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

Primary Purpose

Gastric Residuals Assessment, Prematurity, Sepsis Newborn

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
No aspiration of gastric residuals
Sponsored by
Institute for the Care of Mother and Child, Prague, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastric Residuals Assessment focused on measuring Gastric residuals assessment, Prematurity, Necrotizing Enterocolitis of Newborn, Sepsis Newborn, Nutrition of newborn, feeding tolerance of newborn

Eligibility Criteria

26 Weeks - 30 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Institute for the Care of Mother and ChildRecruiting
  • Coombe Women and Infants University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

GRASS - Intervention group

Standard Approach group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Withholding of enteral feeding
The need to withhold enteral feeds due to clinical situation as per clinical judgement of the clinician in charge
Total duration of parenteral infusion
The length of time (in hours) that parenteral infusion is needed
Total duration of indwelling central venous catheter
The length of time (in hours) that an indwelling central venous catheter is needed
Hypoglycaemia
Any episodes of hypoglycaemia (value less than 2,5 mmol/l) after attainment of full enteral feeding
Late onset sepsis
The incidence of late onset sepsis
Necrotizing enterocolitis
The incidence of necrotizing enterocolitis
Spontaneous intestinal perforation
The incidence of spontaneous intestinal perforation
Bronchopulmonary dysplasia
Incidence of bronchopulmonary dysplasia
Intraventricular and periventricular haemorrhage
The incidence of intraventricular and periventricular haemorrhage (stage I-IV)
Retinopathy of prematurity
Incidence of retinopathy of prematurity (stage I-V)
Neurodevelopment
Assessment of neurodevelopmental outcome

Full Information

First Posted
March 23, 2017
Last Updated
November 19, 2018
Sponsor
Institute for the Care of Mother and Child, Prague, Czech Republic
Collaborators
Coombe Women and Infants University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03111329
Brief Title
Does Routine Assessment of Gastric Residuals in Preterm Neonates Influence Time Taken to Reach Full Enteral Feeding?
Acronym
GRASS
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

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 6, 2017 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute for the Care of Mother and Child, Prague, Czech Republic
Collaborators
Coombe Women and Infants University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization into 2 groups (interventional and control) with crossover rescue strategy.
Masking
Outcomes Assessor
Masking Description
Open label during intervention, assessor of outcomes will be blinded to group allocations
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GRASS - Intervention group
Arm Type
Experimental
Arm Description
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
Arm Title
Standard Approach group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
No aspiration of gastric residuals
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of days taken to achieve full enteral feeding (i.e. dose of 100ml/kg/day)
Description
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 Outcome Measure Information:
Title
Withholding of enteral feeding
Description
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.
Title
Total duration of parenteral infusion
Description
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.
Title
Total duration of indwelling central venous catheter
Description
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.
Title
Hypoglycaemia
Description
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.
Title
Late onset sepsis
Description
The incidence of late onset sepsis
Time Frame
Duration of hospitalization, an average of 8-15 weeks
Title
Necrotizing enterocolitis
Description
The incidence of necrotizing enterocolitis
Time Frame
Duration of hospitalization, an average of 8-15 weeks
Title
Spontaneous intestinal perforation
Description
The incidence of spontaneous intestinal perforation
Time Frame
Duration of hospitalization, an average of 8-15 weeks
Title
Bronchopulmonary dysplasia
Description
Incidence of bronchopulmonary dysplasia
Time Frame
At timepoint of reached 36 gestational weeks of the neonate
Title
Intraventricular and periventricular haemorrhage
Description
The incidence of intraventricular and periventricular haemorrhage (stage I-IV)
Time Frame
Duration of hospitalization, an average of 8-15 weeks
Title
Retinopathy of prematurity
Description
Incidence of retinopathy of prematurity (stage I-V)
Time Frame
Duration of hospitalization, an average of 8-15 weeks
Title
Neurodevelopment
Description
Assessment of neurodevelopmental outcome
Time Frame
Follow up at 24 months of corrected age of the child

10. Eligibility

Sex
All
Minimum Age & Unit of Time
26 Weeks
Maximum Age & Unit of Time
30 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zbynek Stranak, Ass. Prof.
Phone
+420296511806
Email
zbynek.stranak@upmd.eu
First Name & Middle Initial & Last Name or Official Title & Degree
Simona Feyereislova, MD
Phone
+420296511807
Email
simona.feyereislova@upmd.eu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zbynek Stranak, MD
Organizational Affiliation
Institute for the Care of Mother and Child in Prague
Official's Role
Study Chair
Facility Information:
Facility Name
Institute for the Care of Mother and Child
City
Prague
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simona Feyereislova, MD
Phone
+420296511807
Email
simona.feyereislova@upmd.eu
First Name & Middle Initial & Last Name & Degree
Simona Feyereislova, MD
First Name & Middle Initial & Last Name & Degree
Ivan Berka, MD
Facility Name
Coombe Women and Infants University Hospital
City
Dublin
Country
Ireland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Miletin, MD
Phone
087 7386379
First Name & Middle Initial & Last Name & Degree
Jan Miletin, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Available on request after publication of study results

Learn more about this trial

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

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