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Completed

NCT Number: NCT03111329

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

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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Key information

Conditions

Gastric Residuals Assessment Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infections Inflammation Necrotizing Enterocolitis of Newborn Neonatal Sepsis Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Prematurity Sepsis Sepsis Newborn Systemic Inflammatory Response Syndrome Urogenital Diseases

Age range

26 week–30 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for the Care of Mother and Child, Prague, Czechia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Number of days taken to achieve full enteral feeding (i.e. dose of 100ml/kg/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

    Time taken (in hours) to reach full enteral feeding, defined as overall dose of 100ml of feeds/kg of birth weight/ day

Secondary outcomes

  1. Withholding of enteral feeding

    Time frame: 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

  2. Total duration of parenteral infusion

    Time frame: 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

  3. Total duration of indwelling central venous catheter

    Time frame: 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

  4. Hypoglycaemia

    Time frame: 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

  5. Late onset sepsis

    Time frame: Duration of hospitalization, an average of 8-15 weeks

    The incidence of late onset sepsis

  6. Necrotizing enterocolitis

    Time frame: Duration of hospitalization, an average of 8-15 weeks

    The incidence of necrotizing enterocolitis

  7. Spontaneous intestinal perforation

    Time frame: Duration of hospitalization, an average of 8-15 weeks

    The incidence of spontaneous intestinal perforation

  8. Bronchopulmonary dysplasia

    Time frame: At timepoint of reached 36 gestational weeks of the neonate

    Incidence of bronchopulmonary dysplasia

  9. Intraventricular and periventricular haemorrhage

    Time frame: Duration of hospitalization, an average of 8-15 weeks

    The incidence of intraventricular and periventricular haemorrhage (stage I-IV)

  10. Retinopathy of prematurity

    Time frame: Duration of hospitalization, an average of 8-15 weeks

    Incidence of retinopathy of prematurity (stage I-V)

  11. Neurodevelopment

    Time frame: Follow up at 24 months of corrected age of the child

    Assessment of neurodevelopmental outcome

Sponsors and collaborators

Lead sponsor

Institute for the Care of Mother and Child, Prague, Czech Republic

Other

Collaborators

  • Coombe Women and Infants University Hospital

Registry information

Official study 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

Acronym: GRASS

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 12, 2017
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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