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

NCT ID: NCT00409734

Last Updated: 2018-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-09-28

Study Completion Date

2008-12-08

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pyloric Stenosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Children with pyloric stenosis

Intervention Type BEHAVIORAL

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

Children without pyloric stenosis

Intervention Type BEHAVIORAL

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

Interventions

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Children with pyloric stenosis

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

Intervention Type BEHAVIORAL

Children without pyloric stenosis

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* infants ages 2-9 weeks

Exclusion Criteria

* infant not ages 2-9 weeks or patients with history of medical problems
Minimum Eligible Age

2 Weeks

Maximum Eligible Age

9 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maimonides Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beth Loveridge-Lenza, DO

Role: PRINCIPAL_INVESTIGATOR

Maimonides Medical Center

Maya Greenberg, DO

Role: PRINCIPAL_INVESTIGATOR

Maimonides Medical Center

Locations

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Maimonides Medical Center

Brooklyn, New York, United States

Site Status

Countries

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United States

Other Identifiers

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06/09/VA03

Identifier Type: -

Identifier Source: org_study_id

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