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Premature Infants clinical trials

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NCT ID: NCT04190875 Suspended - Premature Infants Clinical Trials

Post-Discharge Growth and Development of Infants Who Received Targeted Fortification in the NICU

Start date: February 20, 2019
Phase:
Study type: Observational

Extremely low birth weight (ELBW) infants are at risk for slow growth, metabolic abnormalities, and poor neurodevelopmental outcomes. Postnatal growth standards are based on estimated intrauterine growth from historical cohort studies and post-mortem analyses. Despite current strategies aimed at appropriate nutrition, a large proportion of these infants have postnatal growth failure (anthropometric values < 10th percentile) reported in the literature as high as 89-99%. More recent data shows lower rates of postnatal growth failure but further improvement is still needed. Adequate growth is key to ensuring improved neurodevelopment and other outcomes. The investigators are currently evaluating the effects of a high versus standard protein enteral diet on growth and body composition in infants less than or equal to 1000 grams birth weight in the Neonatal Intensive Care Unit. (H-38611). Infants less than or equal to 1000 grams birth weight are provided an enteral diet with a level of protein based on individual caloric and protein analysis of human milk also known as targeted fortification. The standard protein diet provides 3.5-3.8 g/kg/day of protein, while the high protein diet provides 4.2-4.5 g/kg/day. The investigators have shown that infants who receive this diet achieve growth at targeted standards. As this diet is well tolerated and associated with improved outcomes in our highest risk neonates, it is imperative to evaluate the benefits of a high protein exclusive human milk diet and the possible positive changes in body composition, specifically lean mass, in these infants. Body composition in these infants receiving targeted fortification is being evaluated at 35-36 weeks post menstrual age. Because these infants are at such high risk for poor growth and neurodevelopment, it is important to investigate the impact of a higher protein exclusive human milk diet on long-term neurodevelopmental outcomes, body composition, and growth at 18-24 months.

NCT ID: NCT03914690 Completed - Premature Infants Clinical Trials

Effect of Erythropoietin on Neurodevelopmental Outcomes in Very Preterm Infants With Intraventricular Hemorrhage

Start date: July 2014
Phase: Phase 2
Study type: Interventional

Erythropoietin (EPO) has been shown to be neurotrophic and neuroprotective in several animal models and some clinical studies. Our hypothesis is that EPO could improve long-term neurological outcomes in very preterm infants with intraventricular hemorrhage (IVH). The aim of this study is to evaluate the long-term neuroprotective effect of repeated low-dose EPO (500 U/kg) in very preterm infants with IVH.

NCT ID: NCT03552952 Recruiting - Premature Infants Clinical Trials

Development of Preterm Infant Gut Microbiome

Start date: March 8, 2018
Phase:
Study type: Observational

This study aims to explore the developmental of the gut microbiome in preterm infants as they grow and mature

NCT ID: NCT03423836 Completed - Periodontitis Clinical Trials

Maternal Oral Therapy to Reduce Obstetric Risk Kids

MOTORKids
Start date: April 30, 2007
Phase: N/A
Study type: Observational

The principal objective was to conduct a 5 year; multi-center, observational follow-up study enrolling infants born to mothers who participated in the MOTOR clinical trial to determine the effects of maternal periodontal therapy during pregnancy on neonatal morbidity and mortality and whether this will result in lower incidence of functional neurological impairment.

NCT ID: NCT03217045 Completed - Premature Infants Clinical Trials

Nutrition Protocol and Premature Infants' Growth

Nutriproto
Start date: May 1, 2013
Phase:
Study type: Observational

Nutrition is a major issue for premature infants. Inappropriate nutritional intake during the first weeks of life is responsible for postnatal growth restriction and adverse long-term outcomes. This study aimed at evaluating the impact of the introduction of an updated, standardized, nutrition protocol on very premature infants' growth and morbidity, and the care givers' compliance to the new protocol.

NCT ID: NCT03188107 Active, not recruiting - Cerebral Palsy Clinical Trials

Interrater Reliability of Infant Motor Profile

IMP
Start date: August 2016
Phase: N/A
Study type: Observational [Patient Registry]

The aim of this study is to assess risky infants (or diagnosed infants) with Infant Motor Profile, and analyze interrater and intrarater reliability of this test.

NCT ID: NCT03110341 Recruiting - Cerebral Palsy Clinical Trials

Effect of Erythropoietin in Premature Infants on White Matter Lesions and Neurodevelopmental Outcome

Start date: April 10, 2017
Phase: Phase 3
Study type: Interventional

Preterm and very preterm infants are at risk of developing encephalopathy of prematurity and long-term neurodevelopmental delay. Magnetic resonance imaging (MRI) allows the characterization of specific features of encephalopathy of prematurity, including structural changes of brain white matter and gray matter. This study wants to investigate important evidence that early repeated high-dose rhEPO(5250 IU/kg) treatment improves long-term neurological outcomes in very preterm infants and without obvious adverse effects.

NCT ID: NCT02971904 Completed - Premature Infants Clinical Trials

Analyzer of Human Milk: Applicability in Clinical Practice in Order to Achieve the Best Nutrition for Infants

MISTU
Start date: August 2015
Phase: N/A
Study type: Observational [Patient Registry]

An observational and prospective study involving about 30 healthy lactating mothers whose preterm infant(s) is/are hospitalized at Neonatal Intensive Care Unit after childbirth and who can provide enough maternal milk (3mL) to be analyzed from 4th day of admission until 15th day of hospitalization or until discharge. Considering the lack of evidence related to breast milk nutritional composition from Brazilian lactating mothers of preterm infants; and also the utilization of human milk analyzer as a tool to optimize nutritional therapy and reach proper growth and development of preterm babies, this study aim to evaluate the nutritional composition of human milk from lactating mothers of preterm infant during the hospitalization, the infant grow and also the applicability of mid infrared (MIR) human milk analyzer (HMA) as a methodology.

NCT ID: NCT02943746 Active, not recruiting - Premature Infants Clinical Trials

Targeted Protein Fortification in Extremely Low Birth Weight Preterm Infants

Start date: November 2016
Phase: N/A
Study type: Interventional

While new innovations in the care of extremely premature infants have led to decreased morbidity and mortality, poor postnatal growth remains as a major challenge. Early growth in the postnatal period influences neurodevelopmental and growth outcomes. This proposed study will challenge current nutritional regimens for infants < 1000 g birth weight (BW) by providing an exclusive human milk based diet with a higher amount of protein based on individual caloric and protein analysis of human milk utilizing targeted fortification. The investigators will evaluate the effects of a high versus standard protein enteral diet on growth and body composition in infants < 1000 g BW. There are no published studies evaluating the effect of an exclusive human milk protein diet on body composition in premature infants. Research has shown that infants who receive this diet achieve growth at targeted standards but body composition has not been evaluated. As an all human milk diet is well tolerated and associated with improved outcomes in the highest risk neonates, it is imperative to evaluate the benefits of a high protein exclusive human milk diet and the possible positive changes in body composition, specifically lean mass, in these infants. Results from this proposed study will immediately influence current nutritional practices and will provide landmark information regarding targeted fortification with provision of adequate protein providing the most optimal body composition in the most fragile and vulnerable infants.

NCT ID: NCT02785926 Completed - Premature Infants Clinical Trials

Impact of Antenatal Exposure to Pesticides on Neurophysiological Functions (Sleep, Respiration) of Preterm Neonates

PHYSIOMECO
Start date: September 24, 2013
Phase:
Study type: Observational

During pregnancy, the foetus is therefore chronically exposed to a large number of substances. A number of studies have started to emphasize the effects of this antenatal exposure on the newborn infant's morphological parameters (weight, crown-rump length, etc.). However, in addition to these morphological effects, pesticides may also induce various effects on physiological functions, as some pesticides act as inhibitors of neurotransmitters involved in many nervous system regulation pathways in man. This is particularly the case for organophosphates, which act as acetylcholinesterase inhibitors. A previous study conducted by the coordinator of the project presented here demonstrated the presence of high levels of this type of pesticide in meconium (1st stool) in neonates born in Picardy. This inhibition of the enzyme metabolizing ACh could have an impact on neurophysiological functions mediated by this neurotransmitter. Sleep or respiratory control, vital functions of the neonate particularly in preterm neonates, could therefore be affected. The PhysioMéco project is therefore designed to study the possible links between antenatal exposure to pesticides and modifications of respiratory control allowed by peripheral chemoreceptor in preterm neonates. Antenatal exposure will be determined by pesticide assays in the meconium of neonates in combination with an exposure questionnaire to determine the sources of these pesticides. Sleep and respiratory control will be studied in these neonates nursed in incubators. Hypoxic test will be used in order to assess respiratory control involving the peripheral chemoreceptors.