Does Routine Assessment of Gastric Residuals in Preterm Neonates Influence

Status Completed

Clinical Trial Summary

The study aims to compare routine assessment of gastric residuals versus no assessment of residuals in preterm neonates with respect to time taken for achieving full enteral feeding and the incidence of possible complications, such as feeding intolerance, necrotizing enterocolitis, sepsis etc.

Clinical Trial Description

In general, regular assessment of gastric residuals and its´ evaluation prior to every feeding is considered standard practice for preterm neonates in neonatal intensive care units. It is believed useful to confirm correct placement of the orogastric or nasogastric tube and thought of as necessary to aid the decision of enteral feeding advancement by informing about possible remains of contents from previous feeding. Furthermore, evaluation of gastric residuals is routinely performed in order to assess for feeding intolerance and used as a possible indicator of risk for development of necrotizing enterocolitis. However there is conflicting evidence to support the approach of routine gastric residuals assessment and it seems unclear whether it confers any clinical benefit. Withholding of enteral feeding or cessation of advancement in the amounts given due to misinterpretation of routine gastric aspirates may have a negative impact on the preterm neonate. This can potentially involve prolonged indwelling of venous catheters, higher risk of infection and growth restriction with potentially worse developmental outcome in particular for very low birth weight infants. This randomized controlled clinical study aims to compare a control group with regular assessment and evaluation of gastric residuals and an intervention group with no routine assessment of residuals prior to feeding advancement, for the time taken to reach full enteral feeding and for occurrence of any observed complications including necrotizing enterocolitis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03111329
Study type	Interventional
Source	Institute for the Care of Mother and Child, Prague, Czech Republic
Contact
Status	Completed
Phase	N/A
Start date	October 6, 2017
Completion date	July 30, 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03670732` - CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure	N/A
Completed	`NCT05322161` - Yoga in the NICU for Parents Study	N/A
Recruiting	`NCT04542096` - Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT
Recruiting	`NCT04911452` - Creating a Calmer NICU: Optimizing Growth and Brain Development in Preterm Infants	N/A
Recruiting	`NCT02901652` - NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome	N/A
Completed	`NCT02148965` - Effects of Exercise During Pregnancy on Maternal and Child Health: a Randomized Clinical Trial	N/A
Terminated	`NCT02032511` - Comparison of RAM Cannula Nasal Continuous Positive Airway Pressure Versus Infant Flow Nasal Continuous Positive Airway Pressure (NCPAP)	N/A
Completed	`NCT02273843` - A Trial on Different Dosages of Vitamin D in Preterm Infants With Late-onset Sepsis	Phase 1
Completed	`NCT01721629` - Weaning of Nasal Continuous Positive Airway Pressure (CPAP) in Premature Infants	N/A
Terminated	`NCT01819532` - Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants < 33 Weeks	N/A
Completed	`NCT01478711` - Comprehensive Clinical Decision Support (CDS) for the Primary Care of Premature Infants	N/A
Completed	`NCT00951860` - Assessment of Autonomic Maturation in Neonatal Period and Early Neural Development From a Longitudinal Prospective Cohort	N/A
Completed	`NCT01523769` - Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants	N/A
Completed	`NCT00749008` - Study of Generalized Movements for Early Prediction of Cerebral Palsy	N/A
Completed	`NCT00787124` - Transfusions and Nitric Oxide Level in Preterm Infants
Terminated	`NCT01208493` - Dietary Protein in the Very-low-birth-weight Infant	N/A
Terminated	`NCT00486395` - Will CPAP Reduce Length Of Respiratory Support In Premature Infants?	Phase 3
Completed	`NCT00527956` - Facilitation and Barriers to Breastfeeding in the NICU	N/A
Completed	`NCT03372590` - NEO Rehab for Infants at Risk of Cerebral Palsy	N/A
Completed	`NCT00033917` - Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Does Routine Assessment of Gastric Residuals in Preterm Neonates Influence Time Taken to Reach Full Enteral Feeding? — GRASS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms