Frequency of Formula Change Prior to the Accurate Diagnosis of Pyloric Stenosis

August 15, 2018 updated by: Maimonides Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study can be described as a prospective and retrospective study in which information will be gathered from questionnaires, analysis of medical records, and the information obtained from diagnostic procedures (i.e. Laboratory results, ultrasonography). The time of enrollment will be at the time of hospital admission for the study group and the control group. The length of time for which the patient will be involved with the study will coincide with the length of stay in the hospital. This will be a single center trial involving Maimonides Medical center. Approximately 50-100 subjects will be enrolled overall to give the study more credibility.

Methods and Procedures:

1. Study Participants: All patients admitted to Maimonides Medical Center with a diagnosis of pyloric stenosis two to nine weeks of age. Patients will be excluded from the study if there is a diagnosed milk allergy, history of prior abdominal surgery, or history of prematurity or metabolic disease. Controls will be made up of the same age range, with similar exclusion criteria, and will consist of patients admitted for other reasons than listed above, such as bronchiolitis and rule out sepsis.

2: Data: Data will be received through the completion of questionnaire.

3. Data collection and processing: Questionnaire responses will be analyzed and the responses will be statistically analyzed for correlation.

Benefits: Through participation in this study, patients may help future patients diagnosed with pyloric stenosis be brought to the attention of a medical professional.

Risks: With maintenance of confidentiality, risks to participants in this study are negligible.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11219
        • Maimonides Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks to 2 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • infants ages 2-9 weeks

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Both cohorts' feeding habits will be observed and recorded for the purposes of comparison
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
Both cohorts' feeding habits will be observed and recorded for the purposes of comparison

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maimonides Medical Center

Investigators

  • Principal Investigator: Beth Loveridge-Lenza, DO, Maimonides Medical Center
  • Principal Investigator: Maya Greenberg, DO, Maimonides Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2006

Primary Completion (Actual)

December 8, 2008

Study Completion (Actual)

December 8, 2008

Study Registration Dates

First Submitted

December 8, 2006

First Submitted That Met QC Criteria

December 8, 2006

First Posted (Estimate)

December 11, 2006

Study Record Updates

Last Update Posted (Actual)

August 17, 2018

Last Update Submitted That Met QC Criteria

August 15, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06/09/VA03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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