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Infant, Newborn, Diseases clinical trials

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NCT ID: NCT02968628 Completed - Clinical trials for Diabetes, Gestational

Effect of Maternal Diabetes on Brain Development, as Measured by Neonatal Electroencephalogram (EEG)

Start date: September 1, 2016
Phase:
Study type: Observational

Alterations in the intrauterine environment can have profound effects on fetal development. Diabetes during gestation results in multiple deleterious short-term outcome differences, and is correlated with long-term developmental deficits. Multiple studies, in neonates through school-aged children, have demonstrated differences in language, attention and psychomotor development in offspring of diabetic pregnancies. Neonatal EEG is a promising and non-invasive tool for assessment of abnormal brain development or "dysmaturity" in this population. Multiple conventional EEG (cEEG) and amplitude-integrated EEG (aEEG) parameters change predictably with advancing gestational development and have been used to differentiate between at risk groups in neonatal studies. The investigators hypothesize that neonatal EEG can identify brain dysmaturity in infants of diabetic mothers (IDMs) compared to gestational-age matched controls. The primary aim is documentation of brain dysmaturity in IDMs using cEEG. The secondary aim is establishment of aEEG as a more accessible tool to quantify the effects of maternal diabetes on neonatal brain development. The investigators will conduct a pilot study comparing cEEG and aEEG parameters of cases to gestational-age matched controls. Cases will be IDM neonates of at least 35 weeks' gestation whose mothers were recommended treatment with either insulin or an oral glycemic agent. Video EEG recording will be planned for approximately 60 minutes and obtained between 24 hours and 5 days of life during birth hospitalization. Additional data will be extracted from maternal and neonatal medical records and a maternal questionnaire. In addition to evaluating the measures of cEEG and aEEG, this project will establish a research cohort. A subsequent study involving developmental evaluations will allow for correlation of EEG results with long-term outcomes. The ability to identify those at risk at birth would provide the opportunity to intervene in order to mitigate outcome differences, particularly in language development. More significantly, we hope to establish neonatal CNS outcome measures for future diabetic pregnancy intervention studies. .

NCT ID: NCT02921906 Completed - Neonatal Diabetes Clinical Trials

Effect of Food Composition on Postprandial Insulin Secretion in Neonatal Diabetes

FoND
Start date: June 2016
Phase: N/A
Study type: Interventional

Neonatal diabetes is diagnosed before 6 months of age and causes high blood glucose levels due to the pancreas not secreting insulin. Neonatal diabetes can be caused by a change in a DNA region called the KCNJ11 gene. KCNJ11 encodes a channel in the pancreas that acts as a switch to turn 'on' and 'off' insulin secretion. A change in KCNJ11 results in a faulty channel, which keeps insulin secretion 'switched off'. The diabetes can be treated with tablets called sulphonylureas that switch the pancreatic channel 'on', allowing it to secrete insulin in response to gut hormones called incretins. Previous research has shown that patients who switch from insulin to sulphonylureas have better blood glucose control, including fewer episodes of hypoglycaemia (glucose dropping too low), and also avoid the need for injections. It is thought that serious side effects from sulphonylureas are uncommon in KCNJ11 neonatal diabetes. Some patients report low glucose after meals and we think this may be because they make too much insulin if they eat a meal with protein but low amounts of carbohydrate. The investigators will test this by giving study participants different meals and measuring the amount of insulin, glucose and incretin hormone in the blood afterwards.

NCT ID: NCT02878993 Completed - Clinical trials for Infant, Newborn, Disease

Predicting Infant Extubation Using Diaphragm Surface Electromyography

EMG
Start date: August 2016
Phase:
Study type: Observational

This study aims to assess whether the electrical signal of the diaphragm (diaphragm electromyogram) and the ratio of that to tidal volume (amount of air breathed in and out of the lungs) can predict which infants will be successfully extubated (have the breathing tube removed without needing it replaced.)

NCT ID: NCT02865772 Completed - Clinical trials for Infant, Newborn, Diseases

Lamellar Body Counts on Gastric Aspirate in Healthy Term Newborns

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

The aim of this study to determine the reference ranges of LBC on gastric aspirate in healthy term newborns.

NCT ID: NCT02794662 Completed - Hypoxia Clinical Trials

Environmental or Nasal Cannula Oxygen for Preterm Infants Receiving Oxygen Therapy: a Randomized Cross-over Pilot Study

ECO
Start date: April 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if, in preterm infants < 37 weeks' gestation at birth receiving oxygen without ventilatory/CPAP support, oxygen environment (OE) compared with nasal cannula oxygen (NC), will decrease the number of episodes with oxygen saturations less than 85% of ≥10 seconds in a 48 hour cross over period on either intervention. This is a randomized cross-over pilot study with a 1:1 parallel allocation of infants to oxygen environment or nasal cannula oxygen using stratified permuted block design. Following a 24 hour period on the first intervention, infants will cross over to a 24 hour period on the second (alternative) intervention before crossing back to the first intervention for a further 24 hours and then back again to the second (alternative) intervention for a further 24 hours.

NCT ID: NCT02727517 Completed - Asphyxia Neonatorum Clinical Trials

Early or Late Cord Clamping in the Depressed Neonate

NepCordIII
Start date: April 2016
Phase: N/A
Study type: Interventional

This study evaluates the hypothesis that delayed compared to early umbilical cord clamping will improve neonatal transition in terms of circulation and breathing during resuscitation.

NCT ID: NCT02701920 Completed - Clinical trials for Infant, Premature, Diseases

HeartLight: Heart Rate Monitoring for Newborn Resuscitation

HeartLight
Start date: March 2016
Phase:
Study type: Observational

This study will compare a newborn heart rate sensor (HeartLight) that is integrated into a hat with other common forms of heart rate monitoring such as electrocardiography (ECG), stethoscope and pulse oximetry (PO) in newborn babies. This will help to evaluate the new heart rate sensor's reliability and accuracy.

NCT ID: NCT02624817 Completed - Clinical trials for Permanent Neonatal Diabetes Mellitus

Long-Term Sulfonylurea Response in KCNJ11 Neonatal Diabetes

SuResponsKIR
Start date: December 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to investigate long term response of sulfonylurea and glucose control in children with diabetes due to mutations in KCNJ11 that have been switched from insulin injections to sulfonylurea tablets.

NCT ID: NCT02585492 Completed - Neonatal Disorder Clinical Trials

Effects of Mother Position in Skin-to-skin Contact Newborn on Oxygen Saturation Levels.

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

The purpose of this study is to determine if the position of the mother in the first two hours after delivery, while she is in skin to skin contact with your child, influences the oxygen saturation and/or heart rate of the newborn. In this way it could provide some useful information for the prevention of seemingly lethal episodes or sudden death of the child when, following current recommendations is skin to skin contact in the first hours of life. These episodes are communicating in all developed countries and have caused great concern and interest in the scientific community. So far we only have information from case series.

NCT ID: NCT02518230 Completed - Clinical trials for Respiratory Insufficiency

Randomized Crossover of NAVA and Synchronized Intermittent Pressure Ventilation in Neonates and Infants

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

This study is a single center, prospective cohort crossover study comparing mechanically ventilated neonates and infants on Neurally Adjusted Ventilatory Assist (NAVA) and synchronized intermittent mandatory ventilation with pressure control plus pressure support (SIMV(PC) + PS) modes. This design will allow for direct comparison of two commonly used ventilator modalities in the neonatal intensive care unit (NICU) to determine if one mode is superior to the other with regards to respiratory mechanics and estimated energy expenditure. It is hypothesized that neonates and infants will have improved respiratory severity score (MAP X FiO2) utilizing NAVA compared to the SIMV (PC) + PS mode but will have increased estimated energy expenditure.