Gastric Residuals Assessment, Necrotizing Enterocolitis of Newborn, Prematurity, Sepsis Newborn
Conditions
Keywords
Gastric residuals assessment, Prematurity, Necrotizing Enterocolitis of Newborn, Sepsis Newborn, Nutrition of newborn, feeding tolerance of newborn
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.
Interventions
OTHERNo 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
Sponsors
Coombe Women and Infants University Hospital
Institute for the Care of Mother and Child, Prague, Czech Republic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Open label during intervention, assessor of outcomes will be blinded to group allocations
Intervention model description
Randomization into 2 groups (interventional and control) with crossover rescue strategy.
Eligibility
Sex/Gender
ALL
Age
26 Weeks to 30 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of days taken to achieve full enteral feeding (i.e. dose of 100ml/kg/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 | Time taken (in hours) to reach full enteral feeding, defined as overall dose of 100ml of feeds/kg of birth weight/ day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total duration of parenteral infusion | Through first (on average) two to three weeks of the study until full enteral feeding is achieved. | The length of time (in hours) that parenteral infusion is needed |
| Total duration of indwelling central venous catheter | Through first (on average) two to three weeks of the study until full enteral feeding is achieved. | The length of time (in hours) that an indwelling central venous catheter is needed |
| Hypoglycaemia | Through first (on average) two to three weeks of the study until full enteral feeding is achieved. | Any episodes of hypoglycaemia (value less than 2,5 mmol/l) after attainment of full enteral feeding |
| Late onset sepsis | Duration of hospitalization, an average of 8-15 weeks | The incidence of late onset sepsis |
| Necrotizing enterocolitis | Duration of hospitalization, an average of 8-15 weeks | The incidence of necrotizing enterocolitis |
| Withholding of enteral feeding | Through first (on average) two to three weeks of the study until full enteral feeding is achieved. | The need to withhold enteral feeds due to clinical situation as per clinical judgement of the clinician in charge |
| Bronchopulmonary dysplasia | At timepoint of reached 36 gestational weeks of the neonate | Incidence of bronchopulmonary dysplasia |
| Intraventricular and periventricular haemorrhage | Duration of hospitalization, an average of 8-15 weeks | The incidence of intraventricular and periventricular haemorrhage (stage I-IV) |
| Retinopathy of prematurity | Duration of hospitalization, an average of 8-15 weeks | Incidence of retinopathy of prematurity (stage I-V) |
| Neurodevelopment | Follow up at 24 months of corrected age of the child | Assessment of neurodevelopmental outcome |
| Spontaneous intestinal perforation | Duration of hospitalization, an average of 8-15 weeks | The incidence of spontaneous intestinal perforation |
Countries
Czechia, Ireland
Outcome results
None listed