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Premature Infant clinical trials

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NCT ID: NCT02813109 Completed - Premature Infant Clinical Trials

Urine Biomarkers for Renal Function Monitoring in Preterm Infants

Start date: June 2016
Phase: N/A
Study type: Observational

The true renal function of preterm infants is difficult to evaluate. Serum creatinine (Cr) levels in infants are unreliable as a detector of renal function in the first few days of life because they may continue to reflect maternal levels. Although few candidates appear to be a useful biomarker for kidney injury, scant reference data on these biomarker in preterm infants exist, and studies have yielded conflicting results. Therefore, we aimed to determine the reliable urinary biomarkers to detect kidney injuries in preterm infants.

NCT ID: NCT02601872 Not yet recruiting - Premature Infant Clinical Trials

Erythropoietin in Premature Infants to Prevent Encephalopathy

Start date: November 2015
Phase: Phase 2
Study type: Interventional

The main goal of this trial is to investigate whether early administration of human erythropoietin(EPO) in preterm infants improves neurodevelopmental outcome at 18 months corrected age. This study is designed as randomized, double-masked, placebo controlled multicenter study involving at least 312 patients.

NCT ID: NCT02550054 Terminated - Premature Infant Clinical Trials

Erythropoietin in Premature Infants to Prevent Encephalopathy

Start date: September 8, 2015
Phase: Phase 2
Study type: Interventional

The main goal of this trial is to investigate whether early administration of human erythropoietin (EPO) in preterm infants improves neurodevelopmental outcome at 18 months corrected age. This study is designed as randomized, double-masked, placebo controlled multicenter study involving at least 312 patients.

NCT ID: NCT02534090 Not yet recruiting - Clinical trials for Necrotizing Enterocolitis

Evaluation of Feeding Intolerance in Premature Infants Using Near Infrared Spectroscopy

NIRS/NICU2
Start date: November 2015
Phase: N/A
Study type: Observational

Nowadays feeding intolerance (FI) is a common condition among preterm infants. It has been estimated that 16%-29% of premature infants admitted to neonatal intensive care units (NICUs) develop feeding intolerance at some point during their length of stay. The most frequent signs of FI are the presence of abdominal distension, abundant and/or bilious gastric residuals and vomiting suggesting an inability of the infant to further tolerate enteral nutrition, it increases with decreasing in gestational age (GA) and birth weight (BW). FI represents one of the most uncontrollable variables in the early nutritional management of these infants, and may lead to suboptimal nutrition, delayed attainment of full enteral feeding and prolonged parenteral nutrition supply. NIRS has been used in preterm infants to evaluate changes in cerebral perfusion and oxygenation. It provides real time insight into the oxygen delivery, presented as regional oxygen saturation rSO2 with lower values than SpO2 distal pulse-oximetry where is mostly measured as arterialized capillary bed (around 55% vs 98% Oxygen saturation in regional NIRS vs conventional pulse-oximetry). Light easily penetrates the thin tissues of the neonate through bone and soft tissue, particularly the thin capillary bed of the tissues; NIRS provides non-invasive, continuous information on tissue perfusion and oxygen dynamics. This technique uses principles of optical spectrophotometry that make use of the fact that biological material, including the skull, is relatively transparent in the NIR range. Dave et al. evaluated the abdominal tissue oxygenation with NIRS, and showed that preterm infants change their cerebral - splanchnic oxygenation ratios during feedings, mainly because an increasing in the splanchnic oxygenation. Gay et al. performed abdominal NIRS in premature piglets showing association of perfusion/oxygen changes with NEC spectrum. The investigators would like to evaluate the association between feeding intolerance and unchanged splanchnic regional saturation and variation in the cerebral splanchnic ratio. Innovation: FI diagnosis follows a subjective approach, where the clinician is worried in further risk of develop Necrotizing enterocolitis (NEC). This non-studied relationship (FI and NEC) lower the threshold for the diagnosis of FI. Furthermore, infants with FI diagnosis commonly are subject of stop or slow the progression of feedings, increasing the risk of intestinal villi atrophy, and increase the length of parenteral nutrition support, and also the length of stay in the NICU settings. If NIRS technology help the clinicians to detect true abnormalities objectively as a new monitor assessing adequate feeds progress decreasing failure to feed, and therefore diminishing the need for parenteral feeds and further complication associated with it.

NCT ID: NCT02528227 Completed - Premature Infant Clinical Trials

NICU Parent Education Program

NICU PEP
Start date: January 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to adminster one of two education programs to parents of preterm infants in the NICU to evaluate language and cognitive outcomes of their infants.

NCT ID: NCT02187510 Completed - Premature Infant Clinical Trials

Umbilical Cord Milking vs Delayed Cord Clamping in Preterm Infants Born by Cesarean Section

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

The purpose of this study is to determine whether the umbilical cord milking in preterm infants born by cesarian section less than 34 weeks is more effective than delayed cord clamping to obtain higher levels of hemoglobin.

NCT ID: NCT02184650 Completed - Premature Infant Clinical Trials

Nutrition and Neurological Development of Very Preterm Infants

EPINUTRI_3
Start date: July 2014
Phase:
Study type: Observational

The main goal of this study is to determine, in preterm infants born with a GA < 32 weeks, the association between: - the quantity of mother's milk and duration and breastfeeding - the intake of polyunsaturated fatty acids and iron during hospitalizations

NCT ID: NCT02133716 Completed - Pain Clinical Trials

Efficacy of Breast Milk Expressed and Sucrose in Procedural Pain in Preterm

LACTEET
Start date: October 2013
Phase: Phase 4
Study type: Interventional

The aim of this study is to assess the non-inferiority of non- pharmacological breast milk expressed versus oral sucrose in relief procedural pain of venipuncture in preterm neonates. This is an experimental comparative study of non-inferiority randomized crossover, to be performed in Neonatal units of hospitals in the Community of Madrid. The 54 pair of preterm that after the selection criteria are included in the study, they performed the randomization of the sequence and breast milk expressed receive oral or 24% sucrose. The doses administered are: 0.1ml preterm less than 27 weeks corrected gestational age (CGA), 0.25 ml for infants 27 to 31 weeks CGA and 0.5 ml for infants of 32-37 weeks. Both groups will be accompanied by non-nutritive sucking and swaddling and administered two minutes prior to venipuncture. The outcome variable, pain, will be determined by the scale Premature Infant Pain Profile (PIPP) and by percent of cry. Data for the primary objective was analysed per intention to treat. This study was approved by local ethical committee.

NCT ID: NCT01988792 Completed - Enteral Nutrition Clinical Trials

Human Milk Fortification in Very Low Birth Neonates

Start date: November 2013
Phase: N/A
Study type: Interventional

The purpose of this study to find out how safely we can add extra nutrients to human milk at different feeding volume.

NCT ID: NCT01965769 Completed - Premature Infant Clinical Trials

Effects Of Not Measuring Gastric Residual Content On Feeding Tolerance In Premature Infants iNFANTS

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

Omitting evaluation of gastric residual contents prior to feeding very premature infants will increase the feeding intake at 2 weeks, and total caloric intake and growth by 3 weeks, as well as decrease the time required for parenteral nutrition.