Clinical trial NCT03111329: Does Routine Assessment of Gastric Residuals in Preterm Neonates Influence Time Taken to Reach Full Enteral Feeding?
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Residuals Assessment
Prematurity
Sepsis Newborn
Necrotizing Enterocolitis of Newborn
Keywords: Gastric residuals assessment
Prematurity
Necrotizing Enterocolitis of Newborn
Sepsis Newborn
Nutrition of newborn
feeding tolerance of newborn
Lead sponsor: Institute for the Care of Mother and Child, Prague, Czech Republic
Sponsor class: OTHER
Collaborators: name: Coombe Women and Infants University Hospital
First posted: 2017-04-12
Enrollment: 95
Sex: ALL
Minimum age (years): 26
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization into 2 groups (interventional and control) with crossover rescue strategy.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of days taken to achieve full enteral feeding (i.e. dose of 100ml/kg/day)
timeFrame: 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:
measure: Withholding of enteral feeding
timeFrame: Through first (on average) two to three weeks of the study until full enteral feeding is achieved.
measure: Total duration of parenteral infusion
timeFrame: Through first (on average) two to three weeks of the study until full enteral feeding is achieved.
measure: Total duration of indwelling central venous catheter
timeFrame: Through first (on average) two to three weeks of the study until full enteral feeding is achieved.
measure: Hypoglycaemia
timeFrame: Through first (on average) two to three weeks of the study until full enteral feeding is achieved.
measure: Late onset sepsis
timeFrame: Duration of hospitalization, an average of 8-15 weeks
measure: Necrotizing enterocolitis
timeFrame: Duration of hospitalization, an average of 8-15 weeks
measure: Spontaneous intestinal perforation
timeFrame: Duration of hospitalization, an average of 8-15 weeks
measure: Bronchopulmonary dysplasia
timeFrame: At timepoint of reached 36 gestational weeks of the neonate
measure: Intraventricular and periventricular haemorrhage
timeFrame: Duration of hospitalization, an average of 8-15 weeks
measure: Retinopathy of prematurity
timeFrame: Duration of hospitalization, an average of 8-15 weeks
measure: Neurodevelopment
timeFrame: Follow up at 24 months of corrected age of the child
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Institute for the Care of Mother and Child
city: Dublin
country: Ireland
facility: Coombe Women and Infants University Hospital
Study officials:
affiliation: Institute for the Care of Mother and Child in Prague
name: Zbynek Stranak, MD
role: STUDY_CHAIR
References: