NCT01965769

Brief Summary

Omitting evaluation of gastric residual contents prior to feeding very premature infants will increase the feeding intake at 2 weeks, and total caloric intake and growth by 3 weeks, as well as decrease the time required for parenteral nutrition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2013

Completed
Last Updated

October 18, 2013

Status Verified

October 1, 2013

Enrollment Period

2.3 years

First QC Date

October 15, 2013

Last Update Submit

October 15, 2013

Conditions

Premature Infant

Keywords

Very low birth weight infantsprematurenutritiongastric residual

Outcome Measures

Primary Outcomes (1)

  • Amount of feeding intake at 2 weeks

    Baseline to 2 weeks

Secondary Outcomes (8)

  • Days to 120 mL/kg/d of enteral feedings

    Baseline to approximately 21 days

  • Days of parenteral nutrition

    Baseline to approximately 21 days

  • Incidence of late onset sepsis

    Baseline to approximately 90 days

  • Weekly or biweekly liver function tests

    Baseline to 42 days

  • Growth indices

    Baseline to approximately 90 days

  • +3 more secondary outcomes

Study Arms (2)

no gastric residual evaluation

EXPERIMENTAL

Infants will not receive routine gastric residual evaluation prior to feeding

Other: No gastric residual evaluation

gastric residual evaluation

NO INTERVENTION

Infants will receive routine gastric residual evaluation

Interventions

No gastric residual evaluationOTHER

Infants will not receive routine gastric residual evaluation prior to feeding.

no gastric residual evaluation

Eligibility Criteria

AgeUp to 3 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Gestational age less than 32 weeks,
  • Birth weight less than or equal to 1250 grams,
  • Initial feeding tolerated within 48 hours of life

You may not qualify if:

  • Congenital or chromosomal disorders,
  • Severe complications leading to death in the first week of life

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF & Shands Hospital

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Josef Neu, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2013

First Posted

October 18, 2013

Study Start

March 1, 2011

Primary Completion

June 1, 2013

Study Completion

October 1, 2013

Last Updated

October 18, 2013

Record last verified: 2013-10

Locations

US(1)