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Clinical Trials/NCT01337622
NCT01337622CompletedNot Applicable

Gastric Residuals in Preterm Infants (GRIP)

McMaster Children's Hospital2 sites in 1 country87 target enrollmentStarted: March 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
87
Locations
2
Primary Endpoint
Time to reach full enteral feeding

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
— to 48 Hours (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

  • growth, tolerance, morbidity(from inclusion (during first 48h of life) until one month)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Christoph Fusch

Division head NICU

McMaster Children's Hospital

Study Sites (2)

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