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Feeding Intolerance clinical trials

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NCT ID: NCT05347706 Recruiting - Preterm Infants Clinical Trials

Protocol for Feeding Intolerance in Preterm Infants

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Background: Feeding intolerance is a common problem in preterm infants, which is associated with increased risk of infections, prolonged hospitalization, and increased economic costs. When human milk is not available, formula feeding is required. Amino acid-based formula and extensively hydrolyzed formula could be considered to use for severe feeding intolerance. A recent Cochrane meta-analysis found that preterm infants fed extensively hydrolyzed formula compared with standard formula could not reduce the risk of feeding intolerance and necrotizing enterocolitis, and weight gain was slower. Some studies reported that preterm infants fed amino acid-based formula could reduce the gastric residual volume. Investigators hypothesize that amino acid-based formula can improve feeding intolerance and establish full enteral feeding more rapidly in preterm infants compared with extensively hydrolyzed formula. Method: The randomized, prospective, controlled trial is to be conducted in Children's Hospital of Chongqing Medical University (Chongqing, China). A total of 190 preterm infants with gestational age < 32 weeks or birth weight < 1500g and with a diagnosis of feeding intolerance will be included. Patients will be randomized to an amino acid-based formula-fed group and an extensively hydrolyzed formula-fed group. The primary outcome is the time (days) to reach full enteral feedings. Secondary outcomes include duration of vomiting and abdominal distension, gastric residual volume, body weight, length and head circumference during hospitalization, length of hospital stay (days), cost of hospitalization, time (days) of parenteral nutrition, change of abdomen circumference, main serum parameters and incidence of adverse events. Discussion: The successful implementation of the study will provide robust evidence for formula alternatives in preterm infants with feeding intolerance.

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: 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: NCT00450697 Recruiting - Prematurity Clinical Trials

Feeding Tolerance in Preterm Infants

Start date: February 2007
Phase: N/A
Study type: Observational

Premature infants, especially those less than 1250 gm at birth are extremely difficult to feed. For unknown physiologic reasons oral feeding also called enteral feeding is not well tolerated in these immature babies. Because of this challenge these infants require intravenous fluids solution called parenteral nutrition (TPN). Intravenous nutrition is inadequate because it cannot supply sufficient calories for growth both of body and brain. The composition of intravenous nutrition is also toxic to the liver. For those reasons it is very important to achieve adequate enteral nutrition in premature infants as soon as possible after birth. However the best feeding method for those babies has not been defined. Since premature babies are unable to suck and swallow properly, feeding is administered by a tube inserted into the infant's stomach. The timing between feeds is inconsistent. Some infants are fed every 3 hours, whereas others are fed every 4 hours. The purpose of this study is to determine which feeding method is better. We hypothesize that feeding every 4 hours by allowing more time for digestion will improve feeding tolerance in premature infants. In addition it will also facilitate discontinuation of TPN sooner, thus causing less side effects.