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Completed

NCT Number: NCT01337622

Gastric Residuals in Preterm Infants

Checking of gastric residuals prior to the continuation/increase of enteral feeding prolongs the time to establish full gastric feeding in the early postnatal period.

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Key information

Conditions

Early Enteral Feeding Advancement Nutrition Preterm Infants

Age range

Up to 48 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Infants with a birth weight ≥ 1500g and < 2000g
  • Age ≤48 hours of life
  • Informed, written parental consent

Exclusion criteria

  • Antenatally recognized gastrointestinal malformation
  • Major congenital anomaly
  • Chromosomal anomaly
  • NEC stage II
  • Severe acidosis, asphyxia (pH <7.0)
  • Severe growth restriction below 3rd percentile

Treatment and study plan

No check of gastric residuals for early enteral feeding advancement

Procedure

Discontinuation of gastric feeding and its advancement will be based on clinical examination of the abdomen and gastric aspirates containing blood or significant vomiting.

Routine check of gastric residuals for early enteral feeding advancement

Procedure

Discontinuation of gastric feeding and its advancement will be based on current practice of clinical examination of the abdomen and checking residual before every feed. Volume and color of gastric residual will be considered according to the current guideline.

Primary outcomes

  1. Time to reach full enteral feeding

    Time frame: from inclusion (during first 48h of life) until 1 month

    Full enteral feeding is defned as an milk intake of equal or more than 120 ml/kg/d.

Secondary outcomes

  1. growth, tolerance, morbidity

    Time frame: from inclusion (during first 48h of life) until one month

    Time to regain birth weight and maintain weight gain. Incidence of sepsis from birth until 48 hours after parenteral nutrition was administered.

    Use of antibiotics. Incidence of feeding intolerance and necrotizing enterocolitis.

Sponsors and collaborators

Lead sponsor

McMaster Children's Hospital

Other

Registry information

Official study title

Gastric Residuals in Preterm Infants (GRIP)

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 19, 2011
Registry last updated
Mar 30, 2015

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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