Gastric Residuals in Preterm Infants

Not Applicable

Completed

• Conditions: Nutrition; Preterm Infants; Early Enteral Feeding Advancement
• Interventions: Procedure: No check of gastric residuals for early enteral feeding advancement; Procedure: Routine check of gastric residuals for early enteral feeding advancement

• Registration Number: NCT01337622
• Lead Sponsor: McMaster Children's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-04-15
• Study First Submitted QC: 2011-04-15
• Study First Posted: 2011-04-19
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-26
• Last Update Posted: 2015-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No routine check for gastric residuals	No check of gastric residuals for early enteral feeding advancement	-
Routine check for gastric residuals	Routine check of gastric residuals for early enteral feeding advancement	-

Primary Outcome Measures

Name	Time	Method
Time to reach full enteral feeding	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 Outcome Measures

Name	Time	Method
growth, tolerance, morbidity	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.

Trial Locations

Locations (1)

McMaster Children's Hospital; 🇨🇦 Hamilton, Ontario, Canada