NCT00409734

Brief Summary

The purpose of this study is to determine if there is an increase in the frequency of formula change in patients with pyloric sctenosis prior to being correctly diagnosed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2006

Typical duration for all trials

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

September 28, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 11, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2008

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

2.2 years

First QC Date

December 8, 2006

Last Update Submit

August 15, 2018

Conditions

Keywords

pyloricstenosis

Study Arms (2)

Children with pyloric stenosis

Male or female children age two to nine weeks with history of vomiting and feeding intolerance, and abdominal sonogram showing presence of pyloric stenosis

Behavioral: Children with pyloric stenosis

Children without pyloric stenosis

Male or female children age two to nine weeks without pyloric stenosis admitted to the hospital for other reasons

Behavioral: Children without pyloric stenosis

Interventions

Both cohorts' feeding habits will be observed and recorded for the purposes of comparison

Children with pyloric stenosis

Both cohorts' feeding habits will be observed and recorded for the purposes of comparison

Children without pyloric stenosis

Eligibility Criteria

Age2 Weeks - 9 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Male and female children age 2 weeks to 9 weeks, either with pyloric stenosis or without

You may qualify if:

  • infants ages 2-9 weeks

You may not qualify if:

  • infant not ages 2-9 weeks or patients with history of medical problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Pyloric StenosisConstriction, Pathologic

Condition Hierarchy (Ancestors)

Gastric Outlet ObstructionStomach DiseasesGastrointestinal DiseasesDigestive System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Beth Loveridge-Lenza, DO

    Maimonides Medical Center

    PRINCIPAL INVESTIGATOR
  • Maya Greenberg, DO

    Maimonides Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2006

First Posted

December 11, 2006

Study Start

September 28, 2006

Primary Completion

December 8, 2008

Study Completion

December 8, 2008

Last Updated

August 17, 2018

Record last verified: 2018-08

Locations