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Infant, Newborn clinical trials

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NCT ID: NCT03266315 Recruiting - Infant, Newborn Clinical Trials

Probiotics Supplementation and Intestinal Microbiome in Neonates With Gastrointestinal Surgery

ProPS
Start date: December 3, 2022
Phase: N/A
Study type: Interventional

Congenital defects of the gastrointestinal tract commonly require surgical intervention in the neonatal period. Intestinal surgery during this critical period of microbiome acquisition results in aberrant colonization of the gastrointestinal tract by several pathways. Surgical stress is known to cause disruption of the gut barrier and increase intestinal permeability and bacterial translocation. This process triggers exaggerated immune responses that lead to inflammation and sometimes infectious complications. Post-operative use of antibiotics has been shown to potentiate the growth of pathogenic bacterial species Adults with abdominal surgery who received post-op probiotics reported a significant reduction in surgical site infection, urinary tract infection, and combined infection. Currently, probiotics used only in the non-surgical population of infants. The main objective of this study is to determine the impact of probiotics administration on the intestinal microbiome in neonates undergoing intestinal surgery.

NCT ID: NCT02899819 Completed - Infant, Newborn Clinical Trials

MecoExpo Study Protocol

MecoExpo
Start date: February 2011
Phase: N/A
Study type: Interventional

The MecoExpo project seeks to evaluate the in utero exposure of newborns in the Picardie region to commonly used pesticides. These pesticides were selected in a pilot study (the Mecopic study) on the basis of their toxicity (effects on foetal development, endocrine perturbation, neurological toxicity and carcinogenicity) and a certain number of indicators of pesticide use and the presence of pesticide in the environment in Picardie. These substances (or their metabolites) will be measured in the each newborn's meconium (the first faeces after birth) and each newborn's mother's hair in the Picardie region during the study period. The mother's exposure will also be assessed using a retrospective questionnaire (filled out within a few days of the delivery). Thus, the MecoExpo project will enable the investigators to: 1. evaluate the relationships between foetal exposure (via the meconium), maternal exposure (via the hair and the questionnaire) and clinical parameters measured at birth (term, length, weight, etc.). 2. map pesticide exposure across the Picardie region. 3. create a meconium bank in Picardie (the first ever meconium bank in France).

NCT ID: NCT02384876 Completed - Infant, Newborn Clinical Trials

Determination of the Optimal Dose of Ephedrine in Intraoperative Arterial Hypotension of Newborns and Infants up to 6 Months of Age.

EPHEDRINE
Start date: June 2015
Phase: Phase 2
Study type: Interventional

The incidence of arterial hypotension under general anesthesia using sevoflurane is particularly high in newborns and infants up to 6 months of age. A decrease of 20% of the initial mean blood pressure (mBP) is the definition of significant arterial hypotension in adults and children. In adults, intraoperative arterial hypotension is associated with an increase of intraoperative mortality and a certain neurological morbidity. In infants under 6 months of age, neurological disorders have been reported following general anesthesia. Neurotoxicity of hypnotics is often incriminated as should be the episodes of arterial hypotension. Current management of hypotension uses vascular filling with crystalloids and vasopressive amines in second intention. Dopamine is the most frequently used amine. Ephedrine can also be used. Ephedrine is particularly interesting because of its action on both α and β receptors and its mode of administration: one dose and peripheral access. Only one study is available in children from birth to adulthood; it demonstrates a lower hemodynamic response in infants than in adults, when administered a low dose of Ephedrine (0.1 to 0.2 mg/kg). A recent retrospective cohort suggests an under efficacy of low doses and the use of higher doses than those recommended. The primary objective is to determine the optimal dose of ephedrine (dose of ephedrine associated with a difference of proportion of newborns/infants in therapeutic success of 55%) compare to the reference dose of 0.1mg/kg as a first line treatment of intraoperative arterial hypotension. Secondary objectives: - Return to a mBP superior to 38mmHg post Ephedrine administration. - To assess occurrence of hypoxemic events during anesthesia. - To assess tolerance of ephedrine. One hundred and twenty newborn and infants up to 6 months of age will be recruited in 3 sites of the Rhone Alpes Auvergne area over 24 months.

NCT ID: NCT02160002 Completed - Infant, Newborn Clinical Trials

Incubator Weaning of Moderately Preterm Infants

Start date: February 2015
Phase: N/A
Study type: Interventional

The objective of this proposal is to evaluate whether weaning from an incubator to a crib at lower versus higher weight, 1600g or 1800g will result in shorter length of hospital stay among moderately preterm infants. The hypothesis of this study is that length of hospital stay (from birth to discharge) will be decreased among moderate preterm infants weaned from an incubator to an open crib at a lower versus higher weight, 1600g vs. 1800g.

NCT ID: NCT02064712 Completed - Infant, Premature Clinical Trials

Determining an Optimal Weaning Method of Nasal Continuous Positive Airway Pressure in Preterm Neonates

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

The purpose of this study is to determine an optimal strategy to wean nasal continuous positive airway pressure (NCPAP) in preterm babies. The investigators hypothesize that babies that are taken off NCPAP at lower settings will need fewer total days on NCPAP than those babies taken off at higher settings.

NCT ID: NCT01793129 Completed - Infant, Newborn Clinical Trials

Preemie Hypothermia for Neonatal Encephalopathy

Start date: May 2015
Phase: N/A
Study type: Interventional

This study is a randomized, controlled trial to assess safety and effectiveness of whole body hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present at <6 hours postnatal age with moderate to severe neonatal encephalopathy (NE). The study will enroll infants with signs of NE at 18 NICHD Neonatal Research Network sites, and randomly assign them to either receive hypothermia or participate in a non-cooled control group.

NCT ID: NCT01793116 Completed - Infant, Newborn Clinical Trials

Generic Database of Moderate Preterm Infants

Start date: March 2012
Phase:
Study type: Observational [Patient Registry]

This is a registry of moderate preterm infants, born alive at 29-33 weeks gestational age, in NICHD Neonatal Research Network (NRN) centers. The registry collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Data are analyzed to find associations and trends between baseline information, treatments, and infant outcome, and to develop future NRN trials.

NCT ID: NCT01682122 Not yet recruiting - Blood Pressure Clinical Trials

Frequency and Persistence of Wide Pulse Pressure in the Neonatal Population

Start date: August 2012
Phase: N/A
Study type: Observational

Wide Pulse Pressure is frequently present in the normal, full-term neonatal population. This study will evaluate the frequency and persistence of wide pulse pressure in the neonatal population. Using a prospective study design in the Regular newborn and Observation nurseries of SIUH, North site. Healthy newborns that are between 0-72 hrs of age will have their blood pressures measured using the oscillometric method. This data will offer insight into whether the presence of wide pulse pressure in otherwise healthy newborn infants warrants further cardiovascular evaluation

NCT ID: NCT01534481 Completed - Infant, Newborn Clinical Trials

Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants

Start date: August 2012
Phase: Phase 3
Study type: Interventional

The Milk Trial seeks to determine the effect on neurodevelopmental outcomes at age 22-26 months of donor human milk as compared to preterm infant formula as the in-hospital diet for infants whose mothers choose not to provide breast milk or are able to provide only a minimal amount. Infants will be randomized to receive donor breast milk or formula during their hospital stay. Infant's will be followed until they reach 22-26 months of age.

NCT ID: NCT01380886 Completed - Infant Newborn Clinical Trials

Growth and Tolerance of Young Infants Fed Infant Formulas

Start date: June 2011
Phase: Phase 3
Study type: Interventional

This is a randomized, multi-center, double blind, parallel study to compare growth and tolerance of healthy term infants fed either control or experimental infant formula.