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

NCT03111329 | Completed

• 1 other identifier: GRASS-1
• Study Type: interventional
• Target: 95
• Locations: 2 countries
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Withholding of enteral feeding

  Through first (on average) two to three weeks of the study until full enteral feeding is achieved.

• Total duration of parenteral infusion

  Through first (on average) two to three weeks of the study until full enteral feeding is achieved.

• Total duration of indwelling central venous catheter

  Through first (on average) two to three weeks of the study until full enteral feeding is achieved.

• Hypoglycaemia

  Through first (on average) two to three weeks of the study until full enteral feeding is achieved.

• Late onset sepsis

  Duration of hospitalization, an average of 8-15 weeks

Study Arms (2)

GRASS - Intervention group

EXPERIMENTAL

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

Standard Approach group

NO INTERVENTION

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.

Interventions

No aspiration of gastric residuals 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

GRASS - Intervention group

Eligibility Criteria

• Age: 26 Weeks - 30 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Preterm neonate, born between 26+0 and 30+0 weeks of gestation
• Birth weight below 1500g
• Parental informed consent obtained

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute for the Care of Mother and Child, Prague, Czech Republic: lead
• Coombe Women and Infants University Hospital: collaborator

Study Sites (2)

Institute for the Care of Mother and Child

Prague, Czechia

Location

Coombe Women and Infants University Hospital

Dublin, Ireland

Location

Related Publications (1)

• Branagan A, Murphy C, O'Sullivan A, Bodnarova I, Feyereislova S, Berka I, Miletin J, Stranak Z. Influence of gastric residual assessment in preterm neonates on time to achieve enteral feeding (the GRASS trial)-Multi-centre, assessor-blinded randomised clinical trial. Eur J Pediatr. 2024 May;183(5):2325-2332. doi: 10.1007/s00431-024-05483-w. Epub 2024 Mar 1.

  PMID: 38427039 DERIVED

MeSH Terms

Conditions

Premature Birth; Neonatal Sepsis

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zbynek Stranak, MD

  Institute for the Care of Mother and Child in Prague

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Open label during intervention, assessor of outcomes will be blinded to group allocations
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: April 12, 2017
• Study Start: October 6, 2017
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

IE (1); CZ (1)