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

Prematurity Clinical Trial

— GRASS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03111329
• Other study ID #: GRASS-1
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: November 2018
• Source: Institute for the Care of Mother and Child, Prague, Czech Republic
• Contact: Zbynek Stranak, Ass. Prof.
• Phone: +420296511806
• Email: zbynek.stranak[@]upmd.eu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 26 Weeks to 30 Weeks

Eligibility

Inclusion Criteria:

• Preterm neonate, born between 26+0 and 30+0 weeks of gestation

• Birth weight below 1500g

• Parental informed consent obtained

Exclusion Criteria:

• Intrauterine growth retardation (birth weight below 5th centile for given gestational age and gender)

• Life-threatening events requiring full resuscitation at the delivery room (severe hypoxia, bleeding), and persistently raised lactate value of more than 5 mmol/l

• Circulatory instability requiring treatment with inotropes

• Highly suspected early onset sepsis with alteration of general clinical state, in particular with worsened peripheral perfusion and circulatory decompensation prior to study begin (during the first 6 hours after admission to NICU)

• Known malformations of gastrointestinal tract, known diagnosis of congenital diaphragmatic hernia, any other life-limiting serious congenital malformations

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Gastric Residuals Assessment
• Necrotizing Enterocolitis of Newborn
• Neonatal Sepsis
• Premature Birth
• Prematurity
• Sepsis
• Sepsis Newborn

Intervention

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

Locations

Country	Name	City	State
Czechia	Institute for the Care of Mother and Child	Prague
Ireland	Coombe Women and Infants University Hospital	Dublin

Sponsors (2)

Lead Sponsor	Collaborator
Institute for the Care of Mother and Child, Prague, Czech Republic	Coombe Women and Infants University Hospital

Countries where clinical trial is conducted

Czechia,  Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days taken to achieve full enteral feeding (i.e. dose of 100ml/kg/day)	Time taken (in hours) to reach full enteral feeding, defined as overall dose of 100ml of feeds/kg of birth weight/ day	5 days after delivery for yes or no answer to whether full enteral feeding has been achieved, thereafter daily for the first three weeks until full enteral feeding has been reached
Secondary	Withholding of enteral feeding	The need to withhold enteral feeds due to clinical situation as per clinical judgement of the clinician in charge	Through first (on average) two to three weeks of the study until full enteral feeding is achieved.
Secondary	Total duration of parenteral infusion	The length of time (in hours) that parenteral infusion is needed	Through first (on average) two to three weeks of the study until full enteral feeding is achieved.
Secondary	Total duration of indwelling central venous catheter	The length of time (in hours) that an indwelling central venous catheter is needed	Through first (on average) two to three weeks of the study until full enteral feeding is achieved.
Secondary	Hypoglycaemia	Any episodes of hypoglycaemia (value less than 2,5 mmol/l) after attainment of full enteral feeding	Through first (on average) two to three weeks of the study until full enteral feeding is achieved.
Secondary	Late onset sepsis	The incidence of late onset sepsis	Duration of hospitalization, an average of 8-15 weeks
Secondary	Necrotizing enterocolitis	The incidence of necrotizing enterocolitis	Duration of hospitalization, an average of 8-15 weeks
Secondary	Spontaneous intestinal perforation	The incidence of spontaneous intestinal perforation	Duration of hospitalization, an average of 8-15 weeks
Secondary	Bronchopulmonary dysplasia	Incidence of bronchopulmonary dysplasia	At timepoint of reached 36 gestational weeks of the neonate
Secondary	Intraventricular and periventricular haemorrhage	The incidence of intraventricular and periventricular haemorrhage (stage I-IV)	Duration of hospitalization, an average of 8-15 weeks
Secondary	Retinopathy of prematurity	Incidence of retinopathy of prematurity (stage I-V)	Duration of hospitalization, an average of 8-15 weeks
Secondary	Neurodevelopment	Assessment of neurodevelopmental outcome	Follow up at 24 months of corrected age of the child