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

Institute for the Care of Mother and Child, Prague, Czech Republic95 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Eligibility

Sex: ALLMin age: 26 WeeksMax age: 30 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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 Outcomes

Withholding of enteral feeding

The need to withhold enteral feeds due to clinical situation as per clinical judgement of the clinician in charge

Time frame: Through first (on average) two to three weeks of the study until full enteral feeding is achieved.

Total duration of parenteral infusion

The length of time (in hours) that parenteral infusion is needed

Time frame: Through first (on average) two to three weeks of the study until full enteral feeding is achieved.

Total duration of indwelling central venous catheter

The length of time (in hours) that an indwelling central venous catheter is needed

Time frame: Through first (on average) two to three weeks of the study until full enteral feeding is achieved.

Hypoglycaemia

Any episodes of hypoglycaemia (value less than 2,5 mmol/l) after attainment of full enteral feeding

Time frame: Through first (on average) two to three weeks of the study until full enteral feeding is achieved.

Late onset sepsis

The incidence of late onset sepsis