Clinical Trials Logo

Feeding Intolerance clinical trials

View clinical trials related to Feeding Intolerance.

Filter by:

NCT ID: NCT03537365 Recruiting - Clinical trials for Necrotizing Enterocolitis

Bovine Colostrum as a Fortifier Added to Human Milk for Preterm Infants

FortiColos
Start date: December 4, 2017
Phase: N/A
Study type: Interventional

Very preterm infants (<32 weeks gestation) with very low birth weight (VLBW, <1500 g) show immaturity of organs and have high nutrient requirements for growth and development. In the first weeks, they have difficulties tolerating enteral nutrition (EN) and are often given supplemental parenteral nutrition (PN). A fast transition to full EN is important to improve gut maturation and reduce the high risk of late-onset sepsis (LOS), related to their immature immunity in gut and blood. Conversely, too fast increase of EN predisposes to feeding intolerance and necrotizing enterocolitis (NEC). Further, human milk feeding is not sufficient to support nutrient requirements for growth of VLBW infants. Thus, it remains a difficult task to optimize EN transition, achieve adequate nutrient intake and growth, and minimize NEC and LOS in the postnatal period of VLBW infants. Mother´s own milk (MM) is considered the best source of EN for VLBW infants and pasteurized human donor milk (DM) is the second choice, if MM is absent or not sufficient. The recommended protein intake is 4-4.5 g/kg/d for VLBW infants, when the target is a postnatal growth similar to intrauterine growth rates. This amount of protein cannot be met by feeding only MM or DM. Thus, it is common practice to enrich human milk with human milk fortifiers (HMFs, based on ingredients used in infant formulas) to increase growth, bone mineralization and neurodevelopment, starting from 7-14 d after birth and 80-160 ml/kg feeding volume per day. Bovine colostrum (BC) is the first milk from cows after parturition and is rich in protein (80-150 g/L) and bioactive components. These components may improve gut maturation, NEC protection and nutrient assimilation, even across species. Studies in preterm pigs show that feeding BC alone, or DM fortified with BC, improves growth, gut maturation and NEC resistance during the first 1-2 weeks, relative to DM, or DM fortified with conventional HMFs.On this background, we hypothesize that BC, used as a fortifier for MM or DM, can induce similar growth and better NEC and LOS resistance, than conventional fortifiers. A pilot trial is required 1) to test the feasibility and initial safety of BC as a fortifier (e.g. similar growth rates and clinical variables as conventional fortification), 2) to calculate the sample size for a later, larger RCT with NEC+LOS as the primary outcome, and 3) record paraclinical outcomes associated with type of fortifier.

NCT ID: NCT03320785 Recruiting - Sepsis Clinical Trials

Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation

NEOINFLAM
Start date: September 1, 2017
Phase: N/A
Study type: Observational

Circulating markers to diagnose complications (sepsis, necrotizing enterocolitis) in preterm infants are often inaccurate, partly due to the lack of comprehensive studies with temporal evaluation from birth until a disease onset. The investigators plan to collect weekly blood samples of preterm infants from birth until 4 weeks of age to comprehensively characterize differential protein and epigenetic markers in infants with and without complications (sepsis, necrotizing enterocolitis, chorioamnionitis).

NCT ID: NCT02980250 Completed - Premature Birth Clinical Trials

Multi-Center Study of Different Doses Domperidone in Feeding Intolerance

MCSDDDFI
Start date: November 2015
Phase: Phase 4
Study type: Interventional

The purpose of this clinical multi-center study is to determine whether different doses of domperidone are effective in the treatment of feeding intolerance in premature infant

NCT ID: NCT02598375 Recruiting - Enteral Nutrition Clinical Trials

Evaluation of Status of Early Reached Target Enteral Nutrition and IFABP as Biomarker of Feeding Intolerance in Critically Ill Children

ERTENIFABPICU
Start date: January 2015
Phase: N/A
Study type: Observational [Patient Registry]

Stage 1 - Evaluation of Status of Early Reached Target Enteral Nutrition in critically ill children in the PICU (ERTEN in PICU). In critically ill children, there is no data on the factors influenced the enteral nutrition and feeding intolerance.The investigators aim to reach these goals in our study - To initiate the enteral feeding in pediatric intensive care units or not - To demonstrate the reasons whether early enteral feeding is initiated or not - To determine the incidence of feeding intolerance - To identify the situations such as analgesia ,sedation, catecholamines or individual preferences of the medical staff which lead to delay or interruption in enteral feeding in pediatric intensive care units - To investigate the relation between the successful enteral feeding and mortality , morbidity du to the sepsis , septic shock and multiorgan failure Stage 2 - IFABP as biomarker of feeding intolerance in critically ill children in the PICU (IFABP in PICU) Critically ill children are at increased risk for intestinal injury, gastrointestinal dysfunction and feeding intolerance, which are associated with delayed recovery and increased morbidity and mortality during their course in the pediatric intensive care unit. In critically ill children, there is little data on the factors influenced the enteral nutrition. We hypothesise that IFABP might be used as a biomarker which shows that the early intestinal damage due to these medications. Aim There is no information which shows that the role of the intestinal microcirculation problems and mucosal integrity on feeding intolerance in pediatric intensive care unit.We aim to reach these goals in our study - To show the value of IFABP regarding the identifying feeding intolerance and early detection of enteral feeding intolerance - To show the relation between the IFABP concentration and enteral feeding intolerance - To show the relation between the mechanical ventilation settings , sedation , inotropic medications doses and IFABP concentration and feeding intolerance - To show the relation between IFABP concentrations and mortality and morbidity due to the sepsis , septic shock and multi system organ failure Stage 1 (ERTEN in PICU) was completed . In many patients, initiation of feeding seems to be delayed without an evidence-based reason. ERTEN was achieved in 43 (25.3%) of 95 patients within 48 h after PICU admission. Patients with Early Initiation of Feeding were statistically significant more likely to have ERTEN. ERTEN was independent significant prognostic factors for survival (p<0.001), with reached target enteral caloric intake on day 2 indicating improved survival.

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: NCT02149407 Recruiting - Feeding Intolerance Clinical Trials

Glycerin Suppositories for Treatment of Feeding Intolerance in Preterm Infants

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

Feeding intolerance is a common problem in preterm infants.

NCT ID: NCT02054091 Completed - Sepsis Clinical Trials

Feeding Bovine Colostrum to Preterm Infants

PreColos
Start date: February 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Feeding preterm infants is of great challenge in the NICUs. Mother's own milk is considered as the best for the digestive system followed by donor milk. Preterm infant formula is related to more feeding problems and other gut complications in these babies, such as necrotizing enterocolitis. Bovine colostrum contains higher amounts of protein, growth factors and immuno-regulatory components (e.g. immunoglobulins), which has been used in many other situations to promote health. The investigators plan to give bovine colostrum to preterm infants with birth weights between 1000 and 1800 g, or born between 27+0 and 32+6 weeks of gestational age, in order to promote feeding and intestinal health in these babies. This current study is a feasibility pilot study and the investigators hypothesized that supplementing BC to MM (if available) is safe and tolerable when used within the first 10-14 days of life in preterm infants.

NCT ID: NCT02028156 Terminated - Feeding Intolerance Clinical Trials

Feeding Intolerance in Formula-Fed Infants

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

This is a non-randomized, single-group, multi-center, two phased study to evaluate formula intolerance.

NCT ID: NCT01987154 Completed - Feeding Intolerance Clinical Trials

Tolerance of an Extensively Hydrolyzed Protein Infant Formula Versus a Premature Infant Formula

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

To evaluate the use of a hypoallergenic infant formula containing an extensively hydrolyzed protein source for routine nutrition.

NCT ID: NCT01441427 Completed - Clinical trials for Necrotizing Enterocolitis

Enteral Granulocyte Colony Stimulating Factor and Erythropoietin Early in Life Increases Feeding Tolerance in Preterm Infants: A Randomized Controlled Trial

Start date: January 2010
Phase: Phase 1/Phase 2
Study type: Interventional

With preterm birth, the ingestion of amniotic fluid containing enterocyte trophic factors ceases abruptly. This likely predisposes them to villous atrophy feeding intolerance and necrotizing enterocolitis(NEC) once feedings are instituted.Granulocyte Colony-Stimulating Factor (G-CSF) and Erythropoietin (EPO) have important non-hematopoietic roles in human developmental biology. Among these roles, they have trophic actions on villous height and bowel length of the developing intestine.The aim of this study is to evaluate the efficacy of enteral recombinant human G-CSF and recombinant human EPO in prevention of feeding intolerance and /or NEC in preterm infants.