accurately assess aldosterone sensitivity at birth.

NCT ID: NCT00420693 Completed - Newborn Clinical Trials

Interest of Using the Sevoflurane in the Prevention of Newborns Pain

Start date: August 2006
Phase: Phase 2/Phase 3
Study type: Interventional

The objective of this randomized and controlled study is to compare the sedation with sevoflurane inhalation versus non-nutritive sucking and sucrose administration to facilitate peripheral inserted central catheter insertion in a pediatric and neonatal intensive care. Main measurements concern success or failure of insertion, duration of procedure, movements of the baby, tolerance of treatments evaluated by, mean arterial pressure, heart rate, respiratory frequency and oxygen saturation.

NCT ID: NCT00337142 Completed - Newborn Clinical Trials

Follow up Glucose Levels Among Infants of Diabetic Mothers

Start date: June 2006
Phase: Phase 1
Study type: Observational

Infants to diabetic mothers (IDM) are at risk for developing hypoglycemia after birth. Glucose level follow ups are recommended to each IDM. However, there are no recommendations as to how long this follow up should be performed for, nor are there "safe" glucose levels that allow stopping glucose monitoring. The aim of the study is to retrospectively follow up glucose levels among IDMs in order to find risk factors for developing hypoglycemia and determine time and glucose levels that would permit monitoring cessation.

NCT ID: NCT00169390 Completed - Pregnancy Clinical Trials

Monoamine Oxidases in Smoking Pregnant Women and Newborns

Start date: March 2004
Phase: N/A
Study type: Observational

Smoking substantially inhibits the activities of both monamine oxidase (MAO) A and B enzymes. Aims of this study: to compare MAO activities and nicotine and cotinine in peripheral blood of smoking and nonsmoking pregnant women, in their placenta and in cord blood and relate them with the behavior of their newborns being observed during 48 hours after birth.