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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-06

Study Completion Date

2021-07-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastric Residuals Assessment Prematurity Sepsis Newborn Necrotizing Enterocolitis of Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization into 2 groups (interventional and control) with crossover rescue strategy.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Open label during intervention, assessor of outcomes will be blinded to group allocations

Study Groups

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GRASS - Intervention group

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

Group Type EXPERIMENTAL

No aspiration of gastric residuals

Intervention Type OTHER

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

Standard Approach group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

26 Weeks

Maximum Eligible Age

30 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes