NCT03111329

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

A Prospective, Randomized and Controlled Trial Comparing the Role of no Gastric Residual ASSessment and Standard Gastric Residual Measurement for the Achievement of Full Enteral Feeding in Preterm Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Institute for the Care of Mother and Child, Prague, Czech Republic · Academic / Other
• Sex: All
• Age: 26 Weeks – 30 Weeks
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Gastric Residuals Assessment
• Prematurity
• Sepsis Newborn
• Necrotizing Enterocolitis of Newborn

Interventions

Type	Name	Description
OTHER	No aspiration of gastric residuals	No assessment of gastric residuals will be performed prior to administering 3-hourly feeds with increasing amounts of the feeds given as per a predefined plan

Timeline

• Start date: 2017-10-06
• Primary completion: 2021-07-30
• Completion: 2021-07-30
• First posted: 2017-04-12
• Last updated: 2024-05-10

Locations

2 sites across 2 countries: Czechia, Ireland