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

Study Overview
=================
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.

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

Conditions
-----------------
Gastric Residuals Assessment, Prematurity, Sepsis Newborn, Necrotizing Enterocolitis of Newborn

Intervention / Treatment
-----------------
* Other: No aspiration of gastric residuals


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 26 Weeks
Maximum Age: 30 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization into 2 groups (interventional and control) with crossover rescue strategy.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GRASS - Intervention group<br>The intervention group (GRASS) will receive 3 hourly feeds, with no gastric residuals being aspirated. Solely opening of the nasogastric tube once every 6 hours to relieve possible backflow of gastric content will be allowed. Amount of enteral feeds given and increase in dose will be specified in an enteral feeding plan prior to start of the study. Amount of enteral feeds given will increase every six hours with a calculated overall increase of 20 ml/kg of birth weight in the total amount given every 24 hours. Intervention = NO aspiration of gastric residuals | Other: No aspiration of gastric residuals<br>* 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<br>|
| No Intervention: Standard Approach group<br>Standard Approach group serving as control group will be treated as per standard approach - participants will be fed 3 hourly and gastric residuals checked via nasogastric tube prior to each feed. Amount of enteral feeds given and increase in dose will be specified in an enteral feeding plan prior to start of the study. Amount of enteral feeds given will increase every six hours with a calculated overall increase of 20 ml/kg of birth weight in the total amount given every 24 hours. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| Late onset sepsis | The incidence of late onset sepsis | Duration of hospitalization, an average of 8-15 weeks | 
| Necrotizing enterocolitis | The incidence of necrotizing enterocolitis | Duration of hospitalization, an average of 8-15 weeks | 
| Spontaneous intestinal perforation | The incidence of spontaneous intestinal perforation | Duration of hospitalization, an average of 8-15 weeks | 
| Bronchopulmonary dysplasia | Incidence of bronchopulmonary dysplasia | At timepoint of reached 36 gestational weeks of the neonate | 
| Intraventricular and periventricular haemorrhage | The incidence of intraventricular and periventricular haemorrhage (stage I-IV) | Duration of hospitalization, an average of 8-15 weeks | 
| Retinopathy of prematurity | Incidence of retinopathy of prematurity (stage I-V) | Duration of hospitalization, an average of 8-15 weeks | 
| Neurodevelopment | Assessment of neurodevelopmental outcome | Follow up at 24 months of corrected age of the child | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric residuals assessment, Prematurity, Necrotizing Enterocolitis of Newborn, Sepsis Newborn, Nutrition of newborn, feeding tolerance of newborn