NCT01509417

Brief Summary

The objective of this study is to scientifically evaluate the ability to discharge patients based on feeding schedule comparing ad lib feeds to our current scheduled regimen. The hypothesis is that patients may be able to be discharged sooner with ad lib feeds.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

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

July 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2011

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 13, 2012

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

May 29, 2013

Status Verified

May 1, 2013

Enrollment Period

1.5 years

First QC Date

December 14, 2011

Last Update Submit

May 28, 2013

Conditions

Emesis

Keywords

pyloric stenosis

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay

    up to 10 days

Secondary Outcomes (1)

  • number of emeses during stay

    up to 10 days

Study Arms (2)

Ad lib feeding

EXPERIMENTAL

ad lib feedings following pyloromyotomy

Other: ad lib feedings after pyloromyotomyOther: FLAP diet after pyloromyotomy

FLAP diet after pyloromyotomy

ACTIVE COMPARATOR

FLAP diet after pyloromyotomy

Other: FLAP diet after pyloromyotomy

Interventions

ad lib feedings after pyloromyotomyOTHER

ad lib feedings after pyloromyotomy

Also known as: post surgical refeeding ad lib
Ad lib feeding
FLAP diet after pyloromyotomyOTHER

FLAP diet after pyloromyotomy

Also known as: Post surgical FLAP refeeding
Ad lib feedingFLAP diet after pyloromyotomy

Eligibility Criteria

Age1 Day - 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients who are diagnosed with pyloric stenosis and scheduled for laparoscopic pyloromyotomy. -

You may not qualify if:

  • Open procedures
  • Patient has alternative diagnosis that would affect feeding (like mucosal perforation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

VomitingPyloric Stenosis

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsGastric Outlet ObstructionStomach DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Shawn D St. Peter, MD

    Children's Mercy Hospital and Clinics

    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

December 14, 2011

First Posted

January 13, 2012

Study Start

July 1, 2010

Primary Completion

January 1, 2012

Study Completion

February 1, 2012

Last Updated

May 29, 2013

Record last verified: 2013-05

Locations

US(1)